Site Feedback

Title 21

Displaying title 21, up to date as of 7/09/2026. Title 21 was last amended 7/09/2026.
eCFR Content

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR.

Learn more about the eCFR, its status, and the editorial process.

Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter DDrugs for Human Use300 – 499
Part 314Applications for FDA Approval to Market a New Drug314.1 – 314.650
Subpart AGeneral Provisions314.1 – 314.3
§ 314.1Scope of this part.
§ 314.2Purpose.
§ 314.3Definitions.
Subpart BApplications314.50 – 314.90
Subpart CAbbreviated Applications314.92 – 314.99
Subpart DFDA Action on Applications and Abbreviated Applications314.100 – 314.170
Subpart EHearing Procedures for New Drugs314.200 – 314.235
§ 314.200Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.
§ 314.201Procedure for hearings.
§ 314.235Judicial review.
Subpart F [Reserved]
Subpart GMiscellaneous Provisions314.410 – 314.445
§ 314.410Imports and exports of new drugs.
§ 314.420Drug master files.
§ 314.430Availability for public disclosure of data and information in an application or abbreviated application.
§ 314.440Addresses for applications and abbreviated applications.
§ 314.445Guidance documents.
Subpart HAccelerated Approval of New Drugs for Serious or Life-Threatening Illnesses314.500 – 314.560
Subpart IApproval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible314.600 – 314.650