Wednesday, May 25, 2022

FDA Issues Final Guidance on Importation of Prescription Drugs Final Rule; Questions and Answers - Drug Information Update – Drug Information Update

This guidance is intended to help small entities better understand the final rule, "Importation of Prescription Drugs"

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FDA Center for Drug Evaluation and Research Division of Drug Information

Small Entity Compliance Guide on Final Rule on Importation of Prescription Drugs from Canada

Today, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription drugs from Canada. On October 1, 2020, the Secretary of Health and Human Services issued the final rule to implement section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act to allow importation of certain prescription drugs from Canada. The final rule became effective November 30, 2020. The guidance issued today does not include any new policy. It clarifies in plain language the legal requirements in the final rule.  

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