Opioid overdose reversal medication access, education, and co-prescribing grant programs

implement strategies that increase access to drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] for emergency treatment of known or suspected opioid overdose, as appropriate, pursuant to a standing order; encourage pharmacies to dispense opioid overdose reversal medication pursuant to a standing order; encourage health care providers to co-prescribe, as appropriate, drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; when and how to safely administer such drug or device; and steps to be taken after administering such drug or device; and educate the public concerning the availability of drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose without a person-specific prescription. A grant may be made under this section only if the State involved has authorized standing orders to be issued for drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose. have not implemented standing orders regarding drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; authorize standing orders to be issued that permit community-based organizations, substance abuse programs, or other nonprofit entities to acquire, dispense, or administer drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; or authorize standing orders to be issued that permit police, fire, or emergency medical services agencies to acquire and administer drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose. A State may not receive more than one grant under this section at a time. A grant under this section shall be for a period of 5 years. use not more than 10 percent of a grant under this section for educating the public pursuant to subsection (a)(5); and use not less than 20 percent of a grant under this section to offset cost-sharing for distribution and dispensing of drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose. To be eligible to receive a grant under this section, a State shall submit an application to the Secretary in such form and manner and containing such information as the Secretary may reasonably require, including detailed proposed expenditures of grant funds. A State that receives a grant under this section shall, at least annually for the duration of the grant, submit a report to the Secretary evaluating the progress of the activities supported through the grant. Such reports shall include information on the number of pharmacies in the State that dispense a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose under a standing order, and other information as the Secretary determines appropriate to evaluate the use of grant funds. In this section the term “standing order” means a document prepared by a person authorized to prescribe medication that permits another person to acquire, dispense, or administer medication without a person-specific prescription. To carry out this section, there are authorized to be appropriated $5,000,000 for the period of fiscal years 2023 through 2027. Not more than 3 percent of the amounts made available to carry out this section may be used by the Secretary for administrative expenses of carrying out this section. The Secretary of Health and Human Services shall ensure that, as appropriate, whenever the Department of Health and Human Services issues a regulation or guidance for any grant program addressing opioid misuse and use disorders, any reference to an opioid overdose reversal drug (such as a reference to naloxone) is inclusive of any opioid overdose reversal drug that has been approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for emergency treatment of a known or suspected opioid overdose. Not later than one year after the date of enactment of this Act [Dec. 1, 2025], the Secretary of Health and Human Services shall update all references described in paragraph (2) to be inclusive of any opioid overdose reversal drug that has been approved or otherwise authorized for use by the Food and Drug Administration. was issued before the date of enactment of this Act; and the grant program for State and Tribal response to opioid use disorders under section 1003 of the 21st Century Cures Act [former] (42 U.S.C. 290ee–3 note) [now 42 U.S.C. 290ee–3a] (commonly referred to as ‘State Opioid Response Grants’ and ‘Tribal Opioid Response Grants’); or the grant program for priority substance use disorder prevention needs of regional and national significance under section 516 of the Public Health Service Act (42 U.S.C. 290bb–22).” The Secretary shall make grants to States, localities, Indian Tribes, and Tribal organizations (as those terms are defined in section 5304 of title 25) to— develop or provide training materials that persons authorized to prescribe or dispense a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose may use to educate the public concerning— In making grants under this section, the Secretary may give preference to States that have a significantly higher rate of opioid overdoses than the national average, and that— A State may— A reference described in this paragraph is any reference to an opioid overdose reversal drug (such as naloxone) in any regulation or guidance of the Department of Health and Human Services that— is included in— (Source: (July 1, 1944, ch. 373, title V, § 545, as added Pub. L. 114–198, title I, § 110(a), July 22, 2016, 130 Stat. 709; amended Pub. L. 117–328, div. FF, title I, § 1220, Dec. 29, 2022, 136 Stat. 5672.))