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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
"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.
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)).
21 U.S.C. ch. 11 — Manufacture of Narcotic Drugs (repealed) 21 U.S.C. ch. 12 — Meat Inspection Meat Inspection Act of 1906; 21 U.S.C. ch. 13 — Drug Abuse Prevention and Control Controlled Substances Act, a part of the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.
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: . 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 food contact materials are described in the Code of Federal Legislation (CFR): 21 CFR 174 – 21 CFR 190. Important starting points are: 21 CFR 175 Indirect food additives: Adhesives and components of coatings; 21 CFR 176 Indirect food additives: Paper and paperboard components; 21 CFR 177 Indirect food additives: Polymers
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.
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