Federal Food, Drug, and Cosmetic Act. Hearings ... 19511951 - 229 pages |
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Common terms and phrases
adequate directions Administrative Procedure Act agency amendment American Pharmaceutical Association authority barbital barbiturates BECKWORTH Benzedrine bill CHAIRMAN circuit court CLUTTER committee Congress Cosmetic Act counter counts court of appeals dangerous drugs dentist Dexedrine dispensed doctor DOLLIVER Drug Administration drug manufacturers drug or device Drug Store efficacy EWING exempt FDC Act Federal Food Federal Security Federal Security Agency FISCHELIS Food and Drug Guilty HALE HARROP hearing HESELTON LARRICK legislation licensed by law medicine misbranded narcotics Nembutal Nolo contendere O'HARA oral prescription Over-the-counter package patient pharmacist pharmacy phenobarbital physician Plea practice practitioner licensed prescriber prescription drug prescription legend prescription-drug law present law problem profession professional prohibited proposed provision public health question refilling of prescriptions regulations restriction Retail Druggists Robert Crosser scription Seconal section 502 sold statement sulfadiazine Sulfathiazole supervision telephone prescriptions tion trial de novo veterinarian WALLER WARNACK WOLVERTON written prescription
Popular passages
Page 17 - ... generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958.
Page 205 - ... immunity; (3) in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; (4) without observance of procedure required by law; (5) unsupported by substantial evidence in any case subject to the requirements of sections 7 and 8 or otherwise reviewed on the record of an agency hearing provided by statute; or (6) unwarranted by the facts to the extent that the facts are subject to trial de novo by the reviewing court. In making the foregoing determinations the court...
Page 36 - ... the United States court of appeals for the circuit wherein such person resides or has his principal place of business...
Page 204 - To the extent necessary to decision and when presented, the reviewing court shall decide all relevant questions of law, interpret constitutional and statutory provisions, and determine the meaning or applicability of the terms of an agency action.
Page 34 - ... because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use...
Page 20 - Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users...
Page 81 - A drug intended for veterinary use which, because of toxicity or other potentiality for harmful effect, or the method of its use, is not safe for animal use except under the supervision of a licensed veterinarian, and hence for which "adequate directions for use...
Page 205 - The reviewing court shall: (1) compel agency action unlawfully withheld or unreasonably delayed; and (2) hold unlawful and set aside agency action, findings, and conclusions found to be — (a) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law...
Page 211 - ... arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; (2) contrary to constitutional right, power, privilege, or immunity; (3) in excess of statutory jurisdiction, authority, or limitations, or short of statutory right...
Page 5 - Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to affirm the order, or to set it aside in whole or in part, temporarily or permanently. If the order of the...