Code of Federal Regulations · Section
§ 117.320 — Requirements For Official Review
21 C.F.R. § 117.320
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All records required by this part must be made promptly available to a duly authorized representative of the Secretary of Health and Human Services for official review and copying upon oral or written request.
Authorizing Statute
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Prohibited acts21 U.S.C. § 331
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General grant of authority for cooperation42 U.S.C. § 243