Compounded drug search added to FDA’s NDC directory webpage

June 8, 2022

FDA recently added a search function to the National Drug Code (NDC) Directory webpage for human drugs compounded by outsourcing facilities that assign NDC numbers to their products. This update was made in response to requests from stakeholders.

Compounded drug data for the NDC Directory is drawn from product reports provided to FDA by outsourcing facilities pursuant to section 503B(b)(2). Outsourcing facilities may, but are not required to, assign NDC numbers to their finished compounded human drug products. Search results for compounded drugs will contain only drug products with assigned NDC numbers and reported with the marketing category “Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements).” The results will not be a complete listing of products compounded by outsourcing facilities. Search results will include data provided in the past two years for products reported under the new marketing category as well as newly submitted changes and additions.

This change provides compounders, healthcare providers, insurers, and other interested parties with the ability to search for compounded human drugs that have NDC numbers and were produced by outsourcing facilities from FDA’s NDC Directory webpage.

To find more information about the NDC Directory, visit the FDA National Drug Code Directory page.

Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.

TAGS:

January 31, 2018

Finding a Roadmap to Approval - Hint: You Can't Pick One Up at the FDA

Earning FDA approval for your drug program is a journey. A misstep at any point of that journey could jeopardize your chance at getting your drug approved. That’s why it’s so important to have a...

November 25, 2020

Understanding EMA and FDA Regulations on Nitrosamine Control

On September 26, 2019, the European Medicines Agency (EMA) released an advice to Marketing Authorization Holders (MAH) of human medicines to review their drug products on possible presence of...

June 18, 2021

How to File Post-Approval Changes to an NDA or ANDA

On November 21, 1997, the Food & Drug Modernization Act (the Modernization Act) was enacted by Congress. Section 116 of the Modernization Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act...