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  4. 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
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GUIDANCE DOCUMENT

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

Final
Docket Number:
FDA-2019-D-5743
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
Office of Regulatory Affairs
Office 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”).


Submit Comments

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:

Dockets Management
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.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
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Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
Human Drug Information
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Silver Spring, MD 20993
druginfo@fda.hhs.gov
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(301) 796-3400
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