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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
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug ... Subpart-C – Electronic Signatures.
21 U.S.C. ch. 18 — Presidents Media Commission on Alcohol and Drug Abuse Prevention 21 U.S.C. ch. 19 — Pesticide Monitoring Improvements 21 U.S.C. ch. 20 — National Drug Control Program
201(f) is the definition for a food, which explicitly includes chewing gum; 201(g) is the definition for a drug; 201(h) is the definition for a medical device; 201(s) is the definition of a food additive; 201(ff) is the definition of a dietary supplement; III. Prohibited Acts and Penalties This section contains both civil law and criminal law ...
For example, 42 C.F.R. § 260.11(a)(1) would indicate "title 42, part 260, section 11, paragraph (a)(1)." Conversationally, it would be read as "forty-two C F R two-sixty point eleven a one" or similar. While new regulations are continually becoming effective, the printed volumes of the CFR are issued once each calendar year, on this schedule:
Title 41 of the Code of Federal Regulations ("CFR"), titled Public Contracts and Property Management, is the portion of the CFR that governs federal government public contracts within the United States. It is available in digital or printed form. Title 41 comprises four volumes, and is divided into six Subtitles.
The United States requires the presence of tartrazine to be declared on food and drug products (21 CFR 74.1705 (revised April 2013), 21 CFR 201.20) and also color batches to be preapproved by the United States Food and Drug Administration (FDA). [14]
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category".