# 21 C.F.R. § 21.53 (2026): Notation and disclosure of disputed records

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P21_S21_53

## Section

- **Citation:** 21 C.F.R. § 21.53 (2026)
- **Heading:** Notation and disclosure of disputed records
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I / Part 21 / Subpart E / § 21.53: § 21.53   Notation and disclosure of disputed records.

## Text

When an individual has filed a statement of disagreement under § 21.52(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 or § 21.71(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. (c) If an accounting was made under § 21.71(d) and (e) of a disclosure of the record under § 21.71(a), provide to all previous recipients of the record a copy of the statement of disagreement and the agency statement, if any.

## Nearby sections

- [21 C.F.R. § 21.50 (2026) § 21.50   Procedures for submitting requests for amendment of records.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P21_S21_50.md)
- [21 C.F.R. § 21.51 (2026) § 21.51   Responses to requests for amendment of records.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P21_S21_51.md)
- [21 C.F.R. § 21.52 (2026) § 21.52   Administrative appeals of refusals to amend records.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P21_S21_52.md)
- [21 C.F.R. § 21.53 (2026) § 21.53   Notation and disclosure of disputed records.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P21_S21_53.md)
- [21 C.F.R. § 21.54 (2026) § 21.54   Amended or disputed records received from other agencies.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P21_S21_54.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P21_S21_53. Check the current official text before relying on it. Not legal advice.