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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".
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
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:
CFR Title 7 – Agriculture is one of 50 titles comprising the United States Code of Federal Regulations (CFR) and contains the principal set of rules and regulations issued by federal agencies regarding agriculture. It is available in digital and printed form and can be referenced online using the Electronic Code of Federal Regulations (e-CFR).
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)).
CFR Title 31 - Money and Finance: Treasury is one of fifty titles comprising the United States Code of Federal Regulations (CFR). Title 31 is the principal set of rules and regulations issued by federal agencies of the United States regarding money, finance, and the treasury.
Volume Chapter Parts Regulatory Entity 1: I: 0-140: U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury: 2: 141-199: U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury
CFR Title 27 – Alcohol, Tobacco Products and Firearms is one of 50 titles composing the United States Code of Federal Regulations (CFR) and contains the principal set of rules and regulations issued by federal agencies regarding alcohol, tobacco products, and firearms.