---
kind: "section"
citation: "21 C.F.R. § 21.54"
title: "21"
number: "21.54"
heading: "Amended or disputed records received from other agencies."
url: "https://uscodex.org/cfr/21/21.54"
---

# §21.54. Amended or disputed records received from other agencies.


Whenever the Food and Drug Administration is notified that a record that it received from another agency was amended or is the subject of a statement of disagreement, the Food and Drug Administration shall:

- (a) Discard the record, or clearly note the amendment or the fact of disagreement in its copy of the record, and
- (b) **Refer persons who subsequently request the record to the agency that provided it.**
- (c) If an accounting was made under § [21.71 (d)](/cfr/21/21.71.md?p=d) and [(e)](/cfr/21/21.71.md?p=e) of the disclosure of the record under [§ 21.71(a)](/cfr/21/21.71.md?p=a), inform all previous recipients of the record about the amendment or provide to them the statement of disagreement and the agency statement, if any.

## Notes

### Authority

Authority: 21 U.S.C. 371; 5 U.S.C. 552, 552a.

### Source

Source: 42 FR 15626, Mar. 22, 1977, unless otherwise noted.