21 CFR 314.1 - Scope of this part.

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§ 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. 201et seq.)) and subchapter F of chapter I of title 21 of the Code of Federal Regulations.

(c) 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]

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 314 after this date.

  • 2016-12-13; vol. 81 # 239 - Tuesday, December 13, 2016
    1. 81 FR 89848 - Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; correction.
      Effective December 13, 2016.
      21 CFR Parts 20, 201, 207, 314, 514, 515, 601, 607, and 1271