---
kind: "section"
citation: "21 C.F.R. § 117.320"
title: "21"
number: "117.320"
heading: "Requirements for official review."
url: "https://uscodex.org/cfr/21/117.320"
---

# §117.320. Requirements for official review.


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.


## Notes

### Authority

Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.

### Source

Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.