# 21 CFR § 20.20: Policy on disclosure of Food and Drug Administration records

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-20.20

## Section

- **Citation:** 21 CFR § 20.20
- **Heading:** Policy on disclosure of Food and Drug Administration records
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER A—GENERAL > PART 20—PUBLIC INFORMATION > Subpart B—General Policy

## Text

(a) The Food and Drug Administration (FDA) will make the fullest possible disclosure of records to the public, consistent with the rights of individuals to privacy, the property rights of persons in trade secrets and confidential commercial or financial information, and the need for the Agency to promote frank internal policy deliberations and to pursue its regulatory activities without disruption.
(b) Except where specifically exempt pursuant to the provisions of this part, all FDA records shall be made available for public disclosure. FDA will withhold requested information only if:
(1) The Agency reasonably foresees that disclosure would harm an interest protected by an exemption described in this part; or
(2) Disclosure is prohibited by law.
(c) Except as provided in paragraph (d) of this section, all nonexempt records shall be made available for public disclosure upon request regardless of whether any justification or need for such records have been shown.
(d) Under § 21.71 of this chapter, a statement of the purposes to which the record requested is to be put, and a certification that the record will be so used, may be requested when:
(1) The requested record is contained in a Privacy Act Record System as defined in § 21.3(c) of this chapter;
(2) The requester is a person other than the individual who is the subject of the record that is so retrieved or a person acting on his behalf; and
(3) The disclosure is one that is discretionary; i.e., not required under this part.
(e) “Record” and any other term used in this part in reference to information includes any information that would be an Agency record subject to the requirements of this part when maintained by the Agency in any format, including an electronic format.
(f) FDA will establish procedures for identifying records of general interest or use to the public that are appropriate for public disclosure, and for posting and indexing such records in a publicly accessible electronic format.
[87 FR 55911, Sept. 13, 2022]

## Nearby sections

- [21 CFR § 20.1 § 20.1 Testimony by Food and Drug Administration employees.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.1.md)
- [21 CFR § 20.2 § 20.2 Production of records by Food and Drug Administration employees.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.2.md)
- [21 CFR § 20.3 § 20.3 Certification and authentication of Food and Drug Administration records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.3.md)
- [21 CFR § 20.20 § 20.20 Policy on disclosure of Food and Drug Administration records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.20.md)
- [21 CFR § 20.21 § 20.21 Uniform access to records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.21.md)
- [21 CFR § 20.22 § 20.22 Partial disclosure of records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.22.md)
- [21 CFR § 20.23 § 20.23 Request for existing records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.23.md)
- [21 CFR § 20.24 § 20.24 Preparation of new records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.24.md)
- [21 CFR § 20.25 § 20.25 Retroactive application of regulations.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.25.md)
- [21 CFR § 20.26 § 20.26 Electronic availability and indexes of certain records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.26.md)
- [21 CFR § 20.27 § 20.27 Submission of records marked as confidential.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.27.md)
- [21 CFR § 20.28 § 20.28 Food and Drug Administration determinations of confidentiality.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.28.md)
- [21 CFR § 20.29 § 20.29 Prohibition on withdrawal of records from Food and Drug Administration files.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.29.md)
- [21 CFR § 20.30 § 20.30 Food and Drug Administration Division of Freedom of Information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.30.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-20.20. Check the current official text before relying on it. Not legal advice.