Importation of Prescription Drugs Final Rule Questions and Answers
May 25, 2022
Small Entity Compliance Guide on Final Rule on Importation of Prescription Drugs from Canada
Guidance for Industry
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.
Spending on prescription drugs in the United States is expected to reach $600 billion by 2023. The continuously increasing need for pharmaceuticals is mostly driven by an aging population, a rise in...