Drug Shortages

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 our Drug Shortage Database, the FDA is aware of the supply situation and is working with the manufactures on efforts to mitigate the supply disruption. We also continue to work with manufacturers on shortage prevention efforts for drugs not yet listed on the Drug Shortage Database.

Drug Shortages Database

Search Extended Use Dates

Report a New Shortage (Public Portal)
 

Spotlight

June 7, 2023: Tenth Annual Report on Drug Shortages for Calendar Year 2022 (PDF - 677 KB)

April 5, 2023: FDA issues guidance to assist applicants and manufacturers with notifying FDA of a permanent discontinuance or interruption in manufacturing of finished products and APIs

• CDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts
• 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 2023-2024

Availability of Antiviral Medications (PDF - 128 KB) [Updated 3/4/2024]

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FDA Drug Shortage Notifications

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.

For Public: Send FDA Drug Shortage Notifications 

Public can notify FDA Drug Shortage Staff via Public Notification Portal

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.