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:

        Guidance, Compliance & Regulatory Information (Biologics)

Biologics Establishment Registration

                        
                Blood Establishment Registration and Product Listing
          Find a Blood Establishment
          Find a Tissue Establishment
          Human Cells, Tissues, and Cellular and Tissue-Based Products OMB Burden Statement
          Tissue Establishment Registration Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Biologics Establishment RegistrationGuidance, Compliance & Regulatory Information (Biologics) Biologics Establishment Registration
  	
        Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    Print**Blood Establishments**

All owners or operators of establishments that manufacture blood products are required to register with the FDA, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65. A list of every blood product manufactured, prepared, or processed for commercial distribution must also be submitted. Products must be registered and listed within 5 days of beginning operation, and annually between November 15 and December 31. Blood product listings must be updated every June and December.

**Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) Establishments**

Establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under Section 361 of the Public Health Service (PHS) Act are required to register with FDA pursuant to 21 CFR Part 1271. Establishments must register and list their HCT/Ps within 5 days of beginning operation and registration must be updated annually in December.

The August 31, 2016 final rule titled Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs amended FDA’s regulations governing drug establishment registration and drug listing, including establishment registration and listing for HCT/Ps. Manufacturers of HCT/Ps that are regulated as drugs, devices, and/or biological products under section 351 of the PHS Act or under the Food, Drug, and Cosmetic Act, must register and list their products in accordance with 21 CFR Part 207 or 807, as applicable, rather than 21 CFR Part 1271. Please refer to the Drug Establishment Registration and Listing or Device Registration and Listing webpages for additional information.

Note: FDA does not require establishments that manufacture drugs (including biological products) and devices that are HCT/Ps for use under an investigational new drug application (IND) (21 CFR Part 312) or an investigational device exemption (IDE) (21 CFR Part 812) to register and list their HCT/Ps until the HCT/P is approved through a biologics license application (BLA), new drug application (NDA), or premarket approval application (PMA); or cleared through a premarket notification submission (510(k)).

Establishment Registration

Blood Establishment Registration and Product Listing
	Tissue Establishment Registration
	Important Registration and Listing Reminder for Manufacturers of Biological Drug Products Subject to 21 C.F.R. Part 207Related Information

Biologic FormsSub-Topic Paragraphs
          Follow CBER
		Division of Communication and Consumer Affairs
			Office of Communication, Outreach and Development
			Center for Biologics Evaluation and Research
			Food and Drug Administration
			10903 New Hampshire Ave WO71-3103
			Silver Spring, MD 20993-0002
		
		ocod@fda.hhs.gov
		
		(800) 835-4709
			(240) 402-8010
		
		For Updates on Twitter, follow @fdacber
	Resources for You (Biologics)
			About the Center for Biologics Evaluation and Research (CBER)
			Report a Problem to the Center for Biologics Evaluation & Research
			Recalls (Biologics)
			CBER-Regulated Products: Shortages and Discontinuations
			Biologics Products & Establishments

                                                                                  Content current as of:
      01/27/2021
                  
                   
Regulated Product(s)
		 BiologicsBiologics Establishment Registration                
                          

                        Blood Establishment Registration and Product Listing
          Find a Blood Establishment
          Find a Tissue Establishment
          Human Cells, Tissues, and Cellular and Tissue-Based Products OMB Burden Statement
          Tissue Establishment Registration
 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