Title 9

SECTION 116.9

116.9 Recording and reporting adverse events.

§ 116.9 Recording and reporting adverse events.

(a) Licensees and permittees must maintain a detailed record for every adverse event report the licensee or permittee receives for any biological product it produces or distributes. These records shall be maintained for a period of 3 years after the date the adverse event report is received. The adverse event report form and guidance on how to complete it, including guidance specific to the various information blocks on the form, is available on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics or by writing to APHIS Center for Veterinary Biologics, 1920 Dayton Avenue, P.O. Box 844, Ames, Iowa 50010.

(b) A report of all adverse events reports received by a licensee or permittee must be compiled and submitted to the Animal and Plant Health Inspection Service. The frequency of report submission is as follows:

(1) Immediate notification is required if at any time there are indications that raise questions regarding the purity, safety, potency, or efficacy of a product, or if it appears that there may be a problem regarding the preparation, testing, or distribution of a product.

(2) Adverse event reports determined by the licensee or permittee to be product-related, serious, and unexpected must also be reported immediately.

(3) All other adverse event reports must be reported within 90 calendar days of the date the report was first received.

(Approved by the Office of Management and Budget under control number 0579-0209) [83 FR 22836, May 17, 2018]

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