§ 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 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 et seq.)) and subchapter F of chapter I of title 21 of the Code of Federal Regulations.

(c) The following provisions do not apply to designated medical gases, which are subject to the certification and postmarketing reporting requirements under part 230 of this chapter:

(1) Sections 314.50 through 314.72;

(2) Section 314.80;

(3) Section 314.81, except paragraph (b)(3);

(4) Section 314.90;

(5) Subpart C of this part;

(6) Sections 314.100 through 314.162;

(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.

[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]