A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments, Volume 22U.S. Department of Health, Education, and Welfare, Public Health Service, Food and Drug Administration, 1979 - Cosmetics |
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Page 46
... 1961 Bead twice and referred to the Committee on the Judiciary JULY • 1963 Reported with amendments 1 87TH CONGRESS 2D SESSION Calendar No. 1703 S. 1552 46 VOL . 22 LEGISLATIVE HISTORY OF THE FOOD , DRUG & COSMETIC ACT.
... 1961 Bead twice and referred to the Committee on the Judiciary JULY • 1963 Reported with amendments 1 87TH CONGRESS 2D SESSION Calendar No. 1703 S. 1552 46 VOL . 22 LEGISLATIVE HISTORY OF THE FOOD , DRUG & COSMETIC ACT.
Page 47
... Congress assembled , 3 That this Act may be eited as the " Drug Industry Antitrust 4 Aet " . 5 6 SHER AN ACT AMENDMENT SEO . 2. The Act entitled " An Act to protect trade and 7 commerce against unlawful restraints and monopolies " , ap ...
... Congress assembled , 3 That this Act may be eited as the " Drug Industry Antitrust 4 Aet " . 5 6 SHER AN ACT AMENDMENT SEO . 2. The Act entitled " An Act to protect trade and 7 commerce against unlawful restraints and monopolies " , ap ...
Page 158
... Congress should act at once . The Harris bill , like the Senate Judici ary bill , would require several amend- ments in order to deal effectively with the thalidomide situation and other seri- ous problems revealed by the drug in ...
... Congress should act at once . The Harris bill , like the Senate Judici ary bill , would require several amend- ments in order to deal effectively with the thalidomide situation and other seri- ous problems revealed by the drug in ...
Page 163
... Congress to look into the possibility of improving this international communication on an official basis ?. " Commissioner LARRICK . Yes I think it would be well to look into it . I do not know how much of it could be done under present ...
... Congress to look into the possibility of improving this international communication on an official basis ?. " Commissioner LARRICK . Yes I think it would be well to look into it . I do not know how much of it could be done under present ...
Page 175
... Congress not only to pro- tect the American public from untested , dangerous drugs , but also to bring within their economic reach drugs of proven medicinal worth . On this day , when Dr. Kelsey is being honored , it is only fitting ...
... Congress not only to pro- tect the American public from untested , dangerous drugs , but also to bring within their economic reach drugs of proven medicinal worth . On this day , when Dr. Kelsey is being honored , it is only fitting ...
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Common terms and phrases
adequate amended by adding American animal testing antibiotics Antitrust approved ask unanimous consent August August 23 authority bacitracin bill CARROLL certification chairman clause clinical Commissioner compulsory licensing Congress CONGRESSIONAL RECORD controls Cosmetic Act Cosmetic Act 21 cost doctors Drug Administration drug application DRUG INDUSTRY ACT druggist EASTLAND efficacy enactment end thereof establishment exemption experience Federal Food filed Food and Drug Government hearings House HUMPHREY ingredient inserting inspection investigation issued JAVITS Judiciary Committee KEFAUVER labeling legislation license Madam President majority manufacture ment metic minority mittee official name patent percent person physicians prednisone prescribed prescription drugs PRESIDING OFFICER printed problem proposed provisions pursuant recommended regulations Republican request respect safe safety section 505 Senator from Tennessee Senator yield staff staffing Subcommittee subsection testing thalidomide thereof the following tion United United States Code Welfare words
Popular passages
Page 67 - CHANGES IN EXISTING LAW In compliance with subsection (4) of rule XXIX of the Standing Rules of the Senate, changes in existing law made by the bill, as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, existing law in which no change is proposed is shown in roman...
Page 692 - The judgment and decree of the court affirming, modifying, or setting aside, in whole or in part, any such order of the Commission shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in sections 239 and 240 of the Judicial Code, as amended (USC, title 28, sees. 346 and 347).
Page 687 - ... effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof...
Page 401 - ... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice...
Page 671 - food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food...
Page 71 - ... (A) the investigations, reports of which are required to be submitted to the 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 under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (B) the results of such tests show that such drug is unsafe for use under such conditions...
Page 68 - ... 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 693 - A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.
Page 215 - 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 79 - 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...