# 21 C.F.R. § 20.80 (2026): Applicability of limitations on exemptions

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_80

## Section

- **Citation:** 21 C.F.R. § 20.80 (2026)
- **Heading:** Applicability of limitations on exemptions
- **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 20 / Subpart E / § 20.80: § 20.80   Applicability of limitations on exemptions.

## Text

(a) The limitations on exemptions established in this subpart shall apply to all Food and Drug Administration records, except as specifically provided herein. Accordingly, a record that is ordinarily exempt from public disclosure in accordance with the provisions in subpart D of this part is available for such disclosure to the extent that it falls within a limitation on the exemption contained in this subpart. For example, an investigatory record that is ordinarily exempt from disclosure under § 20.64 is disclosable to Congress in accordance with the provisions of § 20.87. (b) Disclosure of a record to any member of the public pursuant to the provisions in § 20.81, data and information previously disclosed to the public, in § 20.82, discretionary disclosure by the Commissioner, and in § 20.83, disclosure pursuant to a court order, shall involve the rule established in § 20.21 that the record shall be made available for disclosure to all members of the public who request it. Disclosure of a record only to the limited categories of persons and under the conditions specified in § 20.84, special government employees, in § 20.85, other Federal government departments and agencies, in § 20.86, in camera disclosure in administrative or court proceedings, in § 20.87(b), Congress, in § 20.88, State and local government officials, in § 20.89, foreign government officials, and in § 20.90, contractors, which does not result in disclosure of the record to any member of the public in an authorized manner, shall not invoke the rule established in § 20.21. (c) Disclosure to government employees and special government employees of records exempt from public disclosure shall subject those persons to the same restrictions with respect to the disclosure of such records as any Food and Drug Administration employee
not result in disclosure of the record to any member of the public in an authorized manner, shall not invoke the rule established in § 20.21. (c) Disclosure to government employees and special government employees of records exempt from public disclosure shall subject those persons to the same restrictions with respect to the disclosure of such records as any Food and Drug Administration employee. (d) In the case of a record in a Privacy Act Record System, as defined in § 21.3(c) of this chapter: (1) The availability to an individual, as defined in § 21.3(a), of a record about himself that is retrieved by the individual's name or other personal identifier and is contained in a Privacy Act Record System shall be subject to the special requirements of part 21 of this chapter (the privacy regulations) and shall not be subject to the exemptions in subpart D of this part except that where the system is exempt and the requested record is not available under § 21.61 of this chapter, the provisions of this part shall apply. (2) The availability of a record about an individual to persons other than the individual who is the subject of the record shall be subject to the special requirements of part 21, subpart G, of this chapter (restrictions on disclosure in the privacy regulations), and shall not be subject to the limitations on exemptions in this subpart except as provided in part 21, subpart G, of this chapter.

## Nearby sections

- [21 C.F.R. § 20.80 (2026) § 20.80   Applicability of limitations on exemptions.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_80.md)
- [21 C.F.R. § 20.81 (2026) § 20.81   Data and information previously disclosed to the public.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_81.md)
- [21 C.F.R. § 20.82 (2026) § 20.82   Discretionary disclosure by the Commissioner.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_82.md)
- [21 C.F.R. § 20.83 (2026) § 20.83   Disclosure required by court order.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_83.md)
- [21 C.F.R. § 20.84 (2026) § 20.84   Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_84.md)
- [21 C.F.R. § 20.85 (2026) § 20.85   Disclosure to other Federal Government departments and agencies.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_85.md)
- [21 C.F.R. § 20.86 (2026) § 20.86   Disclosure in administrative or court proceedings.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_86.md)
- [21 C.F.R. § 20.87 (2026) § 20.87   Disclosure to Congress.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_87.md)
- [21 C.F.R. § 20.88 (2026) § 20.88   Communications with State and local government officials.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_88.md)
- [21 C.F.R. § 20.89 (2026) § 20.89   Communications with foreign government officials.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_89.md)
- [21 C.F.R. § 20.90 (2026) § 20.90   Disclosure to contractors.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_90.md)
- [21 C.F.R. § 20.91 (2026) § 20.91   Use of data or information for administrative or court enforcement action.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_91.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P20_S20_80. Check the current official text before relying on it. Not legal advice.
