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.




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