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 11
... Senator Humphrey introduced . Senator NEELY . What is the legend on the front page of the bill ? Mr. LARRICK ( reading ) : In the Senate of the United States , July 5 , legislative day , June 27 , 1951 . It states : Amendments in the ...
... Senator Humphrey introduced . Senator NEELY . What is the legend on the front page of the bill ? Mr. LARRICK ( reading ) : In the Senate of the United States , July 5 , legislative day , June 27 , 1951 . It states : Amendments in the ...
Page 12
... Senator HUMPHREY . That is correct . Did you explain to the committee that the provisions that were left were the prescription refill provisions ? Mr. LARRICK . I have not as yet , sir . Senator HUMPHREY . And the language deleted in ...
... Senator HUMPHREY . That is correct . Did you explain to the committee that the provisions that were left were the prescription refill provisions ? Mr. LARRICK . I have not as yet , sir . Senator HUMPHREY . And the language deleted in ...
Page 13
... Senator . We have to settle it now on a case - to - case basis under a very unsatisfactory regulation . Senator HUMPHREY . Is it not true to say that the present procedure is the procedure proposed in this law upside down ? Mr. LARRICK ...
... Senator . We have to settle it now on a case - to - case basis under a very unsatisfactory regulation . Senator HUMPHREY . Is it not true to say that the present procedure is the procedure proposed in this law upside down ? Mr. LARRICK ...
Page 14
... Senator HUMPHREY . In other words , where there was an honest difference of opinion as to the adequacy of the listing or the propriety of the listing , the manufacturer would have the right to come in and receive what we call a ...
... Senator HUMPHREY . In other words , where there was an honest difference of opinion as to the adequacy of the listing or the propriety of the listing , the manufacturer would have the right to come in and receive what we call a ...
Page 15
... 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 procedure would be different from the ...
... 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 procedure would be different from the ...
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Common terms and phrases
Administrative Procedure Act agency amendment American Pharmaceutical April 24 Association of Retail attacks barbital barbiturates believe Benzedrine bill CARROLL caution Congress correct Cosmetic Act counter counts court CREEVY CULLEN dangerous drugs determination Dexedrine dispensing doctor dosage Drug Administration Drug Manufacturers Drug Store DUNN effect efficacy epilepsy epileptic exemption fact Federal Food Federal Security Agency filed Food and Drug guilty HARROP hearing House committee interest labeling LARRICK legislation Marmola medicines misbranded narcotics nembutal nolo contendere objective definition opinion oral prescriptions over-the-counter over-the-counter drugs paragraph patient Pharmaceutical Association pharmacist pharmacy phenobarbital physician Plea practice prescribed prescription drug prescription legend prescription list present law proposed Proprietary Association protection provisions public health question refill regulation retail druggist scription seconal section 502 Sekov Senator HUMPHREY Senator IVES Senator LEHMAN Senator NEELY sold statement tablets thyroid tion toxicity trading treatment WALLER WARNACK Western Medical Corp
Popular passages
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 262 - 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 261 - 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 287 - ... (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 244 - ... 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 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 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 3 - ... 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 40 - The findings of fact by the Commissioner, unless substantially contrary to the weight of the evidence, shall be conclusive...
Page 244 - Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals...