21 U.S.C. 353: Exemptions and consideration for certain drugs, devices, and biological products

2022

• Pub. L. 117–328 added subsec. (h). (Consolidated Appropriations Act, 2023) Law text · (h)

2016

• 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 Secreta… (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3038(a)(4), added par. (2). Former par. (2) redesignated (7). (21st Century Cures Act) Law text · (g)
• 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." (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3038(a)(4), added pars. (4) to (6). Former pars. (4) and (5) redesignated (8) and (9), respectively. (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3038(a)(2), redesignated par. (2) as (7). (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3038(a)(3), redesignated par. (4) as (8). (21st Century Cures Act) Law text · (g)
• 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 … (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3038(a)(5)(A)(ii), inserted "and alignment" after "the timeliness" in two places. (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3038(a)(5)(A)(iii), added cls. (iii) to (vi). (21st Century Cures Act) Law text · (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. (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3038(a)(5)(B)(ii)–(iv), added cl. (iv). (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3038(a)(3), redesignated par. (5) as (9). (21st Century Cures Act) Law text · (g)
• 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). (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3038(a)(6)(B), added subpar. (D). (21st Century Cures Act) Law text · (g)

2013

• Pub. L. 113–54, §204(b), added par. (4). Law text · (d)
• 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 distributi… Law text · (e)

2004

• 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". Law text · (f)
• Pub. L. 108–282, §102(b)(5)(F)(ii), substituted "section 360b, 360ccc, or 360ccc–1" for "section 360b". Law text · (f)

2002

• 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. (Medical Device User Fee and Modernization Act of 2002) Law text · (g)
• Pub. L. 107–250, §204(1)(B), substituted "the agency center charged" for "the persons charged". (Medical Device User Fee and Modernization Act of 2002) Law text · (g)
• Pub. L. 107–250, §204(3), added par. (4). Former par. (4) redesignated (5). (Medical Device User Fee and Modernization Act of 2002) Law text · (g)
• 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. (Medical Device User Fee and Modernization Act of 2002) Law text · (g)

1997

• 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". (Food and Drug Administration Modernization Act of 1997) Law text · (b)
• Pub. L. 105–115, §126(c)(2), struck out reference to section 352(d) of this title before "355". (Food and Drug Administration Modernization Act of 1997) Law text · (b)
• 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: Federa… (Food and Drug Administration Modernization Act of 1997) Law text · (b)
• Pub. L. 105–115, §123(e)(1), substituted "section 351(i)" for "section 351(a)" and "262(i)" for "262(a)". (Food and Drug Administration Modernization Act of 1997) Law text · (g)
• Pub. L. 105–115, §123(e)(2), substituted "biologics license application under subsection (a)" for "product or establishment license under subsection (a) or (d)". (Food and Drug Administration Modernization Act of 1997) Law text · (g)

1996

• 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. Law text · (f)

1992

• 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." · (d)
• Pub. L. 102–353, §4(2), substituted "authorized distributor of record" for "distributor" wherever appearing. · (d)
• Pub. L. 102–353, §4(2), substituted "authorized distributor of record" for "distributor" and "authorized distributors of record" for "distributors" wherever appearing. · (d)
• 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 provi… · (e)
• 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. · (e)
• Pub. L. 102–353, §2(b), (d), temporarily added par. (3). Former par. (3) redesignated (4). See Termination Date of 1992 Amendment note below. · (e)
• Pub. L. 102–353, §4(4), inserted "and subsection (d) of this section" after "For the purposes of this subsection". · (e)
• Pub. L. 102–353, §2(b), (d), temporarily redesignated par. (3) as (4). See Termination Date of 1992 Amendment note below. · (e)
• 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). · (f)
• Pub. L. 102–300 substituted "clearance" for "approval". · (g)

1991

• Pub. L. 102–108, §2(d)(3), redesignated subsec. (c), relating to veterinary prescription drugs, as (f). Former subsec. (f) redesignated (g). · (c)
• Pub. L. 102–108, §2(d)(1), made technical amendment to reference to subsection (b) of this section involving corresponding provision of original act. · (c), (3)
• 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. · (d)
• Pub. L. 102–108, §2(d)(4), redesignated subsec. (f), relating to regulation of combination products, as (g). · (f)
• Pub. L. 102–108, §2(d)(3), redesignated subsec. (c), relating to veterinary prescription drugs, as (f). · (f)
• Pub. L. 102–108, §2(d)(4), redesignated subsec. (f), relating to regulation of combination products, as (g). · (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.
• Pub. L. 101–629, §16(a)(2), added subsec. (f). · (f)

1988

• Pub. L. 100–670 added subsec. (c) relating to veterinary prescription drugs. · (c)
• Pub. L. 100–293, §4, added subsec. (c) relating to sales restrictions. · (c)
• Pub. L. 100–293, §5, added subsec. (d). · (d)
• Pub. L. 100–293, §6, added subsec. (e). · (e)

1970

• Pub. L. 91–601 included exemption from packaging requirements of subsec. (p) of section 352 of this title. · (b)

1962

• Pub. L. 87–781 substituted "approved" for "effective". · (b)