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. 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 a biological product deviation 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, 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.
Reports involving biological therapeutic products that have been transferred to the Center for Drug Evaluation and Research (CDER), should be sent to:
Office of Surveillance
Quality Deviation Assessment Branch
Building #51, Room 4207
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph: (301) 796-3140
Fax: (301) 847-8742