FDA Guidance for Industry: Importation of Certain FDA-1 Approved Human Prescription Drugs, 2 Including Biological Products, under 3 Section 801(d)(1)(B) of the Federal 4 Food, Drug, and Cosmetic Act

Title:
FDA Guidance for Industry: Importation of Certain FDA-1 Approved Human Prescription Drugs, 2 Including Biological Products, under 3 Section 801(d)(1)(B) of the Federal 4 Food, Drug, and Cosmetic Act

https://www.gmp-compliance.org/files/guidemgr/Importation of Certain FDA-Approved Human Presciption Drugs Including Biological Products.pdf

Origin/Publisher:

FDA

Content:
This guidance describes recommended procedures to obtain an additional National Drug Code (NDC) for an FDA-approved prescription drug that is imported into the United States in compliance with section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 106 U.S.C. 381)

Go back