Biological Product Deviations
Includes Human Tissue and Cellular and Tissue-Based Product (HCT/P) Deviation Reporting
On November 7, 2000, the Food and Drug Administration published a final rule to amend the requirements of reporting errors and accidents in manufacturing of products. The rule amended the regulation at 21 CFR 600.14 for licensed biological products, and added a requirement at 21 CFR 606.171 applicable to all manufacturers of blood and blood components. The amended regulation at 21 CFR 600.14 and the new regulation at 21 CFR 606.171 require reporting of any event associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution of a licensed biological product or a blood or a blood component, in which the safety, purity, or potency of a distributed product may be affected. A manufacturer is required to report to the Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ) as soon as possible, but not to exceed 45 calendar days from the date of discovery of information reasonably suggesting a reportable event has occurred.
On November 24, 2004, the Food and Drug Administration published a final rule that includes requirements in 21 CFR Part 1271.350(b) for reporting certain deviations in manufacturing of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P). This rule is effective on May 25, 2005, for HCT/Ps procured on or after the effective date. This rule requires establishments to report, for distributed HCT/Ps, deviations that occurred in their facility or in a facility that performed a manufacturing step for them under contract, agreement, or other arrangement, and that relate to the core Current Good Tissue Practice requirements that are listed in 21 CFR Part 1271.150(b). The term "HCT/P deviation" is defined in 21 CFR 1271.3(dd) as an event:
- that represents a deviation from applicable regulations or from applicable standards or established specifications that relate to the prevention of communicable disease transmission or HCT/P contamination; or
- that is an unexpected or unforeseeable event that may relate to the transmission or potential transmission of a communicable disease or may lead to HCT/P contamination.
To facilitate reporting, FDA has developed a standardized reporting format that may be used to submit electronically or in paper form by mail. Instructions on completing the form are available. Included in the instructions as attachments are (1) a list of biological product deviation codes; (2) a list of blood product codes; and (3) a list of non-blood product codes, to include allergenics, derivatives, in-vitro diagnostics, therapeutics, vaccines, and HCT/Ps. The biological product deviation codes are used to categorize the deviation or unexpected event. The use of these codes will assist the FDA in analyzing the data submitted and streamline the trend analysis process. The product codes are used to identify the product(s) affected. It is recommended that you print the attachments and have them available when completing the form.
Biological product deviations reports required by 21 CFR 600.14, 21 CFR 606.171, or 21 CFR 1271.350(b) should be sent to:
Center for Biologics Evaluation and Research
Food and Drug Administration, CDER
Office of Compliance
Division of Compliance Risk Management and Surveillance
10903 New Hampshire Ave. Bldg. 51, Rm 4207
Silver Spring, MD 20993-0002
Forms & Instructions
General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486 Instructions for Using the eBPDR System Direct Recall Classification Program CBER’s Direct Recall Classification (DRC) program provides establishments the opportunity to electronically report recall related information directly to CBER. Electronic Submission of Biological Product Deviation Reports (eBPDR) Latest System Changes in the Electronic Biological Product Deviation Reporting (eBPDR) System Biological Product Deviation Guidances & Rules Biological Product Deviation Report (PDF)(PDF - 767KB)