The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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)