The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in subsec. (e)(4)(M)(ii), is Pub. L. 91–513,
The Public Health Service Act, referred to in subsec. (g)(2)(A)(iv)(II), (3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.
Section 357 of this title, referred to in subsec. (g)(9)(C)(i), was repealed by Pub. L. 105–115, title I, § 125(b)(1),
In subsec. (b)(5), “sections 4721, 6001, and 6151 of title 26” and “section 4761 of title 26” substituted for “section 3220 of the Internal Revenue Code (26 U.S.C. 3220)” and “section 3238(b) of the Internal Revenue Code (26 U.S.C. 3238(b))”, respectively, on authority of section 7852(b) of Title 26, Internal Revenue Code.
2022—Subsec. (h). Pub. L. 117–328 added subsec. (h).
2016—Subsec. (g)(1). Pub. L. 114–255, § 3038(a)(4), added par. (1) and struck out former par. (1) which read as follows: “The Secretary shall in accordance with this subsection assign an agency center to regulate products that constitute a combination of a drug, device, or biological product. The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of—
“(A) a drug (other than a biological product), the agency center charged with premarket review of drugs shall have primary jurisdiction,
“(B) a device, the agency center charged with premarket review of devices shall have primary jurisdiction, or
“(C) a biological product, the agency center charged with premarket review of biological products shall have primary jurisdiction.”
Subsec. (g)(2). Pub. L. 114–255, § 3038(a)(4), added par. (2). Former par. (2) redesignated (7).
Subsec. (g)(3). Pub. L. 114–255, § 3038(a)(1), (4), added par. (3) and struck out former par. (3) which read as follows: “The Secretary shall promulgate regulations to implement market clearance procedures in accordance with paragraphs (1) and (2) not later than 1 year after
Subsec. (g)(4) to (6). Pub. L. 114–255, § 3038(a)(4), added pars. (4) to (6). Former pars. (4) and (5) redesignated (8) and (9), respectively.
Subsec. (g)(7). Pub. L. 114–255, § 3038(a)(2), redesignated par. (2) as (7).
Subsec. (g)(8). Pub. L. 114–255, § 3038(a)(3), redesignated par. (4) as (8).
Subsec. (g)(8)(C)(i). Pub. L. 114–255, § 3038(a)(5)(A)(i), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: “In carrying out this subsection, the Office shall ensure timely and effective premarket reviews by overseeing the timeliness of and coordinating reviews involving more than one agency center.”
Subsec. (g)(8)(C)(ii). Pub. L. 114–255, § 3038(a)(5)(A)(ii), inserted “and alignment” after “the timeliness” in two places.
Subsec. (g)(8)(C)(iii) to (vi). Pub. L. 114–255, § 3038(a)(5)(A)(iii), added cls. (iii) to (vi).
Subsec. (g)(8)(G). Pub. L. 114–255, § 3038(a)(5)(B)(i), inserted “(except with respect to clause (iv), beginning not later than one year after
Subsec. (g)(8)(G)(iv). Pub. L. 114–255, § 3038(a)(5)(B)(ii)–(iv), added cl. (iv).
Subsec. (g)(9). Pub. L. 114–255, § 3038(a)(3), redesignated par. (5) as (9).
Subsec. (g)(9)(C). Pub. L. 114–255, § 3038(a)(6)(A), substituted semicolon for comma at end of cl. (i), semicolon for “, and” at end of cl. (ii), and “; and” for period at end of cl. (iii), and added cl. (iv).
Subsec. (g)(9)(D). Pub. L. 114–255, § 3038(a)(6)(B), added subpar. (D).
2013—Subsec. (d)(4). Pub. L. 113–54, § 204(b), added par. (4).
Subsec. (e). Pub. L. 113–54, § 204(a)(1)–(4), added pars. (1) to (6) and struck out former pars. (1) to (3). Prior to amendment, pars. (1) to (3) set out certain disclosure and licensing requirements for wholesale distributors and defined “authorized distributors of record” and “wholesale distribution”.
2004—Subsec. (f)(1)(A)(ii). Pub. L. 108–282, § 102(b)(5)(F)(i), substituted “360b of this title, a conditionally-approved application under section 360ccc of this title, or an index listing under section 360ccc–1 of this title” for “360b of this title”.
Subsec. (f)(3). Pub. L. 108–282, § 102(b)(5)(F)(ii), substituted “section 360b, 360ccc, or 360ccc–1” for “section 360b”.
2002—Subsec. (g)(1). Pub. L. 107–250, § 204(1)(A), substituted “shall in accordance with this subsection assign an agency center” for “shall designate a component of the Food and Drug Administration” in first sentence of introductory provisions.
Subsec. (g)(1)(A) to (C). Pub. L. 107–250, § 204(1)(B), substituted “the agency center charged” for “the persons charged”.
Subsec. (g)(4). Pub. L. 107–250, § 204(3), added par. (4). Former par. (4) redesignated (5).
Subsec. (g)(5). Pub. L. 107–250, § 204(2), (4), redesignated par. (4) as (5), added subpar. (A), and redesignated former subpars. (A) and (B) as (B) and (C), respectively.
1997—Subsec. (b)(1)(A) to (C). Pub. L. 105–115, § 126(c)(1), redesignated subpars. (B) and (C) as (A) and (B), respectively, and struck out former subpar. (A), which read as follows: “is a habit-forming drug to which section 352(d) of this title applies; or”.
Subsec. (b)(3). Pub. L. 105–115, § 126(c)(2), struck out reference to section 352(d) of this title before “355”.
Subsec. (b)(4). Pub. L. 105–115, § 126(a), amended par. (4) generally. Prior to amendment, par. (4) read as follows: “A drug which is subject to paragraph (1) of this subsection shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement ‘Caution: Federal law prohibits dispensing without prescription’. A drug to which paragraph (1) of this subsection does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence.”
Subsec. (g)(4)(A). Pub. L. 105–115, § 123(e)(1), substituted “section 351(i)” for “section 351(a)” and “262(i)” for “262(a)”.
Subsec. (g)(4)(B)(iii). Pub. L. 105–115, § 123(e)(2), substituted “biologics license application under subsection (a)” for “product or establishment license under subsection (a) or (d)”.
1996—Subsec. (f)(1)(A). Pub. L. 104–250 inserted “, other than a veterinary feed directive drug intended for use in animal feed or an animal feed bearing or containing a veterinary feed directive drug,” after “other than man” in introductory provisions.
1992—Subsec. (d)(1). Pub. L. 102–353, § 4(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “Except as provided in paragraphs (2) and (3), no representative of a drug manufacturer or distributor may distribute any drug sample.”
Subsec. (d)(2). Pub. L. 102–353, § 4(2), substituted “authorized distributor of record” for “distributor” wherever appearing.
Subsec. (d)(3). Pub. L. 102–353, § 4(2), substituted “authorized distributor of record” for “distributor” and “authorized distributors of record” for “distributors” wherever appearing.
Subsec. (e)(1). Pub. L. 102–353, § 4(3), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “Each person who is engaged in the wholesale distribution of drugs subject to subsection (b) of this section and who is not an authorized distributor of record of such drugs shall provide to each wholesale distributor of such drugs a statement identifying each sale of the drug (including the date of the sale) before the sale to such wholesale distributor. Each manufacturer shall maintain at its corporate offices a current list of such authorized distributors.”
Subsec. (e)(2)(A). Pub. L. 102–353, § 2(a), (d), temporarily inserted “or has registered with the Secretary in accordance with paragraph (3)”. See Termination Date of 1992 Amendment note below.
Subsec. (e)(3). Pub. L. 102–353, § 2(b), (d), temporarily added par. (3). Former par. (3) redesignated (4). See Termination Date of 1992 Amendment note below.
Subsec. (e)(4). Pub. L. 102–353, § 4(4), inserted “and subsection (d) of this section” after “For the purposes of this subsection”.
Pub. L. 102–353, § 2(b), (d), temporarily redesignated par. (3) as (4). See Termination Date of 1992 Amendment note below.
Subsec. (f)(1)(B). Pub. L. 102–353, § 2(c), which directed the substitution of “an order” for “and order”, could not be executed because “and order” did not appear in subpar. (B).
Subsec. (g)(3). Pub. L. 102–300 substituted “clearance” for “approval”.
1991—Subsec. (c). Pub. L. 102–108, § 2(d)(3), redesignated subsec. (c), relating to veterinary prescription drugs, as (f). Former subsec. (f) redesignated (g).
Subsec. (c)(2), (3)(B)(v). Pub. L. 102–108, § 2(d)(1), made technical amendment to reference to subsection (b) of this section involving corresponding provision of original act.
Subsec. (d)(3)(E). Pub. L. 102–108, § 2(d)(2), made technical amendment to reference to subsection (c)(1) of this section involving corresponding provision of original act.
Subsec. (f). Pub. L. 102–108, § 2(d)(4), redesignated subsec. (f), relating to regulation of combination products, as (g).
Pub. L. 102–108, § 2(d)(3), redesignated subsec. (c), relating to veterinary prescription drugs, as (f).
Subsec. (g). Pub. L. 102–108, § 2(d)(4), redesignated subsec. (f), relating to regulation of combination products, as (g).
1990—Pub. L. 101–629, § 16(a)(1), substituted “Exemptions and consideration for certain drugs, devices, and biological products” for “Exemptions in case of drugs and devices” in section catchline.
Subsec. (f). Pub. L. 101–629, § 16(a)(2), added subsec. (f).
1988—Subsec. (c). Pub. L. 100–670 added subsec. (c) relating to veterinary prescription drugs.
Pub. L. 100–293, § 4, added subsec. (c) relating to sales restrictions.
Subsec. (d). Pub. L. 100–293, § 5, added subsec. (d).
Subsec. (e). Pub. L. 100–293, § 6, added subsec. (e).
1970—Subsec. (b)(2). Pub. L. 91–601 included exemption from packaging requirements of subsec. (p) of section 352 of this title.
1962—Subsec. (b)(1)(C). Pub. L. 87–781 substituted “approved” for “effective”.
1951—Subsec. (b). Act
Pub. L. 113–54, title II, § 204(c),
Amendment by Pub. L. 105–115 effective 90 days after
Pub. L. 102–353, § 2(d),
Pub. L. 100–293, § 8, “(a) Except as provided in subsection (b), this Act and the amendments made by this Act [amending this section and sections 331, 333, and 381 of this title and enacting provisions set out as notes under this section and section 301 of this title] shall take effect upon the expiration of 90 days after the date of the enactment of this Act [“(b) “(1) Section 503(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353(d)] (as added by section 5 of this Act) shall take effect upon the expiration of 180 days after the date of the enactment of this Act [“(2) The Secretary of Health and Human Services shall by regulation issue the guidelines required by section 503(e)(2)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353(e)(2)(B)] (as added by section 6 of this Act) not later than 180 days after the date of the enactment of this Act. Section 503(e)(2)(A) of such Act shall take effect upon the expiration of 2 years after the date such regulations are promulgated and take effect.”
Amendment by Pub. L. 91–601 effective
Amendment by Pub. L. 87–781 effective
Amendment by act
Pub. L. 104–180, title VI, § 601, “(a) Not later than 30 days after the date of enactment of this Act [“(b) Goals consistent with the proposed rule described in subsection (a) are the distribution of useful written information to 75 percent of individuals receiving new precriptions [sic] by the year 2000 and to 95 percent by the year 2006.“(c) The plan described in subsection (a) shall—“(1) identify the plan goals;“(2) assess the effectiveness of the current private-sector approaches used to provide oral and written prescription information to consumers;“(3) develop guidelines for providing effective oral and written prescription information consistent with the findings of any such assessment;“(4) contain elements necessary to ensure the transmittal of useful information to the consuming public, including being scientifically accurate, non-promotional in tone and content, sufficiently specific and comprehensive as to adequately inform consumers about the use of the product, and in an understandable, legible format that is readily comprehensible and not confusing to consumers expected to use the product.[;]“(5) develop a mechanism to assess periodically the quality of the oral and written prescription information and the frequency with which the information is provided to consumers; and“(6) provide for compliance with relevant State board regulations.“(d) The Secretary of the Department of Health and Human Services shall have no authority to implement the proposed rule described in subsection (a), or to develop any similar regulation, policy statement, or other guideline specifying a uniform content or format for written information voluntarily provided to consumers about prescription drugs if, (1) not later than 120 days after the date of enactment of this Act [“(e) Not later than
Pub. L. 100–293, § 2, “(1) American consumers cannot purchase prescription drugs with the certainty that the products are safe and effective.“(2) The integrity of the distribution system for prescription drugs is insufficient to prevent the introduction and eventual retail sale of substandard, ineffective, or even counterfeit drugs.“(3) The existence and operation of a wholesale submarket, commonly known as the ‘diversion market’, prevents effective control over or even routine knowledge of the true sources of prescription drugs in a significant number of cases.“(4) Large amounts of drugs are being reimported to the United States as American goods returned. These imports are a health and safety risk to American consumers because they may have become subpotent or adulterated during foreign handling and shipping.“(5) The ready market for prescription drug reimports has been the catalyst for a continuing series of frauds against American manufacturers and has provided the cover for the importation of foreign counterfeit drugs.“(6) The existing system of providing drug samples to physicians through manufacturer’s representatives has been abused for decades and has resulted in the sale to consumers of misbranded, expired, and adulterated pharmaceuticals.“(7) The bulk resale of below wholesale priced prescription drugs by health care entities, for ultimate sale at retail, helps fuel the diversion market and is an unfair form of competition to wholesalers and retailers that must pay otherwise prevailing market prices.“(8) The effect of these several practices and conditions is to create an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs will be sold to American consumers.”
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.