218 



upon any drug or container or labeling thereof so as 

 to render such drug a counterfeit drug. 



(3) The doing of any act which causes a drug 

 to be a counterfeit drug, or the sale or dispensing, 

 or the holding for sale or dispensing, of a counter- 

 felt druK 



(J) The using by any person to his own advan- 

 tage, or revealing, other than to the Secretary or 

 oflBcers or employees of the Department, or to the 

 courts when relevant in any judicial proceeding 

 under this chapter, any information acquired under 

 authority of sections 344, 348, 355, 356, 357, 360, 

 360b, 360c, 360d, 360e, 360f, 360h, 360i, 360j, 374, 

 376, or 379 of this title concerning any method or 

 process which as a trade secret is entitled to pro- 

 tection. 



(k) The alteration, mutilation, destruction, ob- 

 literation, or removal of the whole or any part of 

 the labeling of. or the doing of any other act with 

 respect to. a food. drug, device, or cosmetic, if such 

 act Is done while such article is held for sale (whether 

 or not the first sale) after shipment in Interstate 

 commerce and results in such article being adulter- 

 ated or misbranded. 



(I) The using, on the labeling of any drug or 

 device or in any advertising relating to such drug 

 or device, of any representation or suggestion that 

 approval of an application with respect to such drug 

 or device is in effect under section 355, 360e, or 

 360j(g), as the case may be of this title, or that 

 such drug or device complies with the provisions of 

 such section. 



(m) The sale or offering for sale of colored oleo- 

 margarine or colored margarine, or the possession or 

 serving of colored oleomargarine or colored mar- 

 garine in violation of subsections (b) or (c) of sec- 

 tion 347 of this title. 



(n) The using, in labeUhg, advertising or other 

 sales promotion of any reference to any report or 

 analysis furnished in compliance with section 374 of 

 this title. 



(o) In the case of a prescription drug distributed 

 or offered for sale in interstate commerce, the failure 

 of the manufacturer, packer, or distributor thereof 

 to maintain for transmittal, or to transmit, to any 

 practitioner licensed by appUcable State law to 

 admmister such drug who makes written request 

 for information as to such drug, true and correct 

 copies of all printed matter which is required to be 

 Included in any package in which that drug is dis- 

 tributed or sold, or such other printed matter as is 

 approved by the Secretary. Nothing in this para- 

 graph shall be construed to exempt any person from 

 any labeling requirement imposed by or under other 

 provisions of this chapter. 



(p) The failure to register in accordance with 

 section 360 of this title, the failure to provide any 

 Information required by section 360(j) or 360k of 

 this title, or the failure to provide a notice required 

 by section 360(J) (2) of this title. 



(q) (1) The failure or refusal to (A) comply with 

 any requirement prescribed under section 360h or 

 360J (g), or (B) furnish any notification or other 

 material or information required by or imder 

 section 3601 or 360j (g) . 



(2) With respect to any device, the submission of 

 any report that is required by or under this Act that 

 Is false or misleading in any material respect. 



(r) The movement of a device in violation of an 

 order under section 334(g) or the removal or alter- 

 ation of any mark or label required by the order to 

 Identify the device as detained. (As amended 

 Aug. 16, 1972. Pub. L. 92-387, § 4(6). 86 Stat. 562; 

 Pub. L. 94-295. §§ 3(b) . 4(b) (1) , 7(b) . May 28. 1976, 

 90Stat. 576,580. 582.) 



Amendments 



1976 — Subsec. (q). Pub. L. 04-^296, 5 3(b), added 

 Subsec. (q) . 



Subsec. (r) . Pub. L. 94-296, { 7(b) , added Subsec. (r) . 



1972 — Subsec. (p). Pub. L. 92-387 added failure to pro- 

 vide Information required by section 360(j) of this title, 

 and failure to provide notice required by section 

 380(J)(2) of this title as prohibited acts. 



1970 — Subsec. (q). Pub. L. 91-513 struck out subsec. 

 (q) which set out penalties for Illegal manufacture, sale, 

 disposition, possession and other traffic In stimulant and 

 depressant drugs. See section 801 et seq. of this title. 



1968 — Subsec. (e). Pub. L. 90-399, 5 103(1), Inserted 

 reference to section 360b (J) , (J) , and (m) of this title. 



Subsec. (J). Pub. L. 90-399, ( 103(2), Inserted reference 

 to section 360b of this title. 



Subsec. (q). Pub. L. 90-639 divided clause (3). which 

 had formerly referred simply to possession In violation of 

 section 360a(c) of this title. Into parts (A) and (B) which 

 refer, respectively, to possession In violation of section 

 360a(c)(l) of this title and possession In violation of 

 section 360a(c) (2) of this title. 



1966 — Subsec. (1) Pub L. 89-74. 5 9(c). designated ex- 

 isting provisions as subpar. (1) and added subpars. (2) 

 and (3). 



1962— Subsec. (e). Pub. L. 87-781, t| 103(c), 106(c). 

 prohibited the failure to establish or maintain any rec- 

 ord, or make any report, required under sections 355 (1) 

 or (J) and 507 (d) or (g) of this title, or the refusal to 

 permit access to, or verification or copying of, any such 

 required record. 



Subsec. (1). Pub. L. 87-781. 5 104(e)(1). Inserted "ap- 

 proval of preceding 'an application", and substituted 

 "In effect" for "effective." 



Subsec. (o). Pub. L. 87-781, f 114(a), added subsec. 



Subsec. (p). Pub. L. 87-781. ! 304, added subsec. (p). 



I960— Subsec. (1) . Pub. L. 86-618. 5 105(a) . eliminated 

 references to sections 346(b) and 364 of this title and 

 inserted a reference to section 376 of this title. 



Subsec. (]). Pub. L. 86-618. 5 104, Inserted a reference 

 to section 376 of this title. 



1958— Subsec. (J). Pub. L. 85-929, Inserted "348" fol- 

 lowing "344". ^ , , 



1953— Subsec. (n) . Act Aug. 7. 1953, added subsec. (n) . 



1950— Subsec. (m). Act Mar. 16. 1950, added subsec. 



(m). . . 



1948— Subsec. (k). Act June 24, 1948, Inserted 

 "(whether or not the first sale)" so as to make It clear 

 that this subsection Is not limited to the case where the 

 act occurs while the article Is held for the first sale 

 after Interstate shipment, and extended coverage of 

 subsection to acts which result In adulteration. 



1947— Subsec. (]). Act Mar. 10, 1947, Inserted "366, 

 357" following "344, 355". 



l945_Subsec. (I). Act July 6, 1945. Inserted 367 fol- 

 lowing "356". ^ , 



1941— Subsec. (I) . Act Dec. 22, 1941. Inserted reference 

 to section 366. 



