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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



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)

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