Special Requirements For Over-The-Counter (OTC) Drugs

80-1-22-.30 Special Requirements For Over-The-Counter (OTC) Drugs.

(1) For the purpose of this Rule, Open-Date Statement shall mean the terms “Sell By_______________”; “Not to be Sold After_____________”; “Best If Used By____________”; “Expiration__________”; or words of similar import; or a date without additional words shall be considered under the jurisdiction of the Rule.

(2) Code of Federal Regulations 21 Part 211.137 is hereby adopted for use herein and non-exempt, Over-The-Counter (OTC) drugs shall bear expiration dates as set forth therein.

(3) OTC drugs shall be considered as not meeting requirements for strength and purity once it reaches the expiration date.

(4) OTC drugs are not to be sold or offered for sale at retail or wholesale after the date stated on the product label.

(5) OTC drugs offered for sale in violation of this Rule shall be deemed adulterated under the provision of Code of Ala. 1975, Section 20-1-24. Author: Reginald L. Sorrells Statutory Authority: Code of Ala. 1975, §§20-1-24; 20-1-25. History: New Rule: Filed May 14, 1996; effective June 18, 1996. Amended: Filed November 15, 2000; effective December 20, 2000.