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# CDER Drug Shortage Management Process
- URL: https://www.fdaweb.com/cder-drug-shortage-management-process/
- Published: 2024-10-15T12:00:00.000Z
- Updated: 2026-09-14T14:44:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157988

FDA has posted seven things consumers should know about how CDER manages drug shortages. The [items](https://www.fda.gov/drugs/news-events-human-drugs/7-things-know-about-drug-shortage-management?utm%5Fmedium=email&utm%5Fsource=govdelivery) are:

- the CDER Drug Shortage Staff (DSS) is the focal point for evaluating and managing drug shortages;
- for many drugs, manufacturers must notify FDA about permanent discontinuances in manufacturing and manufacturing interruptions that are likely to lead to a meaningful disruption in the drug’s supply, and they also must develop and maintain a risk management plan evaluating risks to the supply of their product;
- the DSS will consider that a product is in shortage if three specific criteria are present;
- CDER posts drugs on the Drug Shortage Database once they are determined to be in shortage;
- DSS is responsible for coordinating all activities related to the prevention and mitigation of drug shortages;
- patients, healthcare professionals, and organizations can report new shortages through a public notification portal; and
- DSS will consider that a product is resolved if specific criteria are met.