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# PhRMA Agrees with Discontinuance Recommendations
- URL: https://www.fdaweb.com/phrma-agrees-with-discontinuance-recommendations/
- Published: 2023-06-06T12:00:00.000Z
- Updated: 2026-09-14T18:36:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154626

Pharmaceutical Research and Manufacturers of America (PhRMA) says it generally agrees with the recommendations in an FDA draft guidance on notification of a permanent discontinuance or interruption in manufacturing under section 506C of the Federal Food, Drug, and Cosmetic Act. In a comment [letter](https://downloads.regulations.gov/FDA-2020-D-1057-0036/attachment%5F1.pdf?ref=fdaweb.com), PhRMA says the additional clarity provided on the type of information and process for submitting notifications will help manufacturers as they continue to work with the agency to address potential drug shortages.

The letter notes that section 506C notifications are only one piece of the efforts PhRMA members take to help mitigate or prevent drug shortages. “PhRMA members regularly communicate with FDA, beyond required reports and notifications, to keep the agency abreast of the potential for drug shortages,” the letter says. “This includes voluntary outreach to the agency when there are significant unanticipated spikes in demand that have the potential to lead to drug shortages, consistent with FDA’s recommendations in the draft guidance.”