Compilation of Selected Acts Within the Jurisdiction of the Committee on Energy and Commerce: Including Federal Food, Drug, and Cosmetic Act, Controlled Substances Act .... Food, drug, and related lawU.S. Government Printing Office, 2005 |
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accordance action active ingredient additional agency amended animal drug application appropriate Attorney authorized certification clause clause iv containing controlled substance Controlled Substances Act court deemed described dietary dietary supplement distribution drug or device drug product ecgonine effective date established exemption exported Federal Food Federal Register fees filed fiscal Food and Drug graph Health Service Act hearing individual infant formula inspection investigational isomers issued labeling licensed listed chemical manufacturer ment notice notification optical isomers paragraph patent period pesticide chemical residue petition phenylpropanolamine premarket prescribed prescription drug proceeding pseudoephedrine Public Law purposes reasonable records registration regulation request respect retary safety and effectiveness schedule III Secretary determines Secretary finds sentence specified spect Stat subchapter subclause submission submitted subparagraph subsection substance in schedule supplement term of imprisonment thereof tion title 18 United States Code United States Pharmacopeia unless violation
Popular passages
Page 270 - ... file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order.
Page 583 - Each agency, in accordance with published rules, shall make available for public inspection and copying — (A) final opinions, including concurring and dissenting opinions, as well as orders, made in the adjudication of cases; (B) those statements of policy and interpretations which have been adopted by the agency and are not published in the Federal Register...
Page 196 - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be, concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended,...
Page 423 - Depressants.-Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers...
Page 270 - Code. (2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the...
Page 43 - ... if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health...
Page 42 - A food shall be deemed to be adulterated — (a) (1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health...
Page 584 - To the extent required to prevent a clearly unwarranted invasion of personal privacy, an agency may delete identifying details when it makes available or publishes an opinion, statement of policy, interpretation, or staff manual or instruction.
Page 14 - The giving of a guaranty or undertaking referred to in section 303(c)(2), which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the food, drug, device, or cosmetic; or the giving of a guaranty or undertaking referred to in section 303(c)(3), which guaranty or undertaking is false.
Page 66 - In determining the quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.