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 4
... deal with the very im- portant problems of when , under what circumstances , and under what safeguards prescription drugs can be sold and prescriptions for them . can be refilled . This matter is of great public - health significance ...
... deal with the very im- portant problems of when , under what circumstances , and under what safeguards prescription drugs can be sold and prescriptions for them . can be refilled . This matter is of great public - health significance ...
Page 5
... deals on page 570 with middle - ear inflammation , acute . I quote excerpts from his statement : The attack begins with pain in the ear . The pain may spread over the side of the head . * * * There are two great dangers from middle ...
... deals on page 570 with middle - ear inflammation , acute . I quote excerpts from his statement : The attack begins with pain in the ear . The pain may spread over the side of the head . * * * There are two great dangers from middle ...
Page 29
... deal of that going on today . The bill before you would require new drugs so restricted to pre- scription sale in their effective applications to be sold only upon pre- scription . When physicians write prescriptions for drugs that are ...
... deal of that going on today . The bill before you would require new drugs so restricted to pre- scription sale in their effective applications to be sold only upon pre- scription . When physicians write prescriptions for drugs that are ...
Page 30
... deal with barbiturates . We were content to let that problem of the barbiturates be considered separately by itself and to let the Congress decide what particular safeguards they would want to apply , if any , to deal with those types ...
... deal with barbiturates . We were content to let that problem of the barbiturates be considered separately by itself and to let the Congress decide what particular safeguards they would want to apply , if any , to deal with those types ...
Page 36
... deals with medicines which could ordinarily be sold over the counter anyway , but we do not think it is in the public ... deal with . Senator IVES . Then you can trace that type of operation directly to , we will say , this looseness in ...
... deals with medicines which could ordinarily be sold over the counter anyway , but we do not think it is in the public ... deal with . Senator IVES . Then you can trace that type of operation directly to , we will say , this looseness in ...
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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...