# 21 CFR § 10.1: Scope

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-10.1

## Section

- **Citation:** 21 CFR § 10.1
- **Heading:** Scope
- **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 10—ADMINISTRATIVE PRACTICES AND PROCEDURES > Subpart A—General Provisions

## Text

(a) Part 10 governs practices and procedures for petitions, hearings, and other administrative proceedings and activities conducted by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and other laws which the Commissioner of Food and Drugs administers.
(b) If a requirement in another part of title 21 differs from a requirement in this part, the requirements of this part apply to the extent that they do not conflict with the other requirements.
(c) References in this part and parts 12, 13, 14, 15, and 16 to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
(d) References in this part and parts 12, 13, 14, 15, and 16 to publication, or to the day or date of publication, or use of the phrase to publish, refer to publication in the Federal Register unless otherwise noted.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 69 FR 17290, Apr. 2, 2004]

## Nearby sections

- [21 CFR § 10.1 § 10.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.1.md)
- [21 CFR § 10.3 § 10.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.3.md)
- [21 CFR § 10.10 § 10.10 Summaries of administrative practices and procedures.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.10.md)
- [21 CFR § 10.19 § 10.19 Waiver, suspension, or modification of procedural requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.19.md)
- [21 CFR § 10.20 § 10.20 Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.20.md)
- [21 CFR § 10.25 § 10.25 Initiation of administrative proceedings.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.25.md)
- [21 CFR § 10.30 § 10.30 Citizen petition.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.30.md)
- [21 CFR § 10.31 § 10.31 Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.31.md)
- [21 CFR § 10.33 § 10.33 Administrative reconsideration of action.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.33.md)
- [21 CFR § 10.35 § 10.35 Administrative stay of action.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.35.md)
- [21 CFR § 10.40 § 10.40 Promulgation of regulations for the efficient enforcement of the law.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.40.md)
- [21 CFR § 10.45 § 10.45 Court review of final administrative action; exhaustion of administrative remedies.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.45.md)
- [21 CFR § 10.50 § 10.50 Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.50.md)
- [21 CFR § 10.55 § 10.55 Separation of functions; ex parte communications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.55.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-10.1. Check the current official text before relying on it. Not legal advice.