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

Issue Date: October 1, 2020
Issued by: Center for Biologics Evaluation and Research
Topic(s): Investigation & Enforcement, Labeling, Chemistry, Manufacturing, and Controls (CMC), Combination Products, Pharmaceutical Quality
Status: Final

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

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”).

Download the Guidance Document