CBER-Regulated Products: Shortages and Discontinuations
CBER's Office of Compliance and Biologics Quality (OCBQ) directs the CBER-regulated product shortage program, which includes product discontinuations.
The Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) made substantial changes to section 506C of the FD&C Act related to reporting and addressing interruptions in manufacturing or permanent discontinuances of certain drug products. For example, FDASIA requires manufacturers of certain drug products to notify FDA at least 6 months prior to the date of the permanent discontinuance in the manufacture of the drug or an interruption in the manufacturing of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or, if that is not possible, as soon as practicable. Such drug products include those that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. FDASIA excludes radiopharmaceutical products. More information on FDASIA is provided on FDA’s FDASIA Fact Sheet Page.
Shortages of drugs and biologics pose a significant public health threat, delaying, and in some cases even denying, critically needed care for patients. Preventing shortages remains a top priority for FDA. For more information please see FDA Facts: Drug Shortages in the United States.
Additional information regarding possible causes of CBER-regulated product shortages is provided on the CBER-Regulated Products: Possible Causes of Shortages page.
- SOPP 8506: Management of Shortages of CBER-Regulated Products
- 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
Examines the underlying factors responsible for drug shortages and recommends enduring solutions
- Statement on FDA’s new report regarding root causes and potential solutions to drug shortages
- Ninth Annual Report on Drug Shortages for Calendar Year 2021
- CBER-Regulated Products: Current Shortages
- CBER-Regulated Products: Resolved Shortages
- CBER-Regulated Products: Permanent Discontinuations
- How to Report a Product Shortage or Supply Issue to FDA
- Drug Shortages
- CVM Animal Drug Shortage Information
- CDC's Recommended Immunization Schedules for Adults and Children