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

GUIDANCE DOCUMENT

• Docket Number: FDA-2019-D-5743
• Issued by: Center for Biologics Evaluation and Research; Center for Drug Evaluation and Research; Office of Inspections and Investigations; 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”).

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