Drug Shortages
Coronavirus Disease (COVID-19): The FDA continues to take steps to monitor the supply chain. The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and Research (CDER) has asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms, and any components that may be impacted in any area of the supply chain due to the COVID-19 outbreak. For the latest information from the FDA on COVID-19 see our website at: Coronavirus Disease 2019 (COVID-19).
To report a drug shortage please contact the CDER Drug Shortage Staff at: [email protected]
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.
Shortage notifications and updates may be reported to FDA at [email protected].
Spotlight
[1-10-23] FDA is continuing to closely monitor the pediatric ibuprofen and acetaminophen supplies which have experienced increased demand since the fall of 2022 due to increases in respiratory illnesses. We are working closely with the manufacturers on their efforts to further increase supply in response to the increased demand.
- Webcast: November 2018 Drug Shortages Task Force Public Meeting
- Report | Drug Shortages: Root Causes and Potential Solutions
- Report provides recommendations discussed at the 2018 meeting
- Guidance | Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act
- Report | Drug Shortages: Root Causes and Potential Solutions
(Oct. 2019 Report, Updated Feb. 2020) Report examines the underlying factors responsible for drug shortages and recommends enduring solutions - Search List of Extended Use Dates to Assist with Drug Shortages
- Director's Corner Podcasts: Drug Shortages. Dr. Woodcock discusses what the agency is doing to address the issue of drug shortages, and how the agency is working with industry to help lessen their impact.
Influenza Season 2022-2023
Availability of Antiviral Medications (PDF - 131 KB) [Updated 1/30/2023]
For Industry: Send FDA Drug Shortage and Supply Notifications
Industry can notify FDA Drug Shortage Staff via 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: [email protected].
FDA Drug Shortages Mobile App
Receive notifications when there is new or updated information about a drug product shortage or a drug within selected therapeutic categories.