- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Regulatory Affairs
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2021-D-0958.