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: DRUGSHORTAGES@fda.hhs.gov
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 drugshortages@fda.hhs.gov.
Spotlight
- Seventh Annual Report on Drug Shortages for Calendar Year 2019 (PDF - 321 KB)
- 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 - Sixth Annual Report on Drug Shortages for Calendar Year 2018 (PDF - 400 KB)
- Current Supply of Heparin for U.S. Market Not Impacted By African Swine Fever in China
- CDC and FDA continue efforts to ensure timely access to front-line treatments for severe malaria (PDF - 102KB)
- Agency Drug Shortages Task Force
- Search List of Extended Use Dates to Assist with Drug Shortages
- Webcast: November 2018 Drug Shortages Task Force Public Meeting
- November 2018 Drug Shortages Task Force Meeting Presentations
- Report | Drug Shortages: Root Causes and Potential Solutions
Report provides recommendations discussed at the 2018 meeting
- FDA is Advancing New Efforts to Address Drug Shortages (11/19/2018)
- 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.
- FDA announces Nov. 27, 2018 public meeting, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions
- Statement by FDA Commissioner Scott Gottlieb, M.D., on formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages
- Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products (6/19/2018)
Influenza Season 2020-2021
Availability of Antiviral Medications (PDF - 53 KB) [Updated 11/23/2020]
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: drugshortages@fda.hhs.gov.
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.