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Federal Food Drug Cosmetic Act

The Food Drug Administration has the responsibility for the premarket clearance of all animal drugs. The 1958 food additive amendment to the Federal Food, Drug Cosmetic Act requires sponsors to demonstrate the safety of their products. The Kefauver-Harris amendment of 1962 requires the sponsors to demonstrate, in addition to safety, the efficacy of their drugs. Safety implies safety to the animal as well as to the consumers of animal products. The role of the Center for Veterinary Medicine in the premarket approval process is to establish conditions of drug use and to establish the allowable tolerances for drug residues in animal-derived food products. [Pg.128]

Comprehensive Environmental Response, Compensation and Liability Act Dangerous Cargo Act Federal Coal Mining Safety Health Act Federal Food Drug Cosmetic Act Federal Insecticide, Fungicide Rodent Act Federal Water Pollution Control Act Hazardous Materials Transport Act Occupational Safety and Health Act Safe Drinking Water Act Toxic Substance Control Act... [Pg.228]

The USP Convention is the publisher of the United States Pharmacopeia and National Formulary (USPINF). These texts and supplements are recognized as official compendia under the Federal Food, Drug Cosmetic Act (FD C Act). As such, their standards of strength, quality, purity, packaging, and labeling are directly enforceable under the adulteration and misbranding provisions without further approval or adoption by the FDA (http //www.usp.org frameset.htm http //www. usp,org/standards/fda/jgv testimony.htm). [Pg.700]

U S Code of Federal Regulations 21 CFR Part 314 21 CFR Part 514 21 CFR Part 601 U S Food, Drug Cosmetic Act Chapter 5, Sub chapter B, F... [Pg.165]

Federal Food, Drug and Cosmetic Act, Section 601 (e), U.S. Government Printing Office, Washiagton, D.C. Ibid, Section 601 (a). [Pg.461]

Food and Drug Administration Federal Food, Drug, and Cosmetic Act, Title 21 Environmental Protection Agency, Title 40... [Pg.1949]

US legislation on food additives consists of the Federal Food, Drug, and Cosmetic Act (FD C Act), the Fair Packaging and Labeling Act, and other applicable laws including the Public Health Security and Bioterrorism Preparedness and Response Act. The FD C Act states that foods are adulterated if they contain color additives that have not been approved as safe to the satisfaction of the Food Drug Administration (FDA) for a particular use. ... [Pg.576]

One major problem caused by Section 409 (c) (3) of the Federal Food, Drug and Cosmetic Act, commonly known as the Delaney Clause , which governed the registration of pesticides was the statement, No additive shall be deemed safe if it is found to induce cancer when ingested by man or animal,... . Dr Fred R. Shank, Director, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, in... [Pg.60]

US Food and Drug Administration, Federal Food, Drug and Cosmetic Act (Amended 1997). Also available on the World Wide Web http //www.fda.gov/opacoiii/laws/fdcact/fdctoc.htm. [Pg.75]

Tolerance levels in or on coffee beans, established under the Federal Food, Drug, and Cosmetic Acts, include values for glyphosate and its sulfinyl and sulfonyl metabolites,191 and N,N-dimethyl-2-(l-naphthalenyloxy)propionamide.192... [Pg.156]

In 1902 Congress passed the Biologies Control Act, which licensed and regulated the interstate sale of serums and vaccines used to prevent and treat diseases in humans. The effect of this would seem obvious because, after much discussion before the Committee on Interstate and Foreign Commerce, the final result was passage of the Federal Food, Drug, and Cosmetic Act of 1906 [2]. This bill was signed into law by President Theodore Roosevelt on June 30, 1906 [3]. The Meat... [Pg.627]

Predicate rules The underlying requirements set in the Federal Food, Drug and Cosmetic Act and the Public Health Service Act and FDA regulations (e.g. GLP), other than Part 11. [Pg.279]


See other pages where Federal Food Drug Cosmetic Act is mentioned: [Pg.1779]    [Pg.532]    [Pg.1452]    [Pg.46]    [Pg.747]    [Pg.1779]    [Pg.532]    [Pg.1452]    [Pg.46]    [Pg.747]    [Pg.335]    [Pg.1787]    [Pg.13]    [Pg.393]    [Pg.393]    [Pg.383]    [Pg.273]    [Pg.44]    [Pg.77]    [Pg.135]    [Pg.216]    [Pg.216]    [Pg.28]    [Pg.224]    [Pg.627]    [Pg.628]    [Pg.629]    [Pg.629]    [Pg.643]    [Pg.733]    [Pg.775]    [Pg.775]    [Pg.32]    [Pg.466]    [Pg.224]    [Pg.90]   
See also in sourсe #XX -- [ Pg.36 , Pg.42 ]




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