The Secretary is directed to promulgate regulations exempting from any labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.
21 U.S. Code § 353 - Exemptions and consideration for certain drugs, devices, and biological products
[1] So in original. No subpar. (B) has been enacted.
[2] So in original. The word “and” probably should appear.
[3] So in original. The semicolon probably should be a period.
[4] See References in Text note below.
[5] So in original. Probably should be followed by a period.
The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in subsec. (e)(4)(M)(ii), is Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, which is classified principally to chapter 13 (§ 801 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.
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 (g)(9)(C)(i), was repealed by Pub.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), Nov. 21, 1997, 111 Stat. 2325.
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 November 28, 1990.”
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 December 13, 2016)” after “October 26, 2002” in introductory provisions.
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 Oct. 26, 1951, amended subsec. (b) generally to protect the public from abuses in the sale of potent prescription drugs, and to relieve retail pharmacists and the public from unnecessary restrictions on the dispensation of drugs that are safe to use without supervision of a doctor.
Pub. L. 113–54, title II, § 204(c), Nov. 27, 2013, 127 Stat. 636, provided that:
Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.
Pub. L. 102–353, § 2(d), Aug. 26, 1992, 106 Stat. 941, provided that:
Pub. L. 100–293, § 8, Apr. 22, 1988, 102 Stat. 100, provided that:
Amendment by Pub. L. 91–601 effective Dec. 30, 1970, and regulations establishing special packaging standards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see section 8 of Pub. L. 91–601, set out as an Effective Date note under section 1471 of Title 15, Commerce and Trade.
Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.
Amendment by act Oct. 26, 1951, effective six months after Oct. 26, 1951, see section 3 of act Oct. 26, 1951, set out as a note under section 333 of this title.
Pub. L. 104–180, title VI, § 601, Aug. 6, 1996, 110 Stat. 1593, provided that:
Pub. L. 100–293, § 2, Apr. 22, 1988, 102 Stat. 95, provided that:
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.