---
kind: "section"
citation: "21 C.F.R. § 314.1"
title: "21"
number: "314.1"
heading: "Scope of this part."
url: "https://uscodex.org/cfr/21/314.1"
---

# §314.1. Scope of this part.

- (a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under [section 505](/cfr/21/505.md) of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them.
- (b) This part does not apply to drug products subject to licensing by FDA under the Public Health Service Act (58 Stat. 632 as amended ([42 U.S.C. 201](/usc/42/201.md) et seq.)) and subchapter F of [chapter I of title 21 of the Code of Federal Regulations](/cfr/21/chI.md).
- (c) The following provisions do not apply to designated medical gases, which are subject to the certification and postmarketing reporting requirements under [part 230](/cfr/21/part230.md) of this chapter:
  - (1) [Sections 314.50 through 314.72](/cfr/21/314.50..314.72.md);
  - (2) [Section 314.80](/cfr/21/314.80.md);
  - (3) [Section 314.81](/cfr/21/314.81.md), except paragraph (b)(3);
  - (4) [Section 314.90](/cfr/21/314.90.md);
  - (5) Subpart C of this part;
  - (6) [Sections 314.100 through 314.162](/cfr/21/314.100..314.162.md);
  - (7) Subpart H of this part; and
  - (8) **Subpart I of this part.**
- (d) References in this part to regulations in the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

## Notes

### Amendments

[50 FR 7493, Feb. 22, 1985, as amended at 57 FR 17981, Apr. 28, 1992; 64 FR 401, Jan. 5, 1999; 89 FR 51782, June 18, 2024]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1.

### Source

Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.

### Amendments

[50 FR 7493, Feb. 22, 1985, as amended at 57 FR 17981, Apr. 28, 1992; 64 FR 401, Jan. 5, 1999; 89 FR 51782, June 18, 2024]