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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Direct Recall Classification Program

 

What is DRC ?
 
Direct Recall Classification (DRC) refers to the classification of biologic 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 district office. DRC was designed to utilize current information technology to streamline recall classification of biological 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 biological 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 CBER On-Line Log-In Screen from the provided link and complete BPD Additional Information (AI) for recall classification purposes.  E-mail notifications from CBER_RecallAlerts are sent for each AI report that FDA is requesting be completed.
 
The DRC application consists of four screens of information used to electronically capture recall details.  The first page is the BPD AI – Updated Product Disposition Page, followed by the BPD AI - Notification Method, Distribution Pattern Information, and Industry Recall Contacts.  The user then has the opportunity to preview their report and submit to FDA.
 
Each screen in the DRC application contains on-screen instructions and displays the Reporting FEI, BPD Confirmation Number, Reporting Establishment Name, Tracking Number, and today’s date.
 
What does DRC mean for me ?
 
  • If you are a consumer, DRC means that recalls of biological products are posted in the public domain in a more timely manner. 
  • If you are member of the biologics industry, you will be able to provide information to FDA regarding a recall you are conducting of biological products electronically, thus reducing the burden of copying manual records and sending them to an FDA district office. DRC also facilitates communications with the agency to answer questions or to gather more information regarding a recall.
  • For the agency, DRC has decreased the amount of time previously used by the district office and CBER to gather, evaluate, review and classify a firm’s recall action. The average amount of time from learning of a firm’s recall action to classification of the recall has decreased from years to weeks and through the use of DRC, continues to decrease. CBER personnel have consistently exceeded performance measures for classification of recalls though the use of DRC (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.

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Key Resources

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