Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Safety & Availability (Biologics)

Safety & Availability (Biologics)

                        Biologic Product Security
          Blood Safety & Availability
          CBER-Regulated Products: Shortages and Discontinuations
          Pandemics & Emerging Diseases
          Tissue Safety & Availability
          Vaccine Safety & Availability


                        HIV Home Test Kits
          Recalls (Biologics)
          Report a Problem to the Center for Biologics Evaluation & Research Home
          Vaccines, Blood & Biologics
          Safety & Availability (Biologics)
          CBER-Regulated Products: Shortages and DiscontinuationsSafety & Availability (Biologics) CBER-Regulated Products: Shortages and Discontinuations
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintCBER'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.

Spotlight

SOPP 8506: Management of Shortages of CBER-Regulated Products
	Guidance - Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act
	Guidance - Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J 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
	Tenth Annual Report on Drug Shortages for Calendar Year 2022



Related Information

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

                                                                                  Content current as of:
      11/29/2023
              
              
Regulated Product(s)
		 BiologicsSafety & Availability (Biologics)

          
                        Biologic Product Security
          Blood Safety & Availability
          CBER-Regulated Products: Shortages and Discontinuations
          Pandemics & Emerging Diseases
          Tissue Safety & Availability
          Vaccine Safety & Availability


                        HIV Home Test Kits
          Recalls (Biologics)
          Report a Problem to the Center for Biologics Evaluation & Research
 Subscribe for CBER Updates
                        Get e-mail updates on What’s New at CBER!
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop