# 21 CFR § 25.31: Human drugs and biologics

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-25.31

## Section

- **Citation:** 21 CFR § 25.31
- **Heading:** Human drugs and biologics
- **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 25—ENVIRONMENTAL IMPACT CONSIDERATIONS > Subpart C—Categorical Exclusions

## Text

The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:
(a) Action on an NDA, abbreviated application, application for marketing approval of a biologic product, or a supplement to such applications, or action on an OTC monograph, if the action does not increase the use of the active moiety.
(b) Action on an NDA, abbreviated application, or a supplement to such applications, or action on an OTC monograph, if the action increases the use of the active moiety, but the estimated concentration of the substance at the point of entry into the aquatic environment will be below 1 part per billion.
(c) Action on an NDA, abbreviated application, application for marketing approval of a biologic product, or a supplement to such applications, or action on an OTC monograph, for substances that occur naturally in the environment when the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment.
(d) Withdrawal of approval of an NDA or an abbreviated application.
(e) Action on an IND.
(f) Testing and release by the Food and Drug Administration of lots or batches of a licensed biologic product.
(g) Establishment of bioequivalence requirements for a human drug or a comparability determination for a biologic product subject to licensing.
(h) Issuance, revocation, or amendment of a standard for a biologic product.
(i) Revocation of a license for a biologic product.
(j) Action on an application for marketing approval for marketing of a biologic product for transfusable human blood or blood components and plasma.
[62 FR 40592, July 29, 1997, as amended at 63 FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999; 70 FR 14980, Mar. 24, 2005]

## Nearby sections

- [21 CFR § 25.1 § 25.1 Purpose.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.1.md)
- [21 CFR § 25.5 § 25.5 Terminology.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.5.md)
- [21 CFR § 25.10 § 25.10 Policies and NEPA planning.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.10.md)
- [21 CFR § 25.15 § 25.15 General procedures.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.15.md)
- [21 CFR § 25.16 § 25.16 Public health and safety emergencies.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.16.md)
- [21 CFR § 25.20 § 25.20 Actions requiring preparation of an environmental assessment.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.20.md)
- [21 CFR § 25.21 § 25.21 Extraordinary circumstances.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.21.md)
- [21 CFR § 25.22 § 25.22 Actions requiring the preparation of an environmental impact statement.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.22.md)
- [21 CFR § 25.30 § 25.30 General.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.30.md)
- [21 CFR § 25.31 § 25.31 Human drugs and biologics.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.31.md)
- [21 CFR § 25.32 § 25.32 Foods, food additives, and color additives.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.32.md)
- [21 CFR § 25.33 § 25.33 Animal drugs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.33.md)
- [21 CFR § 25.34 § 25.34 Devices and electronic products.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.34.md)
- [21 CFR § 25.35 § 25.35 Tobacco product applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.35.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-25.31. Check the current official text before relying on it. Not legal advice.