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
U.S. Government Printing Office, 1951 - Drugs - 295 pages
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action adequate agency amendment American appeal Association authority believe bill cause committee Congress consider contained correct Cosmetic Act costs counts court CREEVY dangerous definition determination directions dispensed District doctor dosage Drug Administration effect efficacy evidence experience fact Federal filed fine follows Food and Drug further give given Government hearing House hypothyroidism included individual interest labeling LARRICK legend legislation manufacturer matter means measure medicine misbranded necessary objective opinion passed patient person pharmaceutical pharmacist physician Plea practice prescribed prescription prescription drug present procedure proposed protection provisions question reason recommended record reduced referred refill regulation Representatives respect responsibility restricted result retail druggists safe Senator HUMPHREY Senator LEHMAN sold standard statement tablets taken thyroid tion trading treatment United WALLER written
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 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...