---
kind: "section"
citation: "21 C.F.R. § 21.53"
title: "21"
number: "21.53"
heading: "Notation and disclosure of disputed records."
url: "https://uscodex.org/cfr/21/21.53"
---

# §21.53. Notation and disclosure of disputed records.


When an individual has filed a statement of disagreement under [§ 21.52(b)(2)](/cfr/21/21.52.md?p=b-2), the Food and Drug Administration shall:

- (a) Mark any portion of the record that is disputed to assure that the record will clearly show that portion is disputed whenever the record is disclosed.
- (b) In any subsequent disclosure under [§ 21.70](/cfr/21/21.70.md) or [§ 21.71(a)](/cfr/21/21.71.md?p=a), provide a copy of the statement of disagreement and, if the Food and Drug Administration deems it appropriate, a concise statement of the agency's reasons for not making the amendment(s) requested. While the individual shall have access to any such statement, it shall not be subject to a request for amendment under [§ 21.50](/cfr/21/21.50.md).
- (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 a disclosure of the record under [§ 21.71(a)](/cfr/21/21.71.md?p=a), provide to all previous recipients of the record a copy of 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.