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# Guide on Drug/Biologic Manufacturing Disruptions
- URL: https://www.fdaweb.com/guide-on-drug-biologic-manufacturing-disruptions/
- Published: 2020-03-27T12:00:00.000Z
- Updated: 2026-09-14T16:09:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146434

FDA has released a [guidance](https://www.fda.gov/media/136486/download?ref=fdaweb.com) entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” The document is intend to help FDA with monitoring the medical product supply chain, which may be impacted by the Covid-19 outbreak and potentially leading to supply disruptions or shortages of drug and biological products in the U.S. Drug/biologic makers are required to notify the agency about changes in the production of certain drugs and biological products. The guidance discusses the requirements and recommends that applicants and manufacturers provide additional details and follow additional procedures to ensure FDA has the specific information it needs to help prevent or mitigate product shortages. In addition, it explains how FDA communicates information about such shortages to the public.