Completion and retention of records.
9 C.F.R. § 116.8
in effectEffective: 2024-07-01All records (other than disposition records and adverse event records) required by this part must be completed by the licensee, permittee, or foreign manufacturer before any portion of a serial of any product may be marketed in the United States or exported. All records must be retained at the licensed or foreign establishment or permittee's place of business for a period of 2 years after the expiration date of a product or longer as may be required by the Administrator.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-9.xmlFetched: 7/26/2026
