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  1. Drug Safety and Availability

FDA is aware of a tornado damaging the Pfizer sterile injectable site in Rocky Mount, NC, and hope that the plant’s employees are unharmed. We are following the situation closely as it evolves and are working with the company to understand the extent of the damage and any potential impact to the nation’s drug supply.

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].

Drug Shortages Database

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Spotlight

[6-7-23] Tenth Annual Report on Drug Shortages for Calendar Year 2022 (PDF - 677 KB)

[4-5-23] - FDA issues guidance to assist applicants and manufacturers with notifying FDA of a permanent discontinuance or interruption in manufacturing of finished products and APIs

[1-20-23] FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems

[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.

Influenza Season 2022-2023

Availability of Antiviral Medications (PDF - 141 KB) [Updated 3/3/2023]

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

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Information about new and updated drug shortages plus recent news related to drugs

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