For drugs prepackaged by a pharmac y technician or pharmacy technician trainee, a pharmacist

R4-23-1104. For drugs prepackaged by a pharmac y technician or pharmacy technician trainee, a pharmacist shall: a. Verify the drug to be prepackaged; compen- b. Verify that the label meets the official dium’s standards; c. Check the completed prepackaging procedure an d product; and d. Manually initial the completed label; or e. For automated packaging systems, manually initial com- the completed label or a written log or initial a puter-stored log; 10. Check prescription order data entry to ensure that the dat a input: a. Is for the correct patient by verifying the patient’ s name, address, telephone number, gender, and dat e of birth or age; b. Is for the correct drug by verifying the drug name, strength, and dosage form; c. Communicates the prescriber’s directions precisel y by verifying dose, dosage form, route of administration, dosing frequency, and quantity; and d. Is for the correct medical practitioner by verifyin g the medical practitioner’s name, address, and telephone number; 11. Except as provided in subsection (A)(12), make a final accuracy check of the completed prescription label including verification of medication, accuracy of patient’s name, consistency with prescription order, an d drug utilization review and initial in handwriting or b y another method approved by the Board or its designee th e finished label; 12. If a technology-assisted verification of product program is used, make a final accuracy check of the complete d prescription label including accuracy of patient’s name, consistency with prescription order, and drug utilizatio n review and initial in handwriting or by another metho d approved by the Board or its designee the finished label. If a technology-assisted verification of product program is used, verification of product is not required. 13. Record, or assume responsibility to record, a prescriptio n serial number and date dispensed on the original prescription order; 14. Obtain, or assume responsibility to obtain, permission t o refill a prescription order and record, or assume responsibility to record on the original prescription order: a. Date dispensed, b. Quantity dispensed, and c. Name of medical practitioner or medical practitioner’s agent who communicates permission t o refill the prescription order; March 31, 2026 Supp. Administrative Code 4 A.A.C. 23 AND OCCUPATIONS OF PHARMACY 15. Reduce to written or printed form, or assume responsibility to reduce to written or printed form, a new prescription order received by: a. Fax, b. E-mail, or c. Other means of communication; 16. Verify, or assume responsibility to verify, that a completed prescription medication is sold only to the correct patient, patient’s care-giver, or authorized agent; 17. Record on the original prescription order the name or initials of the pharmacist, graduate intern, or pharmac y intern who originally dispenses the prescription order; and 18. Record on the original prescription order the name or initials of the pharmacist, graduate intern, or pharmac y intern who dispenses each refill. B. Only a pharmacist, graduate intern, or pharmacy intern shall provide oral consultation about a prescription medication to a patient or patient’s care-giver in an outpatient setting, including a patient discharged from a hospital. The oral consultatio n is required whenever the following occurs: 1. The prescription medication has not been previously dispensed to the patient in the same strength or dosage for m or with the same directions; 2. The pharmacist, through the exercise of professional judgment, determines that oral consultation is warranted; or 3. The patient or patient’s care-giver requests oral consultation. C. Oral consultation shall include: 1. Reviewing the name and strength of a prescription medication or name of a prescription-only device and th e labeled indication of use for the prescription medicatio n or prescription-only device; 2. Reviewing the prescription’s directions for use; 3. Reviewing the route of administration; and 4. Providing oral information regarding special instruction s and written information regarding side effects, procedur e for missed doses, or storage requirements. D. When, in the professional judgment of the pharmacist or graduate intern or pharmacy intern under the supervision of a pharmacist, or when circumstance precludes it, oral consultatio n may be omitted if the pharmacist, graduate intern, or pharmac y intern: 1. Personally provides written information to the patient or patient’s care-giver that summarizes the information that would normally be orally communicated; 2. Documents, or assumes responsibility to document, bot h the circumstance and reason for not providing oral consultation by a method approved by the Board or its designee; and 3. Offers the patient or patient’s care-giver the opportunit y to communicate with a pharmacist, graduate intern, or pharmacy intern at a later time and provides a method for the patient or patient’s care-giver to contact a pharmacist, graduate intern, or pharmacy intern at the pharmacy. E. The pharmacist or graduate intern or pharmacy intern under the supervision of a pharmacist, through the exercise of professional judgment, may provide oral consultation that includes: 1. Common severe adverse effects, interactions, or therapeutic contraindications, and the action required if the y occur; 2. Techniques of self-monitoring drug therapy; 26-1 Page 21 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 3. The duration of the drug therapy; and 4. Prescription refill information. F. Nothing in subsection (B) requires a pharmacist, graduat e intern, or pharmacy intern to provide oral consultation if a patient or patient’s care-giver refuses the consultation. phar- G. Using a method approved by the Board or its designee, a macist, graduate intern, or pharmacy intern shall document, or assume responsibility to document, that oral consultation is or is not provided. H. Oral consultation documentation. When oral consultation i s required as specified in subsection (B), a pharmacist, graduat e intern, or pharmacy intern shall: 1. Document, or assume responsibility to document, that oral consultation is provided; or 2. When a patient refuses oral consultation or a person other than the patient or patient’s care-giver picks up a prescription and oral consultation is not provided, document, consulta- or assume responsibility to document, that oral tion is not provided; or 3. When a pharmacist, graduate intern, or pharmacy inter n determines to omit oral consultation under subsection (D) and oral consultation is not provided, document, or assume responsibility to document, both the circumstanc e and reason that oral consultation is not provided; and 4. Document, or assume responsibility to document, th e name, initials, or identification code of the pharmacist, graduate intern, or pharmacy intern who did or did not provide oral consultation. I. When a prescription is delivered to the patient or patient’ s care-giver outside the immediate area of a pharmacy and a pharmacist is not present, the prescription shall be accompanied by written or printed patient medication information that, in addition to the requirements in subsection (C), includes: 1. Approved use for the prescription medication; 2. Possible adverse reactions; 3. Drug-drug, food-drug, or disease-drug interactions; 4. Missed dose information; and 5. Telephone number of the dispensing pharmacy or another method approved by the Board or its designee that allow s a patient or patient’s care-giver to consult with a pharmacist. deliv- J. A prescription medication or prescription-only device, ered to a patient at a location where a licensed health care professional is responsible for administering the prescriptio n medication to the patient, is exempt from the requirement of subsection (C). K. A pharmacist, graduate intern, or pharmacy intern shall wear a badge indicating name and title while on duty. L. Nothing in this Section prevents a hospital pharmacist from accepting a prescription order according to rules pertainin g specifically to hospital pharmacies. Historical Note Former Rule 4.1100; Amended effective August 10, 1978 (Supp. 78-4). Amended effective August 9, 1983 (Supp. 83-4). Amended effective May 16, 1990 (Supp. 90-2). Amended effective July 7, 1998 (Supp. 98-3). Amended by final rulemaking at 6 A.A.R. 4656, effective November 14, 2000 (Supp. 00-4). Amended by final rulemaking at 9 A.A.R. 5030, effective January 3, 2004 (Supp. 03-4). Amended by final rulemaking at 10 A.A.R. 1192, effective May 1, 2004 (Supp. 04-1). Amended by final rulemaking at 11 A.A.R. 2258, effective August 6, 2005 (Supp. 05-2). Amended by final rulemaking at 12 A.A.R. 274, effective March 11, 2006 (Supp. 06-1). Amended by Supp. Administrative Code AND OCCUPATIONS OF PHARMACY final rulemaking at 12 A.A.R. 4691, effective February 3, 2007 (Supp. 06-4). Amended by final rulemaking at 23 A.A.R. 3257, effective January 8, 2018 (Supp. 17-4). R4-23-403. Repealed Historical Note Former Rule 4.1200; Amended effective August 10, 1978 (Supp. 78-4). Amended effective March 28, 1980 (Supp. 80-2). Amended effective August 9, 1983 (Supp. 83-4). Section repealed, new Section adopted effective May 16, 1990 (Supp. 90-2). Amended effective November 1, 1993 (Supp. 93-4). Amended by final rulemaking at 5 A.A.R. 4441, effective November 2, 1999 (Supp. 99-4). Section repealed by final rulemaking at , effective May 1, 2004 (Supp. 04-1). R4-23-404. Unethical Practices A. Rebates prohibited. A pharmacist or pharmacy permittee shall not offer, deliver, receive, or accept any unearned rebate, refund, commission, preference, patronage dividend, discount, or other unearned consideration, whether in the form of mone y or otherwise, as compensation or inducement to refer a patient, client, or customer to any person, except for a rebate or premium paid completely and directly to a patient. A pharmacist or pharmacy permittee shall not: 1. Make payment to a medical practitioner in money or other consideration for a prescription order prescribed b y the medical practitioner; or 2. Make payment to a long-term care or assisted living facility or other health care institution in money, discount, rental, or other consideration in an amount above the prevailing rate for: a. Prescription medication or devices dispensed or sol d for a patient or resident of the facility or institution; or b. Drug selection or drug utilization review services, drug therapy management services, or other pharmacy consultation services provided for a patient or resident of the facility or institution. B. Prescription order-blank advertising prohibited. A pharmacist or pharmacy permittee shall not: 1. Directly or indirectly furnish to a medical practitioner a prescription order-blank that refers to a specific pharmacist or pharmacy in any manner; or 2. Actively or passively participate in any arrangement or agreement where a prescription order-blank is prepared, written, or issued in a manner that refers to a specifi c pharmacist or pharmacy. C. Fraudulent claim for service. A pharmacist or pharmacy permittee shall not claim the performance of a service that th e pharmacist or pharmacy permittee knows or should know wa s not performed, such as, claiming to dispense a prescriptio n medication that is not dispensed. permit- D. Fraudulent claim for a fee. A pharmacist or pharmacy tee: 1. Shall not claim a fee for a service that is not performed or earned; 2. May divide a prescription order into two or more portion s of prescription medication at the request of a patient, or for some other ethical reason, and charge a dispensing fe e for the additional service; and 3. Shall not divide a prescription order merely to obtain a n additional fee. E. Prohibiting a prescription-only drug or device from being dispensed over the counter. A pharmacist shall ensure that: 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 1. A prescription-only drug or device is dispensed only after receipt of a valid prescription order from a licensed medical practitioner; 2. The dispensed prescription-only drug or device is properly prepared, packaged, and labeled according to thi s Chapter; and 3. The prescription order is filed according to this Chapter. F. Drugs dispensed in the course of the conduct of a business of dispensing drugs through diagnosis by mail or the internet. 1. A pharmacist shall not dispense a drug from a prescription order if the pharmacist has knowledge, or reasonabl y prescrip- should know under the circumstances, that the tion order was issued on the basis of an internet-base d questionnaire or an internet-based consultation without a medical practitioner-patient relationship as defined in R4- 23-110. 2. A pharmacist who dispenses a prescription-only drug, viola- prescription-only device, or controlled substance in tion of this Section is engaging in unethical conduct i n violation of A.R.S. § 32-1901.01. Historical Note Former Rules 4.2110, 4.2120, 4.2130, 4.2210, 4.2230, 4.2400, 4.2500, 4.2600, 4.4100, 4.4200, 4.4310, 4.4320, 4.4400, and 4.4500; Amended effective August 10, 1978 (Supp. 78-4); Amended subsection (I) effective August 9, 1983 (Supp. 83-4). Amended by deleting subsections (H) through (M) effective November 18, 1983 (Supp. 83-6). Amended by final rulemaking at 8 A.A.R. 1256, effective March 7, 2002 (Supp. 02-1). Amended by final rulemaking at 14 A.A.R. 3405, effective October 4, 2008 (Supp. 08-3). R4-23-405. Change of Responsibility A pharmacist designated as the pharmacist-in-charge for a pharmacy, manufacturer, or other establishment shall give immediat e notice, as defined in R4-23-110, when: 1. The pharmacist’s responsibility as a pharmacist-in-charg e is terminated; or 2. The pharmacist knows of a pending termination of th e pharmacist’s responsibility as the pharmacist-in-charge. Historical Note Former Rules 4.5100 and 4.5200; Amended effective August 9, 1983 (Supp. 83-4). Amended effective February 8, 1991 (Supp. 91-1). Amended effective November 1, 1993 (Supp. 93-4). Amended by final rulemaking at 8 A.A.R. 1256, effective March 7, 2002 (Supp. 02-1). R4-23-406. Repealed Historical Note Adopted as an emergency effective January 10, 1979, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 79-1). Amended as an emergency effective April 2, 1979, pursuant to A.R.S. § 41-1003, valid for only 90 days. Adopted effective April 10, 1979 (Supp. 79-1). Former Section R4-23-406 repealed, new Section R4-23-406 adopted effective August 9, 1983 (Supp. 83-4). Amended effective April 1, 1995; filed with the Secretary of State January 31, 1995 (Supp. 95-1). Amended by final rulemaking at , effective March 7, 2002 (Supp. 02-1). Section repealed by final rulemaking at 10 A.A.R. 230, effective March 6, 2004 (Supp. 04-1). R4-23-407. Prescription Requirements A. Prescription orders. A pharmacist shall ensure that: March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY 1. A prescription order the pharmacist uses to dispense a drug or device includes the following information: a. Date of issuance; b. Name and address of the patient for whom or th e owner of the animal for which the drug or device i s dispensed; c. Drug name, strength, and dosage form or devic e name; d. Name of the manufacturer or distributor of the dru g or device if the prescription order is written generically or a substitution is made; e. Prescribing medical practitioner’s directions for use; f. Date of dispensing; g. Quantity prescribed and if different, quantity dispensed; h. For a prescription order for a controlled substance, the medical practitioner’s address and DEA number; practi- i. For a written prescription order, the medical tioner’s signature; j. For an electronically transmitted prescription order, signa- the medical practitioner’s digital or electronic ture; k. For an oral prescription order, the medical practitioner’s name and telephone number; and l. Name or initials of the dispensing pharmacist; 2. A prescription order is kept by the pharmacist or pharmacy permittee as a record of the dispensing of a drug or device for seven years from the date the drug or device i s dispensed; 3. The dispensing of a drug or device complies with th e packaging requirements of the official compendium an d state and federal law; and 4. If the drug dispensed is a schedule II controlled substanc e that is an opioid, the drug is placed in a container that ha s a red cap and a warning label stating “CAUTION: OPI- OID, Risk of Overdose and Addiction” or other similarl y clear language indicating the possibility of overdose an d addiction. Under delegation from the Board, the Execuimple- tive Director may waive the red-cap requirement if menting the requirement is not feasible because of th e specific dosage form or packaging type. follow- B. Prescription refills. A pharmacist shall ensure that the ing information is recorded on the back of a prescription order when it is refilled: 1. Date refilled, 2. Quantity dispensed, 3. Name or approved abbreviation of the manufacturer or distributor if the prescription order is written genericall y or a substitution is made, and 4. The name or initials of the dispensing pharmacist. C. Prescription order adaptation. Except for a prescription order for a controlled substance, a pharmacist, using professional judgment, may make the following adaptations to a prescription order if the pharmacist documents the adaptation in th e patient’s record: 1. Change the prescribed quantity if the prescribed quantit y is not a package size commercially available from th e manufacturer; 2. Change the prescribed dosage form or directions for us e medi- if the change achieves the intent of the prescribing cal practitioner; 3. Complete missing information on the prescription order if there is sufficient evidence to support the change; and 26-1 Page 23 Arizona Administrative TITLE 4. PROFESSIONS AND CHAPTER 23. BOARD OF 4. Extend the quantity of a maintenance drug for the limite d quantity necessary to achieve medication refill synchronization for the patient. D. A pharmacist may furnish a copy of a prescription order to th e patient for whom it is prescribed or to the authorized representative of the patient if the copy is clearly marked “COPY FOR REFERENCE PURPOSES ONLY” or other similar statement. A copy of a prescription order is not a valid prescription order and a pharmacist shall not dispense a drug or device from th e information on a copy. E. Transfer of prescription order information. For a transfer of permit- prescription order information to be valid, a pharmacy tee or pharmacist-in-charge shall ensure that: 1. Both the original and the transferred prescription order are maintained for seven years after the last dispensin g date; 2. The original prescription order information for a Schedule III, IV, or V controlled substance is transferred only a s specified in 21 CFR 1306.25; 3. The original prescription order information for a nonlimita- controlled substance drug is transferred without tion only up to the number of originally authorized refills; 4. For a transfer within Arizona: informa- a. The transfer of original prescription order tion for a non-controlled substance drug meets th e following conditions: i. The transfer of information is communicate d electronically, verbally, or by fax directl y between: (1) Two licensed pharmacists, (2) A licensed pharmacist and a license d intern, or (3) Two licensed interns; ii. The following information is recorded by th e transferring pharmacist or intern: (1) The word “void” is written on the face of the invalidated original prescription unles s it is an electronic or oral transfer and th e transferred prescription order informatio n is invalidated in the transferring pharmacy’s computer system; and num- (2) The name and identification code, ber, or address and telephone number of the pharmacy to which the prescription i s 5. transferred, the name of the receivin g pharmacist or intern, the date of transfer, and the name of the transferring pharmacist or intern is written on the back of th e prescription or entered into the transferring pharmacy’s computer system; and iii. The following information is recorded by th e receiving pharmacist or intern on the transferred prescription order: 6. (1) The word “transfer;” (2) Date of issuance of the original prescription order; (3) Original number of refills authorized o n the original prescription order; (4) Date of original dispensing; (5) Number of valid refills remaining and th e date of the last refill; (6) Name and identification code, number, or address, telephone number, and original prescription number of the pharmacy from Supp. 26-1 Code OCCUPATIONS PHARMACY which the prescription is transferred; (7) Name of the transferring pharmacist or intern; and (8) Name of the receiving pharmacist or intern; informa- b. The transfer of original prescription order tion for a Schedule III, IV, or V controlled substanc e meets the following conditions: i. The transfer of information is communicate d directly between two licensed pharmacists or interns electronically or verbally; ii. The following information is recorded by th e transferring pharmacist or intern: (1) The word “void” is written on the face of the invalidated original prescription order unless it is an electronic or oral transfer and the transferred prescription order transfer- information is invalidated in the ring pharmacy’s computer system; and (2) The name, address, and DEA number of the pharmacy to which the prescription i s transferred, the name of the receivin g pharmacist, the date of transfer, and th e name of the transferring pharmacist i s written on the back of the prescriptio n order or entered into the transferring pharmacy’s computer system; and iii. The following information is recorded by th e receiving pharmacist on the transferred prescription order: (1) The word “transfer;” (2) Date of issuance of original prescriptio n order; (3) Original number of refills authorized o n the original prescription order; (4) Date of original dispensing; (5) Number of valid refills remaining and th e date of the last refill; (6) Name, address, DEA number, and original prescription number of the pharmacy fro m which the prescription is transferred; (7) Name of the transferring pharmacist; and (8) Name of the receiving pharmacist; For a transfer from out-of-state: informa- a. The transfer of original prescription order tion for a non-controlled substance drug meets th e conditions in subsections (E)(4)(a)(i) an d (E)(4)(a)(iii); and b. The transfer of original prescription order information for a Schedule III, IV, or V controlled substanc e meets the conditions in subsections (E)(4)(b)(i) an d (E)(4)(b)(iii); and For an electronic transfer, the electronic transfer of original prescription order information meets the followin g conditions: a. The electronic transfer is between pharmacie s owned by the same company using a common or shared database; b. The electronic transfer of original prescription order information for a non-controlled substance drug i s performed by a pharmacist or intern, pharmacy technician trainee, or pharmacy technician under th e supervision of a pharmacist; Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD c. The electronic transfer of original prescription order information for a controlled substance is performe d between two licensed pharmacists; d. The electronic transfer of original prescription order information for a non-controlled substance dru g meets the following conditions: i. The transferring pharmacy’s computer system: (1) Invalidates the transferred original prescription order information; (2) Records the identification code, number, or address of the pharmacy to which th e trans- prescription order information is ferred; (3) Records the name or identification code of the receiving pharmacist, intern, pharmac y technician trainee, or pharmacy technician; and (4) Records the date of transfer; and ii. The receiving pharmacy’s computer system; (1) Records that a prescription transfer occurred; (2) Records the date of issuance of the original prescription order; (3) Records the original number of refill s authorized on the original prescriptio n order; (4) Records the date of original dispensing; (5) Records the number of valid refill s remaining and the date of the last refill; (6) Records the identification code, number, or address and original prescription number of the pharmacy from which the prescription is transferred; (7) Records the name or identification code of the receiving pharmacist or intern, pharmacy technician trainee, or pharmac y technician; and (8) Records the date of transfer; e. The electronic transfer of original prescription order information for a controlled substance meets the following conditions: i. The transferring pharmacy’s computer system: (1) Invalidates the transferred original prescription order information; (2) Records the identification code, number, or address, and DEA number of the pharmacy to which the prescription order information is transferred; (3) Records the name or identification code of the receiving pharmacist; (4) Records the date of transfer; and (5) Records the name or identification code of the transferring pharmacist; and ii. The electronic prescription order informatio n received by the computer system of the receiving pharmacy includes the information require d in subsection (E)(4)(b)(iii); and f. In addition to electronic documentation of a transferred prescription order in the computer system, a n require- original prescription order containing the ments of this Section is filed in compliance wit h A.R.S. § 32-1964. practi- F. Transmission of a prescription order from a medical tioner to a pharmacy by fax. March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY 1. A medical practitioner or medical practitioner’s agent may transmit a prescription order for a Schedule III, IV, non- or V controlled substance, prescription-only drug, or prescription drug to a pharmacy by fax under the following conditions: a. The prescription order is faxed only to the pharmac y of the patient’s choice; b. The faxed prescription order: pre- i. Contains all the information required for a scription order in A.R.S. §§ 32-1968 and 36- 2525; and ii. Is only faxed from the medical practitioner’ s practice location, except that a nurse in a hospital, long-term care facility, or inpatient hospic e may send a fax of a prescription order for a patient of the facility; and c. The faxed prescription order shall contain the following additional information: i. The date the prescription order is faxed; ii. The fax number of the prescribing medical pre- practitioner or the facility from which the scription order is faxed, and the telephone number of the facility; and iii. The name of the person who transmits the fax, if other than the medical practitioner. 2. A medical practitioner or medical practitioner’s agent may fax a prescription order for a Schedule II controlle d substance for information purposes only, unless the faxe d prescription order meets the requirements of A.R.S. § 36- 2525(F) and (G). 3. A pharmacy may receive a faxed prescription order for a Schedule II controlled substance for information pur- Sched- poses only, except a faxed prescription order for a ule II controlled substance that meets the requirements of A.R.S. § 36-2525(F) and (G) may serve as the original written prescription order. 4. To meet the seven-year record retention requirement of A.R.S. § 32-1964, a pharmacy shall receive a faxed prescription order on plain paper or may make a photocop y of the faxed prescription order. 5. A medical practitioner or the medical practitioner’s agent may fax refill authorizations to a pharmacy if the faxe d authorization includes the medical practitioner’s telephone and fax numbers, the medical practitioner’s signature or medical practitioner’s agent’s name, and date of authorization. G. Electronic transmission of a prescription order from a medical practitioner to a pharmacy. 1. Unless otherwise prohibited by law, a medical practitioner or medical practitioner’s agent may transmit a prescription order by electronic means, directly or throug h an intermediary, including an E-prescribing network, t o the dispensing pharmacy as specified in A.R.S. § 32- 1968. 2. For electronic transmission of a Schedule II, III, IV, or V controlled substance prescription order, the medical praccom- titioner and pharmacy shall ensure the transmission plies with any security or other requirements of federal law. 3. The medical practitioner and pharmacy shall ensure all electronic transmissions comply with all the securit y requirements of state or federal law related to the privac y of protected health information. 26-1 Page 25 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 4. In addition to the information required to be included on a prescription order as specified in A.R.S. § 32-1968, a trans- medical practitioner shall ensure an electronically mitted prescription order includes: a. The date of transmission; and b. If the individual transmitting the prescription is not the medical practitioner, the name of the medical practitioner’s authorized agent who transmits th e prescription order. 5. A pharmacy receiving an electronically transmitted prescription order shall maintain the prescription order a s specified in A.R.S. § 32-1964 or R4-23-408(H)(2). 6. A medical practitioner or medical practitioner’s agent shall transmit an electronic prescription order only to th e pharmacy of the patient’s choice. H. Exceptions under A.R.S. § 36-2525 regarding electronic prescribing requirements: 1. Medical practitioner exceptions. A medical practitioner who is authorized to prescribe a controlled substance ma y furnish a written prescription order is accordance wit h pre- R4-23-407 rather than an electronically transmitted scription order if the prescription order is written: a. In this state to be filled in a jurisdiction outside thi s state; b. For a medication that requires compounding two or more ingredients; c. For a medication that is not in the E-prescribin g database; d. For an individual who is detained by or in custody of an Arizona or federal law enforcement agency; or e. Under A.R.S. § 36-2525(N) or (O); and 2. Pharmacist exceptions. A pharmacist may dispense a electroni- controlled substance from a written rather than cally transmitted prescription order if the prescriptio n order: a. Is written by a medical practitioner who is not licensed in this state but rather, is licensed in a jurisdiction outside this state. The pharmacist is not required to verify whether the medical practitioner i s licensed; b. Is written for a medication that requires compounding two or more ingredients; c. Is written for a medication that is not in the E-prescribing database; d. Is written for an individual who is detained by or i n custody of an Arizona or federal law enforcement agency; or e. Is received under A.R.S. § 36-2525(D). Historical Note Adopted effective November 18, 1983 (Supp. 83-6). Amended by final rulemaking at , effective rulemak- March 7, 2002 (Supp. 02-1). Amended by final ing at , effective May 1, 2004 (Supp. 04- 1). Amended by final rulemaking at 13 A.A.R. 440, effective April 7, 2007 (Supp. 07-1). Amended by final rulemaking at 14 A.A.R. 3605, effective November 8, 2008 (Supp. 08-3). Amended by final rulemaking at 25 A.A.R. 1015, effective June 1, 2019 (Supp. 19-2). Amended by final rulemaking at 26 A.A.R. 223, effective March 14, 2020; and amended by final rulemaking at 26 A.A.R. 544, with an immediate effective date of March 3, 2020 (Supp. 20-1). R4-23-407.1. Dispensing an Opioid Antagonist Supp. Administrative Code AND OCCUPATIONS OF PHARMACY A. As used in this Section: 1. “Community member” means any person in position t o assist an individual at risk of experiencing an opioidrelated overdose. This includes emergency first responders, peace officers or other law enforcement personnel, fire department personnel, school district employees, an d personnel of a facility or center that provides services t o individuals at risk of experiencing an opioid-related overdose. 2. “Opioid antagonist” means any drug approved by th e U.S. Food and Drug Administration that binds to opioi d receptors, effectively blocking or inhibiting the receptor and preventing the body from responding to the opioid. Naloxone hydrochloride is an opioid antagonist. 3. “Opioid-related overdose” means an acute conditio n caused by excessive opioids. An opioid-related overdos e can be identified by a triad of symptoms: decreased level depres- of consciousness, pinpoint pupils, and respiratory sion. Other symptoms may include seizures, muscl e spasms, and coma or death. An opioid-related overdos e requires medical assistance. B. When dispensing an opioid antagonist under A.R.S. § 32- 1979, a pharmacist or pharmacy intern shall provide the folantago- lowing education to the individual to whom the opioid nist is dispensed: 1. How to prevent an opioid-related overdose; 2. How to recognize an opioid-related overdose; 3. How to administer an opioid antagonist safely to an individual experiencing an opioid-related overdose; 4. Precautions regarding: a. Potential side effects, and b. Possible adverse events associated with administration of the opioid antagonist; and 5. Importance of seeking emergency medical assistance for the individual experiencing an opioid-related overdos e before or after administering the opioid antagonist. C. Before dispensing an opioid antagonist under A.R.S. § 32- 1979(A), a licensed pharmacist shall complete an opioid prefol- vention and treatment training program that includes the lowing information: 1. How to recognize the symptoms of an opioid-relate d overdose, 2. How to respond to a suspected opioid-related overdose, 3. How to administer all preparations of an opioid antagonist, and 4. The information needed by an individual to whom an opioid antagonist is dispensed. D. A pharmacist who has completed an opioid prevention an d treatment training program described in subsection (C): 1. May administer an opioid antagonist to an individual th e pharmacist believes is experiencing an opioid-relate d overdose, and 2. Is exempt from civil liability under the terms of A.R.S. § 36-2267(B). E. Dispensing an opioid antagonist under A.R.S. § 32-1979 b y invoice to a community member is not wholesale distributio n as defined at A.R.S. § 32-1981. F. When dispensing an opioid antagonist on a standing order, a s defined under A.R.S. § 32-1968, a pharmacist or pharmac y intern shall comply with R4-23-407 except subsectio n (A)(1)(b), R4-23-408, and R4-23-409. Historical Note New Section made by emergency rulemaking at 23 A.A.R. 31, effective December 15, 2016 for 180 days 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD (Supp. 16-4). New Section made by final rulemaking before emergency expired at 23 A.A.R. 967, effective June 3, 2017 (Supp. 17-2). Amended by final rulemaking at 25 A.A.R. 1015, effective June 1, 2019 (Supp. 19-2). R4-23-407.2. Dispensing a Self-administered Hormonal Contraceptive A. Standard procedures. The first time a pharmacist dispenses a self-administered hormonal contraceptive under a standin g prescription order, as authorized under A.R.S. § 32-1979.01, t o a patient, the pharmacist shall: 1. Determine the patient is at least 18 years old; 2. Obtain from the patient a completed self-screening ris k assessment based on nationally recognized guidelines; 3. Provide the patient with written information prepared b y the manufacturer of the hormonal contraceptive; and 4. Provide the following information orally to the patient: a. How hormonal contraception works; hor- b. When and how to take the self-administered monal contraceptive; c. Risks associated with taking a self-administered hormonal contraceptive; and d. When to seek medical assistance while taking a selfadministered hormonal contraceptive. B. A pharmacist who dispenses a self-administered hormonal contraceptive under a standing prescription order shall have a patient complete the self-screening risk assessment based o n nationally recognized guidelines, required under subsectio n (A)(2), annually. C. A pharmacist who dispenses a self-administered hormonal main- contraceptive under a standing prescription order shall tain evidence of the patient’s age at the time of initial dispensing and the completed nationally recognized self-screenin g risk assessment for at least seven years. The pharmacist shall ensure this information is readily retrievable and available t o the Board on request. D. When dispensing a self-administered hormonal contraceptiv e under a standing prescription order, a pharmacist shall compl y with R4-23-407 except subsection (A)(1)(b), R4-23-408, an d R4-23-409. E. During each biennial renewal period, a pharmacist who dispenses self-administered hormonal contraceptives under a standing prescription order shall complete the three contact hours of continuing education specified under R4-23- 204(A)(2)(c). Historical Note New Section made by final rulemaking 29 A.A.R. 1655 (July 28, 2023) with an immediate effective date of July 5, 2023 (Supp. 23-3). R4-23-408. Computer Records A. Systems manual. A pharmacy permittee or pharmacist-incharge shall: pro- 1. Develop, implement, and comply with policies and cedures for the following operational aspects of a computer system: a. Examples of all output documentation provided b y the computer system that contains original or refill prescription order or patient profile information; com- b. Steps a pharmacy employee follows when the puter system is not operational due to scheduled or unscheduled system interruption; c. Regular and routine backup file procedure and fil e maintenance, including secure storage of backu p files; March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY d. Audit procedures, personnel code assignments, an d personnel responsibilities; and valida- e. Quality assurance mechanism for data entry tion; 2. Review biennially and, if necessary, revise the policie s and procedures required under this Section; 3. Document the review required under subsection (A)(2); 4. Assemble the policies and procedures as a written manual desig- or by another method approved by the Board or its nee; and 5. Make the policies and procedures available within th e pharmacy for reference by pharmacy personnel an d inspection by the Board or its designee. B. Computer system data storage and retrieval. A pharmacy persys- mittee or pharmacist-in-charge shall ensure the computer tem is capable of: 1. Producing sight-readable information on all original an d refill prescription orders and patient profiles; 2. Providing online retrieval (via CRT display or hard-cop y printout) of original prescription order informatio n required in A.R.S. § 32-1968(C), R4-23-402(A), and R4- 23-407(A); 3. Providing online retrieval (via CRT display or hard-cop y printout) of patient profile information required in R4-23- 402(A); 4. Providing documentation identifying the pharmacist prescrip- responsible for dispensing each original or refill tion order, except a pharmacy permittee with a computer system that is in use before the effective date of this Section that cannot provide documentation identifying th e dispensing pharmacist may continue to use the computer system by providing manual documentation identifyin g the dispensing pharmacist; 5. Producing a printout of all prescription order information, including a single-drug usage report that contains: a. The name of the prescribing medical practitioner; b. The name and address of the patient; c. The quantity dispensed on each original or refill prescription order; d. The date of dispensing for each original or refill prescription order; e. The name or identification code of the dispensin g pharmacist; and f. The serial number of each prescription order; and infor- 6. Providing a printout of requested prescription order mation to an individual pharmacy within 72 hours of th e request if prescription order information is maintained i n a centralized computer record system. C. A pharmacy permittee or pharmacist-in-charge of a pharmac y that uses a pharmacy computer system: orig- 1. Shall notify the D.E.A. and the Board in writing that inal and refill prescription order information and patient profiles are stored in a pharmacy computer system; 2. Shall comply with this Section if the pharmacy computer system’s refill records are used as an alternative to th e manual refill records required in R4-23-407(B); require- 3. Is exempt from the manual refill recordkeeping ments of R4-23-407(B), if the pharmacy computer system complies with the requirements of this Section; and origi- 4. Shall ensure that documentation of the accuracy of nal and refill prescription order information entered into a computer system is provided by each pharmacist usin g the computer system and kept on file in the pharmacy for 26-1 Page 27 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD seven years from the date of the last refill. Documentation includes one of the following: a. A hard-copy printout of each day’s original and refill prescription order data that: i. States original and refill data for prescription s dispensed by each pharmacist is reviewed for accuracy; ii. Includes the printed name of each dispensin g pharmacist; and iii. Is signed and initialed by each dispensing pharmacist; or b. A log book or separate file of daily statements that: i. States original and refill data for prescription s dispensed by each pharmacist is reviewed for accuracy; ii. Includes the printed name of each dispensin g pharmacist; and phar- iii. Is signed and initialed by each dispensing macist. D. If a pharmacy computer system does not comply with th e requirements of subsections (A), (B), and (F), the pharmac y permittee or pharmacist-in-charge shall bring the computer system into compliance within three months of a notice of noncompliance or violation letter. If the computer system i s still noncompliant with subsection (A), (B), or (F) after thre e months, the pharmacy permittee or pharmacist-in-charge shall require- immediately comply with the manual recordkeeping ments of R4-23-402 and R4-23-407. E. If a pharmacy’s personnel perform manual recordkeepin g under subsection (D), the pharmacy’s personnel shall continu e manual recordkeeping until the pharmacist-in-charge send s proof, verified by a Board compliance officer, that the computer system complies with subsections (A), (B), and (F). F. Security. To maintain the confidentiality of patient records, a pharmacy permittee or pharmacist-in-charge shall ensure: safe- 1. The computer system has security and systems guards designed to prevent and detect unauthorize d access, modification, or manipulation of prescriptio n order information and patient profiles; and 2. After a prescription order is dispensed, any alteration of prescription order information is documented, includin g the identification of the pharmacist responsible for th e alteration. G. A computer system that does not comply with all the requirephar- ments of subsections (A), (B), and (F) may be used in a macy if: 1. The computer system was in use in the pharmacy befor e July 11, 2001, and 2. The pharmacy complies with the manual recordkeepin g requirements of R4-23-402 and R4-23-407. H. Prescription records and retention. 1. Instead of filing the original hard-copy prescription order as required in A.R.S. § 32-1964, a pharmacy permittee or pharmacist-in-charge may use an electronic imagin g recordkeeping system, if: a. The system is capable of capturing, storing, an d reproducing the exact image of a prescription order, including the reverse side of the prescription order if necessary; pre- b. Any notes of clarification of or alterations to a scription order are directly associated with the electronic image of the prescription order; c. A prescription order image and any associated note s of clarification of or alterations to the prescriptio n Supp. Administrative Code AND OCCUPATIONS OF PHARMACY order are retained for no fewer than seven year s from the date the prescription order is last dispensed; d. Policies and procedures for the use of an electroni c imaging recordkeeping system are developed, implemented, reviewed, and revised in the sam e manner described in subsection (A) and complie d with; and e. The prescription is not for a controlled substance. 2. If a pharmacy’s computer system fields are automaticall y populated by an electronically transmitted prescriptio n order, the automated record constitutes the original prescription order and a hard-copy or electronic image is not required if the computer system is capable of maintaining, printing, and providing all the prescription order information required in A.R.S. §§ 32-1968 and 36-252 5 and R4-23-407(A) within 72 hours of a request by th e Board, the Board’s compliance officers, other authorize d regulatory board agents, or authorized officers of the law. I. A pharmacy permittee or pharmacist-in-charge shall make all prescription records available within 72 hours after a Boar d request. Historical Note Adopted effective November 18, 1983 (Supp. 83-6). Amended by final rulemaking at 7 A.A.R. 646, effective January 11, 2001 (Supp. 01-1). Amended by final rulemaking at 9 A.A.R. 5030, effective January 3, 2004 (Supp. 03-4). Amended by final rulemaking at 11 A.A.R. 4270, effective December 6, 2005 (Supp. 05-4). Amended by final rulemaking at 12 A.A.R. 274, effective March 11, 2006 (Supp. 06-1). Amended by final rulemaking at 12 A.A.R. 3032, effective October 1, 2006 (Supp. 06-3). Amended by final rulemaking at 13 A.A.R. 440, effective April 7, 2007 (Supp. 07-1). Amended by final rulemaking at , effective March 14, 2020 (Supp. 20-1). R4-23-409. Returning Drugs and Devices A. After a person for whom a drug is prescribed or the person’ s agent takes the drug from the premises where sold, distributed, or dispensed, a pharmacist or pharmacy permittee shall not accept the drug for return or exchange for the purpose of resal e unless the pharmacist determines that: 1. The drug is in its original, manufacturer’s, unopened container; and 2. The drug or its container has not been subjected to contamination or deterioration. B. The provisions of subsection (A) of this Section do not appl y to a drug dispensed to: 1. A hospital inpatient as defined in R4-23-651; or 2. A resident of a long-term care facility where a license d health care professional administers the drug, and th e pharmacist ensures and documents that the drug: require- a. Has been stored in compliance with the ments of the official compendium; and b. Is not obviously contaminated or deteriorated. C. After a person for whom a device is prescribed or the person’ s agent takes the device from the premises where sold, distributed, or dispensed, a pharmacist or pharmacy permittee shall not accept the device for return or exchange for the purpose of resale or reuse unless the pharmacist determines that: 1. The device is inspected and is free of defects; 2. The device is rendered incapable of transferring disease; and 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 3. The device, if resold or reused, is not claimed to be new or unused. Historical Note Adopted effective November 18, 1983 (Supp. 83-6). Amended by final rulemaking at , effective March 7, 2002 (Supp. 02-1). R4-23-410. Current Good Compounding Practices A. This Section establishes the current good compounding practices to be used by a pharmacist licensed by the Board, in a pharmacy permitted by the Board, and in compliance wit h applicable federal and state law governing the practice of pharmacy. provi- B. A pharmacy permittee shall ensure compliance with the sions in this subsection. 1. All substances for compounding that are received, stored, or used by the pharmacy permittee: a. Meet official compendium requirements; b. Are of high quality, such as Chemically Pure (CP), Chem- Analytical Reagent (AR), certified American ical Society (ACS), or Food Chemical Codex (FCC ) grade; or c. Are obtained from a source that, in the professional judgment of the pharmacist, is acceptable and reliable. 2. Before compounding a pharmaceutical product in exces s of the quantity dispensed in anticipation of receivin g valid prescriptions for the pharmaceutical product, a pharmacist, employed by the pharmacy permittee, shall establish a history of compounding valid prescriptions for the pharmaceutical product. 3. Neither the pharmacy permittee nor a pharmacist employed by the pharmacy permittee provides a compounded pharmaceutical product to a pharmacy, medical practitioner, or other person for dispensing or distributin g except that a compounded pharmaceutical product ma y be provided to a medical practitioner to administer to a patient of the medical practitioner if each container i s accompanied by the written list required in subsectio n (I)(5) and has a label that includes the following: num- a. The pharmacy’s name, address, and telephone ber; b. The pharmaceutical product’s name and the information required in subsection (I)(4); c. A lot or control number; d. A beyond-use-date based upon the pharmacist’s professional judgment, but not more than the maximum guidelines recommended in the Pharmacy Compounding Practices chapter of the official compendium unless there is published or unpublishe d stability test data that shows a longer period i s appropriate; e. The statement “Not For Dispensing;” and f. The statement “For Office or Hospital Administration Only.” 4. A pharmacy or pharmacist may advertise or otherwis e promote the fact that the pharmacy or pharmacist provides prescription compounding services. orga- C. A pharmacy permittee shall ensure compliance with the nization, training, and personnel issues in this subsection. 1. Before dispensing a compounded pharmaceutical product, a pharmacist: a. Inspects and approves or rejects, or assumes responsibility for inspecting and approving or rejecting, March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY components, pharmaceutical product containers an d closures, in-process materials, and labeling; b. Prepares or assumes responsibility for preparing all compounding records; c. Reviews all compounding records to ensure that n o errors occur in the compounding process; d. Ensures the proper use, cleanliness, and maintenance of all compounding equipment; and e. Documents by hand-written initials or signature i n the compounding record the completion of th e requirements of subsections (C)(1)(a), (b), (c), an d (d). 2. A pharmacist engaged in compounding: a. Complies with the current good compounding practices and applicable state pharmacy laws; b. Maintains compounding proficiency through current awareness, training, and continuing education; and c. Ensures that personnel engaged in compoundin g wear: i. Clean clothing appropriate to the work performed; and ii. Protective apparel, such as coats, aprons, gowns, gloves or masks to protect the personphar- nel from chemical exposure and prevent maceutical product contamination. D. A pharmacy permittee shall ensure the security, safety, an d conform- quality of a compounded pharmaceutical product by ing with the following standards: 1. Implement procedures to exclude from direct contact with components, pharmaceutical product containers an d closures, in-process materials, labeling, and pharmaceutical products, any person with an apparent illness or ope n lesion that may adversely affect the safety or quality of a compounded pharmaceutical product, until the illness or lesion, as determined by competent medical personnel, does not jeopardize the safety or quality of a compounde d pharmaceutical product; and 2. Require all personnel to inform a pharmacist of an y health condition that may adversely affect a compounde d pharmaceutical product. E. A pharmacy permittee shall provide compounding facilitie s that conform with the standards in this subsection. 1. In addition to the minimum area requirements of R4-23- 609, R4-23-655, or R4-23-673, the compounding area: a. Complies with the requirements in R4-23-611; and b. Has sufficient space to permit efficient pharmac y practice, free movement of personnel, and visual surveillance by a pharmacist. 2. If sterile pharmaceutical product or radiopharmaceutical product compounding is performed, the compoundin g area complies with the requirements of R4-23-670, R4- 23-681, and R4-23-682. 3. A clean, dry, and temperature-controlled area and, if required, a refrigerated area, in which to store properl y labeled containers of bulk drugs, chemicals, and material s used in compounding, that complies with state statute s and rules. F. To protect pharmaceutical product safety, identity, strength, quality, and purity, a pharmacy permittee shall ensure that com- equipment and utensils used in pharmaceutical product pounding are: 1. Of appropriate design, adequate size, and suitably locate d for proper operation, cleaning, and maintenance; 26-1 Page 29 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 2. Made of material that is not reactive, additive, or absorptive when exposed to components, in-process materials, or pharmaceutical products; 3. Cleaned and protected from contamination before use; 4. Inspected and determined suitable for use before initiation of compounding operations; and 5. Routinely inspected, calibrated, or checked to mak e proper performance certain. G. A pharmacy permittee shall ensure that the pharmacist-incharge establishes, implements, and complies with procedure s to prevent cross-contamination when pharmaceutical product s cross-contamina- that require special precautions to prevent tion, such as penicillin, are used in a compounding procedure. The procedures shall include either the dedication of equipment or the meticulous cleaning of contaminated equipment before its use in compounding other pharmaceutical products. H. A pharmacy permittee shall ensure that the pharmacist-incharge establishes, implements, and complies with control procedures for components and pharmaceutical product containers and closures, either written or electronically store d with printable documentation, that conform with the standard s in this subsection. 1. Components and pharmaceutical product containers an d closures are: a. Stored off the floor, b. Handled and stored to prevent contamination, and c. Rotated so the oldest approved stock is used first. 2. Container closure systems comply with official compendium standards. 3. Pharmaceutical product containers and closures are clea n and made of material that is not reactive, additive, or absorptive. I. A pharmacy permittee shall ensure that the pharmacist-incharge establishes, implements, and complies with pharmaceutical product compounding controls that conform with th e standards in this subsection. 1. Pharmaceutical product compounding procedures ar e available in either written form or electronically store d with printable documentation: a. To ensure that a finished pharmaceutical product ha s the identity, strength, quality, and purity it is purported or represented to possess, the procedure s include, for each pharmaceutical product compounded, a description of: num- i. The components, their manufacturer, lot ber, expiration date, and amounts, the order of component addition, if applicable, and the compounding process; ii. The equipment and utensils used; and iii. The pharmaceutical product container and closure system proper for the sterility and stabilit y of the pharmaceutical product as it is intende d to be used. com- b. To test the pharmaceutical product being pounded, the procedures monitor the output and validate the performance of compounding processe s pharmaceuti- that may cause variability in the final cal product, including assessing: i. Dosage form weight variation; ii. Adequacy of mixing to ensure uniformity an d homogeneity; and iii. Clarity, completeness, and pH of solutions, if applicable. Supp. Administrative Code AND OCCUPATIONS OF PHARMACY 2. Components for pharmaceutical product compoundin g are accurately weighed, measured, or subdivided. T o cor- ensure that each weight, measure, or subdivision is rect as stated in the compounding procedures, a pharmacist: a. Checks and rechecks, or assumes responsibility for checking and re-checking, the operations at eac h stage of the compounding process; and b. Documents by hand-written initials or signature th e completion and accuracy of the compounding process. 3. Compounding equipment and utensils are properl y cleaned and maintained. 4. In addition to the labeling requirements of A.R.S. § 32- 1968(D), the label contains: a. A statement, symbol, designation, or abbreviatio n that the pharmaceutical product is a compounde d pharmaceutical product, and b. A beyond-use-date as specified in subsectio n (B)(3)(d). prod- 5. A written list of the compounded pharmaceutical uct’s active ingredients is given to the patient at the tim e of dispensing. 6. When a component is removed from its original container and transferred to another container, the new container label contains, in full text or an abbreviated code system, the following: a. The component name, b. The manufacturer’s or supplier’s name, c. The lot or control number, d. The weight or measure, e. The beyond-use-date as specified in subsectio n (B)(3)(d), and f. The transfer date. J. A pharmacy permittee shall ensure that the pharmacist-incharge stores any quantity of compounded pharmaceutical product produced in excess of the quantity dispensed in accordance with subsection (B): 1. In an appropriate container with a label that contains: a. A complete list of components or the pharmaceutical product’s name; b. The preparation date; c. The assigned lot or control number; and d. A beyond-use-date as specified in subsectio n (B)(3)(d); and 2. Under conditions, dictated by the pharmaceutical product’s composition and stability characteristics, that ensur e its strength, quality, and purity. K. A pharmacy permittee shall ensure that the pharmacist-incharge establishes, implements, and complies with recordkeeping procedures that comply with this subsection: 1. Pharmaceutical product compounding procedures an d other records required by this Section are maintained b y the pharmacy for not less than seven years, and 2. Pharmaceutical product compounding procedures an d other records required by this Section are readily available for inspection by the Board or its designee. Historical Note Adopted effective August 5, 1997 (Supp. 97-3). Amended by final rulemaking at 10 A.A.R. 3391, effective October 2, 2004 (Supp. 04-3). Amended by final rulemaking at 12 A.A.R. 3981, effective December 4, 2006 (Supp. 06-4). 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD R4-23-411. Pharmacist-administered Immunizations A. Authorization. A pharmacist who is qualified under subsectio n prescrip- (C) is authorized to order and administer, without a tion order, an immunization, vaccine, or emergency medication, including but not limited to epinephrine, corticosteroids, eli- albuterol, and antihistamines, to an eligible adult patient or gible minor patient. B. Authorized immunizations and vaccines: 1. A pharmacist who is authorized under subsection (A) may order and administer, without a prescription order, the following: a. For an eligible adult patient, an immunization or vaccine that is: i. Recommended for adults by the United State s Centers for Disease Control and Preventio n (CDC) Advisory Committee on Immunizatio n Practices (ACIP); or Informa- ii. Recommended by the CDC’s Health tion for International Travel; and iii. Not on the Arizona Department of Health Services’ list required under A.R.S. § 32-1974(H) and specified in A.A.C. R9-6-1301; and b. For an eligible minor patient, an immunization or vaccine that is: i. For influenza or a booster dose as describe d under A.R.S. § 32-1974(A)(3); or ii. Administered in response to an emergenc y declared by the governor; and 2. A pharmacist who is authorized under subsection (A) may order and administer an immunization or vaccine t o an eligible adult patient or eligible minor patient in accordance with: a. A valid standing order, as defined in subsection (J). A pharmacist shall not order or administer an immunization or vaccine under a standing order that ha s expired or been revoked, superseded, or otherwis e terminated; or b. A valid standing order issued by a county or tribal public health department or the Arizona Department of Health Services (DHS) or its authorized medical director even if the standing order differs from current CDC or ACIP guidance. A pharmacist shall not order or administer an immunization or vaccin e under a standing order or DHS standing order that other- has expired or been revoked, superseded, or wise terminated. C. Pharmacist qualifications. To be authorized to order an d medica- administer an immunization, vaccine, or emergency tion, including but not limited to epinephrine, corticosteroids, albuterol, and antihistamines, a pharmacist shall submit a completed application form, which is available on the Board’ s website, to the Board and provide evidence the pharmacist: 1. Is currently licensed to practice pharmacy in this state; 2. Successfully completed a training program that meets th e requirements specified in subsection (D); and 3. Has a current certificate in basic cardiopulmonary resuscitation. D. Training program requirements. The provider of a trainin g program for pharmacists to administer immunizations, vaccines, and emergency medications to an eligible adult patient or eligible minor patient shall ensure the training program includes: 1. Basic immunology and the human immune response; March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY 2. Mechanics of immunity, adverse effects, dose, an d administration schedule of available vaccines; adminis- 3. Response to emergency situations including the tration of emergency medications; 4. Administration of intramuscular injections; 5. Other immunization administration methods; and 6. Recordkeeping and reporting requirements specified i n subsection (E). E. Recordkeeping and reporting. 1. A pharmacist shall document the following for eac h immunization, vaccine, or emergency medication administered: a. Patient name, address, and date of birth; b. Date of administration and site of injection; c. Product name, dose, manufacturer’s lot number, an d expiration date; d. Name and address of the patient’s primary-care provider or physician; e. Name of the authorized pharmacist or qualifie d intern or pharmacy technician who administered th e vaccine and, if the vaccine was administered by a qualified intern or pharmacy technician, the name of the authorized pharmacist who supervised the qualified intern or pharmacy technician; f. Record of consultation confirming patient eligibility; g. Any patient education or consultation provided; h. Name and date of the vaccine information sheet provided to the patient; and i. For an eligible minor patient, a signed consent for m from the parent or guardian. 2. As required under A.R.S. § 32-1974(E)(1), the pharmacist shall provide a report to the patient’s primary-car e provider or physician containing the information require d in subsections (E)(1)(a) through (d) within 48 hours after administration and document the report was provide d within 72 hours. 3. A pharmacy’s pharmacist-in-charge or permittee shall main- ensure the records required in subsection (E)(1) are tained for at least seven years from the administratio n date. compli- F. Confidentiality. A pharmacy permittee shall ensure ance with all applicable state and federal privacy laws whe n patient health information is released. G. Immunizations requiring a prescription order. A pharmacist shall not administer an immunization or vaccine listed i n A.A.C. R9-6-1301 without a prescription order. The pharmacist shall comply with subsection (E)(1) if an immunization or vaccine listed in A.A.C. R9-6-1301 is administered. H. Administration by an intern. immuni- 1. The Board authorizes an intern to administer an zation, vaccine, or emergency medication, only if a pharmacist authorized under subsection (A) verifies the inter n is currently licensed in this state, successfully complete d a training program that meets the requirements specifie d in subsection (D); and has a current certificate in basi c cardiopulmonary resuscitation. 2. An intern authorized under subsection (H)(1) may administer an immunization, vaccine, or emergency medicatio n to an eligible adult patient or eligible minor patient onl y under the supervision of a pharmacist authorized under subsection (A). 3. An intern shall not independently order an immunization, vaccine, or emergency medication. 26-1 Page 31 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD I. Administration by a pharmacy technician. 1. Before a pharmacy technician administers an immunization or vaccine, a pharmacist authorized under subsectio n (A) shall verify the pharmacy technician is currentl y licensed in this state, successfully completed a trainin g subsec- program that meets the requirements specified in tion (D), and has a current certificate in basic cardiopulmonary resuscitation. 2. A pharmacy technician qualified under subsection (I)(1) may administer an immunization or vaccine to an eligibl e adult patient or eligible minor patient only if the administration is delegated by the pharmacist on duty and under the direct supervision of a pharmacist authorized under subsection (A). 3. A pharmacy technician shall not: a. Order an immunization, vaccine, or emergency medication; or b. Administer an emergency medication. J. Definitions. The following definitions apply to this Section: 1. “Eligible adult patient” means an eligible patient who i s 13 years of age or older. 2. “Eligible minor patient” means an eligible patient younger than 13 years of age who meets the followin g minimum age requirements: a. For influenza vaccine: three years of age or older; b. For any other immunization or vaccine: i. Under a standard order or prescription order, three years of age or older; or ii. Without a standing order or prescription order, in accordance with A.R.S. § 32-1974(A)(1). 3. “Standing order” means a written directive issued by a licensed healthcare provider authorized by a county or Depart- tribal public health department or the Arizona ment of Health Services that allows an authorized pharmacist and other qualified pharmacy personnel, to order or administer immunizations, vaccines, or emergenc y medications to individuals who meet the criteria set fort h in the standing order, in accordance with established clinpre- ical protocols, without needing a patient-specific scription order. For the purpose of this Section, a standin g order is a prescription order as defined at A.R.S. § 32- 1901(87)(c) and required under A.R.S. § 32-1974(B). A standing order may include an effective and expiratio n date and shall not be relied on if expired, superseded, revoked, or otherwise terminated. Historical Note New Section made by final rulemaking at 10 A.A.R. 3967, effective November 13, 2004 (Supp. 04-3). Amended by final rulemaking at 12 A.A.R. 279, effective March 11, 2006 (Supp. 06-1). Amended by final rulemaking at 14 A.A.R. 3674, effective November 8, 2008 (Supp. 08-3). Amended by final rulemaking at 15 A.A.R. 1930, effective November 3, 2009 (Supp. 09-4). Amended by final rulemaking at 17 A.A.R. 2596, effective February 4, 2012 (Supp. 11-4). Amended by final rulemaking at 23 A.A.R. 211, effective March 5, 2017 (Supp. 17-1). Amended by final rulemaking at 25 A.A.R. 1015, effective June 1, 2019 (Supp. 19-2). Amended by final rulemaking at , effective March 14, 2020 (Supp. 20-1). Amended by final rulemaking at 28 A.A.R. 994 (May 13, 2022), effective July 2, 2022 (Supp. 22-2). Amended by emergency rulemaking at 31 A.A.R. 4007 (October 10, 2025), effective September 22, 2025, for 180 days (Supp. 25-3). The emergency rulemaking Supp. Administrative Code AND OCCUPATIONS OF PHARMACY was due to expire on March 21, 2026; Before the expiration of the emergency, Section R4-23-411 was amended under final rulemaking at 32 A.A.R. 471 (February 27, 2026, Issue 9) with an immediate effective date of February 3, 2026 (Supp. 26-1). R4-23-412. Emergency Refill Prescription Dispensing A. When a state of emergency is declared under A.R.S. § 32- 1910(A) or (B) and the state of emergency results in individuals being unable to refill existing prescriptions, a pharmacist may work in the affected county, city, or town and may dispense a one-time emergency refill prescription of up to a 30day supply of a prescribed medication to an affected individual if both of the following apply: 1. In the pharmacist’s professional opinion the medication i s essential to the maintenance of life or to the continuatio n of therapy, and 2. The pharmacist makes a good faith effort to reduce th e information to a written prescription marked “emergenc y prescription” and files and maintains the prescription a s required by law. B. If the state of emergency declared under A.R.S. § 32-1910(A) or (B) continues for at least 21-days after the pharmacist dispenses an emergency prescription under subsection (A), th e pre- pharmacist may dispense one additional emergency refill scription of up to a 30-day supply of the prescribed medicatio n if the pharmacist complies with subsection (A)(2). C. A pharmacist’s authority to dispense emergency prescription s under this Section ends when the declared state of emergenc y is terminated. Historical Note New Section made by final rulemaking at 14 A.A.R. 4400, effective January 3, 2009 (Supp. 08-4). R4-23-413. Temporary Recognition of Nonresident Licensure A. When a state of emergency is declared under A.R.S. § 32- 1910(A) or (B): 1. A pharmacist who is not licensed in this state, but who i s currently licensed in another state, may dispense prescription medications in those affected counties, cities, or towns in this state during the time that a declared state of emergency exists under A.R.S. § 32-1910(A) or (B) if both of the following apply: a. The pharmacist provides proof of current licensur e in another state, and b. The pharmacist is engaged in a relief effort during a state of emergency. 2. Acting under the direct supervision of a pharmacist, a pharmacy technician or pharmacy intern not licensed i n this state, but currently licensed or registered in another state, may assist a pharmacist in dispensing prescriptio n medications in affected counties, cities, or towns in thi s state during the time that a declared state of emergenc y exists under A.R.S. § 32-1910(A) or (B) if both of the following apply: a. The pharmacy technician or pharmacy intern provide s proof of current licensure or registration in another state, and b. The pharmacy technician or pharmacy intern is engage d in a relief effort during a state of emergency. B. The recognition of nonresident licensure or registration shall end with the termination of the declared state of emergency. Historical Note 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD New Section made by final rulemaking at 14 A.A.R. 4400, effective January 3, 2009 (Supp. 08-4). R4-23-414. Reserved R4-23-415. Impaired Licensees – Treatment and Rehabilitation oper- A. The Board may contract with qualified organizations to ate a program for the treatment and rehabilitation of licensee s impaired as the result of alcohol or other drug abuse, pursuant to A.R.S. § 32-1932.01. B. Participants in the program are either “confidential” or “known.” Confidential participants are self-referred and ma y com- remain unidentified to the Board, subject to maintaining pliance with their program contract. Known participants ar e under Board order to complete a minimum tenure in the proten- gram. After a known participant completes the minimum ure, the Board may terminate the Board order and reinstate th e participant’s license to practice pharmacy. C. The program contract with a qualified organization shall include as a minimum the following: 1. Duties and responsibilities of each party. 2. Duration, not to exceed two years, of contract and term s of compensation. 3. Quarterly reports from the program administrator to th e Board indicating: a. Identity of participants; i. By name, if a known participant; or ii. By case number, if a confidential participant; b. Status of each participant, including; i. Clinical findings; ii. Diagnosis and treatment recommendations; iii. Program activities; and iv. General recovery and rehabilitation program information. 4. The program administrator shall report immediately t o the Board the name of any impaired licensee who poses a danger to self or others. 5. The program administrator shall report to the Board, a s soon as possible, the name of any impaired licensee: a. Who refuses to submit to treatment, b. Whose impairment is not substantially alleviate d through treatment, or c. Who violates the terms of their contract. 6. The program administrator shall periodically provid e informational programs to the profession, includin g approved continuing education programs on the topic of drug and chemical impairment, treatment, and rehabilitation. D. Under A.R.S. § 32-1903(F), the Board may publish the name s of participants under current Board orders. E. The Board or its executive director may request the treatment records for any participant. The program administrator shall provide treatment records within 10 working days of receivin g a written request from the Board or its executive director for such records. Upon request of the program administrator or th e Board or its executive director, a program participant shall authorize a drug and alcohol treatment facility or program or a partici- private practitioner or treatment program to release the pant’s records to the program administrator or the Board or it s executive director. F. On the recommendation of the program administrator or a Board member and by mutual consent, the program administrator, Board member, Board staff, and program participant may meet informally to discuss program compliance. March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY Historical Note New Section adopted by final rulemaking at 6 A.A.R. 467, effective January 4, 2000 (Supp. 00-1). Amended by final rulemaking at 14 A.A.R. 3611, effective November 8, 2008 (Supp. 08-3). R4-23-416. Reserved R4-23-417. Reserved R4-23-418. Reserved R4-23-419. Reserved R4-23-420. Reserved R4-23-421. Repealed Historical Note New Section made by final rulemaking at 8 A.A.R. 4052, effective November 9, 2002 (Supp. 02-3). Section repealed by final rulemaking at 17 A.A.R. 2600, effective February 4, 2012 (Supp. 11-4). R4-23-422. Repealed Historical Note New Section made by final rulemaking at , effective November 9, 2002 (Supp. 02-3). Section repealed by final rulemaking at , effective February 4, 2012 (Supp. 11-4). R4-23-423. Repealed Historical Note New Section made by final rulemaking at , effective November 9, 2002 (Supp. 02-3). Section repealed by final rulemaking at , effective February 4, 2012 (Supp. 11-4). R4-23-424. Repealed Historical Note New Section made by final rulemaking at , effective November 9, 2002 (Supp. 02-3). Section repealed by final rulemaking at , effective February 4, 2012 (Supp. 11-4). R4-23-425. Repealed Historical Note New Section made by final rulemaking at , effective November 9, 2002 (Supp. 02-3). Section repealed by final rulemaking at , effective February 4, 2012 (Supp. 11-4). R4-23-426. Repealed Historical Note New Section made by final rulemaking at , effective November 9, 2002 (Supp. 02-3). Section repealed by final rulemaking at , effective February 4, 2012 (Supp. 11-4). R4-23-427. Repealed Historical Note New Section made by final rulemaking at , effective November 9, 2002 (Supp. 02-3). Section repealed by final rulemaking at , effective February 4, 2012 (Supp. 11-4). R4-23-428. Repealed 26-1 Page 33 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD Historical Note New Section made by final rulemaking at , effective November 9, 2002 (Supp. 02-3). Section repealed by final rulemaking at , effective February 4, 2012 (Supp. 11-4). R4-23-429. Repealed Historical Note New Section made by final rulemaking at , effective November 9, 2002 (Supp. 02-3). Section repealed by final rulemaking at , effective February 4, 2012 (Supp. 11-4). PRESCRIPTION MONITORING PROGRAM New Article 5, consisting of Sections R4-23-501 through R4- 23-505, made effective August 2, 2014 (Supp. 14-2). Article 5, consisting of Sections R4-23-501 through R4-23- 505, expired effective August 30, 2013 (Supp. 14-1). Article 5, consisting of Sections R4-23-501 and R4-23-502, recodified to Article 8 at 9 A.A.R. 4011, effective August 18, 200 3 (Supp. 03-3). New Article 5, consisting of Sections R4-23-501 through R4- 23-505, made by final rulemaking at 14 A.A.R. 3410, effectiv e October 4, 2008 (Supp. 08-3). Monitor- R4-23-501. Controlled Substances Prescription ing (CSPMP) Program Registration and Database Access A. Under A.R.S. § 36-2606, a medical practitioner who is issue d a license under A.R.S. Title 32, Chapter 7, 11, 13, 14, 15, 16, 17, 21, 25, or 29 and possesses a current DEA registratio n under the Federal Controlled Substances Act shall have a current CSPMP registration issued by the Board. B. Application. 1. An applicant for CSPMP registration shall: registra- a. Submit a completed application for CSPMP tion electronically or manually on a form furnishe d by the Board, and b. Submit with the application form the document s specified in the application form. 2. The Board office shall deem an application form receive d on the date the Board office electronically or manuall y date-stamps the form. C. Registration. Within seven business days of receipt of a completed application specified in subsection (B), the Board offic e shall determine whether an application is complete. If th e application is complete, the Board office shall issue a registration number and provide a current registration certificate to th e applicant by mail or electronic transmission. If the applicatio n is incomplete, the Board office shall issue a written notice of incompleteness. An applicant with an incomplete applicatio n shall comply with the requirements of R4-23-202(F). D. Registration renewal. As specified in A.R.S. § 36-2606(C), th e reg- Board shall automatically suspend the registration of any istrant that fails to renew the registration on or before May 1 of the year in which the renewal is due. The Board shall vacate a suspension if the registrant submits a renewal application. A suspended registrant with CSPMP database access credential s is prohibited from accessing information in the prescriptio n monitoring program database. E. CSPMP database access. 1. A medical practitioner that chooses to use the CSPMP database shall request access from the CSPMP Director Supp. Administrative Code AND OCCUPATIONS OF PHARMACY by completing an access user registration form electronically. Upon receipt of the access user registration form, cre- the CSPMP Director or designee shall issue access dentials provided the medical practitioner is in compliance with the registration requirements of this Section. 2. A pharmacist that chooses to use the CSPMP databas e shall request access from the CSPMP Director by completing an access user registration form electronically. Upon receipt of the access user registration form, th e CSPMP Director or designee shall issue access credentials provided the pharmacist has a current active pharmacist license. 3. A medical practitioner or pharmacist who is not license d in Arizona may request access from the CSPMP Director by: a. Completing an access user registration form electronically; b. Printing the access user registration form; c. Having the access user registration form signed an d notarized; and d. Mailing the notarized access user form along with a current copy of the applicant’s nonresident stat e license and driver’s license. Upon receipt of th e notarized access user registration form and other required documents, the CSPMP Director or designee shall issue access credentials provided the nonresident licensed medical practitioner or pharmacist credentials show an current active license in another state. Historical Note Former Rule 5.2110; Amended effective August 9, 1983 (Supp. 83-4). Amended by final rulemaking at 8 A.A.R. 4898, effective January 5, 2003 (Supp. 02-4). Recodified to R4-23-801 at , effective August 18, 2003 (Supp. 03-3). New Section made by final rulemaking at , effective October 4, 2008 (Supp. 08-3). Amended by final rulemaking at 19 A.A.R. 94, effective March 10, 2013 (Supp. 13-1). Section expired under A.R.S. § 41-1056(J) at 20 A.A.R. 133, effective August 30, 2013 (Supp. 14-1). New Section made by final rulemaking at 20 A.A.R. 1359, effective August 2, 2014 (Supp. 14-2). Trans- R4-23-502. Requirements for Data Format and mission A. Each dispenser shall submit to the Board or its designee b y dis- electronic means information regarding each prescription pensed for a controlled substance listed in Schedules II, III, and IV of A.R.S. Title 36, Chapter 27, the Arizona Unifor m Controlled Substances Act. The information reported shall conform to the August 31, 2005 Version 003, Release 00 0 ASAP Rules-based Standard Implementation Guide for Prescription Monitoring Programs published by the America n Society for Automation in Pharmacy as specified in A.R.S. § 36-2608(B). The information submitted for each prescriptio n shall include: 1. The name, address, telephone number, prescription number, and DEA registration number of the dispenser; 2. The name, address, gender, date of birth, and telephon e number of the person or, if for an animal, the owner of th e animal for whom the prescription is written; registra- 3. The name, address, telephone number, and DEA tion number of the prescribing medical practitioner; 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 4. The quantity and National Drug Code (NDC) number of the Schedule II, III, or IV controlled substance dispensed; 5. The date the prescription was dispensed; 6. The number of refills, if any, authorized by the medical practitioner; 7. The date the prescription was issued; 8. The method of payment identified as cash or third party; and 9. Whether the prescription is new or a refill. B. A dispenser shall submit the required information electronically unless the Board or its designee approves a waiver a s specified in subsection (D). C. A dispenser’s electronic data transfer equipment includin g hardware, software, and internet connections shall meet th e Porta- privacy and security standards of the Health Insurance bility and Accountability Act (HIPAA) of 1996, as amended, and A.R.S. § 12-2292, in addition to common internet industr y standards for privacy and security. A dispenser shall ensur e that each electronic transmission meets the following data protection requirements: 1. Data shall be at least 128-bit encryption in transmissio n and at rest; and 2. Data shall be transmitted via secure e-mail, telephon e modem, diskette, CD-ROM, tape, secure File Transfer Protocol (FTP), Virtual Private Network (VPN), or other Board-approved media. D. A dispenser who does not have an automated recordkeepin g system capable of producing an electronic report in the Boar d established format may request a waiver from electroni c reporting by submitting a written request to the Board or it s designee. The Board or its designee shall grant the request if the dispenser agrees in writing to report the data by submittin g a completed universal claim form supplied by the Board or it s designee. E. Unless otherwise approved by the Board, a dispenser shall report by the close of business on each Friday the require d information for the previous week, Sunday through Saturday. If a Friday falls on a state holiday, the dispenser shall report the information on the following business day. The Board or its designee may approve a less frequent reporting period if a dispenser makes a showing that a less frequent reportin g jeop- period will not reduce the effectiveness of the system or ardize the public health. Historical Note Former Rule 5.2510. Amended by final rulemaking at 8 A.A.R. 4898, effective January 5, 2003 (Supp. 02-4). Recodified to R4-23-802 at , effective August 18, 2003 (Supp. 03-3). New Section made by final rulemaking at , effective October 4, 2008 (Supp. 08-3). Section expired under A.R.S. § 41- 1056(J) at , effective August 30, 2013 (Supp. 14-1). New Section made by final rulemaking at , effective August 2, 2014 (Supp. 14-2). R4-23-503. Access to Controlled Substances Prescription Monitoring Program Data A. Except as provided in A.R.S. § 36-2604(B) and (C) and thi s Section, prescription information submitted to the Board or it s designee is confidential and is not subject to public inspection. B. The Board or its designee shall review the prescription information collected under A.R.S. Title 36, Chapter 28 and R4-23- 502. If the Board or its designee has reason to believe an act of unprofessional or illegal conduct has occurred, the Board or it s designee shall notify the appropriate professional licensin g March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY board or law enforcement or criminal justice agency and provide the prescription information required for an investigation. col- C. The Board or its designee is authorized to release data lected by the program to the following: 1. A person who is authorized to prescribe or dispense a med- controlled substance to assist that person to provide ical or pharmaceutical care to a patient or to evaluate a patient; con- 2. An individual who requests the individual’s own trolled substance prescription information under A.R.S. § 12-2293; 3. A professional licensing board established under A.R.S. Title 32, Chapter 7, 11, 13, 14, 15, 16, 17, 18, 21, 25, or 29. Except as required under subsection (B), the Board or its designee shall provide this information only if th e requesting board states in writing that the information i s necessary for an open investigation or complaint; jus- 4. A local, state, or federal law enforcement or criminal tice agency. Except as required under subsection (B), th e Board or its designee shall provide this information onl y informa- if the requesting agency states in writing that the tion is necessary for an open investigation or complaint; 5. The Arizona Health Care Cost Containment Syste m Administration regarding individuals who are receivin g services under A.R.S. Title 36, Chapter 29. Except a s required under subsection (B), the Board or its designe e shall provide this information only if the Administratio n states in writing that the information is necessary for a n open investigation or complaint; 6. A person serving a lawful order of a court of competent jurisdiction; 7. A person who is authorized to prescribe or dispense a controlled substance and who performs an evaluation o n an individual under A.R.S. § 23-1026; and 8. The Board staff for purposes of administration an d Arti- enforcement of A.R.S. Title 36, Chapter 28 and this cle. D. The Board or its designee may provide data to public or private entities for statistical, research, or educational purpose s after removing information that could be used to identify individual patients or persons who received prescriptions from dispensers. Historical Note Former Rules 5.3500, 5.3520, 5.3540, 5.3550, 5.3560, 5.3570, 5.3580, 5.3590, 5.4110, and 5.6110; Repealed effective August 2, 1982 (Supp. 82-4). New Section made by final rulemaking at , effective October 4, 2008 (Supp. 08-3). Section expired under A.R.S. § 41- 1056(J) at , effective August 30, 2013 (Supp. 14-1). New Section made by final rulemaking at , effective August 2, 2014 (Supp. 14-2). R4-23-504. Computerized Central Database Trackin g System Task Force A. The Board shall appoint a task force to help it administer th e computerized central database tracking system as specified i n A.R.S. § 36-2603. B. The Task Force shall meet at least once each year and at th e condi- call of the chairperson to establish the procedures and tions relating to the release of prescription information specified in A.R.S. § 36-2604 and R4-23-503. C. The Task Force shall determine: 1. The information to be screened; 2. The frequency and thresholds for screening; and 26-1 Page 35 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 3. The parameters for using the information to notify medical practitioners, patients, and pharmacies to educate an d provide for patient management and treatment options. D. The Board shall review and approve the procedures and conditions established by the Task Force as needed but at least onc e every calendar year. Historical Note Former Rule 5.7010; Amended effective August 10, 1978 (Supp. 78-4). Repealed effective August 2, 1982 (Supp. 82-4). New Section made by final rulemaking at , effective October 4, 2008 (Supp. 08-3). Section expired under A.R.S. § 41-1056(J) at 20 A.A.R. Sec- 133, effective August 30, 2013 (Supp. 14-1). New tion made by final rulemaking at , effective August 2, 2014 (Supp. 14-2). R4-23-505. Reports A. Before releasing prescription monitoring program data, th e Board or its designee shall receive a written or electroni c request for controlled substance prescription information. B. A person authorized to access CSPMP data under R4-23- 503(C)(1) through (7) shall submit a written or electroni c request that: 1. Specifies the information requested for the report; 2. For a medical practitioner, provides a statement that th e report’s purpose is to provide medical or pharmaceutical care to a patient or to evaluate a patient; 3. For an individual obtaining the individual’s own controlled substance prescription information, provides a form of non-expired government-issued photo identification; infor- 4. For a professional licensing board, states that the mation is necessary for an open investigation or complaint; 5. For a local, state, or federal law enforcement or criminal justice agency, states that the information is necessary for an open investigation or complaint; informa- 6. For the AHCCCS Administration, states that the tion is necessary for an open investigation or complaint; and compe- 7. For a person serving a lawful order of a court of tent jurisdiction, provides a copy of the court order. C. The Board or its designee may provide reports through U.S. mail, other common carrier, facsimile, or secured electroni c media or may allow reports to be picked up in-person at th e Board office. Historical Note Former Rules 5.7100, 5.8100, 5.8500, 5.9100, and 5.9500; Amended effective August 10, 1978 (Supp. 78- 4). Repealed effective August 2, 1982 (Supp. 82-4). New Section made by final rulemaking at , effective October 4, 2008 (Supp. 08-3). Section expired under A.R.S. § 41-1056(J) at , effective August 30, 2013 (Supp. 14-1). New Section made by final rulemaking at , effective August 2, 2014 (Supp. 14-2). R4-23-506. Repealed Historical Note Adopted effective December 3, 1974 (Supp. 75-1). Repealed effective August 24, 1992 (Supp. 92-3). R4-23-601. General Provisions Supp. Administrative Code AND OCCUPATIONS OF PHARMACY A. Permit required to sell a narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precurcur- sor chemical, or regulated chemical. A person shall have a rent Board permit to: 1. Sell a narcotic or other controlled substance, prescriptiononly drug or device, nonprescription drug, precursor chemical, or regulated chemical in Arizona; or 2. Sell a narcotic or other controlled substance, prescriptiononly drug or device, nonprescription drug, precursor chemical, or regulated chemical from outside Arizon a and ship the narcotic or other controlled substance, prepre- scription-only drug or device, nonprescription drug, cursor chemical, or regulated chemical into Arizona. B. A medical practitioner is exempt from subsection (A) t o prescrip- administer a narcotic or other controlled substance, tion-only drug or device, nonprescription drug, precursor chemical, or regulated chemical for the emergency needs of a patient. C. Permit fee. Permits are issued biennially on an odd- and evenyear expiration based on the assigned permit number. The fee, specified in R4-23-205, is not refundable unless the Boar d fails to comply with the permit time frames established in R4- 23-602. D. Record of receipt and disposal of narcotics or other controlle d substances, prescription-only drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals. con- 1. Every person manufacturing a narcotic or other trolled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulate d pre- chemical, including repackaging or relabeling, shall pare and retain for no fewer than three years the manufacturing, repackaging, or relabeling date for each narcoti c or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical. 2. Every person receiving, selling, delivering, or disposin g of a narcotic or other controlled substance, prescriptiononly drug or device, nonprescription drug, precursor chemical, or regulated chemical shall record and retai n for no fewer than three years the following information: a. The name, strength, dosage form, and quantity of pre- each narcotic or other controlled substance, scription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical received, sold, delivered, or disposed; b. The name, address, and license or permit number, if applicable, of the person from whom each narcoti c or other controlled substance, prescription-only dru g or device, nonprescription drug, precursor chemical, or regulated chemical is received; c. The name, address, and license or permit number, if applicable, of the person to whom each narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical is sold or delivered, or of the person who disposes of each narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical; and d. The receipt, sale, deliver, or disposal date of eac h narcotic or other controlled substance, prescriptiononly drug or device, nonprescription drug, precursor chemical, or regulated chemical. 26-1 March 31, 2026 Arizona Administrative TITLE 4. PROFESSIONS AND CHAPTER 23. BOARD OF 3. The record required in this subsection shall be availabl e 2. for inspection by the Board or its compliance officer during regular business hours. 4. If the record required in this subsection is stored in a centralized recordkeeping system and not immediately available for inspection, a permittee, manager, or pharmacistin-charge shall provide the record within four workin g days of the Board’s or its compliance officer’s request. E. Narcotics or other controlled substances, prescription-onl y drugs or devices, nonprescription drugs, precursor chemicals, 3. or regulated chemicals damaged by water, fire, or from huma n or animal consumption or use. A person shall not sell or offer to sell any narcotic or other controlled substance, prescriptiononly drug or device, nonprescription drug, precursor chemical, or regulated chemical damaged by water, fire, or from huma n or animal consumption or use. 4. F. At least 14 days before there is a change in ownership, a s defined at R4-23-110, of a license or permit issued under thi s Chapter, the new licensee or permittee shall apply to the Boar d for a new license or permit. Historical Note 5. Former Rules 6.1100, 6.1200, 6.1300, 6.1400, and 6.1500. Amended effective August 10, 1978 (Supp. 78- 4). Amended subsection (C) effective August 9, 1983 (Supp. 83-4). Amended subsection (C) effective August 12, 1988 (Supp. 88-3). Amended by final rulemaking at 6 A.A.R. 4656, effective November 14, 2000 (Supp. 00-4). effec- Amended by final rulemaking at 12 A.A.R. 1912, tive July 1, 2006 (Supp. 06-2). Amended by final rulemaking at 14 A.A.R. 3670, effective November 8, 2008 (Supp. 08-3). Amended by final rulemaking at 25 A.A.R. 1015, effective June 1, 2019 (Supp. 19-2). R4-23-602. Permit Application Process and Time Frames A. A person applying for a permit shall: 1. Submit a completed application for the desired permit electronically or manually on a form furnished by th e Board, and 2. Submit with the application form: a. The documents specified in the application form, and b. The permit fee specified in R4-23-205. B. The Board office shall deem an application form received o n the date the Board office electronically or manually datestamps the form. C. Time frames for permits. complete- 1. The Board office shall finish an administrative ness review within 60 days from the date the applicatio n form is received. a. The Board office shall issue a written notice of administrative completeness to the applicant if n o 6. deficiencies are found in the application form. b. If the application form is incomplete, the Boar d office shall provide the applicant with a writte n notice that includes a comprehensive list of the missing information. The 60-day time frame for th e Board office to finish the administrative completeness review is suspended from the date the notice of incompleteness is served until the applicant provide s the Board office with all missing information. c. If the Board office does not provide the applicant com- with written notice regarding administrative pleteness, the application form shall be deeme d complete 60 days after receipt by the Board office. March 31, 2026 Supp. 26-1 Code OCCUPATIONS PHARMACY An applicant with an incomplete application form shall submit to the Board office all of the missing informatio n within 90 days of service of the notice of incompleteness. If an applicant cannot submit all missing informatio n within 90 days of service of the notice of incompleteness, exten- the applicant may send a written notice of a 30-day sion to the Board office postmarked or delivered no later than 90 days from service of the notice of incompleteness. If an applicant fails to submit a complete application for m within the time allowed under subsection (C)(2), th e Board office shall close the applicant’s file. An applicant whose file is closed and who later wishes to obtain a permit shall submit a new application and fee as specified i n subsection (A). For a compressed medical gas distributor permit applicant and a durable medical equipment and compresse d medical gas supplier permit applicant, the Board offic e shall issue a permit on the day the Board office determines an administratively complete application form i s received. Except as described in subsection (C)(4), from the dat e on which the administrative completeness review of a n com- application form is finished, the Board office shall plete a substantive review of the applicant’s qualification s in no more than 120 days. a. If an applicant is found to be ineligible, the Boar d office shall issue a written notice of denial to th e applicant. b. If an applicant is found to be eligible, the Boar d office shall recommend to the Board that the applicant be issued a permit. Upon receipt of the Boar d office’s recommendation, the Board shall either issue a permit to the applicant or if the Board determines the applicant does not meet eligibility requirements, return the matter to the Board office. c. If the Board office finds deficiencies during the substantive review of the application form, the Boar d office shall issue a written request to the applicant for additional documentation. d. The 120-day time frame for a substantive review for the issuance or denial of a permit is suspended fro m the date of the written request for additional documentation until the date all documentation i s received. The applicant shall submit the additional documentation according to subsection (C)(2). e. If the applicant and the Board office mutually agre e in writing, the 120-day substantive review tim e frame may be extended once for no more than 4 5 days. For the purpose of A.R.S. § 41-1072 et seq., the Boar d establishes the following time frames for permits: a. Administrative completeness review time frame: 6 0 days. b. Substantive review time frame: i. Compressed medical gas distributor permit an d durable medical equipment and compresse d medical gas supplier permit: none. ii. Except as described in subsection (C)(6)(b)(i): 120 days. c. Overall time frame: i. Compressed medical gas distributor permit an d durable medical equipment and compresse d medical gas supplier permit: 60 days. Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD ii. Except as described in subsection (C)(6)(c)(i): 180 days. D. Permit renewal. 1. To renew a permit, a permittee shall submit a complete d application for permit renewal electronically or manuall y on a form furnished by the Board with the biennial renewal fee specified in R4-23-205. 2. If the biennial renewal fee is not paid by November 1 of per- the renewal year specified in A.R.S. § 32-1931, the mit is suspended. The permittee shall pay a penalty a s provided in A.R.S. § 32-1931 and R4-23-205 to vacat e the suspension. 3. Time frames for permit renewals. The Board office shall follow the time frames established in subsection (C). E. Display of permit. A permittee shall conspicuously display th e permit in the location to which it applies. Historical Note Former Rules 6.2100, 6.2200, 6.2300, 6.2400, 6.2500, 6.2600, 6.2610, 6.2620, 6.2630, 6.2640, and 6.2650. Amended effective August 10, 1978 (Supp. 78-4). Amended effective August 9, 1983 (Supp. 83-4). Repealed effective August 12, 1988 (Supp. 88-3). New Section adopted effective August 5, 1997 (Supp. 97-3). Amended by final rulemaking at 6 A.A.R. 4589, effective November 14, 2000 (Supp. 00-4). Amended by final rulemaking at 20 A.A.R. 1364, effective August 2, 2014 (Supp. 14-2). Amended by final rulemaking at , effective June 1, 2019 (Supp. 19-2). Amended by final rulemaking at 31 A.A.R. 2363 (July 18, 2025), effective August 30, 2025 (Supp. 25-3). R4-23-603. Repealed Historical Note Adopted effective August 10, 1978 (Supp. 78-4). Amended subsection (D) paragraph (1) and added subsection (G) effective April 20, 1982 (Supp. 82-2). Amended effective August 12, 1988 (Supp. 88-3). Amended effective February 8, 1991 (Supp. 91-1). Amended effective August 5, 1997 (Supp. 97-3). Amended by final rulemaking at , effective November 14, 2000 (Supp. 00-4). Amended by final rulemaking at , effective August 2, 2014 (Supp. 14-2). Amended by final rulemaking at , effective June 1, 2019 (Supp. 19-2). Repealed by final rulemaking at 31 A.A.R. 2363 (July 18, 2025), effective August 30, 2025 (Supp. 25-3). R4-23-604. Resident Drug Manufacturer A. Permit. A person shall not manufacture, package, repackage, label, or relabel any narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical without a current Boardissued drug manufacturer permit. B. Application. To obtain a permit to operate a drug manufacturappli- ing firm in Arizona, a person shall submit a completed cation, on a form furnished by the Board, and the fee specifie d in R4-23-205. C. Before issuing a drug manufacturer permit, the Board shall: 1. Receive and approve a completed permit application; 2. Interview the applicant and manager, if different from th e applicant, at a Board meeting; and 3. Receive a satisfactory compliance inspection report o n the facility from a Board compliance officer. Supp. Administrative Code AND OCCUPATIONS OF PHARMACY D. Notification. A resident drug manufacturer permittee shall notify the Board of changes involving the drug list, address, man- telephone number, business name, or manager, including ager’s telephone number. The resident drug manufacturer permittee shall submit using the permittee’s online profile or a written notice by mail, fax, or e-mail to the Board office withi n 24 hours of the change. E. Change of ownership. A resident drug manufacturer permitte e shall comply with R4-23-601(F). F. Before an existing resident drug manufacturer permittee relocates, the drug manufacturer permittee shall submit the application packet described in subsection R4-23-604(B), excluding the fee. The facility at the new location shall pass a final inspection by a Board compliance officer before operations begin. G. No later than 14 days after the change occurs, a resident dru g manufacturer permittee shall submit the application describe d under subsection R4-23-604(B), excluding the fee, for an y change of officers in a corporation. H. Manufacturing and distribution. 1. A drug manufacturer permittee shall manufacture an d distribute a drug only: a. To a pharmacy, drug manufacturer, or full-service or nonprescription drug wholesaler currently permitte d by the Board; b. To a medical practitioner currently licensed as a medical practitioner as defined in A.R.S. § 32-1901; or c. To a properly permitted, registered, licensed, or certified person or firm of another jurisdiction. 2. Before manufacturing and distributing a drug that is not listed on a drug manufacturer’s permit application, th e drug manufacturer permittee shall send to the Boar d office a written request to amend the permit application, including documentation of FDA approval to manufacture the drug not listed on the original permit application. If a request to amend a permit application includes th e documentation required in this subsection, the Board or its designee shall approve the request to amend within 3 0 days of receipt. I. A drug manufacturer permit is subject to denial, suspension, probation, or revocation under A.R.S. § 32-1927.02. J. Current Good Manufacturing Practice. A drug manufacturer permittee is required under federal law to follow the goo d manufacturing practice requirements of 21 CFR 210 throug h 211. K. Records. A drug manufacturer permittee shall: maintain- 1. Establish and implement written procedures for ing records pertaining to production, process control, labeling, packaging, quality control, distribution, complaints, and any information required by federal or stat e law; 2. Retain the records required by this Article and 21 CF R 210 through 211 for at least two years after distribution of a drug or one year after the expiration date of a drug, whichever is longer; and 3. Make the records required by this Article and 21 CF R 210 through 211 available within 48 hours for review b y a Board compliance officer or other authorized officer of the law as defined in A.R.S. § 32-1901. L. Inspections. A drug manufacturer permittee shall make th e drug manufacturer’s facility available for inspection by th e Board or its compliance officer under A.R.S. § 32-1904. 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD M. Nonresident drug manufacturer. A nonresident drug manufacturer shall comply with the requirements of R4-23-607. N. Manufacturing radiopharmaceuticals. Before manufacturing a radiopharmaceutical, a drug manufacturer permittee shall: 1. Comply with the regulatory requirements of the Arizon a Regula- Radiation Regulatory Agency, the U.S. Nuclear tory Commission, the FDA, and this Section; and 2. Hold a current Arizona Radiation Regulatory Agenc y Radioactive Materials License. If a drug manufacturer permittee who manufactures radiopharmaceuticals fail s to maintain a current Arizona Radiation Regulator y Agency Radioactive Materials License, the permittee’ s drug manufacturer permit shall be immediately suspended pending a hearing by the Board. Historical Note Former Rules 6.4001, 6.4002, 6.4003, 6.4004, 6.4005, 6.4006, 6.4007, 6.4008, 6.4009, 6.4100, 6.4110, 6.4111, 6.4115, 6.4116, 6.4120, 6.4122, 6.4190, 6.4191, 6.4200, 6.4250, 6.4300, 6.4350, 6.4355, 6.4360, 6.4400, 6.4401, 6.4403, 6.4410, 6.4430, 6.4450, 6.4500, 6.4510, 6.4530, 6.4533, 6.4600, 6.4610, 6.4640, 6.4660, 6.4700, 6.4710, and 6.4750. Adopted effective December 3, 1974 (Supp. 75-1). Amended effective August 10, 1978 (Supp. 78-4). Amended subsection (B) paragraph (2) effective April 20, 1982 (Supp. 82-2). Amended subsections (B), (G), (K) and (L) effective August 12, 1988 (Supp. 88-3). Amended effective August 24, 1992 (Supp. 92-3). Amended effective November 1, 1993 (Supp. 93-4). Amended by final rulemaking at 7 A.A.R. 3815, effective August 9, 2001 (Supp. 01-3). Amended by final rulemaking at 11 A.A.R. 1105, effective April 30, 2005 (Supp. 05-1). Amended by final rulemaking at 19 A.A.R. 702, effective June 1, 2013 (Supp. 13-2). Amended by final rulemaking at , effective June 1, 2019 (Supp. 19-2). R4-23-605. Resident Drug Wholesaler Permit A. Permit. A person shall not operate a business or firm for th e wholesale distribution of any drug, device, precursor chemical, or regulated chemical without a current Board-issued fullservice or nonprescription drug wholesale permit. B. Application. 1. To obtain a permit to operate a full-service or nonprescription drug wholesale firm in Arizona, a person shall submit a completed application, on a form furnished b y the Board, and the fee specified in R4-23-205. 2. Before issuing a full-service or nonprescription dru g wholesale permit, the Board shall: a. Receive and approve a completed permit application; b. Interview the applicant and the designated representative, if different from the applicant, at a Boar d meeting; c. Receive a satisfactory compliance inspection report on the facility from a Board compliance officer; and fin- d. For a full-service drug wholesale permit, issue a gerprint clearance to a qualified designated representative, as specified in subsection (L). If th e fingerprint clearance of a designated representativ e for a full-service drug wholesale permit applicant i s denied, the full-service drug wholesale permit applicant shall appoint another designated representativ e and submit the documentation, fingerprints, and fe e March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY specified in the application required in subsectio n (B). C. Notification. A resident full-service or nonprescription dru g wholesale permittee shall notify the Board of changes involving the type of drugs sold or distributed, address, telephon e representa- number, business name, or manager or designated tive, including the manager’s or designated representative’ s telephone number. whole- 1. The resident full-service or nonprescription drug sale permittee shall submit using the permittee’s onlin e profile or a written notice by mail, fax, or e-mail to th e Board office within 10 days of the change. 2. For a change of designated representative, a resident fullservice drug wholesale permittee shall submit the docuapplica- mentation, fingerprints, and fee specified in the tion required in subsection (B). D. Change of ownership. A resident full-service or nonprescription drug wholesale permittee shall comply with R4-23- 601(F). E. Before an existing resident full-service or nonprescriptio n drug wholesaler permittee relocates, the resident full-servic e or nonprescription drug wholesale permittee shall submit th e application required under subsection (B), excluding the fee. The facility at the new location shall pass a final inspection b y a Board compliance officer before operations begin. F. No later than 14 days after the change occurs, a resident fullsub- service or nonprescription drug wholesale permittee shall mit the application described under subsection (B), excludin g the fee, for any change of officers in a corporation. G. Distribution restrictions. In addition to the requirements of thi s subsection, a resident full-service wholesale permittee shall comply with the distribution restrictions specified in A.R.S. § 32-1983. 1. Records. a. A full-service drug wholesale permittee shall: i. Maintain records to ensure full accountabilit y of any narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulate d chemical including dates of receipt and sales, names, addresses, and DEA registration nummer- bers, if required, of suppliers or sources of chandise, and customer names, addresses, an d DEA registration numbers, if required; ii. File the records required in subsectio n (G)(1)(a)(i) in a readily retrievable manner for a minimum of three years; iii. Make the records required in subsectio n (G)(1)(a)(i) available upon request during regular business hours for inspection by a Boar d compliance officer or other authorized officer of the law as defined in A.R.S. § 32-1901(5). Records kept at a central location apart fro m the business location and not electronicall y retrievable shall be made available within tw o business days; and sub- iv. In addition to the records requirements of section (G)(1)(a)(i), comply with the retentio n of track and trace documents required under th e Drug Supply Chain and Security Act for all prescription-only drugs that leave the normal distribution channel as defined in A.R.S. § 32- 1981. b. A nonprescription drug wholesale permittee shall: 26-1 Page 39 Arizona Administrative TITLE 4. PROFESSIONS AND CHAPTER 23. BOARD OF i. Maintain records to ensure full accountabilit y of any nonprescription drug, precursor chemical, or regulated chemical including dates of receipt and sales, names, addresses, and DEA registration numbers, if required, of supplier s or sources of merchandise, and customer names, addresses, and DEA registration numbers, if required; ii. File the records required in subsectio n (G)(1)(b)(i) in a readily retrievable manner for a minimum of three years; and iii. Make the records required in subsectio n (G)(1)(b)(i) available upon request during regular business hours for inspection by a Boar d compliance officer or other authorized officer of the law as defined in A.R.S. § 32-1901(5). Records kept at a central location apart from the business location and not electronicall y retrievable shall be made available within tw o business days. 2. Drug sales. a. A full-service drug wholesale permittee shall: i. Not sell, distribute, give away, or dispose of pre- any narcotic or other controlled substance, scription-only drug or device, nonprescriptio n drug, precursor chemical, or regulated chemical, except in the original container package d and labeled by the manufacturer or repackager; ii. Not package, repackage, label, or relabel an y prescrip- narcotic or other controlled substance, tion-only drug or device, nonprescription drug, precursor chemical, or regulated chemical; iii. Not sell, distribute, give away, or dispose of any narcotic or other controlled substance, or 3. prescription-only drug or device, to anyon e except a pharmacy, drug manufacturer, or fullservice drug wholesaler currently permitted b y the Board or a medical practitioner currentl y licensed under A.R.S. Title 32; iv. Not sell, distribute, give away, or dispose of any nonprescription drug, precursor chemical, phar- or regulated chemical, to anyone except a macy, drug manufacturer, full-service or nonprescription drug wholesaler, or permit- nonprescription drug retailer currently ted by the Board or a medical practitioner currently licensed under A.R.S. Title 32; v. Provide track and trace documents require d under the Drug Supply Chain and Security Act upon request, if immediately available, or within two business days from the date of a request of a Board compliance officer or other authorized officer of the law as defined i n A.R.S. § 32-1901; vi. Maintain a copy of the current permit or licens e of each person that buys, receives, or dispose s of any narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulate d chemical; and vii. Provide permit and license records upo n request, if immediately available, or within tw o business days from the date of the request of a Board compliance officer or other authorize d Supp. 26-1 Code OCCUPATIONS PHARMACY officer of the law as defined in A.R.S. § 32- 1901(5). b. A nonprescription drug wholesale permittee shall: i. Not sell, distribute, give away, or dispose of any nonprescription drug, precursor chemical, or regulated chemical except in the original container packaged and labeled by the manufacturer or repackager; ii. Not package, repackage, label, or relabel an y nonprescription drug, precursor chemical, or regulated chemical; iii. Not sell or distribute any nonprescription drug, precursor chemical, or regulated chemical t o anyone except a pharmacy, drug manufacturer, full-service or nonprescription drug wholesaler, or nonprescription drug retailer currently permitted by the Board or a medical practitioner currently licensed under A.R.S. Title 32; iv. Maintain a record of the current permit or license of each person that buys, receives, or disposes of any nonprescription drug, precursor chemical, or regulated chemical; and v. Provide permit and license records upo n request, if immediately available, or within tw o business days from the date of the request of a Board compliance officer or other authorize d officer of the law as defined in A.R.S. § 32- 1901(5). c. Nothing in this subsection shall be construed to presub- vent the return of a narcotic or other controlled stance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical to the original source of supply. Out-of-state drug sales. a. A full-service drug wholesale permittee shall: i. Not sell, distribute, give away, or dispose of any narcotic or other controlled substance, prescription-only drug or device, nonprescriptio n drug, precursor chemical, or regulated chemical except in the original container packaged an d labeled by the manufacturer or repackager; ii. Not package, repackage, label, or relabel an y narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical; iii. Not sell, distribute, give away, or dispose of any narcotic or other controlled substance, prescription-only drug or device, nonprescriptio n drug, precursor chemical, or regulated chemical to anyone except a person that is properly permitted, registered, licensed, or certified i n another jurisdiction; iv. Provide track and trace documents require d under the Drug Supply Chain and Security Act upon request, if immediately available, or within two business days from the date of th e request of a Board compliance officer or other authorized officer of the law as defined i n A.R.S. § 32-1901; registra- v. Maintain a copy of the current permit, tion, license, or certificate of each person that buys, receives, or disposes of any narcotic or other controlled substance, prescription-onl y Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD drug or device, nonprescription drug, precursor chemical, or regulated chemical; and certif- vi. Provide permit, registration, license, and icate records upon request, if immediatel y available, or within two business days from th e offi- date of the request of a Board compliance cer or other authorized officer of the law a s defined in A.R.S. § 32-1901(5); and b. A nonprescription drug wholesale permittee shall: i. Not sell, distribute, give away, or dispose of any nonprescription drug, precursor chemical, or regulated chemical except in the original container packaged and labeled by the manufacturer or repackager; ii. Not package, repackage, label, or relabel an y nonprescription drug, precursor chemical, or regulated chemical; iii. Not sell or distribute any nonprescription drug, precursor chemical, or regulated chemical t o anyone except a person that is properly permitted, registered, licensed, or certified in another jurisdiction; iv. Maintain a record of the current permit, registration, license, or certificate of each perso n that buys, receives, or disposes of any nonprescription drug, precursor chemical, or regulate d chemical; and v. Provide permit, registration, license, or certificate records upon request, if immediately available, or within two business days from the dat e of the request of a Board compliance officer or other authorized officer of the law as defined i n A.R.S. § 32-1901(5). 4. Cash-and-carry sales. a. A full-service drug wholesale permittee shall comnar- plete a cash-and-carry sale or distribution of any cotic or other controlled substance, prescriptiononly drug or device, nonprescription drug, precursor chemical, or regulated chemical only after: i. Verifying the validity of the order; ii. Verifying the identity of the pick-up person for each transaction by confirming that the perso n represented placed the cash-and-carry order; and iii. For a prescription-only drug order, verifyin g that the cash-and-carry sale or distribution i s used only to meet the immediate needs of a particular patient of the person that placed th e cash-and-carry order; and b. A nonprescription drug wholesale permittee shall complete a cash-and-carry sale or distribution of an y nonprescription drug, precursor chemical, or regulated chemical only after: i. Verifying the validity of the order; and ii. Verifying the identity of the pick-up person for each transaction by confirming that the perso n represented placed the cash-and-carry order. H. Prescription-only drug returns or exchanges. A full-servic e drug wholesale permittee shall ensure that any prescriptionphar- only drug returned or exchanged by a pharmacy or chain macy warehouse under A.R.S. § 32-1983(A) meets the following criteria: counter- 1. The prescription-only drug is not adulterated or feited, except an adulterated or counterfeited prescrip- March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY tion-only drug that is the subject of an FDA or manufacturer recall may be returned for destruction or subsequent return to the manufacturer; 2. The quantity of prescription-only drug returned or exchanged does not exceed the quantity of prescriptiononly drug that the full-service drug wholesale permitte e or a full-service drug wholesale permittee under commo n ownership sold to the pharmacy or chain pharmacy warehouse; and 3. The pharmacy or chain pharmacy warehouse provide s documentation that: a. Lists the name, strength, and manufacturer of th e prescription-only drug being returned or exchanged; and main- b. States that the prescription-only drug was tained in compliance with storage conditions prescribed on the drug label or manufacturer’s packag e insert. I. Returned, outdated, damaged, deteriorated, adulterated, misbranded, counterfeited, and contraband drugs. prescrip- 1. Except as specified in subsection (H)(1) for a tion-only drug, a full-service drug wholesale permitte e shall ensure that the return of any narcotic or other connon- trolled substance, prescription-only drug or device, prescription drug, precursor chemical, or regulate d chemical meets the following criteria. prescrip- a. Any narcotic or other controlled substance, tion-only drug or device, nonprescription drug, precursor chemical, or regulated chemical that i s mis- outdated, damaged, deteriorated, adulterated, branded, counterfeited, or contraband or suspecte d of being adulterated, misbranded, counterfeited, or contraband, or otherwise deemed unfit for human or animal consumption shall be quarantined and physically separated from other narcotics or other controlled substances, prescription-only drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals until the narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical is destroyed or returned to th e manufacturer or wholesale distributor from which it was acquired as authorized by the Board and th e FDA. prescrip- b. Any narcotic or other controlled substance, tion-only drug or device, nonprescription drug, precursor chemical, or regulated chemical whos e immediate or sealed outer or secondary containers or product labeling are misbranded, counterfeited, or contraband or suspected of being misbranded, counterfeited, or contraband shall be quarantined an d physically separated from other narcotics or other controlled substances, prescription-only drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals until the narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical is destroyed or returned to th e manufacturer or wholesale distributor from which it was acquired as authorized by the Board and th e FDA. When the immediate or sealed outer or secondary containers or product labeling are determined to be misbranded, counterfeited, or contraband or suspected of being misbranded, coun- 26-1 Page 41 Arizona Administrative TITLE 4. PROFESSIONS AND CHAPTER 23. BOARD OF terfeited, or contraband, the full-service drug wholesale permittee shall provide notice of th e misbranding, counterfeiting, or contrabanding or suspected misbranding, counterfeiting, or contrabanding within three business days of the determination to the Board, FDA, and manufacturer or wholesale distributor from which the narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical was acquired. c. Any narcotic or other controlled substance, prescrippre- tion-only drug or device, nonprescription drug, cursor chemical, or regulated chemical that has bee n opened or used, but is not adulterated, misbranded, counterfeited, or contraband or suspected of bein g misbranded, counterfeited, or contraband shall b e identified as opened or used, or both, and quarantined and physically separated from other narcotic s or other controlled substances, prescription-onl y drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals until the narcoti c or other controlled substance, prescription-only dru g or device, nonprescription drug, precursor chemical, or regulated chemical is destroyed or returned to th e 2. manufacturer or wholesale distributor from which it was acquired as authorized by the Board and th e FDA. d. If the conditions under which a narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical has been returned cast doubt o n the safety, identity, strength, quality, or purity of th e narcotic or other controlled substance, prescriptiononly drug or device, nonprescription drug, precursor chemical, or regulated chemical, the narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical shall be quarantined and physicon- cally separated from other narcotics or other trolled substances, prescription-only drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals until the narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical is destroyed or returned to th e manufacturer or wholesale distributor from which it was acquired as authorized by the Board and th e FDA, except as provided in subsection (I)(1)(d)(i). i. If examination, testing, or other investigatio n proves that the narcotic or other controlled subnon- stance, prescription-only drug or device, prescription drug, precursor chemical, or regulated chemical meets appropriate standard s of safety, identity, strength, quality, and purity, it does not have to be destroyed or returned t o the manufacturer or wholesale distributor. ii. In determining whether the conditions under which a narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulate d chemical has been returned cast doubt on th e safety, identity, strength, quality, or purity of pre- the narcotic or other controlled substance, scription-only drug or device, nonprescriptio n Supp. 26-1 Code OCCUPATIONS PHARMACY drug, precursor chemical, or regulated chemical, the full-service drug wholesale permitte e condi- shall consider, among other things, the tions under which the narcotic or other controlled substance, prescription-only drug or chemi- device, nonprescription drug, precursor cal, or regulated chemical has been held, stored, or shipped before or during its retur n con- and the condition of the narcotic or other trolled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical and the condition of its container, carton, or product labeling as a result of storage or shipping. pre- e. For any narcotic or other controlled substance, scription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical identifie d under subsections (I)(1)(a) or (b), the full-servic e drug wholesale permittee shall ensure that the identified item or items and other evidence of criminal activity, and accompanying documentation i s retained and not destroyed until its disposition i s authorized by the Board and the FDA. A nonprescription drug wholesale permittee shall ensur e that the return of any nonprescription drug, precursor chemical, or regulated chemical meets the following criteria. a. Any nonprescription drug, precursor chemical, or regulated chemical that is outdated, damaged, deteriorated, adulterated, misbranded, counterfeited, or contraband or suspected of being adulterated, misbranded, counterfeited, or contraband, or otherwis e deemed unfit for human or animal consumptio n shall be quarantined and physically separated fro m other nonprescription drugs, precursor chemicals, or regulated chemicals until the nonprescription drug, precursor chemical, or regulated chemical i s destroyed or returned to the manufacturer or wholeautho- sale distributor from which it was acquired as rized by the Board and the FDA. b. Any nonprescription drug, precursor chemical, or regulated chemical whose immediate or sealed outer or secondary containers or product labeling are misbranded, counterfeited, or contraband or suspecte d of being misbranded, counterfeited, or contraban d shall be quarantined and physically separated fro m other nonprescription drugs, precursor chemicals, or regulated chemicals until the nonprescription drug, precursor chemical, or regulated chemical i s destroyed or returned to the manufacturer or wholeautho- sale distributor from which it was acquired as rized by the Board and the FDA. When th e immediate or sealed outer or secondary containers or product labeling are determined to be misbranded, counterfeited, or contraband or suspected of bein g misbranded, counterfeited, or contraband, the nonprescription drug wholesale permittee shall provid e notice of the misbranding, counterfeiting, or contrabanding or suspected misbranding, counterfeiting, or contrabanding within three business days of th e determination to the Board, FDA, and manufacturer or wholesale distributor from which the nonprescription drug, precursor chemical, or regulated chemical was acquired. Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD c. Any nonprescription drug, precursor chemical, or regulated chemical that has been opened or used, but is not adulterated, misbranded, counterfeited, or contraband or suspected of being misbranded, counterfeited, or contraband, shall be identified a s physi- opened or used, or both, and quarantined and cally separated from other nonprescription drugs, precursor chemicals, or regulated chemicals until th e regu- nonprescription drug, precursor chemical, or lated chemical is destroyed or returned to the manufacturer or wholesale distributor from which it wa s acquired as authorized by the Board and the FDA. d. If the conditions under which a nonprescriptio n drug, precursor chemical, or regulated chemical ha s been returned cast doubt on the safety, identity, strength, quality, or purity of the nonprescriptio n drug, precursor chemical, or regulated chemical, th e regu- nonprescription drug, precursor chemical, or lated chemical shall be quarantined and physicall y separated from other nonprescription drugs, precurnon- sor chemicals, or regulated chemicals until the prescription drug, precursor chemical, or regulate d chemical is destroyed or returned to the manufacturer or wholesale distributor from which it wa s acquired as authorized by the Board and the FDA, except as provided in subsection (I)(2)(d)(i). i. If examination, testing, or other investigatio n proves that the nonprescription drug, precursor chemical, or regulated chemical meets appropriate standards of safety, identity, strength, quality, and purity, the nonprescription drug, precursor chemical, or regulated chemical doe s man- not need to be destroyed or returned to the ufacturer or wholesale distributor. ii. In determining whether the conditions under chemi- which a nonprescription drug, precursor cal, or regulated chemical has been returne d cast doubt on the safety, identity, strength, qualpre- ity, or purity of the nonprescription drug, cursor chemical, or regulated chemical, th e nonprescription drug wholesale permittee shall consider, among other things, the condition s under which the nonprescription drug, precursor chemical, or regulated chemical has bee n held, stored, or shipped before or during it s return and the condition of the nonprescriptio n drug, precursor chemical, or regulated chemical and the condition of its container, carton, or product labeling as a result of storage or shipping. e. For any nonprescription drug, precursor chemical, or regulated chemical identified under subsection s (I)(2)(a) or (b), the nonprescription drug wholesal e permittee shall ensure that the identified item or items and other evidence of criminal activity, an d accompanying documentation is retained and not destroyed until its disposition is authorized by th e Board and the FDA. 3. A full-service drug wholesale permittee and nonprescription drug wholesale permittee shall comply with th e recordkeeping requirements of subsection (G) for all outdated, damaged, deteriorated, adulterated, misbranded, con- counterfeited and contraband narcotics or other trolled substances, prescription-only drugs or devices, March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY nonprescription drugs, precursor chemicals, or regulate d chemicals. per- J. Facility. A full-service or nonprescription drug wholesale mittee shall: 1. Ensure that the facility occupied by the full-service or nonprescription drug wholesale permittee is of adequat e size and construction, well-lighted inside and outside, adequately ventilated, and kept clean, uncluttered, an d sanitary; 2. Ensure that the permittee’s warehouse facility: a. Is secure from unauthorized entry; and pro- b. Has an operational security system designed to vide protection against theft; 3. In a full-service drug wholesale facility, ensure that onl y authorized personnel may enter areas where any narcoti c or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical is kept; 4. In a nonprescription drug wholesale facility, ensure that only authorized personnel may enter areas where an y nonprescription drug, precursor chemical, or regulate d chemical is kept; 5. In a full-service drug wholesale facility, ensure that an y pre- thermolabile narcotic or other controlled substance, scription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical is stored in a n compli- area where room temperature is maintained in ance with storage conditions prescribed on the product label; 6. In a nonprescription drug wholesale facility, ensure that any thermolabile nonprescription drug, precursor chemical, or regulated chemical is stored in an area where roo m temperature is maintained in compliance with storag e conditions prescribed on the product label; 7. Make the facility available for inspection by a Boar d compliance officer or other authorized officer of the la w as defined in A.R.S. § 32-1901(5) during regular busines s hours; quar- 8. In a full-service drug wholesale facility, provide a antine area for storage of any narcotic or other controlle d substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical that is outdated, damaged, deteriorated, adulterated, misbranded, counterfeited, or contraband or suspected of contra- being adulterated, misbranded, counterfeited, or band, otherwise deemed unfit for human or animal consumption, or that is in an open container; and 9. In a nonprescription drug wholesale facility, provide a quarantine area for storage of any nonprescription drug, precursor chemical, or regulated chemical that is outdated, damaged, deteriorated, adulterated, misbranded, counterfeited, or contraband or suspected of being adulterated, misbranded, counterfeited, or contraband, otherwise deemed unfit for human or animal consumption, or that is in an open container. K. Quality controls. 1. A full-service drug wholesale permittee shall: a. Ensure that any narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulate d chemical that meets the criteria specified in subsection (I)(1) is not sold, distributed, or delivered to an y person for human or animal consumption; 26-1 Page 43 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD b. Ensure that a narcotic or other controlled substance, prescription-only drug or device, nonprescriptio n drug, precursor chemical, or regulated chemical i s not manufactured, packaged, repackaged, labeled, or relabeled by any of its employees; sub- c. Ensure that any narcotic or other controlled stance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulate d chemical stocked, sold, offered for sale, or delivere d is: i. Kept clean, deteri- ii. Protected from contamination and other orating environmental factors, and iii. Stored in a manner that complies with applicacompen- ble federal and state law and official dium storage requirements; d. Maintain manual or automatic temperature an d con- humidity recording devices or logs to document ditions in areas where any narcotic or other controlled substance, prescription-only drug or device, regu- nonprescription drug, precursor chemical, or lated chemical is stored; and e. Develop and implement a program to ensure that: con- i. Any expiration-dated narcotic or other trolled substance, prescription-only drug or device, nonprescription drug, precursor chemiregu- cal, or regulated chemical is reviewed larly; ii. Any narcotic or other controlled substance, prescription-only drug or device, nonprescriptio n drug, precursor chemical, or regulated chemical that has less than 120 days remaining on th e expiration date, or is deteriorated, damaged, or does not comply with federal law, is moved to a quarantine area and not sold or distributed; and iii. Any quarantined narcotic or other controlle d substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical is destroyed or returned t o the manufacturer or wholesale distributor from which it was acquired. 2. A nonprescription drug wholesale permittee shall: a. Ensure that any nonprescription drug, precursor chemical, or regulated chemical that meets the critedistrib- ria specified in subsection (I)(2) is not sold, uted, or delivered to any person for human or animal consumption; chemi- b. Ensure that a nonprescription drug, precursor cal, or regulated chemical is not manufactured, packaged, repackaged, labeled, or relabeled by an y of its employees; c. Ensure that any nonprescription drug, precursor chemical, or regulated chemical stocked, sold, offered for sale, or delivered is: i. Kept clean, ii. Protected from contamination and other deteriorating environmental factors, and iii. Stored in a manner that complies with applicable federal and state law and official compendium storage requirements; d. Maintain manual or automatic temperature an d humidity recording devices or logs to document conpre- ditions in areas where any nonprescription drug, cursor chemical, or regulated chemical is stored; and Supp. Administrative Code AND OCCUPATIONS OF PHARMACY e. Develop and implement a program to ensure that: i. Any expiration-dated nonprescription drug, precursor chemical, or regulated chemical i s reviewed regularly; ii. Any nonprescription drug, precursor chemical, or regulated chemical that has fewer than 12 0 days remaining on the expiration date, or i s deteriorated, damaged, or does not comply wit h federal law, is moved to a quarantine area an d not sold or distributed; and iii. Any quarantined nonprescription drug, precursor chemical, or regulated chemical i s destroyed or returned to the manufacturer or wholesale distributor from which it wa s acquired. L. Fingerprint clearance. 1. After receiving the state and federal criminal histor y record of a designated representative, the Board shall compare the record with the list of criminal offenses that preclude a designated representative from receiving a fingerprint clearance. If the designated representative’ s criminal history record does not contain any of th e offenses listed in subsection (L)(2), the Board shall issu e the designated representative a fingerprint clearance. 2. The Board shall not issue a fingerprint clearance to a designated representative who is awaiting trial for or wh o con- has been convicted of committing or attempting or spiring to commit one or more of the following offense s in this state or the same or similar offenses in another state or jurisdiction: a. Unlawfully administering intoxicating liquors, controlled substances, dangerous drugs, or prescriptiononly drugs; b. Sale of peyote; c. Possession, use, or sale of marijuana, dangerou s sub- drugs, prescription-only drugs, or controlled stances; d. Manufacture or distribution of an imitation controlled substance; e. Manufacture or distribution of an imitation prescription-only drug; imita- f. Possession or possession with intent to use an tion controlled substance; g. Possession or possession with intent to use an imitation prescription-only drug; or h. A felony offense involving sale, distribution, or transportation of, offer to sell, transport, or distribute, or conspiracy to sell, transport, or distribut e marijuana, dangerous drugs, prescription-onl y drugs, or controlled substances. fed- 3. If the Board determines, after conducting a state and eral criminal history record check, that it is not authorize d to issue a fingerprint clearance, the Board shall notify th e full-service drug wholesale applicant or permittee that employs the designated representative that the Board i s not authorized to issue a fingerprint clearance. Thi s notice shall include the criminal history information o n which the denial was based. This criminal history information is subject to dissemination restrictions under A.R.S. § 41-1750 and federal law. Historical Note Former Rules 6.5110, 6.5120, 6.5130, 6.5140, 6.5210, 6.5220, 6.5230, 6.5240, 6.5310, 6.5320, 6.5410, and 6.5420. Amended effective August 10, 1978 (Supp. 78- 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 4). Amended effective April 20, 1982 (Supp. 82-2). Amended subsection (A) effective August 12, 1988 (Supp. 88-3). Amended effective February 8, 1991 (Supp. 91-1). Amended effective August 24, 1992 (Supp. 92-3). Amended by final rulemaking at , effective November 14, 2000 (Supp. 00-4). Amended by final rulemaking at 10 A.A.R. 232, effective March 6, 2004 (Supp. 04-1). Amended by final rulemaking at 11 A.A.R. 1105, effective April 30, 2005 (Supp. 05-1). Amended by final rulemaking at 11 A.A.R. 4270, effective December 6, 2005 (Supp. 05-4). Amended by final rulemaking at 13 A.A.R. 3477, effective December 1, 2007 (Supp. 07-4). Amended by final rulemaking at 19 A.A.R. 702, effective June 1, 2013 (Supp. 13-2). Amended by final rulemaking at , effective June 1, 2019 (Supp. 19-2). R4-23-606. Resident-Pharmacy Permit: Community, Hospital, and Limited Service A. Permit. A person shall not operate a pharmacy in Arizon a without a current Board-issued pharmacy permit. B. Application. 1. To obtain a permit to operate a pharmacy in Arizona, a person shall submit a completed application, on a form available from the Board, and the fee specified in R4-23- 205. 2. Before issuing a pharmacy permit, the Board shall: a. Receive and approve a completed permit application; and b. Receive a satisfactory compliance inspection report on the facility from a Board compliance officer. inter- 3. Before issuing a pharmacy permit, the Board may view the applicant and the pharmacist-in-charge, if different from the applicant, at a Board meeting based on th e need for additional information. C. Notification. A pharmacy permittee shall notify the Boar d office within 10 days of changes involving the type of pharmacy operated, telephone or fax number, e-mail or mailin g address, business name, or staff pharmacist. A pharmacy permittee shall provide the Board office immediate notice of a change of the pharmacist-in-charge. D. If any nonprescription drugs are sold outside the pharmac y area when the pharmacy area is closed, the pharmacy permittee shall ensure that the business has a current, Board-issue d nonprescription drug permit as required in Section R4-23-603. E. Change of ownership. A pharmacy permittee shall compl y with R4-23-601(F). F. Relocation or remodel. 1. No fewer than 30 days before the relocation or remodel of sub- an existing pharmacy, the pharmacy permittee shall mit, electronically or manually, a completed applicatio n for remodel or relocation using the form specified under subsection (B). A fee is not required with an applicatio n for remodel or relocation. 2. The new or remodeled facility shall pass a final inspection by a Board compliance officer before operation s begin. G. Permit renewal. To renew a pharmacy permit, the permitte e shall comply with R4-23-602(D). Historical Note Former Rules 6.6010, 6.6020, 6.6030, 6.6040, 6.6050, 6.6060, 6.6071, 6.6072, 6.6073, 6.6074, 6.6075, and 6.6076. Amended effective August 10, 1978 (Supp. 78- 4). Amended subsections (G) and (H) effective April 20, 1982 (Supp. 82-2). Amended subsection (L) effective March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY July 2, 1982 (Supp. 82-4). Amended subsections (G) and (H) effective August 12, 1988 (Supp. 88-3). Amended head- effective November 1, 1993 (Supp. 93-4). Section ing amended effective April 5, 1996 (Supp. 96-2). Amended by final rulemaking at 7 A.A.R. 3825, effective rulemak- August 9, 2001 (Supp. 01-3). Amended by final ing at , effective August 2, 2014 (Supp. 14-2). Amended by final rulemaking at , effective June 1, 2019 (Supp. 19-2). R4-23-607. Nonresident Permits A. Permit. A person that is not a resident of Arizona shall not sell pre- or distribute any narcotic or other controlled substance, scription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical into Arizona without possessing both: 1. A current Board-issued nonresident pharmacy permit, nonresident manufacturer permit, or nonresident full-service or nonprescription drug wholesale permit; and 2. A current equivalent license or permit issued by th e licensing authority in the jurisdiction where the perso n resides. B. Application. To obtain a nonresident pharmacy, nonresident manufacturer, or nonresident full-service or nonprescriptio n drug wholesale, a person shall submit a completed application, on a form furnished by the Board, and the fee specified in R4- 23-205. C. Notification. A permittee shall submit notification of an y change required in this subsection using the permittee’s onlin e profile or as a written notice by mail, fax, or e-mail to th e Board office within 10 days of the change. 1. Nonresident pharmacy. A nonresident pharmacy permittee shall notify the Board of changes involving the type of pharmacy operated, address, telephone number, busines s name, or pharmacist-in-charge. 2. Nonresident manufacturer. A nonresident manufacturer permittee shall notify the Board of changes involvin g listed drugs, address, telephone number, business name, or manager, including manager’s telephone number. 3. Nonresident drug wholesaler. A nonresident full-servic e or nonprescription drug wholesale permittee shall notif y the Board of changes involving the types of drugs sold or distributed, address, telephone number, business name, or manager or designated representative, including the manager’s or designated representative’s telephone number. For a change of designated representative, a nonresident full-service drug wholesale permittee shall submit th e documentation, fingerprints, and fee required with th e application under subsection (B). D. Change of ownership. A nonresident permittee shall compl y with R4-23-601(F). E. Drug sales. 1. Nonresident pharmacy. A nonresident pharmacy permittee shall: nar- a. Not sell, distribute, give away, or dispose of any cotic or other controlled substance or prescriptiononly drug or device to anyone in Arizona except: i. A pharmacy, drug manufacturer, or full-servic e drug wholesaler currently permitted by th e Board; ii. A medical practitioner currently licensed under A.R.S. Title 32; or iii. An Arizona resident upon receipt of a valid prescription order for the resident; 26-1 Page 45 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD b. Not sell, distribute, give away, or dispose of an y nonprescription drug, precursor chemical, or regulated chemical to anyone in Arizona except: i. A pharmacy, drug manufacturer, or full-servic e or nonprescription drug wholesaler currentl y permitted by the Board; ii. A medical practitioner currently licensed under A.R.S. Title 32; or iii. An Arizona resident either upon receipt of a valid prescription order for the resident or i n the original container packaged and labeled b y the manufacturer; c. Except for a drug sale that results from the receipt and dispensing of a valid prescription order for a n per- Arizona resident, maintain a copy of the current mit or license of each person in Arizona that buys, receives, or disposes of any narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical; and d. Provide permit and license records upon request, if immediately available, or in no fewer than two business days from the date of the request of a Boar d compliance officer or other authorized officer of th e law as defined in A.R.S. § 32-1901. 2. Nonresident manufacturer. A nonresident manufacturer permittee shall: a. Not sell, distribute, give away, or dispose of any narcotic or other controlled substance or prescriptiononly drug or device to anyone in Arizona except a pharmacy, drug manufacturer, or full-service dru g wholesaler currently permitted by the Board or a medical practitioner currently licensed under A.R.S. Title 32; b. Not sell, distribute, give away, or dispose of an y regu- nonprescription drug, precursor chemical, or lated chemical to anyone in Arizona except a pharmacy, drug manufacturer, or full-service or nonprescription drug wholesaler currently permitte d by the Board or a medical practitioner currentl y licensed under A.R.S. Title 32; c. Maintain a copy of the current permit or license of each person in Arizona that buys, receives, or disposes of any narcotic or other controlled substance, prescription-only drug or device, nonprescriptio n drug, precursor chemical, or regulated chemical; and d. Provide permit and license records upon request, if busi- immediately available, or in no more than two ness days from the date of the request of a Boar d compliance officer or other authorized officer of th e law as defined in A.R.S. § 32-1901. 3. Nonresident full-service drug wholesaler. In addition t o complying with the distribution restrictions specified i n whole- A.R.S. § 32-1983, a nonresident full-service drug sale permittee shall: a. Not sell, distribute, give away, or dispose of, an y narcotic or other controlled substance, prescriptiononly drug or device, nonprescription drug, precursor chemical, or regulated chemical to anyone in Arizona, except in the original container, packaged an d labeled by the manufacturer or repackager; b. Not package, repackage, label, or relabel any narcotic or other controlled substance, prescriptiononly drug or device, nonprescription drug, precursor Supp. Administrative Code AND OCCUPATIONS OF PHARMACY chemical, or regulated chemical for shipment or delivery to anyone in Arizona; c. Provide track and trace documents required under the Drug Supply Chain and Security Act upo n request, if immediately available, or in no more tha n two business days from the date of the request of a Board compliance officer or other authorized officer of the law as defined in A.R.S. § 32-1901; nar- d. Not sell, distribute, give away, or dispose of any cotic or other controlled substance, prescription onl y drug or device, nonprescription drug, precursor Ari- chemical, or regulated chemical to anyone in zona except a pharmacy, drug manufacturer, or full service drug wholesaler currently permitted by th e Board or a medical practitioner currently license d under A.R.S. Title 32; e. Not sell, distribute, give away, or dispose of an y regu- nonprescription drug, precursor chemical, or lated chemical to anyone in Arizona except a pharmacy, drug manufacturer, or full-service or nonprescription drug wholesaler currently permitte d by the Board or a medical practitioner currentl y licensed under A.R.S. Title 32; f. Maintain a copy of the current permit or license of each person in Arizona that buys, receives, or disposes of any narcotic or other controlled substance, prescription-only drug or device, nonprescriptio n drug, precursor chemical, or regulated chemical; and g. Provide permit and license records upon request, if busi- immediately available, or in no more than two ness days from the date of the request of a Boar d compliance officer or other authorized officer of th e law as defined in A.R.S. § 32-1901. 4. Nonresident nonprescription drug wholesaler. A nonresident nonprescription drug wholesale permittee shall: a. Not sell, distribute, give away, or dispose of an y nonprescription drug, precursor chemical, or regulated chemical to anyone in Arizona, except in th e man- original container, packaged and labeled by the ufacturer or repackager; b. Not package, repackage, label, or relabel any nonprescription drug, precursor chemical, or regulate d chemical for shipment or delivery to anyone in Arizona; c. Not sell, distribute, give away, or dispose of an y nonprescription drug, precursor chemical, or regulated chemical to anyone in Arizona except a pharmacy, drug manufacturer, or full-service or nonprescription drug wholesaler currently permitte d by the Board or a medical practitioner currentl y licensed under A.R.S. Title 32; d. Maintain a copy of the current permit or license of each person in Arizona that buys, receives, or dischemi- poses of any nonprescription drug, precursor cal, or regulated chemical; and e. Provide permit and license records upon request, if busi- immediately available, or in no more than two ness days from the date of the request of a Boar d compliance officer or other authorized officer of th e law as defined in A.R.S. § 32-1901. F. When selling or distributing any narcotic or other controlle d substance, prescription-only drug or device, nonprescriptio n drug, precursor chemical, or regulated chemical into Arizona, a nonresident pharmacy, nonresident manufacturer, or nonresi- 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD dent full-service or nonprescription drug wholesaler shall comply with federal law, the permittee’s resident state dru g law, and this Section. Historical Note Former Rules 6.6110, 6.6120, and 6.6130; Amended effective August 10, 1978 (Supp. 78-4). Repealed effective July 24, 1985 (Supp. 85-4). New Section adopted by final rulemaking at , effective November 14, 2000 (Supp. 00-4). Amended by final rulemaking at 7 A.A.R. 3825, effective August 9, 2001 (Supp. 01-3). Amended by final rulemaking at 10 A.A.R. 232, effective March 6, 2004 (Supp. 04-1). Amended by final rulemaking at 13 A.A.R. 520, effective April 7, 2007 (Supp. 07- 1). Amended by final rulemaking at 13 A.A.R. 3477, effective December 1, 2007 (Supp. 07-4). Amended by final rulemaking at , effective June 1, 2019 (Supp. 19-2). Amended by final rulemaking at 26 A.A.R. 223, effective March 14, 2020 (Supp. 20-1). Amended by final rulemaking at 31 A.A.R. 2363 (July 18, 2025), effective August 30, 2025 (Supp. 25-3). R4-23-608. Change of Personnel and Responsibility A. A community, hospital, or limited-service pharmacy permitte e shall give the Board: 1. Notice by mail, facsimile, or electronic mail within te n days of employing or terminating a pharmacist; and 2. Immediate notice of designating or terminating a pharmacist-in-charge. B. Responsibility of ownership and management. The owner an d management of a pharmacy shall: 1. Ensure that pharmacists, interns, and other pharmac y admin- employees comply with state and federal laws and istrative rules; and 2. Not overrule a pharmacist in matters of pharmacy ethic s phar- and interpreting laws pertaining to the practice of macy or the distribution of drugs and devices. C. The Board may suspend or revoke a pharmacy permit if th e owner or management of a pharmacy violates subsection (B). Historical Note Former Rules 6.6140 and 6.6150; Amended subsection (A) effective August 9, 1983 (Supp. 83-4). Amended effective November 1, 1993 (Supp. 93-4). Amended by final rulemaking at 7 A.A.R. 4253, effective September 11, 2001 (Supp. 01-3). R4-23-609. Pharmacy Area of Community Pharmacy A. Minimum area of community pharmacy. The minimum area of a community pharmacy, the actual area primarily devoted t o compound- stocking drugs restricted to pharmacists, and to the ing and dispensing of prescription medication, exclusive of office area or other support function area, shall not be less tha n 300 square feet. A maximum of three pharmacy personnel may practice or work simultaneously in the minimum area. The pharmacy permittee shall provide an additional 60 squar e feet of floor area for each additional pharmacist, graduat e intern, pharmacy intern, pharmacy technician, pharmacy technician trainee, or support personnel who may practice or wor k includ- simultaneously. All of the allotted square footage area, ing adequate shelving, shall lend itself to efficient pharmaceutical practice and permit free movement and visual surveillance of personnel by the pharmacist. B. Compounding and dispensing counter. On or after January 6, 2004, a pharmacy permit applicant or remodel or relocatio n applicant shall provide a compounding and dispensing counter March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY that provides a minimum of three square feet of pharmac y counter working area of not less than 16 inches in depth and 2 4 inches in length for the practice of one pharmacist, graduat e intern, pharmacy intern, pharmacy technician, or pharmac y technician trainee. For each additional pharmacist, graduat e intern, pharmacy intern, pharmacy technician, or pharmac y technician trainee practicing simultaneously, there shall be a n additional three square feet of pharmacy counter working are a of not less than 16 inches in depth and 24 inches in length. Th e Board shall determine a pharmacy’s total required compounding and dispensing counter area by multiplying the maximu m number of personnel allowed in the pharmacy area using th e requirements specified in subsection (A) by three square feet per person. A pharmacy permittee or pharmacist-in-charg e may operate the pharmacy with a total pharmacy counter working area specified in subsection (A) that is equal to th e actual maximum number of pharmacists, graduate interns, tech- pharmacy interns, pharmacy technicians, and pharmacy nician trainees, working simultaneously in the pharmacy are a times three square feet per person. C. Working area for compounding and dispensing counter. Th e aisle floor area used by the pharmacist, graduate intern, pharmacy intern, pharmacy technician, or pharmacy technicia n trainee at the compounding and dispensing counter shall extend the full length of the counter and be clear and continuous for a minimum of 36 inches from any counter, fixture, or structure. D. Area for patient counseling. On or after April 1, 1995, a pharmacy permit applicant or remodel or relocation applicant shall provide a separate and distinct patient counseling area that provides patient privacy. This subsection does not apply to a pharmacy exempt from the requirements of R4-23-402(B). E. Narcotic cabinet or safe. To prevent diversion, narcotics an d other controlled substances may be: 1. Kept in a separate locked cabinet or safe, or 2. Dispersed throughout the pharmacy’s prescription-onl y drug stock. F. Building security standard of community pharmacy area. Th e par- pharmacy area shall be enclosed by a permanent barrier or tition from floor or counter to structural ceiling or roof, wit h entry doors that can be securely locked. The barrier shall b e designed so that only a pharmacist can access the area wher e prescription-only drugs, narcotics, and other controlled substances are stored, compounded and dispensed. The permanent barrier may be constructed of other than a solid material. If constructed of a material other than a solid, the openings or interstices of the material shall not be large enough to permit removal of items in the pharmacy area through the barrier. Any material used in the construction of the permanent barrier must be of sufficient strength and thickness that it cannot b e readily or easily removed, penetrated, or bent. The pharmac y permittee shall submit plans and specifications of the permanent barrier to the Board for approval. G. Drug storage and security. 1. The pharmacy permittee shall ensure that drugs an d devices are stored in a dry, well-lit, ventilated, and clea n and orderly area. The pharmacy permittee shall maintai n the drug storage area at temperatures that ensure th e integrity of the drugs before dispensing as stated in th e official compendium defined in A.R.S. § 32-1901(55) or the manufacturer’s or distributor’s labeling. 2. If the pharmacy permittee needs additional storage are a for drugs that are restricted to sale by a pharmacist, th e pharmacy permittee shall ensure that the area is containe d 26-1 Page 47 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD by a permanent barrier from floor or counter to structural ceiling or roof. The pharmacy permittee shall lock all pharma- doors and gates to the drug storage area. Only a cist with a key is permitted to enter the storage area, except in an extreme emergency. H. A pharmacy permittee or pharmacist-in-charge shall ensur e that the pharmacy working counter area is protected from unauthorized access while the pharmacy is open for busines s by a barrier not less than 66 inches in height or another metho d approved by the Board or its designee. Historical Note Former Rules 6.6210, 6.6220, 6.6230, 6.6240, 6.6250, 6.6310, 6.6320, and 6.6330; Amended effective August 10, 1978 (Supp. 78-4). Amended effective August 9, 1983 (Supp. 83-4). Amended effective November 1, 1993 (Supp. 93-4). Amended effective April 1, 1995; filed with the Secretary of State January 31, 1995 (Supp. 95-1). Amended by final rulemaking at 9 A.A.R. 5030, effective January 3, 2004 (Supp. 03-4). Amended by final rulemaking at 19 A.A.R. 97, effective March 10, 2013 (Supp. 13-1). Secu- R4-23-610. Community Pharmacy Personnel and rity Procedures A. Every pharmacy shall have a pharmacist designated as th e “pharmacist-in-charge.” 1. The pharmacist-in-charge shall ensure the communication and compliance of Board directives to the management, other pharmacists, interns, and technicians of th e pharmacy. 2. The pharmacist-in-charge shall: a. Ensure that all pharmacy policies and procedure s required under are prepared, implemented, and complied with; phar- b. Review biennially and, if necessary, revise all macy policies and procedures required under 4 A.A.C. 23; c. Document the review required under subsectio n (A)(2)(b); d. Ensure that all pharmacy policies and procedure s writ- required under are assembled as a ten or electronic manual; and e. Make all pharmacy policies and procedures require d under available in the pharmacy for employee reference and inspection by the Board or its staff. B. Personnel permitted in the pharmacy area of a communit y pharmacy include pharmacists, graduate interns, pharmac y interns, compliance officers, drug inspectors, peace officer s acting in their official capacity, other persons authorized b y law, pharmacy technicians, pharmacy technician trainees, support personnel, and other designated personnel. Pharmac y interns, graduate interns, pharmacy technicians, pharmac y technician trainees, support personnel, and other designate d personnel shall be permitted in the pharmacy area only when a pharmacist is on duty, except in an extreme emergency a s defined in R4-23-110. 1. The pharmacist-in-charge shall comply with the minimum area requirements as described in R4-23-609 for a community pharmacy and for compounding and dispensing counter area. 2. A pharmacist employed by a pharmacy shall ensure that the pharmacy is physically secure while the pharmacist i s on duty. Supp. Administrative Code AND OCCUPATIONS OF PHARMACY C. In a community pharmacy, a pharmacist shall ensure that th e pharmacy area, and any additional storage area for drugs that is restricted to access only by a pharmacist is locked when a pharmacist is not present, except in an extreme emergency. D. A pharmacist is the only person permitted by the Board t o unlock the pharmacy area or any additional storage area for drugs restricted to access only by a pharmacist, except in a n extreme emergency. E. A pharmacy permittee or pharmacist-in-charge shall ensur e that any prescription-only drugs and controlled substance s received in an area outside the pharmacy area are immediatel y transferred unopened to the pharmacy area. The pharmacistin-charge shall ensure that any prescription-only drug and controlled substance shipments are opened and marked by pharmacy personnel in the pharmacy area under the supervision of a pharmacist, graduate intern, or pharmacy intern. F. A pharmacy permittee or pharmacist-in-charge may provide a small opening or slot through which a written prescriptio n order or prescription medication container to be refilled ma y be left in the prescription area when the pharmacist is not present. G. A pharmacist shall ensure that prescription medication is not left outside the prescription area or picked up by the patient when the pharmacist is not present by either: 1. Delivering the prescription medication to the patient, or 2. Securing the prescription medication inside the locke d pharmacy, except when using an automated storage an d distribution system that complies with the requirement s of R4-23-614. Historical Note Former Rules 6.6410, 6.6420, 6.6430, 6.6440, 6.6450, 6.6460, 6.6470, 6.6480, and 6.6490; Amended subsection (F), deleted subsection (I) effective August 9, 1983 (Supp. 83-4). Amended effective May 16, 1990 (Supp. 90-2). Amended effective November 1, 1993 (Supp. 93- 4). Amended effective April 1, 1995; filed with the Secretary of State January 31, 1995 (Supp. 95-1). Amended by final rulemaking at 5 A.A.R. 4441, effective November 2, 1999 (Supp. 99-4). Amended by final rulemaking at 10 A.A.R. 4453, effective December 4, 2004 (Supp. 04-4). Amended by final rulemaking at , effective October 1, 2006 (Supp. 06-3). Amended by final rulemaking at 13 A.A.R. 2631, effective September 8, 2007 (Supp. 07-3). R4-23-611. Pharmacy Facilities A. Facilities. A pharmacy permittee or pharmacist-in-charge shall ensure that: 1. A pharmacy’s facilities are constructed according to stat e and local laws and ordinances; 2. A pharmacy facility’s: a. Walls, ceilings, windows, floors, shelves, and equipment are clean and in good repair and order; and b. Counters, shelves, aisles, and open spaces are not cluttered; 3. Adequate trash receptacles are provided and emptie d periodically during the day; 4. A pharmacy facility of any pharmacy permit issued or pharmacy remodeled after February 1, 2014 provide s access to toilet facilities either: a. Within the pharmacy area, or b. No further than a walking distance of 100 feet fro m the pharmacy area or an alternative distanc e approved by the Board or its designee; 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 5. The toilet facilities are maintained in a sanitary conditio n and in good repair; 6. All professional personnel and staff of the pharmacy kee p themselves and their apparel clean while in the pharmac y area; 7. No animals, except licensed assistant animals and guar d animals, are allowed in the pharmacy; 8. The pharmacy facility is kept free of insects and rodents; and 9. There is a sink with hot and cold running water, other than a sink in a toilet facility, within the pharmacy are a for use in preparing drug products. B. Supply of drugs and chemicals. A pharmacy permittee or pharmacist-in-charge shall ensure that: 1. A pharmacy maintains a stock of drugs and chemical s that: a. Are sufficient to meet the normal demands of th e trading area or patient base the pharmacy serves; and b. Meet all standards of strength and purity as established by the official compendiums; ulti- 2. All stock, materials, drugs, and chemicals held for mate sale or supply to the consumer are not contaminated; 3. Policies and procedures are developed, implemented, an d complied with to prevent the sale or use of a drug or chemical: a. That exceeds its expiration date; b. That is deteriorated or damaged by reason of age, heat, light, cold, moisture, crystallization, chemical solidifi- reaction, rupture of coating, disintegration, cation, separation, discoloration, change of odor, precipitation, or other change as determined b y organoleptic examination or by other means; c. That is improperly labeled; d. Whose container is defective; or e. That does not comply with federal law; and 4. The policies and procedures described in subsectio n (B)(3): a. Are made available in the pharmacy for employe e reference and inspection by the Board or its designee; and b. Provide the following: i. Any expiration-dated drug or chemical i s reviewed regularly; expira- ii. Any drug or chemical that exceeds its tion date, is deteriorated or damaged, improperly labeled, has a defective container, or doe s not comply with federal law, is moved to a quarantine area and not sold or distributed; and iii. Any quarantined drug or chemical is properl y destroyed or returned to its source of supply. Historical Note Former Rules 6.6510, 6.6520, 6.6530, 6.6540, 6.6550, 6.6560, 6.6570, 6.6580, 6.6600, 6.6610, 6.6620, 6.6630, 6.6640, 6.6650, and 6.6660; Amended subsection (B) effective August 9, 1983 (Supp. 83-4). Amended effective April 1, 1995; filed with the Secretary of State January 31, 1995 (Supp. 95-1). Amended by final rulemaking at 7 A.A.R. 4253, effective September 11, 2001 (Supp. 01-3). Amended by final rulemaking at , effective October 1, 2006 (Supp. 06-3). Amended by final rulemaking at 19 A.A.R. 4165, effective February 1, 2014 (Supp. 13-4). March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY R4-23-612. Equipment A pharmacy permittee or pharmacist-in-charge shall ensure that a pharmacy has the necessary equipment to allow a pharmacist t o practice the profession of pharmacy, including the following: 1. Adequate refrigeration equipment dedicated to the storage of drugs and biologicals; 2. A C-V controlled substance register, if C-V controlle d substances are sold without an order of a medical practitioner; 3. Graduates in assorted sizes; 4. One mortar and pestle, not required if the pharmacy permittee states in the application that compounding will not be performed in the pharmacy; 5. Spatulas of assorted sizes including one nonmetallic; elec- 6. Prescription balance, Class A with weights or an tronic balance of equal or greater accuracy, not required if the pharmacy permittee states in the application that compounding will not be performed in the pharmacy; 7. One ointment tile or equivalent, not required if the pharmacy permittee states in the application that compounding will not be performed in the pharmacy 8. A current hard-copy or access to a current electroniccopy of the Arizona Pharmacy Act and administrativ e rules and Arizona Controlled Substance Act; 9. A professional reference library consisting of a minimu m of one current reference or text, in hard-copy or electronic media, addressing the following subject areas: a. Pharmacology or toxicology, b. Therapeutics, c. Drug compatibility, and d. Drug product equivalency; 10. An assortment of labels, including prescription labels, transfer labels for controlled substances, and cautionar y and warning labels; 11. A red C stamp as defined in R4-23-110, if C-III, C-IV, sepa- and C-V controlled substance invoices are not filed rately from other invoices; 12. Current antidote and drug interaction information; and dis- 13. Regional poison control phone number prominently played in the pharmacy area. Historical Note Former Rule 6.6670; Former Section R4-23-612 repealed, new Section R4-23-612 adopted effective August 10, 1978 (Supp. 78-4). Amended effective August 9, 1983 (Supp. 83-4). Amended effective April 5, 1996 (Supp. 96-2). Amended by final rulemaking at 7 A.A.R. 4253, effective September 11, 2001 (Supp. 01-3). Amended by final rulemaking at 19 A.A.R. 4165, effective February 1, 2014 (Supp. 13-4). R4-23-613. Procedure for Discontinuing a Pharmacy A. A pharmacy permittee or pharmacist-in-charge shall provid e Admin- written notice to the Board and the Drug Enforcement istration (D.E.A.) at least 14 days before discontinuing operation of the pharmacy. The notice shall contain the followin g information: 1. Name, address, pharmacy permit number, and D.E.A. registration number of the pharmacy discontinuing business; 2. Name, address, pharmacy permit number (if applicable), and D.E.A. registration number (if applicable) of th e licensee, permittee, or registrant to whom any narcotic or other controlled substance, prescription-only drug or 26-1 Page 49 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD device, nonprescription drug, precursor chemical, or regulated chemical will be sold or transferred; 3. Name and address of the location where the discontinuin g pharmacy’s records of purchase and disbursement of an y narcotic or other controlled substance, prescription-onl y drug or device, nonprescription drug, precursor chemical, or regulated chemical will be kept and the person responsible for the records. These records shall be kept for a minimum of three years from the date the pharmacy i s discontinued; 4. Name and address of the location where the discontinuin g pharmacy’s prescription files and patient profiles will b e kept and the person responsible for the files and profiles. These records shall be kept for a minimum of seven year s from the date the last original or refill prescription wa s dispensed; and 5. The proposed date of discontinuing business operations. B. The pharmacy permittee shall ensure that all pharmacy sign s and symbols are removed from both the inside and outside of the premises. C. The pharmacy permittee or pharmacist-in-charge shall ensur e that all state permits and certificates of registration ar e returned to the Board office and that D.E.A. registration certificates and unused D.E.A. Schedule II order forms are returne d to the D.E.A. Regional Office in Phoenix. D. The pharmacist-in-charge of the pharmacy discontinuing business shall ensure that: 1. Only a pharmacist has access to the prescription-onl y drugs and controlled substances until they are transferre d subsec- to the licensee, permittee, or registrant listed in tion (A)(2); 2. All narcotics or other controlled substances, prescriptiononly drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals are removed from th e premises on or before the date the pharmacy is discontinued; and 3. All controlled substances are transferred as follows: a. Take an inventory of all controlled substances that are transferred using the procedures in R4-23-1003; b. Include a copy of the inventory with the controlle d substances that are transferred; discon- c. Keep the original of the inventory with the tinued pharmacy’s records of narcotic or other controlled substance, prescription-only drug or device, regu- nonprescription drug, precursor chemical, or lated chemical purchase and disbursement for a minimum of three years from the date the pharmacy i s discontinued; d. Use a D.E.A. form 222 to transfer any Schedule II controlled substances; and e. Transfer controlled substances that need destructio n in the same manner as all other controlled substances. E. Upon receipt of outdated or damaged controlled substance s from a discontinued pharmacy, the licensee, permittee, or registrant described in subsection (A)(2) shall contact a D.E.A. out- registered reverse distributor for proper destruction of dated or damaged controlled substances. If there are controlle d substances a reverse distributor will not accept, the licensee, permittee, or registrant shall then contact the Board office an d request an inspection for the purpose of drug destruction. F. During the three-year record retention period specified in subsection (A)(3), the person described in subsection (A)(3) shall provide to the Board upon its request a discontinued phar- Supp. Administrative Code AND OCCUPATIONS OF PHARMACY macy’s records of the purchase and disbursement of narcotic s or other controlled substances, prescription-only drugs or regu- devices, nonprescription drugs, precursor chemicals, or lated chemicals. G. During the seven-year record retention period specified in subsection (A)(4), the person described in subsection (A)(4) shall provide to the Board upon its request a discontinued pharmacy’s records of prescription files and patient profiles. Historical Note New Section made by final rulemaking at 7 A.A.R. 3825, effective August 9, 2001 (Supp. 01-3). Amended by final rulemaking at 11 A.A.R. 1105, effective April 30, 2005 (Supp. 05-1). Amended by final rulemaking at 12 A.A.R. 1912, effective July 1, 2006 (Supp. 06-2). Amended by final rulemaking at 14 A.A.R. 3670, effective November 8, 2008 (Supp. 08-3). R4-23-614. Automated Storage and Distribution System A. Before using an automated storage and distribution system, a pharmacy permittee or pharmacist-in-charge shall: 1. Ensure that the automated storage and distribution syste m and the policies and procedures comply with subsectio n (B); and 2. Notify the Board in writing of the intent to use an automated storage and distribution system, including the typ e or name of the system. B. A pharmacy permittee or pharmacist-in-charge shall establis h policies and procedures for appropriate performance and us e of the automated storage and distribution system that: 1. Ensure that the automated storage and distribution syste m is in good working order while maintaining appropriat e recordkeeping and security safeguards; 2. Ensure that an automated storage and distribution syste m used by the pharmacy that allows access to drugs or devices by a patient: a. Only contains prescriptions that: i. Do not require oral consultation as specified i n R4-23-402(B); and ii. Are properly labeled and verified by a pharmacist before placement into the automated storage and distribution system and subsequent release to patients; b. Allows a patient to choose whether or not to use th e system; c. Is located either in a wall of a properly permitte d pharmacy or within 20 feet of a properly permitte d pharmacy if the automated storage and distributio n system is secured against the wall or floor in such a manner that prevents the automated storage and distribution system’s unauthorized removal; d. Provides a method to identify the patient and onl y release that patient’s prescriptions; e. Is secure from access and removal of drugs or devices by unauthorized individuals; f. Provides a method for a patient to obtain a consultation with a pharmacist if requested by the patient; and g. Does not allow the system to dispense refilled prescriptions if a pharmacist determines that the patient requires oral counseling as specified in R4-23- 402(B); 3. Ensure that an automated storage and distribution syste m used by the pharmacy that allows access to drugs or devices only by authorized licensed personnel for the pur- 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD poses of administration based on a valid prescriptio n order or medication order: unautho- a. Provides for adequate security to prevent rized individuals from accessing or obtaining drug s or devices; and b. Provides for the filling, stocking, or restocking of all drugs or devices in the system only by a Boar d licensee or other authorized licensed personnel; and 4. Implement an ongoing quality assurance program that monitors compliance with the established policies an d procedures of the automated storage and distribution system and federal and state law. C. A pharmacy permittee or pharmacist-in-charge shall: 1. Ensure that the policies and procedures required under subsection (B) are prepared, implemented, and complie d with; 2. Review biennially and, if necessary, revise the policie s and procedures required under subsection (B); 3. Document the review required under subsection (C)(2); 4. Assemble the policies and procedures as a written or electronic manual; and 5. Make the policies and procedures available for employe e reference and inspection by the Board or its staff withi n the pharmacy and at any location outside the pharmac y where the automated storage and distribution system i s used. D. The Board may prohibit a pharmacy permittee or pharmacistin-charge from using an automated storage and distributio n system if the pharmacy permittee or the pharmacy permittee’ s employees do not comply with the requirements of subsection s (A), (B), or (C). Historical Note New Section made by final rulemaking at 13 A.A.R. 616, effective April 7, 2007 (Supp. 07-1). R4-23-615. Mechanical Storage and Counting Device for a Drug in Solid, Oral Dosage Form A. A pharmacy permittee or pharmacist-in-charge shall ensur e that a mechanical storage and counting device for a drug in a solid, oral dosage form that is used by a pharmacist or a pharphar- macy intern, graduate intern, pharmacy technician, or macy technician trainee under the supervision of a pharmacist complies with the following method to identify the contents of the device: 1. The drug name and strength are affixed to the front of each cell or cassette of the device; 2. A paper or electronic log is kept for each cell or cassett e that contains: a. An identification of the cell or cassette by the dru g cas- name and strength or the number of the cell or sette; b. The drug’s manufacturer or National Drug Cod e (NDC) number; c. The expiration date and lot number from the manufacturer’s stock bottle that is used to fill the cell or cassette. If multiple lot numbers of the same dru g are added to a cell or cassette, each lot number an d expiration date shall be documented, and the earliest expiration date shall become the expiration date of the mixed lot of drug in the cell or cassette; d. The date the cell or cassette is filled; e. Documentation of the identity of the licensee wh o placed the drug into the cell or cassette; and March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY f. If the licensee who filled the cell or cassette is not a pharmacist, documentation of the identity of th e pharmacist who supervised the non-pharmacist licensee who filled the cell or cassette; and 3. The paper or electronic log is available in the pharmac y for inspection by the Board or its designee for not les s than two years. B. A pharmacy permittee or pharmacist-in-charge shall ensur e that any drug previously counted by a mechanical storage an d counting device for a drug in a solid, oral dosage form that ha s not left the pharmacy is not returned to the drug’s cell, cassette, or stock bottle, unless the drug return method i s approved by the Board or its designee as specified in subsection (G). This subsection does not prevent a pharmacy permittee or pharmacist-in-charge from using a manual or mechanical counting device to count and dispense a previousl y counted drug that has not left the pharmacy if the previousl y counted drug is dispensed before its beyond-use-date. C. A pharmacy permittee or pharmacist-in-charge shall ensur e the accuracy of any mechanical storage and counting devic e phar- for a drug in a solid, oral dosage form that is used by a macist or a pharmacy intern, graduate intern, pharmacy technician, or pharmacy technician trainee under the supervision of a pharmacist by documenting completion of the following: 1. Training in the maintenance, calibration, and use of th e mechanical storage and counting device for eac h employee who uses the mechanical storage and countin g device; 2. Maintenance and calibration of the mechanical storag e and counting device as recommended by the device’ s manufacturer; and 3. Routine quality assurance and accuracy validation testin g for each mechanical storage and counting device. D. A pharmacy permittee or pharmacist-in-charge shall ensur e that the documentation required in subsection (C) is availabl e for inspection by the Board or its designee. E. A pharmacy permittee or pharmacist-in-charge shall: 1. Ensure that policies and procedures for the performanc e and use of a mechanical storage and counting device for a drug in a solid, oral dosage form are prepared, implemented, and complied with; 2. Review biennially and, if necessary, revise the policie s and procedures required under subsection (E)(1); 3. Document the review required under subsection (E)(2); elec- 4. Assemble the policies and procedures as a written or tronic manual; and 5. Make the policies and procedures available within th e pharmacy for employee reference and inspection by th e Board or its staff. F. The Board may prohibit a pharmacy permittee or pharmacistin-charge from using a mechanical storage and countin g device for a drug in a solid, oral dosage form if the pharmac y permittee or the pharmacy permittee’s employees do not comply with the requirements of subsections (A), (B), (C), (D), or (E). G. Returning a drug previously counted by a mechanical storag e and counting device for a drug in a solid, oral dosage form that has not left the pharmacy to the drug’s cell or cassette. 1. Before returning a drug previously counted by a mechanphar- ical storage and counting device that has not left the macy to the drug’s cell or cassette, a pharmacy permitte e or pharmacist-in-charge shall: 26-1 Page 51 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD a. Apply for approval from the Board or its designe e for the drug return method to be used in returnin g the drug; b. Develop a drug return method that uses technology, such as bar coding, to prevent drug return errors; c. Provide documentation depicting the drug retur n method; d. Demonstrate the drug return method for a Boar d Compliance Officer; and e. Receive approval from the Board or its designee for the drug return method to be used in returning th e drug. 2. Before approving a request to waive the drug return prohibition in subsection (B), the Board or its designee shall: per- a. Receive a request in writing from the pharmacy mittee or pharmacist-in-charge; b. Review the documentation of the drug retur n method; and c. Receive a satisfactory inspection report from a Board Compliance Officer that the drug retur n method uses technology to prevent drug retur n errors. Historical Note New Section made by final rulemaking at 13 A.A.R. 616, effective April 7, 2007 (Supp. 07-1). Amended by final rulemaking at 14 A.A.R. 3677, effective November 8, 2008 (Supp. 08-3). R4-23-616. Mechanical Counting Device for a Drug in Solid, Oral Dosage Form A. A pharmacy permittee or pharmacist-in-charge shall ensur e the accuracy of any mechanical counting device for a drug in a solid, oral dosage form that is used by a pharmacist or a pharmacy intern, graduate intern, pharmacy technician, or pharmacy technician trainee under the supervision of a pharmacist by documenting completion of the following: 1. Training in the maintenance, calibration, and use of th e mechanical counting device for each employee who use s the mechanical counting device; 2. Maintenance and calibration of the mechanical countin g device as recommended by the device’s manufacturer; and 3. Routine quality assurance and accuracy validation testin g for each mechanical counting device. B. A pharmacy permittee or pharmacist-in-charge shall ensur e that the documentation required in subsection (A) is availabl e for inspection by the Board or its designee. C. A pharmacy permittee or pharmacist-in-charge shall: 1. Ensure that policies and procedures for the performanc e and use of a mechanical counting device for a drug in a solid, oral dosage form are prepared, implemented, an d complied with; 2. Review biennially and, if necessary, revise the policie s and procedures required under subsection (C)(1); 3. Document the review required under subsection (C)(2); elec- 4. Assemble the policies and procedures as a written or tronic manual; and 5. Make the policies and procedures available within th e pharmacy for employee reference and inspection by th e Board or its staff. D. The Board may prohibit a pharmacy permittee or pharmacistin-charge from using a mechanical counting device for a dru g in a solid, oral dosage form if the pharmacy permittee or th e Supp. Administrative Code AND OCCUPATIONS OF PHARMACY pharmacy permittee’s employees do not comply with th e requirements of subsections (A), (B), or (C). Historical Note New Section made by final rulemaking at 13 A.A.R. 616, effective April 7, 2007 (Supp. 07-1). R4-23-617. Temporary Pharmacy Facilities or Mobil e Pharmacies A. Pharmacies located in declared disaster areas, nonresident pharmacies, and pharmacies licensed or permitted in another state but not licensed or permitted in this state, if necessary t o provide pharmacy services during a declared state of emergency, may arrange to temporarily locate to a temporary pharmacy facility or mobile pharmacy or relocate to a temporar y pharmacy facility or mobile pharmacy if the pharmacist-incharge of the temporary pharmacy facility or mobile pharmac y ensures that: 1. The pharmacy is under the control and management of the pharmacist-in-charge or a supervising pharmacist designated by the pharmacist-in-charge; 2. The pharmacy is located within or adjacent to th e declared disaster area; 3. The Board is notified of the pharmacy’s location; 4. The pharmacy is properly secured to prevent theft an d diversion of drugs; 5. The pharmacy’s records are maintained in accordanc e with Arizona statutes and rules; and 6. The pharmacy stops providing pharmacy services whe n the declared state of emergency ends, unless it possesse s a current resident pharmacy permit issued by the Boar d under A.R.S. §§ 32-1929, 32-1930, and 32-1931. tempo- B. The Board shall have the authority to approve or deny rary pharmacy facilities, mobile pharmacies, and shall mak e arrangements for appropriate monitoring and inspection of th e temporary pharmacy facilities and mobile pharmacies on a case-by-case basis. C. A temporary pharmacy facility wishing to permanently operate at its temporary site shall apply for and have received a permit issued under A.R.S. §§ 32-1929, 32-1930, and 32-193 1 by following the application process under R4-23-606. D. A mobile pharmacy, placed in operation during a declare d state of emergency, shall not operate permanently. Historical Note New Section made by final rulemaking at 14 A.A.R. 4400, effective January 3, 2009 (Supp. 08-4). R4-23-618. Reserved R4-23-619. Reserved R4-23-620. Continuous Quality Assurance Program A. Each pharmacy permittee shall implement or participate in a continuous quality assurance (CQA) program. A pharmac y permittee meets the requirements of this Section if it holds a current general, special or rural general hospital license fro m the Arizona Department of Health Services and is any of th e following: 1. Certified by the Centers for Medicare and Medicaid Services to participate in the Medicare or Medicaid programs; 2. Accredited by the Joint Commission on the Accreditatio n of Healthcare Organizations; or 3. Accredited by the American Osteopathic Association. B. A pharmacy permittee or the pharmacist-in-charge shall ensure that: 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 1. The pharmacy develops, implements, and utilizes a CQ program consistent with the requirements of this Sectio n and A.R.S. § 32-1973; 2. The medication error data generated by the CQA program is utilized and reviewed on a regular basis, as required b y subsection (D); and 3. Training records, policies and procedures, and other program records or documents, other than medication error data, are maintained for a minimum of two years in th e pharmacy or in a readily retrievable manner. C. A pharmacy permittee or pharmacist-in-charge shall: 1. Ensure that policies and procedures for the operation an d management of the pharmacy’s CQA program are prepared, implemented, and complied with; 2. Review biennially and, if necessary, revise the policie s and procedures required under subsection (C)(1); 3. Document the review required under subsection (C)(2); elec- 4. Assemble the policies and procedures as a written or tronic manual; and 5. Make the policies and procedures available within th e pharmacy for employee reference and inspection by th e Board or its staff. D. The policies and procedures shall address a planned proces s to: 1. Train all pharmacy personnel in relevant phases of th e CQA program; 2. Identify and document medication errors; 3. Record, measure, and analyze data collected to: a. Assess the causes and any contributing factors relating to medication errors, and b. Improve the quality of patient care; 4. Utilize the findings from subsections (D)(2) and (3) t o develop pharmacy systems and workflow processe s designed to prevent or reduce medication errors; and 5. Communicate periodically, and at least annually, wit h pharmacy personnel to review CQA program finding s and inform pharmacy personnel of any changes made t o pharmacy policies, procedures, systems, or processes as a result of CQA program findings. E. The Board’s regulatory oversight activities regarding a pharmacy’s CQA program are limited to inspection of the pharmacy’s CQA policies and procedures and enforcing th e pharmacy’s compliance with those policies and procedures. F. A pharmacy’s compliance with this Section shall be considered by the Board as a mitigating factor in the investigatio n and evaluation of a medication error. Historical Note New Section made by final rulemaking at 18 A.A.R. 2603, effective December 2, 2012 (Supp. 12-4). R4-23-621. Shared Services A. Before participating in shared services, a pharmacy shall hav e either a current resident or non-resident pharmacy permit issued by the Board. B. A pharmacy may provide or utilize shared services function s only if the pharmacies involved: 1. Have the same owner, or 2. Have a written contract or agreement that outlines the services provided and the shared responsibilities of eac h party in complying with federal and state pharmacy statutes and rules, and 3. Share a common electronic file or technology that allow s access to information necessary or required to perform March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY shared services in conformance with the pharmacy act and the Board’s rules. C. Notifications to patients. 1. Before using shared services provided by another pharmacy, a pharmacy permittee shall: a. Notify patients that their orders may be processed or filled by another pharmacy; and b. Provide the name of that pharmacy or, if the pharcom- macy is part of a network of pharmacies under mon ownership and any of the network pharmacie s may process or fill the order, notify the patient of this fact. The notification may be provided through a one-time written notice to the patient or through us e of a sign in the pharmacy. 2. If an order is delivered directly to the patient by a fillin g pharmacy and not returned to the requesting pharmacy, the filling pharmacy permittee shall ensure that the folsep- lowing is placed on the prescription container or on a arate sheet delivered with the prescription container: a. The local, and if applicable, the toll-free telephon e number of the pharmacy utilizing shared service s that has access to the patient’s records; and b. A statement that conveys to the patient or patient’ s infor- care-giver the following information: “Written mation about this prescription has been provided for you. Please read this information before you take th e medication. If you have questions concerning thi s prescription, a pharmacist is available during normal business hours to answer these questions at (insert the local and toll-free telephone numbers of th e pharmacy utilizing shared services that has access t o the patient’s records).” 3. The provisions of subsection (C) do not apply to order s delivered to patients in facilities where a licensed healt h care professional is responsible for administering the prescription medication to the patient. D. A pharmacy permittee engaged in shared services shall: 1. Maintain manual or electronic records that identify, individually for each order processed, the name, initials, or identification code of each pharmacist, graduate intern, pharmacy intern, pharmacy technician, and pharmac y interpreta- technician trainee who took part in the order tion, order entry verification, drug utilization review, drug compatibility and drug allergy review, final order authoriza- verification, therapeutic intervention, or refill tion functions performed at that pharmacy; 2. Maintain manual or electronic records that identify, indiini- vidually for each order filled or dispensed, the name, tials, or identification code of each pharmacist, graduat e intern, pharmacy intern, pharmacy technician, and phardis- macy technician trainee who took part in the filling, pensing, and counseling functions performed at that pharmacy; 3. Report to the Board as soon as practical the results of an y disciplinary action taken by another state’s pharmacy regulatory agency involving shared services; 4. Maintain a mechanism for tracking the order during eac h step of the processing and filling procedures performed at the pharmacy; confidential- 5. Provide for adequate security to protect the ity and integrity of patient information; and 6. Provide for inspection of any required record or information within 72 hours of any request by the Board or it s designee. 26-1 Page 53 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD E. Each pharmacy permittee that provides or utilizes shared services shall develop, implement, review, revise, and compl y with joint policies and procedures for shared services in th e manner described in R4-23-610(A)(2). Each pharmacy permittee is required to maintain only those portions of the joint policies and procedures that relate to that pharmacy’s operations. The policies and procedures shall: 1. Outline the responsibilities of each of the pharmacies; 2. Include a list of the name, address, telephone numbers, and all license and permit numbers of the pharmacie s involved in shared services; and 3. Include policies and procedures for: a. Notifying patients that their orders may be processe d or filled by another pharmacy and providing th e name of that pharmacy; b. Protecting the confidentiality and integrity of patient information; c. Dispensing orders when the filled order is not received or the patient comes in before the order i s received; d. Maintaining required manual or electronic records t o identify the name, initials, or identification code an d specific activity or activities of each pharmacist, techni- graduate intern, pharmacy intern, pharmacy cian, or pharmacy technician trainee who performe d any shared services; e. Complying with federal and state laws; and f. Operating a continuous quality improvement program for shared services, designed to objectivel y and systematically monitor and evaluate the qualit y and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identifie d problems. F. Nothing in this Section shall prohibit an individual pharmacist licensed in Arizona, who is an employee of or under contract phar- with a pharmacy, or an Arizona-licensed graduate intern, macy intern, pharmacy technician, or pharmacy technicia n trainee, working under the supervision of the pharmacist, from accessing that pharmacy’s electronic database from inside or outside the pharmacy and performing the order processin g functions permitted by the pharmacy act, if both of the following conditions are met: 1. The pharmacy establishes controls to protect the confidentiality and integrity of patient information; and 2. None of the database is duplicated, downloaded, or removed from the pharmacy’s electronic database. Historical Note New Section made by final rulemaking at 13 A.A.R. 520, effective April 7, 2007 (Supp. 07-1). Amended by final rulemaking at 19 A.A.R. 97, effective March 10, 2013 (Supp. 13-1). R4-23-622. Reserved R4-23-623. Reserved R4-23-624. Reserved R4-23-625. Reserved R4-23-626. Reserved R4-23-627. Reserved R4-23-628. Reserved R4-23-629. Reserved Supp. Administrative Code AND OCCUPATIONS OF PHARMACY R4-23-630. Reserved R4-23-631. Reserved R4-23-632. Reserved R4-23-633. Reserved R4-23-634. Reserved R4-23-635. Reserved R4-23-636. Reserved R4-23-637. Reserved R4-23-638. Reserved R4-23-639. Reserved R4-23-640. Reserved R4-23-641. Reserved R4-23-642. Reserved R4-23-643. Reserved R4-23-644. Reserved R4-23-645. Reserved R4-23-646. Reserved R4-23-647. Reserved R4-23-648. Reserved R4-23-649. Reserved R4-23-650. Reserved R4-23-651. Definitions The following definitions apply to R4-23-651 through R4-23-659: “Administration” means the giving of a dose of medication t o a patient as a result of an order of a medical practitioner. “Direct copy” means an electronic, facsimile or carbonize d copy. “Dispensing for hospital inpatients” means the interpreting, evaluating, and implementing a medication order includin g preparing for delivery a drug or device to an inpatient or inpatient’s agent in a suitable container appropriately labeled for subsequent administration to, or use by, an inpatient (hereafter referred to as “dispensing”). “Drug distribution” means the delivery of drugs other tha n “administering” or “dispensing.” “Emergency medical situation” means a condition of emergency in which immediate drug therapy is required for th e preservation of health, life, or limb of a person or persons. “Floor stock” means a supply of essential drugs not labeled for a specific patient and maintained and controlled by the pharadminis- macy at a patient care area for the purpose of timely tration to a patient of the hospital. “Formulary” means a continually revised compilation of pharmaceuticals (including ancillary information) that reflects th e current clinical judgment of the medical staff. “Hospital pharmacy” means a pharmacy, as defined in A.R.S. § 32-1901, that holds a current permit issued by the Board pur- 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD suant to A.R.S. § 32-1931, and is located in a hospital a s defined in A.R.S. § 32-1901. “Inpatient” means any patient who receives non-self-administered drugs from a hospital pharmacy for use while within a facility owned by the hospital. “Intravenous admixture” means a sterile parenteral solution t o which one or more additional drug products have been added. “Medication order” means a written, electronic, or verbal order from a medical practitioner or a medical practitioner’ s authorized agent for administration of a drug or device. “On-call” means a pharmacist is available to: Consult or provide drug information regarding drug therapy or related issues; or Dispense a medication order and review a patient’s medifeasibil- cation order for pharmaceutical and therapeutic ity under R4-23-653(E)(2) before any drug i s administered to a patient, except as specified in R4-23- 653(E)(1). “Patient care area” means any area for the primary purpose of providing a physical environment that is owned by or operate d in conjunction with a hospital, for a patient to obtain healt h care services, except those areas where a physician, dentist, veterinarian, osteopath, or other medical practitioner engage s primarily in private practice. “Repackaged drug” means a drug product that is transferred b y pharmacy personnel from an original manufacturer’s container to another container properly labeled for subsequent dispensing. “Satellite pharmacy” means a work area in a hospital settin g under the direction of a pharmacist that is a remote extensio n of a centrally licensed hospital pharmacy and owned by an d dependent upon the centrally licensed hospital pharmacy for administrative control, staffing, and drug procurement. “Single unit” means a package of medication that contains on e discrete pharmaceutical dosage form. “Supervision” means the process by which a pharmacist directs the activities of hospital pharmacy personnel to a suffiaccu- cient degree to ensure that all activities are performed rately, safely, and without risk of harm to patients. Historical Note Former Rules 6.7110, 6.7120, and 6.7130; Amended sub- effective August 10, 1978 (Supp. 78-4). Amended section (B) effective April 20, 1982 (Supp. 82-2). Section repealed, new Section adopted effective February 7, 1990 (Supp. 90-1). Amended effective November 1, 1993 (Supp. 93-4). Amended effective April 5, 1996 (Supp. 96-2). Amended by final rulemaking at 8 A.A.R. 4902, effective January 5, 2003 (Supp. 02-4). R4-23-652. Hospital Pharmacy Permit A. The following rules are applicable to all hospitals as define d by A.R.S. § 32-1901 and hospital pharmacies as defined b y R4-23-651. B. Before opening a hospital pharmacy, a person shall obtain a pharmacy permit as specified in R4-23-602 and R4-23-606. C. Discontinued hospitals. If a hospital license is discontinued b y the state Department of Health Services, the pharmacy permittee or pharmacist-in-charge shall follow the procedure s described in R4-23-613 for discontinuing a pharmacy. March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY Historical Note Former Rules 6.7210, 6.7220, 6.7230, 6.7231, 6.7232, effec- and 6.7233. Section repealed, new Section adopted tive February 7, 1990 (Supp. 90-1). Amended by final rulemaking at , effective January 5, 2003 (Supp. 02-4). R4-23-653. Personnel: Professional or Technician A. Each hospital pharmacy shall be directed by a pharmacist wh o is licensed to engage in the practice of pharmacy in Arizon a and is referred to as the Director of Pharmacy. The Director of Pharmacy shall be the pharmacist-in-charge, as defined i n A.R.S. § 32-1901 or shall appoint a pharmacist-in-charge. Th e Director of Pharmacy and the pharmacist-in-charge, if a different individual, shall: phar- 1. Be responsible for all the activities of the hospital macy and for meeting the requirements of the Arizon a Pharmacy Act and these rules; 2. Ensure that the policies and procedures required by thes e rules are prepared, implemented, and complied with; 3. Review biennially and, if necessary, revise the policie s and procedures required under these rules; 4. Document the review required under subsection (A)(3); 5. Assemble the policies and procedures as a written manual desig- or by another method approved by the Board or its nee; and 6. Make the policies and procedures available within th e pharmacy for employee reference and inspection by th e Board or its designee. B. In all hospitals, a pharmacist shall be in the hospital during th e time the pharmacy is open for pharmacy services, except for an extreme emergency as defined in R4-23-110. Pharmacy services shall be provided for a minimum of 40 hours per week, unless an exception for less than the minimum hours is mad e upon written request by the hospital and with express permission of the Board or its designee. C. In a hospital where the pharmacy is not open 24 hours per da y for pharmacy services, a pharmacist shall be “on-call” a s defined in R4-23-651 when the pharmacy is closed. D. The Director of Pharmacy may be assisted by other personnel approved by the Director of Pharmacy in order to operate th e pharmacy competently, safely, and adequately to meet th e needs of the hospital’s patients. E. Pharmacists. A pharmacist or a pharmacy intern or graduat e intern under the supervision of a pharmacist shall perform th e following professional practices: 1. Verify a patient’s medication order before administratio n of a drug to the patient, except: a. In an emergency medical situation; or b. In a hospital where the pharmacy is open less tha n 24 hours a day for pharmacy services, a pharmacist shall verify a patient’s medication order within four hours of the time the pharmacy opens for pharmac y services; therapeu- 2. Verify a medication order’s pharmaceutical and tic feasibility based upon: a. The patient’s medical condition, b. The patient’s allergies, c. The pharmaceutical and therapeutic incompatibilities, and d. The recommended dosage limits; 3. Measure, count, pour, or otherwise prepare and package a drug needed for dispensing, except a pharmacy technician or pharmacy technician trainee may measure, count, pour, or otherwise prepare and package a drug needed for 26-1 Page 55 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD dispensing under the supervision of a pharmacist according to written policies and procedures approved by th e Board or its designee; 4. Compound, admix, combine, or otherwise prepare an d package a drug needed for dispensing, except a pharmac y technician may compound, admix, combine, or otherwis e prepare and package a drug needed for dispensing under the supervision of a pharmacist according to written polidesig- cies and procedures approved by the Board or its nee; 5. Verify the accuracy, correct procedure, compounding, pre- admixing, combining, measuring, counting, pouring, paring, packaging, and safety of a drug prepared an d packaged by a pharmacy technician or pharmacy technician trainee according to subsections (E)(3) and (4) an d according to the policies and procedures in subsectio n (G); 6. Supervise drug repackaging and check the complete d repackaged product as specified in R4-23-402(A); 7. Supervise training and education in aseptic technique an d drug incompatibilities for all personnel involved in th e admixture of parenteral products within the hospital pharmacy; 8. Consult with the medical practitioner regarding th e patient’s drug therapy or medical condition; 9. When requested by a medical practitioner, patient, neces- patient’s agent, or when the pharmacist deems it sary, provide consultation with a patient regarding th e medication order, patient’s profile, or overall drug therapy; 10. Monitor a patient’s drug therapy for safety and effectiveness; pro- 11. Provide drug information to patients and health care fessionals; 12. Manage the activities of pharmacy technicians, pharmac y technician trainees, other personnel, and systems t o ensure that all activities are performed accurately, safely, and without risk of harm to patients; com- 13. Verify the accuracy of all aspects of the original, pleted medication order; and 14. Ensure compliance by pharmacy personnel with a qualit y assurance program developed by the hospital. F. Pharmacy technicians and pharmacy technician trainees. Before working as a pharmacy technician or pharmacy technilicen- cian trainee, an individual shall meet the eligibility and sure requirements prescribed in , Article 11 G. Pharmacy technician policies and procedures. Before employing a pharmacy technician or pharmacy technician trainee, a Director of Pharmacy or pharmacist-in-charge shall develo p the policies and procedures required under R4-23-1104. H. Pharmacy technician training program. 1. A Director of Pharmacy or pharmacist-in-charge shall comply with the training program requirements of R4-23- 1105 based on the needs of the hospital pharmacy; 2. A pharmacy technician or pharmacy technician traine e shall: a. Perform only those tasks for which training an d competency have been demonstrated; and b. Not perform professional practices reserved for a pharmacist, graduate intern, or pharmacy intern i n subsection (E), except as specified in subsection s (E)(3) and (4). I. Supervision. A hospital pharmacy’s Director of Pharmacy an d the pharmacist-in-charge, if a different individual, shall super- Supp. Administrative Code AND OCCUPATIONS OF PHARMACY vise all of the activities and operations of a hospital pharmacy. A pharmacist shall supervise all functions and activities of pharmacy technicians, pharmacy technician trainees, and other hospital pharmacy personnel to ensure that all functions an d activities are performed competently, safely, and without ris k of harm to patients. Historical Note Former Rules 6.7310 and 6.7320; Amended effective August 10, 1978 (Supp. 78-4). Section repealed, new Section adopted effective February 7, 1990 (Supp. 90-1). Amended effective November 1, 1993 (Supp. 93-4). Amended by final rulemaking at , effective January 5, 2003 (Supp. 02-4). Amended by final rulemaking at , effective May 1, 2004 (Supp. 04-1). Amended by final rulemaking at 12 A.A.R. 3032, effective October 1, 2006 (Supp. 06-3). R4-23-654. Absence of Pharmacist A. If a pharmacist will not be on duty in the hospital, the Director of Pharmacy or pharmacist-in-charge shall arrange, before th e pharmacist’s absence, for the medical staff and other authorized personnel of the hospital to have access to drugs in th e hospi- remote drug storage area defined in R4-23-110 or in the tal pharmacy if a drug is not available in a remote drug storag e area and is required to treat the immediate needs of a patient. A pharmacist shall be on-call during all absences. B. If a pharmacist will not be on duty in the hospital pharmacy, the Director of Pharmacy or pharmacist-in-charge shall arrange, before the pharmacist’s absence, for the medical staff and other authorized personnel of the hospital to have telephone access to an on-call pharmacist. C. The hospital pharmacy permittee shall ensure that the hospital pharmacy is not without a pharmacist on duty in the hospital for more than 72 consecutive hours. phar- D. Remote drug storage area. The Director of Pharmacy or macist-in-charge shall, in consultation with the appropriat e committee of the hospital: 1. Develop and maintain an inventory listing of the drugs t o be included in a remote drug storage area; and 2. Develop, implement, review, and revise in the same manner described in R4-23-653(A) and comply with policie s and procedures that ensure proper storage, access, an d accountability for drugs in a remote drug storage area. E. Access to hospital pharmacy. If a drug is not available from a remote drug storage area and the drug is required to treat th e immediate needs of a patient whose health may be compromised, the drug may be obtained from the hospital pharmac y according to the requirements of this subsection. 1. The Director of Pharmacy or pharmacist-in-charge shall, hos- in consultation with the appropriate committee of the pital, develop, implement, review, and revise in the sam e manner described in R4-23-653(A) and comply with policies and procedures to ensure that access to the hospital pharmacy during the pharmacist’s absence conforms t o the following requirements: a. Access is delegated to only one supervisory nurse i n each shift; b. The policy and name of supervisory nurse is comhos- municated in writing to the medical staff of the pital; c. Access is delegated only to a nurse who has receive d training from the Director of Pharmacy, pharmacistin-charge, or Director’s designee in the procedure s 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD required for proper access, drug removal, an d recordkeeping; and d. Access is delegated by the supervisory nurse t o another nurse only in an emergency. 2. If a nurse to whom authority is delegated to access th e phar- hospital pharmacy removes a drug from the hospital macy, the nurse shall: a. Record the following information on a form or b y desig- another method approved by the Board or its nee: i. Patient’s name; ii. Drug name, strength, and dosage form; iii. Quantity of drug removed; and iv. Date and time of removal; b. Sign or initial, if a corresponding signature is on fil e in the hospital pharmacy, the form recording th e drug removal; c. Attach the original or a direct copy of the medicatio n order for the drug to the form recording the dru g removal; and conspicu- d. Place the form recording the drug removal ously in the hospital pharmacy. 3. Within four hours after a pharmacist returns from a n absence, the pharmacist shall verify all records of dru g removal that occurred during the pharmacist’s absenc e according to R4-23-653(E). Historical Note Former Rules 6.7410, 6.7420, 6.7430, 6.7440, 6.7450, and 6.7460; Amended subsection (A) effective Aug. 9, 1983 (Supp. 83-4). Section repealed, new Section adopted effective February 7, 1990 (Supp. 90-1). Amended by final rulemaking at , effective January 5, 2003 (Supp. 02-4). Amended by final rulemaking at , effective May 1, 2004 (Supp. 04-1). Amended by final rulemaking at 12 A.A.R. 3032, effective October 1, 2006 (Supp. 06-3). R4-23-655. Physical Facility A. General. A hospital pharmacy permittee shall ensure that th e hospital pharmacy has sufficient equipment and physical facilities for proper compounding, dispensing, and storage of drugs, including parenteral preparations. B. Minimum area of hospital pharmacy. The minimum area of a hospital pharmacy depends on the type of hospital, the number of beds, and the pharmaceutical services provided. Any hospital pharmacy permit issued or hospital pharmacy remodele d phar- after January 31, 2003 shall provide a minimum hospital macy area, the actual area primarily devoted to drug dispensing and preparation functions, exclusive of bulk drug storage, satellite pharmacy, and office areas that is not less than 50 0 square feet. The minimum area requirement, not includin g unusable area, may be varied upon approval by the Board for out-of-the-ordinary conditions or for systems that require les s space. C. The Board may also require that a hospital pharmacy permitte e or applicant provide: 1. More than the minimum area if equipment, inventory, personnel, or other factors cause crowding to a degre e that interferes with safe pharmacy practice; 2. Additional dispensing, preparation, or storage area s because of the increased number of specific drugs preirri- scribed per day, the increased use of intravenous and gating solutions, and the increased use of disposable an d prepackaged products; March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY 3. Additional dispensing, preparation, or storage areas t o handle investigational drugs, emergency drug kits, chemotherapeutics, alcohol and other flammables, poisons, external preparations, and radioisotopes, and to accommodate quality control procedures; and num- 4. Additional office space to provide for an increased ber of personnel, a drug information library, a poiso n information library, research support, teaching and conferences, and a waiting area. D. Hospital pharmacy area. A hospital pharmacy permittee shall ensure that the hospital pharmacy area is enclosed by a permanent barrier or partition from floor to ceiling with entry door s that can be securely locked, constructed according to R4-23- 609(F). per- E. Hospital pharmacy storage areas. The hospital pharmacy mittee, Director of Pharmacy, or pharmacist-in-charge shall ensure that all undispensed or undistributed drugs are stored i n designated areas within the hospital pharmacy or other locke d areas under the control of a pharmacist that ensure proper sanitation, temperature, light, ventilation, moisture control, segregation, and security. Historical Note Former Rules 6.7471, 6.7472, 6.7473, 6.7474, and 6.7490; Amended effective Aug. 9, 1983 (Supp. 83-4). Section repealed, new Section adopted effective February 7, 1990 (Supp. 90-1). Correction to Table 1 (“spare feet” changed to “square feet”) (Supp. 91-1). Amended by final rulemaking at , effective January 5, 2003 (Supp. 02-4). Amended by final rulemaking at 11 A.A.R. 462, effective March 5, 2005 (Supp. 05-1). R4-23-656. Sanitation and Equipment A hospital pharmacy permittee or Director of Pharmacy shall ensure that a hospital pharmacy: 1. Has a professional reference library consisting of hardcopy or electronic media appropriate for the scope of pharmacy services provided by the hospital; 2. Has a sink, other than a sink in a toilet facility, that: a. Has hot and cold running water; b. Is within the hospital pharmacy area for use in preparing drug products; and c. Is maintained in a sanitary condition and in goo d repair; 3. Maintains a room temperature within a range compatibl e with the proper storage of drugs; 4. Has a refrigerator and freezer with a temperature maintained within a range compatible with the proper storag e of drugs requiring refrigeration or freezing; and 5. Has a designated area for a laminar air flow hood an d prod- other supplies required for the preparation of sterile ucts as specified in R4-23-670. Historical Note Former Rule 6.7480. Section repealed, new Section adopted effective February 7, 1990 (Supp. 90-1). Amended by final rulemaking at , effective January 5, 2003 (Supp. 02-4). R4-23-657. Security A. Personnel security standards. A Director of Pharmacy shall ensure that: 1. No one is permitted in the pharmacy unless a pharmacist is present except as provided in this Section and R4-23- 654. If only one pharmacist is on duty in the pharmac y emer- and that pharmacist must leave the pharmacy for an 26-1 Page 57 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD gency or patient care duties, nonpharmacist personnel may remain in the pharmacy to perform duties as outline d in R4-23-653, provided that all C-II controlled substance s are secured to prohibit access by other than a pharmacist, and that the pharmacist remains available in the hospital; 2. All hospital pharmacy areas are kept locked by key or programmable lock to prevent access by unauthorize d personnel; and 3. Pharmacists, pharmacy or graduate interns, pharmac y technicians, pharmacy technician trainees, and other personnel working in the pharmacy wear identificatio n badges, including name and position, whenever on duty. B. Prescription blank security. The Director of Pharmacy shall develop, implement, review, and revise in the same manner pro- described in R4-23-653(A) and comply with policies and cedures for the safe distribution and control of prescriptio n blanks bearing identification of the hospital. Historical Note Former Rule 6.7500; Amended effective Aug. 9, 1983 (Supp. 83-4). Section repealed, new Section adopted effective February 7, 1990 (Supp. 90-1). Amended by final rulemaking at , effective January 5, 2003 (Supp. 02-4). Amended by final rulemaking at 10 A.A.R. 1192, effective May 1, 2004 (Supp. 04-1). effec- Amended by final rulemaking at , tive October 1, 2006 (Supp. 06-3). R4-23-658. Drug Distribution and Control A. General. The Director of Pharmacy or pharmacist-in-charg e shall in consultation with the medical staff, develop, implement, review, and revise in the same manner described in R4- 23-653(A) and comply with written policies and procedure s for the effective operation of a drug distribution system that optimizes patient safety. B. Responsibility. The Director of Pharmacy is responsible for the safe and efficient procurement, dispensing, distribution, administration, and control of drugs, including the following: 1. In consultation with the appropriate department personnel and medical staff committee, develop a medication formulary for the hospital; 2. Proper handling, distribution, and recordkeeping of investigational drugs; and 3. Regular inspections of drug storage and preparation area s within the hospital. C. Physician orders. A Director of Pharmacy or pharmacist-incharge shall ensure that: 1. Drugs are dispensed from the hospital pharmacy onl y upon a written order, direct copy or facsimile of a writte n order, or verbal order of an authorized medical practitioner; and 2. A pharmacist reviews the original, direct or facsimil e copy, or verbal order before an initial dose of medicatio n is administered, except as specified in R4-23-653(E)(1). D. Labeling. A Director of Pharmacy or pharmacist-in-charg e shall ensure that all drugs distributed or dispensed by a hospital pharmacy are packaged in appropriate containers an d labeled as follows: 1. For use inside the hospital. mini- a. Labels for all single unit packages contain at a mum, the following information: i. Drug name, strength, and dosage form; ii. Lot number and beyond-use-date; and iii. Appropriate auxiliary labels; Supp. Administrative Code AND OCCUPATIONS OF PHARMACY b. Labels for repackaged preparations contain at a minimum the following information: i. Drug name, strength, and dosage form; ii. Lot number and beyond-use-date; iii. Appropriate auxiliary labels; and iv. Mechanism to identify pharmacist accountabl e for repackaging; c. Labels for all intravenous admixture preparation s contain at a minimum the following information: i. Patient’s name and location; ii. Name and quantity of the basic parenteral solution; iii. Name and amount of drug added; iv. Date of preparation; v. Beyond-use-date and time; vi. Guidelines for administration; vii. Appropriate auxiliary label or precautionar y statement; and viii. Initials of pharmacist responsible for admixtur e preparation; and 2. For use outside the hospital. Any drug dispensed to a patient by a hospital pharmacy that is intended for selfadministration outside of the hospital is labeled as specified in A.R.S. §§ 32-1963.01(C) and 32-1968(D) an d A.A.C. R4-23-402. E. Controlled substance accountability. A Director of Pharmac y or pharmacist-in-charge shall ensure that effective policies an d procedures are developed, implemented, reviewed, an d revised in the same manner described in R4-23-653(A) an d record- complied with regarding the use, accountability, and keeping of controlled substances in the hospital, including th e use of locked storage areas when controlled substances ar e stored in patient care areas. F. Emergency services dispensing. If a hospital permits dispensing of drugs from the emergency services department when th e pharmacy is unable to provide this service, the Director of Pharmacy, in consultation with the appropriate department personnel and medical staff committee shall develop, implement, review, and revise in the same manner described in R4- 23-653(A) and comply with written policies and procedure s for dispensing drugs for outpatient use from the hospital’ s emergency services department. The policies and procedure s shall include the following requirements: 1. Drugs are dispensed only to patients who have bee n admitted to the emergency services department; 2. Drugs are dispensed only by an authorized medical practitioner, not a designee or agent; 3. The nature and type of drugs available for dispensing ar e designed to meet the immediate needs of the patient s treated within the hospital; 4. Drugs are dispensed only in quantities sufficient to meet patient needs until outpatient pharmacy services ar e available; 5. Drugs are prepackaged by a pharmacist or a pharmac y intern, graduate intern, pharmacy technician, or pharmacy technician trainee under the supervision of a pharmacist in suitable containers and appropriately prelabele d with the drug name, strength, dosage form, quantity, manufacturer, lot number, beyond-use-date, and any appropriate auxiliary labels; 6. Upon dispensing, the authorized medical practitioner completes the label on the prescription container that complies with the requirements of R4-23-658(D); and 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 7. The hospital pharmacy maintains a dispensing log, hardcopy prescription, or electronic record, approved by th e Board or its designee and includes the patient name an d address, drug name, strength, dosage form, quantity, directions for use, medical practitioner’s signature or identification code, and DEA registration number, if applicable. Historical Note Former Rules 6.7610, 6.7620, and 6.7710; Amended effective Aug. 9, 1983 (Supp. 83-4). Section repealed, new Section adopted effective February 7, 1990 (Supp. 90-1). Correction to subsection (I)(5) (“unnecessary” changed to “necessary”) (Supp. 91-1). Amended effective November 1, 1993 (Supp. 93-4). Amended by final rulemaking at , effective January 5, 2003 (Supp. 02-4). Amended by final rulemaking at 10 A.A.R. 1192, effective May 1, 2004 (Supp. 04-1). Amended by final rulemaking at , effective October 1, 2006 (Supp. 06-3). R4-23-659. Administration of Drugs A. Self-administration. A hospital shall not allow self-administra- Phar- tion of medications by a patient unless the Director of macy or pharmacist-in-charge, in consultation with th e appropriate department personnel and medical staff committee, develops, implements, reviews, and revises in the sam e manner described in R4-23-653(A) and complies with policie s and procedures for self-administration of medications by a patient. The policies and procedures shall specify that selfadministration of medications, if allowed, occurs only when: 1. Specifically ordered by a medical practitioner, and 2. The patient is educated and trained in the proper manner of self-administration. B. Drugs brought in by a patient. If a hospital allows a patient t o bring a drug into the hospital and before a patient brings a dru g into the hospital, the Director of Pharmacy or pharmacist-incharge shall, in consultation with the appropriate department personnel and medical staff committee, develop, implement, review, and revise in the same manner described in R4-23- 653(A) and comply with policies and procedures for a patientproce- owned drug brought into the hospital. The policies and dures shall specify the following criteria for a patient-owne d drug brought into the hospital: 1. When policy allows the administration of a patientowned drug, the drug is not administered to the patient unless: a. A pharmacist or medical practitioner identifies th e drug, and b. A medical practitioner writes a medication order specifying administration of the identified patientowned drug; and 2. If a patient-owned drug will not be used during th e person- patient’s hospitalization, the hospital pharmacy’s nel shall: a. Package, seal, and give the drug to the patient’ s agent for removal from the hospital; or b. Package, seal, and store the drug for return to th e patient at the time of discharge from the hospital. C. Drug samples. The Director of Pharmacy or pharmacist-incharge is responsible for the receipt, storage, distribution, an d accountability of drug samples within the hospital, includin g developing, implementing, reviewing, and revising in th e same manner described in R4-23-653(A) and complying wit h specific policies and procedures regarding drug samples. March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY Historical Note Former Rules 6.7720, 6.7730, 6.7740, 6.7760, 6.7770, 6.7780, 6.7800, 6.7810, 6.7820, 6.7830, 6.7840, 6.7850, 6.7871, 6.7872, and 6.7873; Amended effective Aug. 9, 1983 (Supp. 83-4). Section repealed, new Section Correc- adopted effective February 7, 1990 (Supp. 90-1). tion to Section heading (“rules” changed to “roles”) (Supp. 91-1). Section repealed; new Section made by final rulemaking at , effective January 5, 2003 (Supp. 02-4). Amended by final rulemaking at 10 A.A.R. 1192, effective May 1, 2004 (Supp. 04-1). effec- Amended by final rulemaking at , tive October 1, 2006 (Supp. 06-3). R4-23-660. Investigational Drugs The Director of Pharmacy or pharmacist-in-charge shall ensur e that: 1. The following information concerning an investigational drug is available for use by hospital personnel: a. Composition, b. Pharmacology, c. Adverse reactions, d. Administration guidelines, and e. All other available information concerning the drug, and 2. An investigational drug is: a. Properly stored in, labeled, and dispensed from th e pharmacy, and b. Not dispensed before the drug is approved by th e appropriate medical staff committee of the hospital. Historical Note sub- Former Rules 6.7881, 6.7882, and 6.7883; Amended section (A) effective Aug. 9, 1983 (Supp. 83-4). Repealed, new Section adopted effective February 7, 1990 (Supp. 90-1). Section repealed; new Section made by final rulemaking at , effective January 5, 2003 (Supp. 02-4). R4-23-661. Repealed Historical Note Former Rules 6.7910, 6.7920, 6.7930, 6.7940, and 6.7950. Section repealed, new Section adopted effective February 7, 1990 (Supp. 90-1). Section repealed by final rulemaking at , effective January 5, 2003 (Supp. 02-4). R4-23-662. Repealed Historical Note Adopted effective February 7, 1990 (Supp. 90-1). Section repealed by final rulemaking at , effective January 5, 2003 (Supp. 02-4). R4-23-663. Repealed Historical Note Adopted effective February 7, 1990 (Supp. 90-1). Sec- Amended effective November 1, 1993 (Supp. 93-4). tion repealed by final rulemaking at , effective January 5, 2003 (Supp. 02-4). R4-23-664. Repealed Historical Note Adopted effective February 7, 1990 (Supp. 90-1). Subsection label removed (Supp. 91-1). Section repealed by final rulemaking at , effective January 5, 26-1 Page 59 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 2003 (Supp. 02-4). R4-23-665. Reserved R4-23-666. Reserved R4-23-667. Reserved R4-23-668. Reserved R4-23-669. Reserved R4-23-670. Sterile Pharmaceutical Products A. In addition to the minimum area requirement of R4-23-609(A) pharma- and R4-23-655(B) and before compounding a sterile ceutical product, a pharmacy permittee, limited-service pharmacy permittee, or applicant shall provide a minimum steril e pharmaceutical product compounding area that is not less tha n 100 square feet of contiguous floor area, except any pharmac y permit issued or pharmacy remodeled before November 1, 2006 may continue to use a sterile pharmaceutical product compounding area that is not less that 60 square feet of contiguous floor area, until a pharmacy ownership change occur s that requires issuance of a new permit or the pharmacy i s remodeled. The pharmacy permittee or the pharmacist-incharge shall ensure that the sterile pharmaceutical product compounding area: 1. Is dedicated to the purpose of preparing and compounding sterile pharmaceutical products; 2. Is isolated from other pharmacy functions; 3. Restricts entry or access; 4. Is free from unnecessary disturbances in air flow; ceil- 5. Is made of non-porous and cleanable floor, wall, and ing material; and 6. Meets the minimum air cleanliness standards of an ISO Class 7 environment as defined in R4-23-110, except a n ISO class 7 environment is not required if all sterile pharmaceutical product compounding occurs within an ISO phar- class 5 environment isolator, such as a glove box, maceutical isolator, barrier isolator, pharmacy isolator, or hospital pharmacy isolator. B. In addition to the equipment requirements in R4-23-611 an d R4-23-612 or R4-23-656 and before compounding a steril e pharmaceutical product, a pharmacy permittee, limited-servic e pharma- pharmacy permittee, or applicant shall ensure that a cist who compounds a sterile pharmaceutical product has th e following equipment: 1. Environmental control devices capable of maintaining a compounding area environment equivalent to an “ISO class 5 environment” as defined in R4-23-110. Device s air- capable of meeting these standards include: laminar flow hoods, hepa filtered zonal airflow devices, glov e boxes, pharmaceutical isolators, barrier isolators, pharbiologi- macy isolators, hospital pharmacy isolators, and cal safety cabinets; 2. Disposal containers designed for needles, syringes, an d pharmaceuti- other material used in compounding sterile cal products and if applicable, separate containers to dispose of cytotoxic, chemotherapeutic, and infectious wast e products; 3. Freezer storage units with thermostatic control and thermometer, if applicable; 4. Packaging or delivery containers capable of maintainin g official compendial drug storage conditions; 5. Infusion devices and accessories, if applicable; and Supp. Administrative Code AND OCCUPATIONS OF PHARMACY 6. In addition to the reference library requirements of R4- 23-612, a current reference pertinent to the preparation of sterile pharmaceutical products. C. Before compounding a sterile pharmaceutical product, th e pharmacy permittee, limited-service pharmacy permittee, or pharmacist-in-charge shall: 1. Prepare, implement, and comply with policies and procedures for compounding and dispensing sterile pharmaceutical products, 2. Review biennially and if necessary revise the policies an d procedures required under subsection (C)(1), 3. Document the review required under subsection (C)(2), 4. Assemble the policies and procedures as a written manual or by another method approved by the Board or its designee, and 5. Make the policies and procedures available in the pharmacy for employee reference and inspection by the Boar d or its designee. D. The assembled policies and procedures shall include, wher e applicable, the following subjects: 1. Supervisory controls and verification procedures t o ensure the quality and safety of sterile pharmaceutical products; 2. Clinical services and drug monitoring procedures for: a. Patient drug utilization reviews; b. Inventory audits; c. Patient outcome monitoring; d. Drug information; and e. Education of pharmacy and other health professionals; 3. Controlled substances; 4. Supervisory controls and verification procedures for: a. Cytotoxics handling, storage, and disposal; b. Disposal of unused supplies and pharmaceutical products; and c. Handling and disposal of infectious wastes; 5. Pharmaceutical product administration, including guidelines for the first dosing of a pharmaceutical product; 6. Drug and component procurement; 7. Pharmaceutical product compounding, dispensing, an d storage; 8. Duties and qualifications of professional and support staff; 9. Equipment maintenance; 10. Infusion devices and pharmaceutical product deliver y systems; 11. Investigational drugs and their protocols; 12. Patient profiles; 13. Patient education and safety; 14. Quality management procedures for: a. Adverse drug reactions; b. Drug recalls; c. Expired pharmaceutical products; sub- d. Beyond-use-dating for both standard-risk and stantial-risk sterile pharmaceutical products consistent with the requirements of R4-23-410(B)(3)(d); e. Temperature and other environmental controls; f. Documented process and product validation testing; and g. Semi-annual certification of the laminar air flo w hood or other ISO class 5 environment, other equipment, and the ISO class 7 environment, includin g documentation of routine cleaning and maintenanc e for each laminar air flow hood or other ISO class 5 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD environment, other equipment, and the ISO class 7 environment; and 15. Sterile pharmaceutical product delivery requirements for: a. Shipment to the patient; b. Security; and c. Maintaining official compendial storage conditions. E. Standard-risk sterile pharmaceutical product compounding. Before compounding a standard-risk sterile pharmaceutical product, a pharmacy permittee or pharmacist-in-charge shall ensure compliance with the following minimum standards: 1. Compounding occurs only in an ISO class 5 environment within an ISO class 7 environment, and the ISO class 7 environment may have a specified prep area inside th e environment; ster- 2. Compounding sterile pharmaceutical products from ile commercial drugs or sterile pharmaceutical otic or ophthalmic products from non-sterile ingredients occur s using procedures that involve only a few closed-system, basic, simple aseptic transfers and manipulations; 3. Each person who compounds wears adequate personnel protective clothing for sterile preparation that include s gown, gloves, head cover, and booties. Each person wh o compounds is not required to wear personnel protectiv e clothing when all sterile pharmaceutical compoundin g occurs within an ISO class 5 environment isolator, an d the ISO Class 5 environment isolator is not inside an ISO Class 7 environment; and 4. Each person who compounds completes an annual mediafill test to validate proper aseptic technique. F. Substantial-risk sterile pharmaceutical product compounding. Before compounding a substantial-risk sterile pharmaceutical product, a pharmacy permittee or pharmacist-in-charge shall ensure compliance with the following minimum standards: 1. Compounding parenteral or injectable sterile pharmaceutical products from non-sterile ingredients occurs only i n envi- an ISO class 5 environment within an ISO class 7 ronment and the ISO class 7 environment shall not have a prep area inside the environment; 2. Each person who compounds wears adequate personnel protective clothing for sterile preparation that include s gown, gloves, head cover, and booties. Each person wh o compounds is not required to wear personnel protectiv e clothing when all sterile pharmaceutical compoundin g occurs within an ISO class 5 environment isolator, an d the ISO Class 5 environment isolator is not inside an ISO Class 7 environment; and 3. Each person who compounds completes a semi-annual media-fill test that simulates the most challenging or stressful conditions for compounding using dry non-sterile media to validate proper aseptic technique. Historical Note Adopted effective November 1, 1993 (Supp. 93-4). Amended by final rulemaking at 10 A.A.R. 3391, effective October 2, 2004 (Supp. 04-3). Amended by final rulemaking at 12 A.A.R. 3981, effective December 4, 2006 (Supp. 06-4). R4-23-671. General Requirements for Limited-servic e Pharmacy A. Before opening a limited-service pharmacy, a person shall obtain a permit in compliance with A.R.S. §§ 32-1929, 32- 1930, 32-1931, and R4-23-606. March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY B. The limited-service pharmacy permittee shall secure the limited-service pharmacy by conforming with the following standards: 1. Permit no one to be in the limited-service pharmac y unless the pharmacist-in-charge or a pharmacist authorized by the pharmacist-in-charge is present; 2. Require the pharmacist-in-charge to designate in writing, by name, title, and specific area, those persons who will have access to particular areas of the limited-servic e pharmacy; 3. Implement procedures to guard against theft or diversio n of drugs, including controlled substances; and 4. Require all persons working in the limited-service pharmacy to wear badges, with their names and titles, whil e on duty. C. To obtain permission to deviate from the minimum are a requirement set forth in R4-23-609, R4-23-673, or R4-23-682, a limited-service pharmacy permittee shall submit a writte n request to the Board and include documentation that the deviation will facilitate experimentation or technological advance s in the practice of pharmacy as defined in A.R.S. § 32-1901. If the Board determines the requested deviation from the minimum area requirement will enhance the practice of pharmac y and benefit the public, the Board shall grant the requeste d deviation. D. The Board shall require more than the minimum area in a limequip- ited-service pharmacy when the Board determines that ment, personnel, or other factors in the limited-servic e pharmacy cause crowding that interferes with safe pharmac y practice. E. Before dispensing from a limited-service pharmacy, the limited-service pharmacy permittee or pharmacist-in-charge shall: 1. Prepare, implement, and comply with written policies an d procedures for pharmacy operations and drug dispensin g and distribution, 2. Review biennially and if necessary revise the policies an d procedures required under subsection (E)(1), 3. Document the review required under subsection (E)(2), 4. Assemble the policies and procedures as a written manual or by another method approved by the Board or its designee, and phar- 5. Make the policies and procedures available in the macy for employee reference and inspection by the Boar d or its designee. Historical Note Adopted effective April 5, 1996 (Supp. 96-2). Amended by final rulemaking at 9 A.A.R. 1064, effective May 4, 2003 (Supp. 03-1). Amended by final rulemaking at 10 A.A.R. 3391, effective October 2, 2004 (Supp. 04-3). Amended by final rulemaking at , effective October 1, 2006 (Supp. 06-3). R4-23-672. Limited-service Correctional Pharmacy A. The limited-service pharmacy permittee shall ensure that th e limited-service correctional pharmacy complies with the standards for area, personnel, security, sanitation, equipment, dru g distribution and control, administration of drugs, drug source, quality assurance, investigational drugs, and inspections as set forth in R4-23-608, R4-23-609(A) through (D) and (F) through (H), R4-23-610(A), R4-23-611, R4-23-612, R4-23- 653(E), R4-23-658(B) through (E), R4-23-659, and R4-23- 660. B. The pharmacist-in-charge of a limited-service correctional pharmacy shall authorize only pharmacists, interns, pharmac y 26-1 Page 61 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD technicians, pharmacy technician trainees, compliance officers, drug inspectors, peace officers, and correctional officer s acting in their official capacities, other persons authorized b y law, support personnel, and other designated personnel to be i n the limited-service correctional pharmacy. facil- C. When no pharmacist will be on duty in the correctional ity, the pharmacist-in-charge shall arrange, before there is n o pharmacist on duty, for the medical staff and other authorize d personnel of the correctional facility to have access to drugs i n remote drug storage areas or, if a drug is not available in a remote drug storage area and is required to treat the immediat e phar- needs of a patient, in the limited-service correctional macy. 1. The pharmacist-in-charge shall, in consultation with th e appropriate committee of the correctional facility, develop and implement procedures to ensure that remot e drug storage areas: rea- a. Contain only properly labeled drugs that might sonably be needed and can be administered safel y during the pharmacist’s absence, b. Contain drugs packaged only in amounts sufficient for immediate therapeutic requirements, c. Are accessible only with a physician’s written order, d. Provide a written record of each drug withdrawn, e. Are inventoried at least once each week, and f. Are audited for compliance with the requirements of this rule at least once each month. 2. The pharmacist-in-charge shall, in consultation with th e appropriate committee of the correctional facility, develop and implement procedures to ensure that acces s to the limited-service correctional pharmacy when n o pharmacist is on duty conforms to the following requirements: a. Is delegated to only one nurse, who is in a supervisory position; b. Is communicated in writing to medical staff of th e correctional facility; c. Is delegated only to a nurse who has received trainmeth- ing from the pharmacist-in-charge in proper ods of access, removal of drugs, and recordkeepin g procedures; and d. Is delegated by the supervisory nurse to another nurse only in an emergency. 3. When a nurse to whom authority to access the limitedservice correctional pharmacy is delegated removes a drug from the limited-service correctional pharmacy, th e nurse shall: a. Record the following information on a form: i. Patient’s name, ii. Name of the drug and its strength and dosag e form, iii. Dose prescribed, iv. Amount of drug removed, and v. Date and time of removal; b. Sign the form recording the drug removal; c. Attach the original or a direct copy of a physician’ s written order for the drug to the form recording th e drug removal; and d. Place the form recording the drug removal conspicuously in the limited-service correctional pharmacy. 4. Within four hours after a pharmacist in the limited-service correctional pharmacy returns to duty following a n phar- absence in which the limited-service correctional macy was accessed by a nurse to whom authority ha d Supp. Administrative Code AND OCCUPATIONS OF PHARMACY been delegated, the pharmacist shall verify all records of drug removal according to R4-23-402. facil- D. When no pharmacist will be on duty in the correctional ity, the pharmacist-in-charge shall arrange, before there is n o pharmacist on duty, for the medical staff and other authorize d personnel of the correctional facility to have telephone acces s to a pharmacist. E. The limited-service pharmacy permittee shall ensure that th e phar- limited-service correctional pharmacy is not without a macist on duty for more than 96 consecutive hours. F. In addition to the requirements of R4-23-671, the limited-sercor- vice pharmacy permittee shall secure the limited-service rectional pharmacy as follows: 1. Permit no one to be in the limited-service correctional pharmacy unless a pharmacist is on duty except: a. As provided in subsection (C)(3) when a pharmacist is not on duty; or b. A pharmacy technician or pharmacy technicia n trainee may remain to perform duties in R4-23- 1104(A), when a pharmacist is on duty and availabl e in the correctional facility but temporarily absent from the pharmacy, provided: i. All controlled substances are secured in a manner that prohibits access by persons other than a pharmacist; ii. Activities performed by a pharmacy technicia n phar- or pharmacy technician trainee while the macist is temporarily absent are verified by th e pharmacist immediately upon returning to th e pharmacy; iii. Any drug measured, counted, poured, or otherwise prepared and packaged by a pharmac y technician or pharmacy technician traine e while the pharmacist is temporarily absent i s verified by the pharmacist immediately upo n returning to the pharmacy; and iv. Any drug that has not been verified by a pharmacist for accuracy is not dispensed, supplied, temporar- or distributed while the pharmacist is ily absent from the pharmacy; and 2. Provide keyed or programmable locks to all areas of th e limited-service correctional pharmacy. G. The pharmacist-in-charge of a limited-service correctional pharmacy shall ensure that the written policies and procedure s cor- for pharmacy operations and drug distribution within the rectional facility include the following: 1. Physicians’ orders, prescription orders, or both; 2. Authorized abbreviations; 3. Formulary system; 4. Clinical services and drug utilization management including: a. Participation in drug selection, b. Drug utilization reviews, c. Inventory audits, d. Patient outcome monitoring, e. Committee participation, f. Drug information, and g. Education of pharmacy and other health professionals; 5. Duties and qualifications of professional and support staff; 6. Products of abuse and contraband medications; 7. Controlled substances; 8. Drug administration; 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 9. Drug product procurement; 10. Drug compounding, dispensing, and storage; 11. Stop orders; 12. Pass or discharge medications; 13. Investigational drugs and their protocols; 14. Patient profiles; 15. Quality management procedures for: a. Adverse drug reactions; b. Drug recalls; c. Expired and beyond-use-date drugs; d. Medication or dispensing errors; e. Drug storage; and f. Education of professional staff, support staff, an d patients; 16. Recordkeeping; 17. Sanitation; 18. Security; 19. Access to remote drug storage areas by non-pharmacists; and 20. Access to limited-service correctional pharmacy by nonpharmacists. Historical Note Adopted effective April 5, 1996 (Supp. 96-2). Amended by final rulemaking at 10 A.A.R. 4453, effective December 4, 2004 (Supp. 04-4). R4-23-673. Limited-service Mail-order Pharmacy A. The limited-service pharmacy permittee shall design and construct the limited-service mail-order pharmacy to conform with the following requirements: 1. A dispensing area devoted to stocking, compounding, an d dispensing prescription medications, which is physicall y separate from a non-dispensing area devoted to non-dispensing pharmacy services; 2. A dispensing area of at least 300 square feet if three or fewer persons work in the dispensing area simultaneously; 3. A dispensing area that provides 300 square feet plus 6 0 square feet for each person in excess of three persons if more than three persons work in the dispensing are a simultaneously; 4. Space in the dispensing area permits efficient pharmaceutical practice, free movement of personnel, and visual surveillance by the pharmacist; 5. A non-dispensing area of at least 30 square feet for eac h person working simultaneously in the non-dispensin g area; and 6. Space in the non-dispensing area permits free movement of personnel and visual surveillance by the pharmacist; or con- B. The limited-service pharmacy permittee shall design and struct the limited-service mail-order pharmacy to conform with the following requirements: non-dis- 1. A contiguous area in which both dispensing and pensing pharmacy services are provided; 2. A contiguous area of at least 300 square feet if three or fewer persons work in the area simultaneously; 3. A contiguous area that provides 300 square feet plus 6 0 square feet for each person in excess of three persons if more than three persons work in the area simultaneously; and 4. Space in the contiguous area permits efficient pharmaceutical practice, free movement of personnel, and visual surveillance by the pharmacist. March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY C. The limited-service pharmacy permittee shall ensure that th e limited-service mail-order pharmacy complies with the standards for area, personnel, security, sanitation, and equipment set forth in R4-23-608, R4-23-609(B) through (H), R4-23-61 0 (A) and (C) through (F), R4-23-611, and R4-23-612. phar- D. The pharmacist-in-charge of a limited-service mail-order macy shall authorize only pharmacists, interns, pharmac y technicians, pharmacy technician trainees, compliance officers, drug inspectors, peace officers acting in their official capacities, support personnel, other persons authorized by law, and other designated personnel to be in the limited-servic e mail-order pharmacy. E. The pharmacist-in-charge of a limited-service mail-order pharmacy shall ensure that prescription medication is delivered t o the patient or locked in the dispensing area when a pharmacist is not present in the pharmacy. F. In addition to the delivery requirements of R4-23-402, the limited-service pharmacy permittee shall, during regular hours of operation but not less than five days and a minimum 40 hour s per week, provide toll-free telephone service to facilitate communication between patients and a pharmacist who has acces s to patient records at the limited-service mail-order pharmacy. The limited-service pharmacy permittee shall disclose thi s toll-free number on a label affixed to each container of drug s dispensed from the limited-service mail-order pharmacy. G. The pharmacist-in-charge of a limited-service mail-order pharmacy shall ensure that the written policies and procedures for pharmacy operations and drug distribution include the following: 1. Prescription orders; 2. Clinical services and drug utilization management for: a. Drug utilization reviews, b. Inventory audits, c. Patient outcome monitoring, d. Drug information, and profession- e. Education of pharmacy and other health als; 3. Duties and qualifications of professional and support staff; 4. Controlled substances; 5. Drug product procurement; 6. Drug compounding, dispensing, and storage; 7. Patient profiles; 8. Quality management procedures for: a. Adverse drug reactions, b. Drug recalls, c. Expired and beyond-use-date drugs, d. Medication or dispensing errors, and e. Education of professional and support staff; 9. Recordkeeping; 10. Sanitation; 11. Security; 12. Drug delivery requirements for: a. Transportation, b. Security, c. Temperature and other environmental controls, d. Emergency provisions, and 13. Patient education. Historical Note Adopted effective April 5, 1996 (Supp. 96-2). Amended by final rulemaking at , effective May 1, 2004 (Supp. 04-1). Amended by final rulemaking at 10 A.A.R. 4453, effective December 4, 2004 (Supp. 04-4). 26-1 Page 63 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD R4-23-674. Limited-service Long-term Care Pharmacy A. A limited-service pharmacy permittee shall ensure that th e limited-service long-term care pharmacy complies with: 1. The general requirements of R4-23-671; 2. The professional practice standards of Article 4 and Article 11; and 3. The permits and drug distribution standards of R4-23-60 6 through R4-23-612, R4-23-670, and this Section. con- B. If a limited-service long-term care pharmacy permittee tracts with a long-term care facility as a Provider Pharmacy, a s defined in R4-23-110, the limited-service long-term care pharmacy permittee shall ensure that the long-term care consultant pharmacist and the pharmacist-in-charge of the limited-servic e long-term care pharmacy comply with R4-23-701, R4-23- 701.01, R4-23-701.02, R4-23-701.03, R4-23-701.04, and thi s Section. C. The limited-service long-term care pharmacy permittee or pharmacist-in-charge shall ensure that prescription medicatio n is delivered to the patient’s long-term care facility or locked i n the dispensing area of the pharmacy when a pharmacist is not present in the pharmacy. D. The pharmacist-in-charge of a limited-service long-term car e pharmacy shall authorize only those individuals listed in R4phar- 23-610(B) to be in the limited-service long-term care macy. E. In consultation with the long-term care facility’s medical director and director of nursing, the long-term care consultant pharmacist and pharmacist-in-charge of the long-term car e facility’s provider pharmacy may develop, if necessary, a medication formulary for the long-term care facility that ensure s the safe and efficient procurement, dispensing, distribution, administration, and control of drugs in the long-term car e facility. F. The limited-service long-term care pharmacy permittee or pharmacist-in-charge shall ensure that the written policies an d procedures required in R4-23-671(E) include the following: 1. Clinical services and drug utilization management for: a. Drug utilization reviews, b. Inventory audits, c. Patient outcome monitoring, d. Drug information, and profession- e. Education of pharmacy and other health als; 2. Controlled substances; 3. Drug compounding, dispensing, and storage; 4. Drug delivery requirements for: a. Transportation, b. Security, c. Temperature and other environmental controls, and d. Emergency provisions; 5. Drug product procurement; 6. Duties and qualifications of professional and support staff; 7. Emergency drug supply unit procedures; 8. Formulary, including development, review, modification, use, and documentation, if applicable; 9. Patient profiles; 10. Patient education; 11. Prescription orders, including: a. Approved abbreviations, b. Stop-order procedures, and c. Leave-of-absence and discharge prescription order procedures; 12. Quality management procedures for: Supp. Administrative Code AND OCCUPATIONS OF PHARMACY a. Adverse drug reactions, b. Drug recalls, c. Expired and beyond-use-date drugs, d. Medication or dispensing errors, and e. Education of professional and support staff; 13. Recordkeeping; 14. Sanitation; and 15. Security. Historical Note New Section made by final rulemaking at , effective May 4, 2003 (Supp. 03-1). Amended by final rulemaking at , effective May 1, 2004 (Supp. 04-1). Amended by final rulemaking at 19 A.A.R. 2894, effective November 10, 2013 (Supp. 13-3). R4-23-675. Limited-service Sterile Pharmaceutical Products Pharmacy A. The limited-service pharmacy permittee or the pharmacist-incharge shall ensure that the limited-service sterile pharmaceutical products pharmacy complies with the standards for area, personnel, security, sanitation, equipment, sterile pharmaceutical products, and limited-service pharmacies established i n R4-23-608, R4-23-609, R4-23-610, R4-23-611, R4-23-612, R4-23-670, and R4-23-671. B. The pharmacist-in-charge of a limited-service sterile pharmaceutical products pharmacy shall authorize only pharmacists, interns, compliance officers, peace officers acting in their official capacities, pharmacy technicians, pharmacy technicia n trainees, support personnel, and other designated personnel t o be in the limited-service sterile pharmaceutical products pharmacy. pharma- C. The pharmacist-in-charge of a limited-service sterile ceutical products pharmacy shall ensure that prescription medication is delivered to the patient or locked in the dispensin g area when a pharmacist is not present in the pharmacy. D. In addition to the delivery requirements of R4-23-402, the limited-service pharmacy permittee shall, during regular hours of operation, but not less than a minimum 40 hours per week, provide toll-free telephone service to facilitate communicatio n between patients and a pharmacist who has access to patient records at the limited-service sterile pharmaceutical product s pharmacy. The limited-service pharmacy permittee shall disclose this toll-free number on a label affixed to each container dispensed from the limited-service sterile pharmaceutical products pharmacy. E. The limited-service pharmacy permittee or the pharmacist-incharge shall ensure development, implementation, review an d revision in the same manner described in R4-23-671(E) an d compliance with policies and procedures for pharmacy operadis- tions, including pharmaceutical product compounding, pensing, and distribution, that comply with the requirements of R4-23-402, R4-23-410, R4-23-670, and R4-23-671. F. The non-dispensing roles of the pharmacist may include chart reviews, audits, drug therapy monitoring, committee participation, drug information, and in-service training of pharmac y and other health professionals. Historical Note New Section made by final rulemaking at 10 A.A.R. 3391, effective October 2, 2004 (Supp. 04-3). Amended by final rulemaking at , effective October 1, 2006 (Supp. 06-3). This Section was not amended as originally stated in the historical note published in Supp. 13-3; therefore the reference to the amendment has been removed (Supp. 18-2). 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD R4-23-676. Third-party Logistics Provider Permit A. A person shall not provide logistics services, as describe d under A.R.S. § 32-1941(A), until the Board issues a thirdparty logistics provider permit for the facility. B. A person that wants to provide logistics services shall obtain a Board-issued third-party logistics provider permit for eac h facility. C. Application. To obtain a third-party logistics provider permit for a facility, a person shall submit a completed application, using a form available on the Board’s website, and the fe e specified in R4-23-205. permit- D. Change of ownership. A third-party logistics provider tee shall comply with R4-23-601(F). E. A third-party logistics provider permittee shall renew the permit as specified under R4-23-602(D). F. The Board shall adhere to the time frames specified under R4- 23-602(C) when processing an initial or renewal applicatio n for a third-party logistics provider permit. Historical Note New Section made by final rulemaking at , effective June 1, 2019 (Supp. 19-2). R4-23-677. Automated Prescription-dispensing Kiosk Permit A. General provisions. 1. Only a person issued a Board permit under A.R.S. § 32- 1929 to operate a pharmacy in Arizona may apply to th e Board under A.R.S. § 32-1930 for a permit to operate a n automated prescription-dispensing kiosk. 2. A pharmacy permittee described under subsection (A)(1) shall apply for a separate permit for each automated prescription-dispensing kiosk to be operated. 3. To obtain an automated prescription-dispensing kios k permit, a pharmacy permittee shall submit a complete d web- application, using a form available on the Board’s site, and the fee specified in R4-23-205. 4. A pharmacy permittee to which the Board issues an autodesig- mated prescription-dispensing kiosk permit shall nate a pharmacist in charge of the automate d prescription-dispensing kiosk. auto- 5. A pharmacy permittee to which the Board issues an mated prescription-dispensing kiosk permit shall not place the automated prescription-dispensing kiosk in a gas station or convenience store. B. Policies and procedures. A pharmacy permittee to which th e Board issues an automated prescription-dispensing kiosk permit shall: 1. Ensure policies and procedures are established for th e appropriate performance and use of the automated prescription-dispensing kiosk. The policies and procedure s shall address: a. Maintaining a record of each transaction in a manner that attaches the record to the permit number of th e automated prescription-dispensing kiosk; b. Controlling access to the automated prescriptiondispensing kiosk; c. Operating the automated prescription-dispensin g kiosk; prescrip- d. Training personnel who use the automated tion-dispensing kiosk; e. Maintaining patient services when the automate d prescription-dispensing kiosk is not operating or th e prescribed drug or device is not available; March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY f. Securing the automated prescription-dispensin g kiosk against unauthorized removal of the kiosk or access to or removal of drugs or devices from th e kiosk; g. Assuring a patient receives the pharmacy service s necessary for appropriate pharmaceutical car e including consultation with a pharmacist; h. Maintaining integrity of information in the syste m and patient confidentiality; i. Stocking and restocking the automated prescriptiondispensing kiosk; j. Ensuring compliance with packaging and labelin g requirements; and k. Removing drugs and devices from the automate d prescription-dispensing kiosk without dispensin g them and handling wasted or discarded drugs an d devices; 2. Ensure the policies and procedures are implemented an d complied with by all personnel using the automated prescription-dispensing kiosk; 3. Maintain the policies and procedures by: a. Reviewing the policies and procedures bienniall y and making needed revisions, if any; b. Documenting the review required under subsectio n (B)(3)(a); c. Assembling the policies and procedures as a writte n or electronic manual; and d. Making the policies and procedures available withi n the pharmacy permittee to which the Board issue d an automated prescription-dispensing kiosk permit for reference by pharmacy personnel and inspectio n by the Board; and com- 4. Implement a quality assurance program to monitor pliance with the policies and procedures and all state an d federal law. C. Change of ownership. An automated prescription-dispensin g kiosk permittee shall comply with R4-23-601(F). D. An automated prescription-dispensing kiosk permittee shall renew the permit as specified under R4-23-602(D). E. The Board shall adhere to the time frames specified under R4- 23-602(C) when processing an initial or renewal applicatio n for an automated prescription-dispensing kiosk permit. Historical Note New Section made by final rulemaking at 25 A.A.R. 1012, effective June 1, 2019 (Supp. 19-2). R4-23-678. Reserved R4-23-679. Reserved R4-23-680. Reserved R4-23-681. General Requirements for Limited-servic e Nuclear Pharmacy A. To be an authorized nuclear pharmacist, a pharmacist shall: 1. Hold a current pharmacist license issued by the Board; and 2. Be certified as a nuclear pharmacist by: a. The Board of Pharmaceutical Specialties, or b. A similar group recognized by the Arizona Stat e Board of Pharmacy; or 3. Satisfy each of the following requirements: a. Meet minimal standards of training for status as a n authorized user of radioactive material, as specifie d 26-1 Page 65 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD by the Arizona Radiation Regulatory Agency an d the United States Nuclear Regulatory Commission; b. Submit certification of completion of a Boardapproved nuclear pharmacy training program or other training program recognized by the Arizon a Radiation Regulatory Agency, with 200 hours of didactic training in the following areas: i. Radiation physics and instrumentation, ii. Radiation protection, iii. Mathematics pertaining to the use and measurement of radioactivity, iv. Radiation biology, and v. Radiopharmaceutical chemistry; c. Submit evidence of a minimum of 500 hours of clinical/practical nuclear pharmacy training under th e supervision of an authorized nuclear pharmacist i n the following areas: i. Procuring radioactive materials; ii. Compounding radiopharmaceuticals; iii. Performing routine quality control procedures; iv. Dispensing radiopharmaceuticals; v. Distributing radiopharmaceuticals; vi. Implementing basic radiation protection procedures; and vii. Consulting and educating the nuclear medicin e community, patients, pharmacists, other healt h professionals, and the general public; and d. Submit written certification, signed by a preceptor who is an authorized nuclear pharmacist, that th e above training was satisfactorily completed. B. Radiopharmaceuticals are prescription-only drugs that requir e specialized techniques in their handling and testing, to obtai n optimum results and minimize hazards. 1. A person shall not sell, barter, or otherwise dispose of, or be in possession of any radiopharmaceutical except under the conditions detailed in A.R.S. § 32-1929. 2. A person shall not manufacture, compound, sell, or dispense any radiopharmaceutical unless the person is a pharmacist or a pharmacy intern acting under the direct supervision of a pharmacist in accordance with A.R.S. § 32-1961 and these rules, with the exception of the follow- Radia- ing, if the following are licensed by the Arizona tion Regulatory Agency to use radiopharmaceuticals i n compliance with A.R.S. § 30-673; radiophar- a. A medical practitioner who administers a maceutical to the medical practitioner’s patient a s provided in A.R.S. § 32-1921(A), b. A hospital nuclear medicine department, and c. A medical practitioner’s office. 3. The Board shall cooperate with the Arizona Radiatio n Regulatory Agency and other interested state and federal agencies, in the enforcement of these rules for the protection of the public. This cooperation may includ e inspec- exchange of licensing and other information, joint tions, and other activities where indicated. C. In addition to compliance with all the applicable federal an d state laws and rules governing drugs, whether radioactive or not, a limited-service nuclear pharmacy permittee shall comply with all laws and rules of the Arizona Radiation Regulatory Agency and the U.S. Nuclear Regulatory Commission, including emergency and safety provisions. D. A limited-service nuclear pharmacy permittee shall compl y with the education, experience, and licensing requirements of the Arizona Radiation Regulatory Agency. Supp. Administrative Code AND OCCUPATIONS OF PHARMACY E. A limited-service nuclear pharmacy permittee shall ensure that radiopharmaceuticals are transferred only to a person or fir m that holds a current Radioactive Materials License issued b y the Arizona Radiation Regulatory Agency. Historical Note Adopted effective December 3, 1974 (Supp. 75-1). Amended subsections (A), (C) and (D) effective Aug. 12, 1988 (Supp. 88-3). Amended effective July 8, 1997 (Supp. 97-3). R4-23-682. Limited-service Nuclear Pharmacy A. Before operating a limited-service nuclear pharmacy, a perso n shall obtain a permit in compliance with A.R.S. §§ 32-1929, 32-1930, and 32-1931, and R4-23-606. B. A permit to operate a limited-service nuclear pharmacy shall be issued only to a person who is or employs an authorize d nuclear pharmacist and holds a current Arizona Radiatio n Regulatory Agency Radioactive Materials License. A limitedservice nuclear pharmacy permittee that fails to maintain a current Arizona Radiation Regulatory Agency Radioactiv e Materials License shall be immediately suspended pendin g revocation by the Board. A limited-service nuclear pharmac y permittee shall have copies of Arizona Radiation Regulator y Agency inspection reports available upon request for Boar d inspection. des- 1. A limited-service nuclear pharmacy permittee shall ignate an authorized nuclear pharmacist as the pharmacist-in-charge. The pharmacist-in-charge shall b e responsible to the Board: a. For the operations of the pharmacy related to th e practice of pharmacy and distribution of drugs an d devices; b. For communicating Board directives to the management, pharmacists, interns, and other personnel of the pharmacy; and c. For the pharmacy’s compliance with all federal an d state pharmacy laws and rules. 2. An authorized nuclear pharmacist shall directly supervis e all personnel performing tasks in the preparation and distribution of radiopharmaceuticals and ancillary drugs. when- 3. An authorized nuclear pharmacist shall be present ever the limited-service nuclear pharmacy is open for business. C. A limited-service nuclear pharmacy permittee shall ensure that the limited-service nuclear pharmacy complies with the standards for personnel, area, security, sanitation, and general requirements in R4-23-608, R4-23-609, R4-23-610, R4-23- 611, and R4-23-671. 1. A limited-service nuclear pharmacy shall contain separate areas for: a. Preparing and dispensing radiopharmaceuticals, b. Receiving and shipping radiopharmaceuticals, c. Storing radiopharmaceuticals, and d. Decaying radioactive waste. 2. The Board may require more than the minimum area i n instances where equipment, inventory, personnel, or other factors cause crowding to a degree that interferes wit h safe pharmacy practice. D. The pharmacist-in-charge shall designate in writing, by titl e and specific area, the persons who may have access to particular pharmacy areas. E. A limited-service nuclear pharmacy permittee shall maintai n records of acquisition, inventory, and disposition of radiophar- 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD maceuticals, other radioactive substances, and other drugs i n accordance with federal and state statutes and rules. 1. A prescription order, in addition to the requirements i n A.R.S. § 32-1968(C) and R4-23-407(A), shall contain: a. The date and time of calibration of the radiopharmaceutical, b. The name of the procedure for which the radiopharmaceutical is prescribed, and c. The words “Physician’s Use Only” instead of th e name of the patient if the radiopharmaceutical i s nontherapeutic or for a nonblood product. 2. The lead container used to store and transport a radiopharmaceutical shall have a label that, in addition to th e requirements in A.R.S. § 32-1968(D), includes: radiopharma- a. The date and time of calibration of the ceutical, b. The name of the radiopharmaceutical, c. The molybdenum 99 content to USP limits, d. The name of the procedure for which the radiopharmaceutical is prescribed, e. The words “Physician’s Use Only” instead of th e name of the patient if the radiopharmaceutical i s nontherapeutic or for a nonblood product, f. The words “Caution: Radioactive Material,” and g. The standard radiation symbol. 3. The radiopharmaceutical container shall have a label that includes: a. The date and time of calibration of the radiopharmaceutical; b. The name of the patient, recorded before dispensing, if the radiopharmaceutical is therapeutic or for a blood product; c. The words “Physician’s Use Only” instead of th e name of the patient if the radiopharmaceutical i s nontherapeutic or for a nonblood product; d. The name of the radiopharmaceutical; e. The dose of radiopharmaceutical; f. The serial number; g. The words “Caution: Radioactive Material”; and h. The standard radiation symbol. F. The following minimum requirements are in addition to th e requirements of the Arizona Radiation Regulatory Agency, th e applicable U.S. Nuclear Regulatory Commission regulations, and the applicable regulations of the federal Food and Dru g Administration. A limited-service nuclear pharmacy permitte e shall provide: 1. In addition to the minimum pharmacy area requirement s in R4-23-609: a. An area for the storing, compounding, and dispensing of radiopharmaceuticals completely separat e from pharmacy areas for nonradioactive drugs; b. A minimum of 80 sq. ft. for a hot lab and storag e area; and dis- c. A minimum of 300 sq. ft. of compounding and pensing area; 2. The following equipment: a. Fume hood, approved by the Arizona Radiatio n Regulatory Agency; b. Laminar flow hood; c. Dose calibrator; d. Refrigerator; e. Prescription balance, Class A, and weights or a n electronic balance of equal or greater accuracy; f. Well scintillation counter; March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY g. Incubator oven; h. Microscope; i. An assortment of labels, including prescriptio n labels and cautionary and warning labels; j. Glassware necessary for compounding and dispensing radiopharmaceuticals as required by the Arizon a Radiation Regulatory Agency; k. Other equipment necessary for radiopharmaceutical dis- quality control for products compounded or pensed as required by the Arizona Radiation Regulatory Agency; l. Current antidote and drug interaction information; and m. Regional poison control phone number prominentl y displayed in the pharmacy area; 3. Supplies necessary for compounding and dispensin g radiopharmaceuticals as required by the Arizona Radiation Regulatory Agency; 4. A professional reference library consisting of a minimu m of one current reference or text addressing each of the following subject areas: a. Therapeutics, b. Nuclear pharmacy practice, and c. Imaging; 5. Current editions and supplements of: a. A.R.S. §§ 30-651 through 30-696 pertaining to th e Arizona Radiation Regulatory Agency, b. Rules of the Arizona Radiation Regulatory Agency, c. Regulations of the federal Food and Drug Administration pertaining to radioactive drugs, d. Arizona Pharmacy Act and rules, e. Arizona Uniform Controlled Substances Act, and f. Radiological Health Handbook. G. The pharmacist-in-charge of a limited-service nuclear pharmacy shall prepare, implement, review, and revise in the sam e manner described in R4-23-671(E) and comply with writte n policies and procedures for pharmacy operations and drug distribution. H. The written policies and procedures of a limited-servic e nuclear pharmacy shall include the following: 1. Prescription orders; includ- 2. Clinical services and drug utilization management ing: a. Drug utilization reviews, b. Inventory audits, c. Patient outcome monitoring, d. Drug information, and profession- e. Education of pharmacy and other health als; 3. Duties and qualifications of professional and support staff; 4. Radioactive material handling, storage, and disposal; 5. Drug product procurement; 6. Drug compounding, dispensing, and storage; 7. Investigational drugs and their protocols; 8. Patient profiles; 9. Quality management procedures for: a. Adverse drug reaction reports; b. Drug recall; c. Expired and beyond-use-date drugs; d. Medication or dispensing errors; e. Radiopharmaceutical quality assurance; f. Radiological health and safety; g. Drug storage and disposition; and 26-1 Page 67 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD h. Education of professional staff, support staff, an d patients; 10. Recordkeeping; 11. Sanitation; 12. Security; 13. Drug delivery requirements for: a. Transportation, b. Security, c. Radiological health and safety procedures, d. Temperature and other environmental controls, and e. Emergency provisions; and 14. Patient education. Historical note Adopted effective July 8, 1997 (Supp. 97-3). Amended by final rulemaking at , effective October 1, 2006 (Supp. 06-3). R4-23-683. Reserved R4-23-684. Reserved R4-23-685. Reserved R4-23-686. Reserved R4-23-687. Reserved R4-23-688. Reserved R4-23-689. Reserved R4-23-690. Reserved R4-23-691. Repealed Historical Note Adopted effective Dec. 3, 1974 (Supp. 75-1). Amended effective Aug. 12, 1988 (Supp. 88-3). Amended effective November 1, 1993 (Supp. 93-4). Repealed effective July 8, 1997 (Supp. 97-3). R4-23-692. Compressed Medical Gas (CMG) Distributor- Resident or Nonresident A. Permit. 1. A person shall not manufacture, process, transfill, package, or label a compressed medical gas in Arizona, or manufacture, process, transfill, package, or label a compressed medical gas outside Arizona and ship into Arizona without a current Board-issued resident or nonresident compressed medical gas distributor permit. 2. Before operating as a compressed medical gas distributor, a person shall register with the FDA as a medical ga s manufacturer and comply with the drug listing requirements of the federal act. distrib- B. Application. To obtain a resident or nonresident CMG utor permit, a person shall submit to the Board a complete d application form and the fee specified in R4-23-205. 1. A resident CMG distributor permit applicant shall includ e documentation of compliance with local zoning laws, if required by the Board. 2. A nonresident CMG distributor permit applicant that resides in a jurisdiction that issues an equivalent licens e or permit shall include a copy of the equivalent license or permit. C. Notification. A resident or nonresident CMG distributor permittee shall submit using the permittee’s online profile or provide written notice by mail, fax, or e-mail to the Board offic e Supp. Administrative Code AND OCCUPATIONS OF PHARMACY within 10 days of changes involving the telephone or fax number, e-mail or mailing address, or business name. distrib- D. Change of ownership. A resident or nonresident CMG utor permittee shall comply with R4-23-601(F). E. Relocation. 1. No fewer than 30 days before a resident CMG distributor permittee relocates, the permittee shall electronically or manually submit a completed application for relocatio n documenta- using a form furnished by the Board, and the tion required in subsection (B). A fee is not required wit h an application for relocation. 2. A nonresident CMG distributor permittee shall provid e written notice by mail, fax, or e-mail to the Board offic e no fewer than 10 days before relocating. autho- F. A resident or nonresident CMG distributor permittee is rized to sell or distribute a compressed medical gas under a compressed medical gas order only to durable medical equipment and compressed medical gas suppliers and other entitie s that are registered, licensed, or permitted to use, administer, or distribute compressed medical gases. G. Facility. A resident or nonresident CMG distributor permitte e shall ensure the facility is clean, uncluttered, sanitary, temperature controlled, and secure from unauthorized access. nonresi- H. Current Good Manufacturing Practice: A resident or dent CMG distributor permittee is required under federal la w to follow the good manufacturing practice requirements of 2 1 CFR parts 210 and 211. I. Records: A resident or nonresident CMG distributor permitte e shall: maintain- 1. Establish and implement written procedures for ing records pertaining to production, transfilling, proces s control, labeling, packaging, quality control, distribution, returns, recalls, training of personnel, complaints, an d any information required by federal or state law. 2. Retain the records required by Section R4-23-601, thi s Section, and 21 CFR parts 210 and 211 for not fewer tha n three years or one year after the expiration date of th e compressed medical gas, whichever is longer. 3. Make the records required by Section R4-23-601, thi s Section, and 21 CFR parts 210 and 211 available for inspection by the Board or its compliance officer, or if stored in a centralized recordkeeping system apart fro m the inspection location and not electronically retrievable, provide the records within four working days of a request by the Board or its compliance officer. J. Inspection. 1. A resident CMG distributor permittee shall make th e CMG distributor’s facility available for inspection by th e Board or its compliance officers under A.R.S. § 32-1904. 2. Within 10 days from the date of a request by the Board or its staff, a nonresident CMG distributor permittee shall provide a copy of the most recent inspection report completed by the permittee’s resident licensing authority or the FDA or a copy of the most recent inspection report completed by a third-party auditor approved by the permittee’s resident licensing authority or the Board or it s designee. The Board may inspect, or may employ a thirdparty auditor to inspect, a nonresident permittee as specified in A.R.S. § 32-1904. per- K. Permit renewal. To renew a CMG distributor permit, the mittee shall comply with R4-23-602(D). L. Nothing in this Section shall be construed to prohibit the emerper- gency administration of oxygen by licensed health-care sonnel, emergency medical technicians, first responders, fir e 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD fighters, law enforcement officers, and other emergency personnel trained in the proper use of emergency oxygen. Historical Note Adopted effective January 12, 1998 (Supp. 98-1). Amended by final rulemaking at 19 A.A.R. 97, effective March 10, 2013 (Supp. 13-1). Amended by final rulemaking at , effective August 2, 2014 (Supp. 14-2). Amended by final rulemaking at , effective June 1, 2019 (Supp. 19-2). R4-23-693. Durable Medical Equipment (DME) and Compressed Medical Gas (CMG) Supplier-Resident or Nonresident medi- A. Permit. A person shall not sell, lease, or supply durable cal equipment or a compressed medical gas to a patient or consumer in Arizona for use in a home or residence without a current Board-issued resident or nonresident durable medical equipment and compressed medical gas supplier permit. Th e permit requirements of this Section do not apply to the following unless there is a separate business entity engaged in th e business of providing durable medical equipment or a compressed medical gas to a patient or consumer for use in a hom e or residence: 1. A medical practitioner licensed under A.R.S. Title 32; 2. A hospital, long-term care facility, hospice, or other health-care facility using durable medical equipment or a compressed medical gas in the normal course of treating a patient; and 3. A pharmacy. B. Application. To obtain a resident or nonresident DME an d CMG supplier permit, a person shall submit a complete d application form and fee specified in R4-23-205. 1. A resident DME and CMG supplier permit applicant shall include documentation of compliance with local zonin g laws, if required by the Board. 2. A nonresident DME and CMG supplier permit applicant that resides in a jurisdiction that issues an equivalent license or permit shall include a copy of the equivalent license or permit. C. Notification. A resident or nonresident DME and CMG supplier permittee shall submit using the permittee’s online profil e or provide written notice by mail, fax, or e-mail to the Boar d office within 10 days of changes involving the telephone or fax number, email or mailing address, or business name. D. Change of ownership. A resident or nonresident DME an d CMG supplier permittee shall comply with R4-23-601(F). E. Relocation. 1. No fewer than 30 days before a resident DME and CMG supplier permittee relocates, the permittee shall submit a completed application for relocation electronically or manually on a form furnished by the Board, and the documentation required in subsection (B). A fee is not required with an application for relocation. 2. A nonresident DME and CMG supplier permittee shall provide written notice by mail, fax, or e-mail to the Boar d office no fewer than 10 days before relocating. F. Orders. A resident or nonresident DME and CMG supplier shall sell, lease, or provide: 1. Durable medical equipment that is a prescription-onl y device, as defined in A.R.S. § 32-1901, only under a prescription or medication order from a medical practitioner; and 2. A compressed medical gas only under a compressed medical gas order from a medical practitioner. March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY G. Restriction. A DME and CMG supplier permit authorizes th e permittee to procure, possess, and provide a prescription-onl y device or compressed medical gas to a patient or consumer a s specified in subsection (F). A DME and CMG supplier permit does not authorize the permittee to procure, possess, or provide narcotics or other controlled substances, prescriptiononly drugs other than compressed medical gases, precursor chemicals, or regulated chemicals. H. Facility. A resident or nonresident DME and CMG supplier permittee shall ensure the facility is clean, uncluttered, sanitary, temperature controlled, and secure from unauthorize d stor- access. A permittee shall maintain separate and identified age areas in the facility and in delivery vehicles for clean, dirty, contaminated, or damaged durable medical equipment or compressed medical gases. I. A resident or nonresident DME and CMG supplier permitte e shall not manufacture, process, transfill, package, or label a compressed medical gas, except as stated in subsection (K). J. Records. A resident or nonresident DME and CMG supplier permittee shall establish and implement written procedures for maintaining records about acquisition, distribution, returns, recalls, training of personnel, maintenance, cleaning, and complaints. K. A permittee shall: 1. Ensure a prescription order, medication order, or compressed medical gas order is obtained as specified in subsection (F); 2. Ensure each compressed medical gas container supplie d by the permittee contains a label bearing the name an d address of the permittee; 3. Ensure all appropriate warning labels are present on th e durable medical equipment or compressed medical gas; 4. Retain the records required by Section R4-23-601 an d this Section for not fewer than three years, or if supplyin g a compressed medical gas, one year after the expiratio n date of the compressed medical gas, whichever is longer; and 5. Make the records required by Section R4-23-601 and thi s com- Section available for inspection by the Board or its pliance officer, or if stored in a centralized recordkeepin g system apart from the inspection location and not electronically retrievable for inspection, provide the record s within four working days of a request by the Board or it s staff. L. Inspection. 1. A resident DME and CMG supplier permittee shall mak e the DME and CMG supplier’s facility available for inspection by the Board or its compliance officers under A.R.S. § 32-1904. 2. Within 10 days from the date of a request by the Board or its staff, a nonresident DME and CMG supplier permitte e shall provide a copy of the most recent inspection report completed by the permittee’s resident licensing authority, or a copy of the most recent inspection report complete d by a third-party auditor approved by the permittee’s resident licensing authority or the Board or its designee. Th e Board may inspect, or may employ a third-party auditor to inspect, a nonresident permittee as specified in A.R.S. § 32-1904. M. Permit renewal. To renew a resident or nonresident DME an d CMG supplier permit, the permittee shall comply with in R4- 23-602(D). emer- N. Nothing in this Section shall be construed to prohibit the gency administration of oxygen by licensed health-care per- 26-1 Page 69 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD sonnel, emergency medical technicians, first responders, fir e fighters, law enforcement officers, and other emergency personnel trained in the proper use of emergency oxygen. Historical Note Adopted effective January 12, 1998 (Supp. 98-1). Amended by final rulemaking at , effective August 2, 2014 (Supp. 14-2). Amended by final rulemaking at , effective June 1, 2019 (Supp. 19-2). Amended by final rulemaking at 31 A.A.R. 2363 (July 18, 2025), effective August 30, 2025 (Supp. 25-3). GENERAL PROVISIONS R4-23-701. Long-term Care Facilities Pharmacy Services: Consultant Pharmacist A. The long-term care consultant pharmacist as defined in R4-23- 110 shall: 1. Possess a valid Arizona pharmacist license issued by th e Board; 2. Ensure the provision of pharmaceutical patient care services as defined in R4-23-110; 3. Review the distribution and storage of drugs and device s and assist the facility in establishing policies and procedures for the distribution and storage of drugs an d devices; 4. Provide resident evaluation programs that relate to monitoring the therapeutic response and utilization of all drug s and devices prescribed or administered to residents, usin g as guidelines the most current indicators established b y the Centers for Medicare and Medicaid Services, Unite d States Department of Health and Human Services a s required in 42 CFR 483.60 (revised October 1, 2010, incorporated by reference and on file with the Board. This incorporated material contains no future editions or amendments.). 5. Serve as a resource for pharmacy-related education services within the facility; 6. Participate in quality management of resident care in th e facility; and 7. Communicate with the provider pharmacy regardin g areas of mutual concern and resolution. B. A long-term care consultant pharmacist shall ensure that: 1. When a provider pharmacy is not open for business, arrangements are made in advance by the long-term car e consultant pharmacist, in cooperation with the pharmacist-in-charge of the provider pharmacy and the director of nursing and medical staff of the long-term care facility, for providing emergency drugs for the licensed nursin g staff to administer to the residents of the facility using a n emergency drug supply unit located at the facility; 2. The label and packaging of prescription-only and nonprescription drugs intended for use within a long-term car e facility complies with state and federal law; and 3. The long-term care facility: a. Stores controlled substances listed in A.R.S. § 36- 2513 in a separately locked and permanently affixe d compartment, unless the facility uses a single-unit package medication distribution system; and b. Maintains accurate records of controlled substanc e administration or ultimate disposition. C. The long-term care consultant pharmacist shall: 1. Ensure availability of records and reports designed t o provide the data necessary to evaluate the drug use of Supp. Administrative Code AND OCCUPATIONS OF PHARMACY each long-term care facility resident that include the following: a. Provider pharmacy patient profiles and long-ter m care facility medication administration records; b. Reports of suspected adverse drug reactions; empha- c. Inspection reports of drug storage areas with sis on detecting outdated drugs; and d. Accountability reports, that include: i. Date and time of administration, ii. Name of the person who administered the drug, iii. Documentation and verification of any waste d or partial doses, iv. Exception reports for refused doses, and v. All drug destruction forms; and 2. Identify and report drug irregularities and dispensin g errors to the prescriber, the director of nursing of th e facility, and the provider pharmacy. D. A long-term care consultant pharmacist or pharmacist-incharge of a provider pharmacy shall ensure that: 1. Discontinued or outdated drugs, including controlled substances, are destroyed or disposed of in a timely manner using methods consistent with federal, state, and local requirements and subject to review by the Board or it s staff; and 2. Drug containers with illegible or missing labels are: a. Identified; and b. Replaced or relabeled by a pharmacist employed b y the pharmacy that dispensed the prescription medication. Historical Note Former Rules 6.8110, 6.8120, 6.8130, 6.8140, 6.8150, 6.8160, and 6.8170; Amended effective Aug. 10, 1978 (Supp. 78-4). Section repealed, new Section adopted effective December 18, 1992 (Supp. 92-4). Amended by final rulemaking at , effective May 4, 2003 (Supp. 03-1). Amended by final rulemaking at 12 A.A.R. 3032, effective October 1, 2006 (Supp. 06-3). Amended by final rulemaking at 19 A.A.R. 2894, effective November 10, 2013 (Supp. 13-3). Ser- R4-23-701.01. Long-term Care Facilities Pharmacy vices: Provider Pharmacy The limited-service pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall ensure that: 1. A prescription medication is provided only by a valid prescription order for an individual long-term care facilit y resident, properly labeled for that resident, as specified i n this subsection. Nothing in this Section shall prevent a provider pharmacy from supplying nonprescription drug s in a manufacturer’s unopened container or emergenc y drugs using an emergency drug supply unit as specified i n R4-23-701.02; facil- 2. A prescription medication label for a long-term care ity resident complies with A.R.S. §§ 32-1968 and 36- 2525 and contains: a. The drug name, strength, dosage form, and quantity; and b. The beyond-use-date; dis- 3. Only a pharmacist employed by the pharmacy that pensed the prescription medication may, through th e exercise of professional judgment, relabel or alter a prescription medication label that is illegible or missing; 4. The provider pharmacy develops and implements dru g recall policies and procedures that protect the health an d 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD safety of facility residents. The drug recall procedure s shall include immediate discontinuation of any patient level recalled drug and notification of the prescriber an d director of nursing of the facility; and 5. Drugs previously dispensed to a resident of the long-term care facility by another pharmacy, and drugs previousl y dispensed by the provider pharmacy, are not repackaged. Historical Note Adopted effective December 18, 1992 (Supp. 92-4). Amended by final rulemaking at , effective May 4, 2003 (Supp. 03-1). Amended by final rulemaking at , effective November 10, 2013 (Supp. 13-3). R4-23-701.02. Long-term Care Facilities Pharmacy Services: Emergency Drugs A. The limited-service pharmacy permittee or pharmacist-incharge of a provider pharmacy shall ensure that: 1. An emergency drug supply unit is available within th e long-term care facility, 2. Drugs contained in an emergency drug supply unit remain the property of the provider pharmacy, and 3. Controlled substance drugs contained in an emergenc y drug supply unit are included in all inventories require d under A.R.S. § 36-2523(B) and R4-23-1003(A). crite- B. An emergency drug supply unit shall meet the following ria: 1. The drugs are necessary to meet the immediate and emerresi- gency therapeutic needs of long-term care facility dents as determined by the provider pharmacy’ s pharmacist-in-charge in consultation with the long-term care facility’s medical director and nursing director; 2. The purpose of the emergency drug supply unit in a longterm care facility is not to relieve a provider pharmacy of the responsibility for timely provision of the resident’ s routine drug needs, but to ensure that an emergency dru g supply unit is available for facility residents in need of immediate and emergency therapeutic drugs; and 3. The drugs are provided in a manufacturer’s unit of us e package or are prepackaged and labeled to include th e num- drug name, strength, dosage form, manufacturer, lot ber, and expiration date and provider pharmacy’s name, address, telephone number, and pharmacist’s initials. C. The limited-service pharmacy permittee or pharmacist-incharge of a provider pharmacy shall ensure that an emergenc y drug supply unit: 1. Is stored in an area that: a. Is temperature controlled; and b. Prevents unauthorized access; 2. Contains on the exterior of the emergency drug suppl y unit a label to indicate that the contents are for emergenc y use only; 3. Contains on the exterior of the emergency drug suppl y unit a complete list of the contents of the unit by dru g name, strength, dosage form, and quantity and the provider pharmacy’s name, address, and telephone number; 4. Contains on the exterior of the emergency drug suppl y unit a label that indicates the date of the earliest dru g expiration date; 5. Contains on the exterior of the emergency drug suppl y unit a label that indicates the date of and pharmacist responsible for the last inspection of the emergency dru g supply unit; and March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY 6. Is secured with a tamper-evident seal, or is locked an d sealed in a manner that obviously reveals when the unit has been opened or tampered with. D. The limited-service pharmacy permittee or pharmacist-incharge of a provider pharmacy shall: man- 1. Prepare, implement, review, and revise in the same ner described in R4-23-671(E) and comply with writte n policies and procedures for the storage and use of a n emergency drug supply unit in a long-term care facility; 2. Make the policies and procedures available in the provider pharmacy and long-term care facility for employe e reference and inspection by the Board or its staff; 3. Ensure that the written policies and procedures includ e the following: a. Drug removal procedures that require: i. The long-term care facility’s personnel receiv e a valid prescription order for each dru g removed from the emergency drug supply unit, ii. The long-term care facility’s personnel notif y the provider pharmacy when a drug is remove d from the emergency drug supply unit, b. Outdated drug replacement procedures, and c. Security and inspection procedures; 4. Exchange or restock the emergency drug supply unit weekly, or more often as necessary, to ensure the availability of an adequate supply of emergency drugs withi n the long-term care facility. Restocking of the emergenc y drug supply unit at the facility shall be completed by a n Arizona licensed pharmacist employed by the provider pharmacy, or by an Arizona licensed intern, graduat e intern, technician or technician trainee under the direct onsite supervision of an Arizona licensed pharmacist; and 5. Educate pharmacy and long-term care facility personnel in the storage and use of an emergency drug supply unit. E. In addition to the requirements of subsections (A) through (D), pro- an automated emergency drug supply unit may be used vided: 1. The pharmacy permittee or pharmacist-in-charge of th e writ- provider pharmacy notifies the Board or its staff in ing of the intent to use an automated emergency drug supply unit, including the name and type of unit; 2. The provider pharmacy is notified electronically whe n the automated emergency drug supply unit has bee n accessed; emer- 3. All events involving the access of the automated gency drug supply unit are recorded electronically an d maintained for not less than two years; 4. The provider pharmacy is capable of producing a report of all transactions of the automated emergency drug supply unit including a single drug usage report as require d in R4-23-408(B)(5) on inspection by the Board or it s staff; 5. The provider pharmacy develops written policies an d procedures for: a. Accessing the automated emergency drug suppl y unit in the event of a system malfunction or downtime, b. Authorizing and modifying user access, c. An ongoing quality assurance program that includes: i. Training in the use of the automated emergenc y drug supply unit for all authorized users, ii. Maintenance and calibration of the automate d emergency drug supply unit as recommende d by the device manufacturer; and 26-1 Page 71 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 6. Documentation of the requirements of subsectio n (E)(5)(c)(ii) is maintained for inspection by the Board or its staff for not less than two years. F. The Board may prohibit a pharmacy permittee or pharmacistin-charge of a provider pharmacy from using an automate d phar- emergency drug supply unit if the pharmacy permittee or macy permittee’s employees do not comply with the requirements of subsections (A) through (E). Historical Note Adopted effective December 18, 1992 (Supp. 92-4). Amended by final rulemaking at , effective May 4, 2003 (Supp. 03-1). Amended by final rulemaking at , effective October 1, 2006 (Supp. 06-3). Amended by final rulemaking at 19 A.A.R. 2894, effective November 10, 2013 (Supp. 13-3). Ser- R4-23-701.03. Long-term Care Facilities Pharmacy vices: Emergency Drug Prescription Order The limited-service pharmacy permittee or pharmacist-in-charge of pre- a provider pharmacy shall ensure that every emergency drug scription order is evaluated according to the requirements of R4-23- 402(A) by a pharmacist within 72 hours of the first dose of dru g emer- administered by long-term care facility personnel under the gency drug prescription order. Historical Note Adopted effective December 18, 1992 (Supp. 92-4). Amended by final rulemaking at , effective May 4, 2003 (Supp. 03-1). R4-23-701.04. Long-term Care Facilities Pharmacy Services: Automated Dispensing Systems A. Before using an automated dispensing system as defined i n R4-23-110, a pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall: 1. Notify the Board or its staff in writing of the intent to us e an automated dispensing system, including the name an d type of system; 2. Obtain a separate controlled substances registration at th e location of each long-term care facility at which an autosub- mated dispensing system containing controlled stances will be located as required by federal law; and 3. Maintain copies of the registrations required under subsection (A)(2) at the provider pharmacy for inspection b y the Board or its staff. B. A pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall ensure: 1. Drugs contained in an automated dispensing system remain the property of the provider pharmacy, 2. Controlled substance drugs contained in an automate d dispensing system are included in all inventories require d under A.R.S. § 36-2523(B) and R4-23-1003(A), dis- 3. Schedule II drugs are not stocked in an automated pensing system, and 4. A separate emergency drug supply unit is available in th e long-term care facility to meet the requirements of R4- 23-701.02. C. A pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall: 1. Ensure that policies and procedures as required in subsection (D) for the use of an automated dispensing system i n a long-term care facility are prepared, implemented, an d complied with; 2. Review biennially and, if necessary, revise the policie s and procedures required under subsection (D); Supp. Administrative Code AND OCCUPATIONS OF PHARMACY 3. Document the review required under subsection (C)(2); 4. Assemble the policies and procedures as a written or electronic manual; and 5. Make the policies and procedures available for employe e reference and inspection by the Board or its staff withi n the pharmacy and at any location outside of the pharmac y where the automated dispensing system is used. D. A pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall ensure the written policies and procedure s include: 1. Drug removal procedures that include the following: a. A drug is provided only by a valid prescription order for an individual long-term care facility resident; b. A drug is dispensed from an automated dispensin g system only after a pharmacist has: i. Reviewed and verified the resident’s prescription order as required by R4-23-402(A), and ii. Electronically authorized the access for that drug for that particular resident, and c. The automated dispensing system labels each individual drug packet with a resident specific label that complies with R4-23-701.01(2) and contains the resident’s room number or facility identification number; and 2. Security procedures that include the following: a. The pharmacy permittee or pharmacist-in-charge of the provider pharmacy is responsible for authorizin g user access, including adding and removing user s and modifying user access; b. Each authorized user is a licensee of the Board or authorized licensed personnel of the long-term car e facility; and c. The automated dispensing system is secured at th e long-term care facility by electronic or mechanical means or a combination thereof designed to prevent unauthorized access; 3. Drug stocking procedures that include the following: a. Automated dispensing systems that use non-removable containers that do not allow prepackaging of th e container as set out in subsection (D)(3)(b): i. Are stocked at the long-term care facility by a n Arizona licensed pharmacist employed by th e provider pharmacy, or by an Arizona license d intern, graduate intern, technician or technicia n trainee under the direct onsite supervision of a n Arizona licensed pharmacist; and ii. Utilize bar code or other technologies to ensur e the correct drug is placed in the correct canister or container; and b. Automated dispensing systems that use removabl e containers may be stocked at the long-term car e facility by an authorized user provided: i. The prepackaging of the container occurs at th e provider pharmacy; ii. A pharmacist verifies the container has bee n properly filled and labeled, and the container i s secured with a tamper-evident seal; iii. The individual containers are transported to th e long-term care facility in a secure, tamper-evident shipping container; and iv. The automated dispensing system uses microchip, bar-coding, or other technologies t o ensure the containers are accurately loaded i n the automated dispensing system; and 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 4. Recordkeeping and report procedures that include the following: dis- a. All events involving the access of the automated pensing system are recorded electronically an d maintained for not less than two years; b. The provider pharmacy is capable of producing a report of all transactions of the automated dispensing system including: i. A single drug usage report that complies wit h R4-23-408(B)(5); and ii. An authorized user history including date an d time of access and type of transaction; and c. The provider pharmacy has procedures to safeguar d the storage, packaging, and distribution of drugs b y monitoring: i. Current inventory; ii. Expiration dates; iii. Controlled substance dispensing; iv. Re-dispense requests; and v. Wastage. E. A pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall: 1. Ensure that an electronic log is kept for each container fill that includes: a. An identification of the container by drug name an d strength, and container number; b. The drug’s manufacturer or National Drug Cod e (NDC) number; c. The expiration date and lot number from the manucon- facturer’s stock bottle that is used to fill the tainer. If multiple lot numbers of the same drug ar e added to a container, each lot number and expiratio n date shall be documented; d. The date the container is filled; e. Documentation of the identity of the licensee wh o placed the drug into the container; and f. If the licensee who filled the container is not a pharmacist, documentation of the identity of the pharmacist who supervised the non-pharmacist licensee; and 2. Maintain the electronic log for inspection by the Board or its staff for not less than two years. F. A pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall: 1. Implement an ongoing quality assurance program that monitors performance of the automated dispensing system and compliance with the established policies and procedures that includes: a. Training in the use of the automated dispensing system for all authorized users, dis- b. Maintenance and calibration of the automated pensing system as recommended by the device manufacturer, c. Routine accuracy validation testing no less tha n every three months, and d. Downtime and malfunction procedures to ensure th e timely provision of medication to the long-term car e facility resident, and 2. Maintain documentation of the requirements of subsections (F)(1)(b) and (F)(1)(c) for inspection by the Board or its staff for not less than two years. G. The Board may prohibit a pharmacy permittee or pharmacistin-charge from using an automated dispensing system in a long-term care facility if the pharmacy permittee or the phar- March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY macy permittee’s employees do not comply with the requirements of subsections (A) through (F). Historical Note New Section made by final rulemaking at 19 A.A.R. 2894, effective November 10, 2013 (Supp. 13-3). R4-23-702. Hospice Inpatient Facilities ser- A. If a pharmacy permittee contracts to provide pharmacy vices to the patients of a hospice inpatient facility as defined i n R4-23-110, the pharmacy permittee shall ensure that: pre- 1. A prescription medication is provided only by a valid scription order for an individual hospice inpatient facilit y patient, properly labeled for that patient, as specified i n this subsection. Nothing in this section shall prevent a provider pharmacy from supplying non-prescriptio n drugs in a manufacturer’s unopened container; 2. A prescription medication label for a hospice inpatient facility patient complies with A.R.S. §§ 32-1968 and 36- 2525 and contains: a. The drug name, strength, dosage form, and quantity; and b. The beyond-use date; and 3. If the label on the hospice inpatient facility patient’s dru g container becomes damaged or soiled, a pharmacist employed by the pharmacy that dispensed the drug container, through the exercise of professional judgment, may relabel the drug container. Only a pharmacist is permitted to label a drug container or alter the label of a dru g container. B. A pharmacist may help hospice inpatient facility personnel develop written policies and procedures for the procurement, administration, storage, control, recordkeeping, and disposal of drugs in the facility. C. The provider pharmacy may contract with the hospice inpatient facility to provide pharmacist services at the facility that include evaluation of the patient’s response to medication therapy, identification of potential adverse drug reactions, and recommended appropriate corrective action. D. A provider pharmacy that places an emergency drug suppl y unit at a hospice inpatient facility shall comply with th e requirements of R4-23-701.02. E. A pharmacy shall not place an automated dispensing system a s defined in R4-23-701.04 in a hospice inpatient facility. inpa- F. Drugs previously dispensed to a patient of the hospice tient facility by another pharmacy, and drugs previously dispensed by the provider pharmacy, shall not be repackaged. Historical Note Former Rules 6.8210, 6.8211, 6.8212, 6.8213, 6.8214, 6.8221, 6.8222, 6.8223, 6.8824, 6.8231, 6.8232, 6.8233, 6.8241, 6.8242, and 6.8243; Amended effective August 10, 1978 (Supp. 78-4). Repealed effective December 18, 1992 (Supp. 92-4). New Section made by final rulemaking at , effective November 10, 2013 (Supp. 13-3). R4-23-703. Assisted Living Facilities A. Before dispensing, selling, or delivering a prescription or nonphar- prescription drug to an assisted living facility resident, a macy permittee shall verify the assisted living facility has a current and active license issued by the Arizona Department of Health Services. B. A pharmacy permittee shall ensure that, except as provide d under subsection (C): 26-1 Page 73 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 1. A controlled substance prescription drug is dispensed, sold, or delivered to an assisted living facility resident con- only after receiving a valid prescription order for the trolled substance prescription drug from the resident’ s medical practitioner; and 2. The controlled substance prescription drug is labeled i n accordance with A.R.S. §§ 32-1963.01, 32-1968, and 36- 2525 and includes the beyond-use date on the label. C. A pharmacy permittee may dispense, sell, or deliver to a n assisted living facility resident a Schedule III, IV, or V controlled substance prescription if the pharmacy permittee: 1. Receives a written or oral prescription order for th e Schedule III, IV, or V controlled substance from: a. The resident’s medical practitioner, b. An individual licensed by the Arizona Board of Nursing who is acting within the scope of practice of the individual’s license, or c. The manager or a caregiver of the assisted livin g facility if the resident’s medical practitioner has a written agreement with the assisted living facilit y designating a representative of the assisted livin g facility as an agent of the medical practitioner and a licensed medical practitioner provided the prescription order; 2. Complies with subsection (D)(2); and 3. Labels the Schedule III, IV, or V controlled substance a s specified under subsection (B)(2). D. A pharmacy permittee may dispense, sell, or deliver to a n assisted living facility resident a non-controlled substance prescription or non-prescription drug if the pharmacy permittee: 1. Receives a written or oral prescription order for the noncontrolled substance prescription or non-prescriptio n drug from: a. The resident’s medical practitioner, b. An individual licensed by the Arizona Board of Nursing who is acting within the scope of practice of the individual’s license, or c. An assisted living facility manager or caregiver actpracti- ing under the authority of a licensed medical tioner; 2. Determines the written or oral prescription order: a. Meets the requirements of R4-23-407, and b. Includes the name and title of the individual transmitting the prescription order; and 3. Labels the non-narcotic prescription or non-prescriptio n drug in accordance with A.R.S. §§ 32-1963.01 and 32- 1968 and includes the beyond-use date on the label. con- E. If the label on an assisted living facility resident’s drug tainer becomes damaged or soiled, a pharmacist employed b y the pharmacy permittee that dispensed the drug container, through the exercise of professional judgment, may relabel th e drug container. Only a pharmacist is permitted to label a dru g container or alter the label of a drug container. F. A pharmacist may help assisted living facility personnel develop written policies and procedures regarding procuring, administering, storing, controlling, keeping records, and discon- posing of drugs in the facility and provide information cerning safe and effective supervision of drug selfadministration. sup- G. A pharmacy permittee shall not place an emergency drug ply unit as described in R4-23-701.02 or an automated dispensing system as described in R4-23-701.04 in an assiste d living facility. Supp. Administrative Code AND OCCUPATIONS OF PHARMACY H. A pharmacist shall not repackage a drug previously dispense d to an assisted living facility resident. Historical Note Former Rules 6.8310, 6.8320, 6.8330, 6.8340, 6.8350, 6.8360, and 6.8370; Amended effective August 10, 1978 (Supp. 78-4). Amended by final rulemaking at 5 A.A.R. 2561, effective July 16, 1999 (Supp. 99-3). Amended by final rulemaking at , effective November 10, 2013 (Supp. 13-3). Amended by final rulemaking at 23 A.A.R. 2424, effective October 14, 2017 (Supp. 17-3). R4-23-704. Customized Patient Medication Packages In lieu of dispensing two or more prescribed drugs in separate containers, a pharmacist may, with the consent of the patient, th e patient’s caregiver, the prescriber, or the facility caring for th e patient, provide a customized patient medication package. Th e pharmacist preparing a customized patient medication packag e shall abide by the guidelines set forth in the current edition of th e official compendium for labeling, packaging, and recordkeeping, and state and federal law. Historical Note Former Rules 6.8410, 6.8411, 6.8412, 6.8413, 6.8414, 6.8415, 6.8416, and 6.8417. Section R4-23-704 repealed by final rulemaking at 5 A.A.R. 862, effective March 3, 1999 (Supp. 99-1). Amended by final rulemaking at 19 A.A.R. 2894, effective November 10, 2013 (Supp. 13-3). R4-23-705. Repealed Historical Note Former Rules 6.8420, 6.8421, 6.8422, 6.8423, 6.8424, 6.8425, 6.8426, 6.8427, 6.8428, and 6.8429. Amended effec- effective August 10, 1978 (Supp. 78-4). Amended tive August 24, 1992 (Supp. 92-3). Repealed effective December 18, 1992 (Supp. 92-4). R4-23-706. Repealed Historical Note Former Rules 6.8431, 6.8432, 6.8433, 6.8434, 6.8435, 6.8436, and 6.8437; Amended effective August 10, 1978 (Supp. 78-4). Amended subsections (C), (E), (F), and (G) effective April 20, 1982 (Supp. 82-2). Section R4-23-706 repealed by final rulemaking at , effective March 3, 1999 (Supp. 99-1). R4-23-707. Repealed Historical Note Former Rules 6.8441, 6.8442, 6.8450, 6.8451, 6.8452, 6.8453, 6.8454, 6.8455, 6.8456, and 6.8457. Section R4- 23-707 repealed by final rulemaking at , effective March 3, 1999 (Supp. 99-1). R4-23-708. Repealed Historical Note Former Rules 6.8461, 6.8462, 6.8463, and 6.8464. Section R4-23-708 repealed by final rulemaking at 5 A.A.R. 862, effective March 3, 1999 (Supp. 99-1). R4-23-709. Repealed Historical Note Former Rules 6.8471, 6.8472, and 6.8473. Section R4- 23-709 repealed by final rulemaking at , effective March 3, 1999 (Supp. 99-1). 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD Article 8, consisting of Sections R4-23-801 and R4-23-802, recodified from Article 5 at , effective August 18, 200 3 (Supp. 03-3). R4-23-801. Repealed Historical Note Former Rules 7.1110, 7.1120, and 7.1130. Repealed effective November 4, 1998 (Supp. 98-4). Recodified from R4-23-501 at , effective August 18, 2003 (Supp. 03-3). Repealed by final rulemaking at 26 A.A.R. 223, effective March 14, 2020 (Supp. 20-1). R4-23-802. Veterinary Veterinary preparation: A veterinary drug manufacturer or supplier may distribute: 1. A prescription-only veterinary drug to: a. A veterinary medical practitioner licensed under A.R.S. Title 32, Chapter 21, b. A full-service drug wholesaler permitted under A.R.S. Title 32, Chapter 18, or c. A pharmacy permitted under A.R.S. Title 32, Chapter 18, and 2. A nonprescription veterinary drug to: a. A veterinary medical practitioner licensed under A.R.S. Title 32, Chapter 21, b. A full-service or nonprescription drug wholesaler permitted under A.R.S. Title 32, Chapter 18, or c. A pharmacy permitted under A.R.S. Title 32, Chapter 18. Historical Note Former Rules 7.1210, 7.1220, and 7.1230. Repealed effective November 4, 1998 (Supp. 98-4). Recodified from R4-23-502 at , effective August 18, 2003 (Supp. 03-3). Amended by final rulemaking at 31 A.A.R. 2363 (July 18, 2025), effective August 30, 2025 (Supp. 25-3). R4-23-803. Repealed Historical Note Former Rules 7.1300, 7.1400, 7.1500, and 7.1000. Repealed effective November 4, 1998 (Supp. 98-4). R4-23-804. Repealed Historical Note Former Rules 7.2100, 7.2200, 7.2300, 7.2410, 7.2420, and 7.2430. Repealed effective November 4, 1998 (Supp. 98-4). R4-23-901. Penalty for Violations Any person, firm, or corporation violating any provision of 4 addi- A.A.C. 23 is subject to the penalties in A.R.S. § 32-1996. In tion, a license or permit issued under the provisions of A.R.S. Titl e 32, Chapter 18 is subject to suspension or revocation for violatio n of . Historical Note Former Rule 9.0000. Amended by final rulemaking at 6 A.A.R. 3177, effective August 3, 2000 (Supp. 00-3). R4-23-902. Non-disciplinary Civil Penalties As authorized under A.R.S. § 32-1904(D), the Board may issue th e following non-disciplinary civil penalties to a licensee or permitte e March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY who engages in the specified acts or omissions without posing a n imminent threat to public health or safety: remodel- 1. Failing to submit a remodel application before ing a permitted facility: $250; 2. Failing to provide notice before a business is relocated: $500; 3. Failing to update contact information: $50/occurrence t o a maximum of twice; 4. Failing to update change of employment information: $50/occurrence to a maximum of twice; 5. Failing to complete required continuing education: con- a. Registered pharmacist: $100/deficient hour of tinuing education for the first occurrence, $150/deficient hour for second occurrence; and continu- b. Pharmacy technician: $25/deficient hour of ing education for the first occurrence, $37.50/deficient hour for second occurrence; 6. Failing to provide notice of a new pharmacist in charge: $100/occurrence to a maximum of twice; 7. Failing to provide notice of a new designated representative: $100/occurrence to a maximum of twice; 8. Failing to provide notice of a new criminal charge, arrest, or conviction in any jurisdiction: $250/occurrence to a maximum of twice; 9. Failing to provide notice of disciplinary action take n against the licensee or permittee by another jurisdiction: $250/occurrence to a maximum of twice; 10. Failing to renew a license timely and continuing to wor k with an expired license: a. Registered pharmacist: $100/day worked not t o exceed $1,000; and b. Pharmacy technician: $50/day worked not to excee d $500; 11. Failing to conduct a controlled substance inventory whe n there is a new pharmacist in charge: $250/occurrence to a maximum of twice; 12. Failing to obtain a permit before shipping into Arizon a anything for which a permit is required: $100/ite m shipped; 13. Failing to respond timely to a subpoena: $50; 14. Failing to provide notice before there is a change in ownership: $250; and 15. Failing to conduct required controlled substance inventories: $250. Historical Note New Section made by final rulemaking at 28 A.A.R. 611 (March 18, 2022), effective May 2, 2022 (Supp. 22-1). AND DRUG OFFENSES R4-23-1001. Repealed Historical Note Adopted effective August 2, 1982 (Supp. 82-4). Section repealed by final rulemaking at 6 A.A.R. 3177, effective August 3, 2000 (Supp. 00-3). R4-23-1002. Repealed Historical Note Adopted effective August 2, 1982 (Supp. 82-4). Repealed effective November 4, 1998 (Supp. 98-4). R4-23-1003. Records and Order Forms A. Records. 26-1 Page 75 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 1. If the pharmacist-in-charge of a pharmacy is replaced b y another pharmacist-in-charge, the new pharmacist-insub- charge shall complete an inventory of all controlled stances in the pharmacy within 10 days of assuming th e responsibility. This inventory and any other required controlled substance inventory shall: a. Include an exact count of all Schedule II controlle d substances; b. Include an exact count of all Schedule III throug h Schedule V controlled substances or an estimate d count if the stock container contains fewer than 100 1 units; c. Indicate the date the inventory is taken and whether the inventory is taken before opening of business or after close of business for the pharmacy; d. Be signed by: i. The pharmacist-in-charge; or ii. For other required inventories, the pharmacist who does the inventory; e. Be kept separately from all other records; and f. Be available in the pharmacy for inspection by th e Board or its designee for not less than three years. 2. A loss of a controlled substance shall be reported: a. Within 10 days of discovery; b. On a DEA form 106; c. By the pharmacist-in-charge of a pharmacy or a manufacturer; d. By the permittee or designated representative of a full-service wholesaler; and e. To the federal Drug Enforcement Administratio n (DEA), the Narcotic Division of the Department of Public Safety (DPS), and the Board of Pharmacy. A copy of the DEA form 106 shall be kept on file b y the pharmacy permittee. The DEA form 106 shall state whether the police investigated the loss. 3. Every person manufacturing any controlled substance, including repackaging or relabeling, shall record an d retain for not less than three years the manufacturing, sub- repackaging, or relabeling date for each controlled stance. 4. Every person receiving, selling, delivering, or disposin g of any controlled substance shall record and retain for not less than three years the following information: a. The name, strength, dosage form, and quantity of each controlled substance received, sold, delivered, or disposed; b. The name, address, and DEA registration number of the person from whom each controlled substance i s received; c. The name, address, and DEA registration number of the person to whom each controlled substance i s sold or delivered or who disposes of each controlle d substance; and d. The date of each transaction. 5. A full-service drug wholesale permittee or the designate d representative shall complete an inventory of all controlled substances in the manner prescribed in subsectio n (A)(1). The permittee or designated representative shall conduct this inventory: a. On May 1 of each year or as directed by the Board; and b. If there is a change of ownership, or discontinuanc e desig- of business, or within 10 days of a change of a nated representative. Supp. Administrative Code AND OCCUPATIONS OF PHARMACY 6. A drug manufacturer permittee or the pharmacist-incharge shall complete an inventory of all controlled substances in the manner prescribed in subsection (A)(1). The permittee or pharmacist-in-charge shall conduct thi s inventory: a. On May 1 of each year or as directed by the Board; and b. If there is a change of ownership, or discontinuanc e phar- of business, or within 10 days of a change of a macist-in-charge. B. Order form. For purposes of A.R.S. § 36-2524, “Order Form ” means DEA Form 222c. Historical Note Adopted effective August 2, 1982 (Supp. 82-4). Amended effective November 1, 1993 (Supp. 93-4). Amended effective April 1, 1995; filed January 31, 1995 (Supp. 95-1). Amended by final rulemaking at 6 A.A.R. 3177, effective August 3, 2000 (Supp. 00-3). Amended by final rulemaking at 12 A.A.R. 1912, effective July 1, 2006 (Supp. 06-2). Amended by final rulemaking at 14 A.A.R. 3670, effective November 8, 2008 (Supp. 08-3). R4-23-1004. Schedules of Controlled Substances As of the effective date of this Section and as required under A.R.S. §§ 36-2512 through 36-2516, the Board adopts the followin g schedules of controlled substances. The schedules adopted includ e no later amendments. The adopted schedules are available on th e Board’s website: 1. Schedule I. 21 CFR, Chapter II, Part 1308.11; 2. Schedule II. 21 CFR, Chapter II, Part 1308.12; 3. Schedule III. 21 CFR, Chapter II, Part 1308.13; 4. Schedule IV. 21 CFR, Chapter II, Part 1308.14; and 5. Schedule V. 21 CFR, Chapter II, Part 1308.15. Historical Note Adopted effective August 2, 1982 (Supp. 82-4). Repealed effective November 4, 1998 (Supp. 98-4). New Section made by final rulemaking at 28 A.A.R. 611 (March 18, 2022), effective May 2, 2022 (Supp. 22-1). R4-23-1005. Products Excluded or Exempted from th e Schedules of Controlled Substances The following lists of products are excluded or exempted from th e schedules of controlled substances adopted in R4-23-1004. All list s are available on the Board’s website and at https://www.ecfr.gov/ current/title-21/chapter-II/part-1308: 1. Excluded nonnarcotic substances that may be lawfull y sold over-the-counter without a prescription order. 2 1 CFR, Chapter II, Part 1308.22; 2. Exempted chemical preparations and mixtures. 21 CFR, Chapter II, Part 1308.24; and 3. Exempted prescription products containing a nonnarcoti c controlled substance. 21 CFR, Chapter II, Part 1308.32. Historical Note Adopted effective August 2, 1982 (Supp. 82-4). Amended by final rulemaking at 6 A.A.R. 3177, effective rulemak- August 3, 2000 (Supp. 00-3). Amended by final ing at 18 A.A.R. 2609, effective December 2, 2012 (Supp. 12-4). Amended by final rulemaking at 28 A.A.R. 611 (March 18, 2022), effective May 2, 2022 (Supp. 22- 1). R4-23-1006. Substances Excepted from Drug Offenses The following materials, compounds, mixtures, or preparation s containing any stimulant or depressant substance included i n 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD A.R.S. §§ 13-3401(6)(b) or 13-3401(6)(c) are excepted from th e definition of dangerous drugs under the authority of A.R.S. § 32- 1904(B)(14): 1. Over-the-counter drugs excepted in R4-23-1005(A). 2. Chemical preparations excepted in R4-23-1005(B). 3. Prescription-only drugs excepted in R4-23-1005(C). Historical Note Adopted effective August 2, 1982 (Supp. 82-4). Amended by final rulemaking at 6 A.A.R. 3177, effective August 3, 2000 (Supp. 00-3). TECHNICIAN TRAINEES Article 11, consisting of R4-23-1101 through R4-23-1105, made by final rulemaking at , effective May 1, 200 4 (Supp. 04-1). R4-23-1101. Repealed Historical Note New Section made by final rulemaking at , effective May 1, 2004 (Supp. 04-1). Amended by final rulemaking at 19 A.A.R. 102, effective March 10, 2013 (Supp. 13-1). Repealed by final rulemaking at 30 A.A.R. 3095 (October 25, 2024), effective November 30, 2024 (Supp. 24-4). R4-23-1102. Pharmacy Technician Licensure tech- A. License required. A person shall not work as a pharmacy nician in Arizona unless the person possesses a license issue d by the Board. A licensed pharmacy technician shall maintai n the certificate of licensure, which is in good standing, at th e practice site for inspection by the Board or its designee or review by the public. A license issued by the Board is not transferable. B. Eligibility. An applicant for licensure as a pharmacy technician, as defined at A.R.S. § 32-1901, shall provide the Boar d proof the applicant is eligible under A.R.S. § 32-1923.01(A), including documentation the applicant: 1. Passed a Board-approved pharmacy technician examination; 2. Passed the Foreign Pharmacy Graduate Equivalenc y Examination, if applicable; or 3. Graduated from a Board-approved pharmacy school. C. Application. 1. An applicant for licensure as a pharmacy technician shall: a. Submit a completed application electronically or manually on a form furnished by the Board, and b. Submit with the application form: i. The documents specified in the applicatio n form, ii. The initial licensure fee specified in R4-23- 205, and iii. The wall license fee specified in R4-23-205. 2. The Board office shall deem an application form receive d on the date the Board office electronically or manuall y date-stamps the form. D. Licensure. 1. If an applicant is found to be ineligible for pharmac y technician licensure under statute and rule, the Boar d office shall issue a written notice of denial to the applicant. 2. If an applicant is found to be eligible for pharmacy technician licensure under statute and rule, the Board offic e shall issue a certificate of licensure and a wall license. A n March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY applicant who is assigned a license number and grante d “open” or “active” status on the Board’s license verification site may begin practice as a pharmacy technician. A n applicant shall not practice as a pharmacy technician if the Board’s license verification site indicates any statu s other than “open” or “active.” E. License renewal. 1. To renew a license, a pharmacy technician shall submit a completed license renewal application electronically or manually on a form furnished by the Board with the biennial renewal fee specified in R4-23-205. 2. If the biennial renewal fee is not paid by November 1 of the renewal year specified in A.R.S. § 32-1925, the pharmacy technician license is suspended and the license e shall not practice as a pharmacy technician. The license e shall pay a reinstatement penalty as provided in A.R.S. § 32-1925 and R4-23-205 to vacate the suspension. 3. Continuing education requirement. Under A.R.S. § 32- 1925(H), continuing professional education is mandator y for a licensee. a. The Board shall accept continuing education hour s awarded only by an approved provider. b. The Board shall not renew a pharmacy technicia n license unless the licensee successfully completes 2 0 continuing education hours during the two year s since the licensee’s last renewal date and attests t o that on the biennial renewal form. c. Special continuing education requirements. If applicable, during each two-year license period, a pharmacy technician: i. Shall not administer a vaccine under R4-23- 1104(B)(5) unless the pharmacy technician ha s educa- successfully completed two continuing tion hours relating to administration of vaccines; and ii. As described under A.R.S. § 32-1925(H), shall successfully complete two continuing education hours regarding remote dispensing sit e pharmacy practices. d. A pharmacy technician licensee is exempt from th e continuing education requirement in subsectio n (E)(3)(b) between the time of initial licensure an d first renewal. e. A pharmacy technician licensee shall maintain for five years continuing education records that indicat e the number of hours successfully completed and th e approved provider of each continuing education. The pharmacy technician licensee shall make th e records available to the Board on request. f. The Board shall deem failure to comply with th e continuing education requirements as unprofessional conduct and grounds for disciplinary action under A.R.S. § 32-1927.01. g. A pharmacy technician who is aggrieved by a Boar d decision concerning continuing education ma y request a hearing before the Board. F. Delinquent license for five or more consecutive years. Th e Board shall reinstate a delinquent Arizona pharmacy technician license only if the individual furnishes satisfactory proof of fitness to be licensed as a pharmacy technician and pays all fees for the two most recent renewal periods and penalty fees. Satisfactory proof includes: 26-1 Page 77 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD 1. For an individual who is practicing as a pharmacy technician out-of-state with a pharmacy technician licens e issued by another jurisdiction: a. Proof of current, unrestricted pharmacy technicia n licensure in another jurisdiction; and b. Proof of employment as a pharmacy technicia n during the last 12 months; or 2. For an individual who did not practice as a pharmac y technician within the last 12 months: a. Take and pass a Board-approved pharmacy technician examination, and b. Complete 20 continuing education hours. G. Time frames for pharmacy technician licensure and licens e renewal. The Board office shall follow the time frames established in R4-23-202(F). H. Verification of license. A pharmacy permittee or pharmacistin-charge shall not allow a person to practice as a pharmac y technician until the pharmacy permittee or pharmacist-incharge verifies the person is currently licensed by the Board a s a pharmacy technician. Historical Note New Section made by final rulemaking at , effective May 1, 2004 (Supp. 04-1). Amended by final rulemaking at 19 A.A.R. 102, effective March 10, 2013 (Supp. 13-1). Amended by final rulemaking at 19 A.A.R. 2911, effective November 10, 2013 (Supp. 13-3). Amended by final rulemaking at , effective June 1, 2019 (Supp. 19-2). Amended by final rulemaking at 30 A.A.R. 3095 (October 25, 2024), effective November 30, 2024 (Supp. 24-4). R4-23-1103. Pharmacy Technician Trainee Registration A. Registration required. As indicated under A.R.S. § 32- 1923.01, a person shall not work as a pharmacy technicia n trainee in Arizona unless the person has registered with th e Board. A registered pharmacy technician trainee shall maintain the registration certificate at the practice site for inspection by the Board or its designee or review by the public. Registration as a pharmacy technician trainee is not transferable. regis- B. Eligibility. An applicant for a 36-month, non-renewable tration as a pharmacy technician trainee shall provide th e Board proof the applicant is eligible under A.R.S. § 32- 1923.01(B). C. Application. 1. An applicant for a 36-month, non-renewable registratio n as a pharmacy technician trainee shall: a. Submit a completed application electronically on a form available on the Board’s website, and b. Submit with the application form: i. The documents specified in the applicatio n form, and ii. The registration fee specified in R4-23-205. 2. The Board office shall deem an application form receive d on the date the Board office electronically date-stamp s the form. D. Registration. 1. If an applicant is found to be ineligible for registration a s a pharmacy technician trainee under statute and rule, th e Board office shall issue a written notice of denial to th e applicant. 2. If an applicant is found to be eligible for registration as a pharmacy technician trainee under statute and rule, th e Board office shall issue a certificate of registration. A n Supp. Administrative Code AND OCCUPATIONS OF PHARMACY applicant who is assigned a registration number an d granted “open” or “active” status on the Board’s websit e may begin practice as a pharmacy technician trainee. A n applicant shall not practice as a pharmacy technicia n trainee if the Board’s website indicates any status other than “open” or “active.” E. Time frames for pharmacy technician trainee registration. Th e Board office shall follow the time frames established in R4- 23-202(F). F. Verification of registration. A pharmacy permittee or pharmacist-in-charge shall not allow a person to practice as a pharmacy technician trainee until the pharmacy permittee or pharmacist-in-charge verifies that the person is currently registered by the Board as a pharmacy technician trainee. Historical Note New Section made by final rulemaking at , effective May 1, 2004 (Supp. 04-1). Amended by final rulemaking at 19 A.A.R. 2911, effective November 10, 2013 (Supp. 13-3). Amended by final rulemaking at , effective June 1, 2019 (Supp. 19-2). Amended by final rulemaking at , effective March 14, 2020 (Supp. 20-1). Amended by final rulemaking at (October 25, 2024), effective November 30, 2024 (Supp. 24-4). Techni- R4-23-1104. Pharmacy Technicians and Pharmacy cian Trainees A. Permissible tasks of a pharmacy technician trainee. Acting i n compliance with all applicable statutes and rules and under th e supervision of a pharmacist, a pharmacy technician traine e registered under R4-23-1103 may assist an intern or pharmaprac- cist with the following when applicable to the pharmacy tice site: 1. Record on the original prescription order the serial number of the prescription medication and date dispensed; 2. Initiate or accept verbal or electronic refill authorizatio n from a medical practitioner or medical practitioner’ s agent and record, on the original prescription order or b y an alternative method approved by the Board or its designee, the medical practitioner’s name, patient name, nam e and quantity of prescription medication, specific refill information, and name of medical practitioner’s agent, if any; 3. Record information in the refill record or patient profile; 4. Enter information for a new or refill prescription medication as required under A.R.S. § 32-1964; 5. Type and affix a label for the prescription medication. A pharmacist or intern working under the supervision of a pharmacist shall verify the accuracy of the label a s described under R4-23-402(A)(11); 6. Reconstitute a prescription medication, if a pharmacist checks the ingredients and procedure before reconstitution and verifies the final product after reconstitution; 7. Retrieve, count, or pour a prescription medication, if a pharmacist verifies the contents of the prescription medicon- cation against the original prescription medication tainer or by an alternative drug identification metho d approved by the Board or its designee; 8. Prepackage drugs in accordance with R4-23-402(A); and 9. Measure, count, pour, or otherwise prepare and package a drug needed for hospital inpatient dispensing, if a pharpour- macist verifies the accuracy, measuring, counting, ing, preparing, packaging, and safety of the drug befor e the drug is delivered to a patient care area. 26-1 March 31, 2026 Arizona TITLE 4. PROFESSIONS CHAPTER 23. BOARD B. Permissible tasks of a pharmacy technician. Acting in compliance with all applicable statutes and rules and under the supervision of a pharmacist, a pharmacy technician licensed under R4-23-1102 may: 1. Perform the tasks listed in subsection (A); compound- 2. After completing a pharmacy technician drug ing training program developed by the pharmacy permittee or pharmacist-in-charge under R4-23-1105(C), assist medi- a pharmacist or intern in compounding prescription cations and sterile or non-sterile pharmaceuticals i n accordance with written policies and procedures, if th e preparation, accuracy, and safety of the final product i s verified by a pharmacist before dispensing; 3. Administer a vaccine when: a. Administration of the vaccine is done under an order that complies with A.R.S. § 32-1974 and R4-23-411; b. Administration of the vaccine is delegated by an d done under the supervision of a pharmacist on dut y who is certified under A.R.S. § 32-1974 to administer vaccines; and c. There is documentation by the permittee that th e pharmacy technician has completed the following: i. A practical training program that is approve d by the Accreditation Council for Pharmac y Education and includes hands-on injectio n technique and recognition and treatment of emergency reactions to vaccines; and ii. Current certification in basic cardiopulmonar y resuscitation. 4. Perform a task not related to professional judgment if th e task is delegated to the pharmacy technician by the pharmacist on duty after the pharmacist on duty ensures th e pharmacy technician is trained to do the task and there i s documentation by the permittee of the training; and 5. A pharmacist on duty shall not delegate or attempt to delegate the following tasks to a pharmacy technician: a. Administering an emergency medication, b. Counseling a patient, c. Conducting a drug utilization review, d. Performing any task that requires the exercise of clinical judgment, e. Issuing a prescription order, f. Receiving a new prescription order for a controlle d substance, or g. Transferring by telephone an existing prescriptio n order for a controlled substance. C. Prohibited activities. A pharmacy technician or pharmac y technician trainee shall not perform a professional practic e reserved for a pharmacist or intern in accordance with R4-23- 402 or R4-23-653 unless otherwise allowed by rule. D. A pharmacy technician or pharmacy technician trainee shall wear a badge indicating name and title while on duty. E. Before employing a pharmacy technician or pharmacy technician trainee, a pharmacy permittee or pharmacist-in-charg e shall develop, implement, review, revise, and enforce, in th e manner described in R4-23-653(A), policies and procedure s addressing tasks to be performed by the pharmacy technicia n or pharmacy technician trainee that are consistent with stat e and federal law and the site at which the pharmacy technicia n or pharmacy technician trainee will be employed. Historical Note New Section made by final rulemaking at , effective May 1, 2004 (Supp. 04-1). Amended by final rulemaking at , effective October 1, March 31, 2026 Supp. Administrative Code AND OCCUPATIONS OF PHARMACY 2006 (Supp. 06-3). Amended by final rulemaking at 19 A.A.R. 102, effective March 10, 2013 (Supp. 13-1). effec- Amended by final rulemaking at 23 A.A.R. 3257, tive January 8, 2018 (Supp. 17-4). Amended by final rulemaking at 28 A.A.R. 994 (May 13, 2022), effective July 2, 2022 (Supp. 22-2). Section made by emergency rulemaking at 29 A.A.R. 1196 (May 26, 2023), with an immediate effective date of May 4, 2023; effective for 180 days (Supp. 23-2). Amended by final rulemaking at 29 A.A.R. 2191 (September 22, 2023), with an immediate effective date of September 6, 2023 (Supp. 23-3). (Octo- Amended by final rulemaking at ber 25, 2024), effective November 30, 2024 (Supp. 24-4). R4-23-1104.01 Repealed Historical Note New Section made by final rulemaking at 23 A.A.R. 3257, effective January 8, 2018 (Supp. 17-4). Repealed by final rulemaking at (October 25, 2024), effective November 30, 2024 (Supp. 24-4).