42 U.S.C. 262: Regulation of biological products

2022

• Pub. L. 117–328, §3209(b), amended item (bb) generally. Prior to amendment, item (bb) read as follows: "animal studies (including the assessment of toxicity); and". (Consolidated Appropriations Act, 2023) Law text · (k)
• Pub. L. 117–328, §3206(2), substituted "taken, and the term 'first interchangeable biosimilar biological product' means any interchangeable biosimilar biological product that is approved on the first day on which such a product is approved as interchangeable with the reference produ… (Consolidated Appropriations Act, 2023) Law text · (k)
• Pub. L. 117–328, §3206(1), substituted "The Secretary shall not make approval as an interchangeable biological product effective with respect to" for "Upon review of" and "that relies on" for "relying on" and struck out "the Secretary shall not make a determination under paragraph (4) that the seco… (Consolidated Appropriations Act, 2023) Law text · (k)

2020

• Pub. L. 116–260, §322, added subcl. (III). (Consolidated Appropriations Act, 2021) Law text · (k)
• Pub. L. 116–260, §325(a), added par. (9). (Consolidated Appropriations Act, 2021) Law text · (k)

2019

• Pub. L. 116–94, §605, struck out "(except any chemically synthesized polypeptide)" after "protein". (Further Consolidated Appropriations Act, 2020) Law text · (i)
• Pub. L. 116–94, §606, added subpar. (D). (Further Consolidated Appropriations Act, 2020) Law text · (k)

2017

• Pub. L. 115–52 substituted "section 505A(d)(4)" for "section 505A(d)(3)". (FDA Reauthorization Act of 2017) Law text · (m)

2016

• Pub. L. 114–255 added subpar. (E). (21st Century Cures Act) Law text · (a)

2015

• Pub. L. 114–89 added subsec. (n). (Improving Regulatory Transparency for New Medical Therapies Act) Law text · (n)

2012

• Pub. L. 112–144 substituted "(f), (h), (i), (j), (k), (l), (n), and (p)" for "(f), (i), (j), (k), (l), (p), and (q)". (Food and Drug Administration Safety and Innovation Act) Law text · (m)

2010

• Pub. L. 111–148, §7002(a)(1), inserted "under this subsection or subsection (k)" after "biologics license". (Patient Protection and Affordable Care Act) Law text · (a)
• Pub. L. 111–148, §7002(b), substituted "In this section:" for "In this section,", designated remainder of existing provisions as par. (1), substituted "The term" for "the term", inserted "protein (except any chemically synthesized polypeptide)," after "allergenic product,", and added p… (Patient Protection and Affordable Care Act) Law text · (i)
• Pub. L. 111–148, §7002(a)(2), added subsecs. (k) and (l). (Patient Protection and Affordable Care Act) Law text · (k), (l)
• Pub. L. 111–148, §7002(g)(1), added subsec. (m). (Patient Protection and Affordable Care Act) Law text · (m)

2007

• Pub. L. 110–85, §901(c)(1), added subpar. (D). (Food and Drug Administration Amendments Act of 2007) Law text · (a)
• Pub. L. 110–85, §901(c)(2), inserted ", including the requirements under sections 505(o), 505(p), and 505–1 of such Act," after "and Cosmetic Act". (Food and Drug Administration Amendments Act of 2007) Law text · (j)

2003

• Pub. L. 108–155 added subpar. (B) and redesignated former subpar. (B) as (C). (Pediatric Research Equity Act of 2003) Law text · (a), (C)

1997

• Pub. L. 105–115, §123(a)(1), amended subsec. (a) generally. Prior to amendment, subsec. (a) related to intrastate and interstate traffic in biological products and suspension or revocation of licenses as affecting prior sales. (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §123(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) read as follows: "No person shall falsely label or mark any package or container of any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other p… (Food and Drug Administration Modernization Act of 1997) Law text · (b)
• Pub. L. 105–115, §123(c), substituted "biological product." for "virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product aforesaid for sale, barter, or exchange in the District of Columbia, or to be sent, carried, or brought f… (Food and Drug Administration Modernization Act of 1997) Law text · (c)
• Pub. L. 105–115, §123(a)(2), designated par. (2) as subsec. (d), redesignated subpars. (A) and (B) of par. (2) as pars. (1) and (2), respectively, in par. (2), substituted "Any violation of paragraph (1)" for "Any violation of subparagraph (A)" and substituted "this paragraph" for "thi… (Food and Drug Administration Modernization Act of 1997) Law text · (d)
• Pub. L. 105–115, §123(d), added subsec. (i). (Food and Drug Administration Modernization Act of 1997) Law text · (i)
• Pub. L. 105–115, §123(g), added subsec. (j). (Food and Drug Administration Modernization Act of 1997) Law text · (j)

1996

• Pub. L. 104–134, §2104, amended subsec. (h) generally, revising and restating former provisions, which also related to exportation of partially processed biological products. (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1996.) Law text · (h)
• Pub. L. 104–134, §2102(d)(2), substituted "in a country listed under section 802(b)(1)" for "in a country listed under section 802(b)(A)" and "to a country listed under section 802(b)(1)" for "to a country listed under section 802(b)(4)". (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1996.) Law text · (h)

1992

• Pub. L. 102–300, which directed substitution of "Health and Human Services" for "Health, Education, and Welfare", could not be executed because the words "Health, Education, and Welfare" did not appear in original statutory text. Previously, references to Department and Secretary of He… · (c)

1986

• Pub. L. 99–660, §315, designated existing provisions as par. (1) and added par. (2). · (d)
• Pub. L. 99–660, §105(a), added subsec. (h). · (h)

1970

• Pub. L. 91–515 inserted "vaccine, blood, blood component or derivative, allergenic product," after "antitoxin" wherever appearing. · (a), (b), (c)

1958

• Pub. L. 85–881 struck out "made jointly by the Surgeon General, the Surgeon General of the Army, and the Surgeon General of the Navy, and approved by the Secretary" after "regulations" in first sentence. · (d)