The US Food and Drug Administration (FDA) has offered some clarity on the legal requirements for small entities to import prescription drugs from Canada.
In final guidance, issued on 25 May 2022, the agency provided 12 questions and answers aimed at providing a plain language guide to implementation of the Importation of Prescription Drugs final rule, which became effective on 30 November 2020. That regulation was aimed at reducing prescription drug costs by implementing section 804 of the Federal Food, Drugs, and Cosmetic Act, allowing importation of certain prescription drugs from Canada. (RELATED: HHS opens pathway to importing Canadian drugs, Regulatory Focus 25 September 2020)…
