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Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
"About Code of Federal Regulations". Government Publishing Office. 9 March 2017. "A Research Guide to the Federal Register and the Code of Federal Regulations". Law Librarians' Society of Washington, D.C. July 21, 2012. "Report to Congress on the Costs and Benefits of Federal Regulations". Office of Management and Budget. September 30, 1997.
[code of federal regulations] [title 21, volume 5] [revised as of april 1, 2015] [cite: 21cfr314.50] title 21food and drugs chapter ifood and drug administration department of health and human services subchapter ddrugs for human use part 314 applications for fda approval to market a new drug
21 U.S.C. ch. 11 — Manufacture of Narcotic Drugs (repealed) 21 U.S.C. ch. 12 — Meat Inspection Meat Inspection Act of 1906; 21 U.S.C. ch. 13 — Drug Abuse Prevention and Control Controlled Substances Act, a part of the Comprehensive Drug Abuse Prevention and Control Act of 1970.
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility ...
The CFR is revised annually according to the following schedule: Titles 1–16 - as of Jan. 1; 17–27 - as of April 1; 28–41 - as of July 1; 42–50 - as of Oct. 1; To bring these regulations up to date, consult the most recent LSA for any changes, additions, or removals published after the revision date of the volume you are using.