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 8
... question whether barbiturates are habit - forming drugs Herman S. Waller , legal counsel , National Association of Retail Drug- gists : Memorandum to the members of the Committee on Labor and Public Welfare of the U. S. Senate re H. R. ...
... question whether barbiturates are habit - forming drugs Herman S. Waller , legal counsel , National Association of Retail Drug- gists : Memorandum to the members of the Committee on Labor and Public Welfare of the U. S. Senate re H. R. ...
Page 11
... question of whether the drug in question is safe and efficacious for use only after professional diagnosis by , or under the supervision of , a practitioner licensed by law to administer such drug . The Administrator shall thereupon ...
... question of whether the drug in question is safe and efficacious for use only after professional diagnosis by , or under the supervision of , a practitioner licensed by law to administer such drug . The Administrator shall thereupon ...
Page 11
... question - different manufacturers would come to different conclusions and the present confusion would be perpetu- ated . It is true that both the present law and the bill as it passed the House provide authority for the Food and Drug ...
... question - different manufacturers would come to different conclusions and the present confusion would be perpetu- ated . It is true that both the present law and the bill as it passed the House provide authority for the Food and Drug ...
Page 14
... question of whether or not that new drug is safe for over - the - counter sale or whether it has certain elements of danger in it so that only a physician could use it with safety . Now , we recognize that when new drugs come on the ...
... question of whether or not that new drug is safe for over - the - counter sale or whether it has certain elements of danger in it so that only a physician could use it with safety . Now , we recognize that when new drugs come on the ...
Page 15
... question of that sort has come up . Senator HUMPHREY . Will you differentiate between the procedure which you used in the case of the antihistamine drugs and the pro- cedure proposed in the bill ? Tell us how , under the bill , the ...
... question of that sort has come up . Senator HUMPHREY . Will you differentiate between the procedure which you used in the case of the antihistamine drugs and the pro- cedure proposed in the bill ? Tell us how , under the bill , the ...
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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...