Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry October 2020
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and ResearchOffice of Regulatory AffairsOffice of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products
This guidance describes recommended procedures to obtain a National Drug Code (NDC) for certain FDA-approved prescription drug products that are imported into the United States in compliance with section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381). As described in further detail in the Background section of this guidance, this guidance specifically addresses FDA-approved drugs that are also authorized for sale in a foreign country in which the drugs were originally intended to be marketed (hereinafter “multi-market approved products” or “MMA products”).
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-2019-D-5743.