Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act: Drugs and devices, Edições 6661-6700;Edições 6961-7000

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Página 112 - 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...
Página 112 - 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.
Página 112 - G of this section unless its label bears (1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient...
Página 112 - If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein: Provided, That the method of packing may be modified with the consent of the Secretary.
Página 111 - SEC. 304 (a). Any article of food, drug, device, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce, or while held for sale after shipment in interstate commerce...
Página 114 - The liniment was misbranded by false claims on the bottle label and accompanying circulars which represented that the article was adequate and effective as a treatment for swollen joints, swollen glands, arthritis, neuritis, neuralgia, sinusitis, headache, bruises, sprains, minor burns, cramps, toothache, calluses, corns, and bunions. Disposition. — Default decree entered ; destroyed July 31, 1961.
Página 115 - ... a label containing the name and place of business of the manufacturer, packer or distributor, and an accurate statement of the quantity of the contents in terms of weight, measure or numerical count...
Página 112 - Section 403(e)(l) and (2) in that the article failed to bear a label containing the name and place of business of the manufacturer, packer, or distributor, and an accurate statement of the quantity of contents.
Página 112 - Required by an official compendium. (6) In the case of a drug which is not designated solely by a name recognized in an official compendium and which is fabricated from two or more ingredients, its label also bears a statement of the quantity or proportion of each active ingredient.
Página 113 - Individuals are taking the drug or drugs containing such a substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs in the course of his professional practice...

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