Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability; Correction

요약

This document corrects the Notice of Availability from the Food and Drug Administration (FDA, Agency, or we) announcing the availability of a draft guidance for industry entitled "Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act," which published in the Federal Register on Monday, December 23, 2019. This draft guidance describes procedures to obtain a National Drug Code (NDC) for an FDA-approved prescription drug that is imported into the United States in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), which would provide an additional avenue through which drugs could be sold at a lower cost in the U.S. market. This draft guidance is intended to address certain challenges in the private market faced by manufacturers seeking to sell their drugs at lower costs. The Notice was published with two omissions. This document corrects those omissions by republishing the Notice in its entirety to include the omitted language.