A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments, Том 21Department of Health, Education and Welfare, Public Health Service, Food and Drug Administration, 1979 |
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Act is amended additional adulterated advertising amended by adding amended to read amphetamines antibiotics Antitrust approval authority bacitracin barbiturate BEESLEY bill BRECK certification CHAIRMAN clause clinical committee Congress CONGRESSIONAL RECORD consumer Cosmetic Act court deemed determine DINGELL Drug Administration drug application DRUG INDUSTRY ACT drug or device drug or drugs EASTLAND effective date enactment end thereof establishment exempt factory inspection facturers FDCA Federal Food Federal Trade Commission filing food additives Food and Drug habit-forming stimulant drug hearing HRUSKA ingredients inserting in lieu interstate commerce investigations issue June 18 KEFAUVER labeling LARRICK legislation letter dated ment metic misbranded officer or employee official name paragraph patent person prescribed prescription drugs President processing propagation proposed protection provisions public health reasonable registration regulations reports safe Secretary finds section 505 statement subcommittee tests thereof the following tion United States Code unsafe violation vote Welfare
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Сторінка 20 - If any party shall apply to the court for leave to adduce additional evidence, and shall show to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for failure to adduce such evidence in the proceeding before the Secretary...
Сторінка 56 - ... 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...
Сторінка 44 - As used in this paragraph (e), the term "established name", with respect to a drug or ingredient thereof, means (A) the applicable official name designated pursuant to section 508, or (B) if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this subparagraph...
Сторінка 14 - Secretary, the court may order such additional evidence to be taken before the Secretary and to be adduced upon the hearing in such manner and upon such terms and conditions as to the court may seem proper. The...
Сторінка 50 - ... the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such...
Сторінка 20 - A copy of such petition shall be forthwith transmitted by the clerk of the court to the Secretary...
Сторінка 19 - Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use...
Сторінка 14 - Secretary thereupon shall file in the court the record of the proceedings on which he based his action, as provided in section 2112 of title 28, United States Code. Upon the filing of such petition, the court shall have jurisdiction to affirm the action of the Secretary or to set it aside, in whole or in part, temporarily or permanently, but until the filing of the record, the Secretary may modify or set aside his order.
Сторінка 60 - The Bureau of the Budget advised there would be no objection to the submission of this report from the standpoint of the administration's program. Sincerely yours, EDWARD GUDEMAN, Under Secretary of Commerce.
Сторінка 46 - Department. (b) For purposes of enforcement of this Act, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge...