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USFDA- Q&A Guide on Importation of Prescription Drugs from Canada

Yesterday, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription drugs from Canada.

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 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.


This guidance document restates in plain language the legal requirements set forth in the final rule and is intended to assist small entities in complying with the final rule.


Small businesses can now better understand what the legal requirements are for importing prescription drugs from Canada after reading the 12 Questions & Answers.


Click on this LINK to see the 12 Questions & Answers.

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