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:

                Report a Problem to the Center for Biologics Evaluation & Research

Report a Problem to the Center for Biologics Evaluation & Research

                        Biological Product Deviations
          Good Tissue Practices (GTP) & Reporting
          Transfusion/Donation Fatalities
          Direct Recall Classification Program
          Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting


                        Vaccine Adverse Events Home
          Vaccines, Blood & Biologics
          Safety & Availability (Biologics)
          Report a Problem to the Center for Biologics Evaluation & Research
          Direct Recall Classification ProgramReport a Problem to the Center for Biologics Evaluation & Research Direct Recall Classification Program
  
  	
    Share
    Post
    Linkedin

    Email
    Print**What is DRC?**

Direct Recall Classification (DRC) refers to the classification of biologics recalls directly by personnel in the Center for Biologics Evaluation and Research in lieu of more traditional methods that require additional hours of work by personnel located in each FDA program office. DRC was designed to utilize current information technology to streamline recall classification of CBER-regulated products. Through the use of an electronic interface between two existing agency databases, the time and resources previously needed to review and classify recalls of CBER-regulated products have been greatly reduced.

Following CBER’s review of a submitted electronic Biological Product Deviation Report (eBPDR) that represents a recall situation, an e-mail notification from CBER_RecallAlerts is sent to both the eBPD submitter and eBPD contact. This e-mail notification requests the submitter re-access the electronic Biological Product Deviation Reports module (eBPDR) from the provided link and complete BPD Additional Information (AI) requests for recall classification purposes. E-mail notifications from CBER_RecallAlerts are sent for each AI report that FDA is requesting be completed.

What does DRC mean for me?

If you are a consumer, DRC means that recalls of CBER-regulated products are posted in the public domain in a timely manner.
	If you are member of the biologics industry, you will be able to electronically provide information to FDA regarding a recall, thus reducing the burden of copying manual records and sending them to an FDA program office. DRC also facilitates communications with the agency to answer questions or to gather more information regarding a recall.
	Performance measures for classification of recalls though the use of DRC is monitored through (FDA-TRACK).
	For the agency, as well as for the public, DRC decreased the resources needed to classify and publish recalls, and allows the reallocation of resources to other agency priorities related to protection of the public health.Collection of BPD Additional Information (BPD AI) for Recall Classification Purposes

General Instructions

If you need assistance or have a question, you may e-mail CBER_RecallAlerts@fda.hhs.gov.

Key Resources

Instructions for Using the eBPDR SystemSee "Collection of BPD Additional Information (BPD AI) for Recall Classification Purposes" and "General Instructions"

                                                                                  Content current as of:
      02/14/2020
              
              
Regulated Product(s)
		 BiologicsReport a Problem to the Center for Biologics Evaluation & Research

          
                        Biological Product Deviations
          Good Tissue Practices (GTP) & Reporting
          Transfusion/Donation Fatalities
          Direct Recall Classification Program
          Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting


                        Vaccine Adverse Events
 
 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