§ 116.8 - Completion and retention of records.

§ 116.8 Completion and retention of records.

Cross Reference

Link to an amendment published at 83 FR 22836, May 17, 2018.

All records (other than disposition records and adverse event records) required by this part shall 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 shall must be retained at the licensed or foreign establishment or permittee's place of business for a period of two 2 years after the expiration date of a product , or for such longer period as may be required by the Administrator.

(Approved by the Office of Management and Budget under control number 0579-0013)

[61 83 FR 52874, Oct. 9, 199622836, May 17, 2018]