FDA Publishes Guidance on NDC Codes

News
Article

The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.

On Dec. 18, 2019, FDA published draft guidance that details the procedures for obtaining an additional National Drug Code (NDC) for FDA-approved prescription drugs imported into the United States in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). Specifically, the guidance discusses the importation of FDA-approved drugs that were also authorized for sale in a foreign country in which the drugs were originally intended to be marketed.

The guidance addresses labeling of multi-market approved products (MMA products); submissions of new drug application (NDA) and biologic license application (BLA) supplements of an MMA product; registering, listing, and proposing an NDC for an MMA product; importation of an MMA product; and supply chain issues.

Source: FDA

 

Recent Videos
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Mike Baird from Schlafender Haser discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer.
Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes