Vaccines, Blood & Biologics
Direct Recall Classification Program
- 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.
If you need assistance or have a question, you may e-mail CBER_RecallAlerts@fda.hhs.gov.
Instructions for Using the eBPDR System
See "Collection of BPD Additional Information (BPD AI) for Recall Classification Purposes" and "General Instructions"