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21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
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All 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.
(Approved by the Office of Management and Budget under control number 0579-0013)
[83 FR 22836, May 17, 2018]