Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide

On 25 May 2022 the FDA published the final Q&A guidance for industry.

This guidance is intended to help small entities better understand the final rule, “Importation of Prescription Drugs,” published October 1, 2020 (85 FR 62094). 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 (FD&C Act) (21 U.S.C. 384(b) through (h)) to allow importation of certain prescription drugs from Canada. The purpose of the final rule is to achieve a significant reduction in the cost of covered products to the American consumer while posing no additional risk to the public’s health and safety.

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