Drug Shortages
The notification portal will be undergoing monthly maintenance actions in production during the following dates. During this time, users will be unable to make submissions in the portal. If there are any questions, please submit any inquiries to CDER Platform Support team at edmsupport@fda.hhs.gov.
- 6/14/2024 at 5PM EST to 6/24/2024 at 12:00AM EST
- 7/19/2024 at 5PM EST to 7/22/2024 at 12:00AM EST
- 8/16/2024 at 5PM EST to 8/19/2024 at 12:00AM EST
Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages. When a shortage is listed as current on the Drug Shortage Database, the FDA is aware of the supply situation and is working with the manufactures on efforts to mitigate the supply disruption. FDA also continue to work with manufacturers on shortage prevention efforts for drugs not yet listed on the Drug Shortage Database.
Current and resolved drug
shortages and discontinuations.
List of extended use dates to
assist with drug shortages.
Public portal for patients, healthcare providers,
and organizations to report a drug shortage.
Note for public: Please check the Drug Shortages Database for current shortages.
Drug Shortage Notifications
For Industry
Industry can notify FDA Drug Shortage Staff of drug and supply shortages via the CDER Direct NextGen Portal.
This portal is intended ONLY for drug manufacturers/applicants. Industry can notify the FDA Drug Shortage Staff of new discontinuances, GMP issues, increase in product demand, recalls, supply interruptions, or other events. If you have any questions, please contact: drugshortages@fda.hhs.gov.
Spotlight
2022 Drug Shortages Report
Annual report to Congress summarizing the major actions taken by FDA in 2022 to prevent or mitigate drug shortages in the United States.
Guidance for Industry: Notify FDA
Guidance to assist applicants and manufacturers in notifying FDA about finished drugs and biological products production changes.