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.

Shortage notifications and updates may be reported to FDA at drugshortages@fda.hhs.gov.

• 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)

Lists of Products in Shortage with Extended Use Dates

• Extended Use Dates to Assist with Lidocaine Hydrochloride for Injection Manufactured Intermittent Supply Interruptions

• Extended Use Dates Provided by Impax Generics to Assist with Epinephrine Auto-Injector Intermittent Supply Interruptions 

• Extended Use Dates to Assist with Sterile Water for Injection (small-volume vials in 10 mL, 20 mL, 50 mL and 100 mL presentations) Manufactured Intermittent Supply Interruptions 

• Extended Use Dates to Assist with Sodium Bicarbonate Injection Shortage 

• Extended Use Dates to Assist with Aminophylline Injection Intermittent Supply Interruptions

• Extended Use Dates Provided by Pfizer to Assist with EpiPen Intermittent Supply Interruptions

• Extension of Shelf  Life Provided by Baxter Healthcare Corporation to Assist with IV Solution Shortages

• Extended Use Dates Provided by Pfizer to Assist with Emergency Syringe Shortages

Influenza Season 2018-2019

Availability of Antiviral Medications (PDF - 45KB) [Updated 1/7/2019]

Statement from FDA Commissioner Scott Gottlieb, M.D.

FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities

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.

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