To Amend Section 503 (b) of the Federal Food, Drug and Cosmetic Act of 1938, as Amended.Hearings, Eighty-second Congress, First Session, on S. 1186 and H.R. 3298. September 11, 12, and 13, 1951 |
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Page 9
... tion , Lincoln , Nebr . , letter dated Sept. 12 , 1951 274 274 Bristol , Henry P. , Bristol - Myers Co. , New York , N. Y. , letter dated Aug. 15 , 1951 275 Burns , Jacob , New York , N. Y. , letter dated Aug. 28 , 1951 . Burroughs ...
... tion , Lincoln , Nebr . , letter dated Sept. 12 , 1951 274 274 Bristol , Henry P. , Bristol - Myers Co. , New York , N. Y. , letter dated Aug. 15 , 1951 275 Burns , Jacob , New York , N. Y. , letter dated Aug. 28 , 1951 . Burroughs ...
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... tion ' . A drug to which paragraph ( 1 ) of this subsection does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence or any other statement ...
... tion ' . A drug to which paragraph ( 1 ) of this subsection does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence or any other statement ...
Page 11
... tion - which each of the 1,300 manufacturers would need to interpret and apply to his own products . Inevitably - and this , Senator Neely , is an answer to your question - different manufacturers would come to different conclusions and ...
... tion - which each of the 1,300 manufacturers would need to interpret and apply to his own products . Inevitably - and this , Senator Neely , is an answer to your question - different manufacturers would come to different conclusions and ...
Page 12
... tion would be made by the Administrator of the Federal Security Agency . He would promulgate the regulation , and it would be re- viewable in the courts . Senator LEHMAN . Is the work now being done by different divisions ? Mr. LARRICK ...
... tion would be made by the Administrator of the Federal Security Agency . He would promulgate the regulation , and it would be re- viewable in the courts . Senator LEHMAN . Is the work now being done by different divisions ? Mr. LARRICK ...
Page 13
... tion to happen before we got the new drug act . Mr. LARRICK . That is right . If no one objected to the Administrator's proposed list , the list would be promulgated as a regulation with the force and effect of law . If anyone objected ...
... tion to happen before we got the new drug act . Mr. LARRICK . That is right . If no one objected to the Administrator's proposed list , the list would be promulgated as a regulation with the force and effect of law . If anyone objected ...
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Common terms and phrases
Administrative Procedure Act agency amendment American Pharmaceutical April 24 Association of Retail attacks barbital barbiturates Benzedrine bill capsules CARROLL Congress contained correct Cosmetic Act counter counts court CREEVY CULLEN dangerous drugs dangerous to health determination Dexedrine dispensing doctor dosage Drug Administration Drug Manufacturers Drug Store DUNN effect efficacy epilepsy epileptic exemption fact Federal Food Federal Security Federal Security Agency filed Food and Drug guilty HARROP hearing hypothyroidism interest labeling LARRICK legislation Marmola medicines misbranded nolo contendere obesity objective definition opinion oral prescriptions over-the-counter packages patient Pharmaceutical Association pharmacist pharmacy phenobarbital physician Plea practice prescribed prescription drug prescription legend present law proposed Proprietary Association protection provisions public health question refill regulation retail druggist seconal section 502 Sekov Senator HUMPHREY Senator IVES Senator LEHMAN Senator NEELY sold statement tablets thyroid tion toxicity trading treatment United States attorney WALLER WARNACK Western Medical Corp
Popular passages
Page 77 - The study shall incorporate guidelines which are consistent with criteria provided in resolutions adopted by the Committee on Labor and Public Welfare of the United States Senate or the Committee on Education and Labor of the United States House of Representatives, or both.
Page 116 - ... 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 264 - 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 268 - If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.
Page 85 - ... (B) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug...
Page 246 - ... representations made or suggested by statement, word, design, device, sound, or any combination thereof, but also the extent to which the advertisement fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the commodity to which the advertisement relates under the conditions prescribed in said advertisement, or under such conditions as are customary or usual.
Page 11 - ... by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.
Page 150 - Nor does it mean that even as to matters not requiring expertise a court may displace the board's choice between two fairly conflicting views, even though the court would justifiably have made a different choice had the matter been before it de novo.
Page 151 - When an agency finds that justice so requires, it may postpone the effective date of action taken by it, pending judicial review. On such conditions as may be required and to the extent necessary to prevent irreparable injury...
Page 40 - The findings of fact by the Commissioner, unless substantially contrary to the weight of the evidence, shall be conclusive...