Biological Product Deviation Reporting (BPDR)
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.
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 and vaccines. 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 or 21 CFR 606.171 should be sent to:
Director, Office of Compliance and Biologics Quality (HFM-600)
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448
Reports involving biological therapeutic products that have been transferred to the Center for Drug Evaluation and Research (CDER), should be sent to:
Division of Compliance Risk Management and Surveillance (HFD-330)
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Contact information for questions concerning Biological Product Deviation Reports
Electronic Submission of Biological Product Deviation Reports
Latest System Changes
Form 3486 - Biological Product Deviation Report
Form Instructions -
(Text) - Updated 10/31/2003
Electronic Form Instructions -
(Text) - Updated 10/1/2002
Deviation Codes -
(PDF),
(Text) - Updated 9/28/2004
Blood Product Codes -
(PDF),
(Text) - Updated 10/31/2003
Non-Blood Products Codes -
(PDF),
(Text) - Updated 10/31/2003
Biological Product Deviation Annual Summary
Publications
Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments - 8/10/2001 -
(PDF),
(Text)
Comment period ends 11/13/2001
Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components - 8/10/2001 -
(PDF),
(Text)
Comment period ends 11/13/2001
FEDERAL REGISTER Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule - 11/7/2000 - (PDF), (Text)
FEDERAL REGISTER Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule
CORRECTION: Effective date is May 7, 2001 - 11/9/2000 -
(PDF),
(Text)
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