Page:United States Statutes at Large Volume 52.djvu/1082

 52 STAT.] 75TH CONG. , 3 D SESS.-CH. 675-JUNE 25, 1938 1041 (g) The term "drug" means (1) articles recognized in the official "Drug." United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supple- ment to any of them; and (2) articles intended for use in the diag- nosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other ani- mals; and (4) articles intended for use as a component of any article specified in clause (1), (2), or (3); but does not include devices or their components, parts, or accessories. (h) The term "device" (except when used in paragraph (n) of "Device"; excep- this section and in sections 301 (i), 403 (f), 502 (c), and 602 (c)) ot, pp. 1042, 1047, means instruments, apparatus, and contrivances, including their com- 1050,1054 ponents, parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (2) to affect the structure or any function of the body of man or other animals. (i) The term "cosmetic" means (1) articles intended to be rubbed, "cosmetic." poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beau- tifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap. (j) The term "official compendium" means the official United States "fficial compendi. Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United u. States, official National Formulary, or any supplement to any of them. (k) The term "label" means a display of written, printed, or "Label." graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be con- sidered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. (1) The term "immediate container" does not include package taImmediate con- liners. (m) The term "labeling" means all labels and other written, "Labeling." printed, or graphic matter (1) upon any article or any of its con- tainers or wrappers, or (2) accoml)anying such article. (n) If an article is alleged to be mnisbranlded because the labeling Dotermination as to then . in ' im n1 whethe 1V lbl is n ii wihether article is mis- is misleading, then in determining whether the labeling is misleading brandedbecauselabel- ing misleading. there shall be taken into account (among other things) not only rep- isledi resentations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling 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 article to which the labeling relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual. (o) The representation of a drug, in its labeling, as an antiseptic Drugrepresented as shall be considered to be a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antisep- tic for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body. (p) The term "new drug" means- Term "new drug" (1) Any drug the composition of which is such that such drug construed. is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe 36525°-3s

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