21 U.S.C. 360b: New animal drugs

2021

• Pub. L. 117–9 substituted "active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))" for "active ingredient (including any ester or salt of the active ingredient)" in cls. (i), (ii), and (v). Law text · (c)

2018

• Pub. L. 115–234 added par. (4). Law text · (b)

2016

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

2015

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

2008

• Pub. L. 110–316 added par. (3). Law text · (l)

2004

• Pub. L. 108–282, §102(b)(5)(I), added pars. (1) and (2) and struck out former pars. (1) and (2) which deemed as unsafe new animal drugs and animal feed bearing or containing a new animal drug which did not have in effect certain approvals. Law text · (a), (2)
• Pub. L. 108–282, §102(b)(5)(J), substituted "under paragraph (1), section 360ccc of this title, or a request for an investigational exemption under subsection (j)" for "under paragraph (1) or a request for an investigational exemption under subsection (j)". Law text · (b)
• Pub. L. 108–282, §102(b)(2), substituted "(other than bioequivalence studies or residue depletion studies, except residue depletion studies for minor uses or minor species)" for "(other than bioequivalence or residue studies)". Law text · (c), (iii), (v)
• Pub. L. 108–282, §102(b)(5)(K), substituted "have previously been separately approved pursuant to an application submitted under subsection (b)(1)" for "have previously been separately approved" in introductory provisions. Law text · (d)
• Pub. L. 108–282, §102(b)(3), added par. (5). Law text · (d)
• Pub. L. 108–282, §102(b)(5)(L), substituted "subsection (d), (e), or (m), or section 360ccc(c), (d), or (e) of this title" for "subsection (d), (e), or (m)". Law text · (f)
• Pub. L. 108–282, §102(b)(5)(M), substituted "this section, or section 360ccc of this title" for "this section". Law text · (g)
• Pub. L. 108–282, §102(b)(5)(N), substituted "subsection (b) or section 360ccc of this title" for "subsection (b)" and inserted "or upon failure to renew a conditional approval under section 360ccc of this title" after "or upon its suspension". Law text · (i)
• Pub. L. 108–282, §102(b)(5)(O), substituted "subsection (b) or section 360ccc of this title" for "subsection (b)". Law text · (l)
• Pub. L. 108–282, §102(b)(5)(P), substituted "applicable regulations published pursuant to subsection (i) or for indexed new animal drugs in accordance with the index listing published pursuant to section 360ccc–1(e)(2) of this title and the labeling requirements set forth in sect… Law text · (m)
• Pub. L. 108–282, §102(b)(5)(Q), inserted "or an index listing pursuant to section 360ccc–1(e) of this title" after "subsection (i)" in subpar. (C) and concluding provisions. Law text · (m)
• Pub. L. 108–282, §102(b)(5)(R), (S), substituted "subsection (b)(1) or section 360ccc(a) of this title" for "subsection (b)(1)". Law text · (p), (2)

1999

• Pub. L. 106–113 substituted "United States Patent and Trademark Office" for "Patent and Trademark Office of the Department of Commerce". (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2000) Law text · (o)

1998

• Pub. L. 105–277 inserted before semicolon ", except that for purposes of this clause, antibacterial ingredient or animal drug does not include the ionophore or arsenical classes of animal drugs". (Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 1999) Law text · (d)

1997

• Pub. L. 105–115 added par. (4). (Food and Drug Administration Modernization Act of 1997) Law text · (c)

1996

• Pub. L. 104–250, §6(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of section 351(a)(5) and section 342(a)(2)(D) of this title … Law text · (a)
• Pub. L. 104–250, §6(a), amended par. (2) generally. Prior to amendment, par. (2) read as follows: "An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed, be deemed unsafe for the purposes of section 351(a… Law text · (a)
• Pub. L. 104–250, §4, added par. (6). Law text · (a)
• Pub. L. 104–250, §2(d), added par. (3). Law text · (b)
• Pub. L. 104–250, §2(b)(1), substituted "substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or," for "reports of new clinical or field investigations (other than bioequivalence or residue studies) and," and "required for the ap… Law text · (c), (iii)
• Pub. L. 104–250, §2(b)(2), substituted "clause (iv)" for "subparagraph (B)(iv)" in two places, "substantial evidence of the effectiveness of the drug involved, any studies of animal safety," for "reports of clinical or field investigations" and "required for the new approval" … Law text · (c)
• Pub. L. 104–250, §3, amended subpar. (F) generally. Prior to amendment, subpar. (F) read as follows: "upon the basis of the information submitted to him as part of the application or any other information before him with respect to such drug, the tolerance limitation proposed, if… Law text · (d)
• Pub. L. 104–250, §2(a), amended par. (3) generally. Prior to amendment, par. (3) read as follows: "As used in this subsection and subsection (e) of this section, the term 'substantial evidence' means evidence consisting of adequate and well-controlled investigations, including field… Law text · (d)
• Pub. L. 104–250, §2(c), added par. (4). Law text · (d)
• Pub. L. 104–250, §5(c), inserted "and any requirement that an animal feed bearing or containing the new animal drug be limited to use under the professional supervision of a licensed veterinarian" after "(including special labeling requirements". Law text · (i)
• Pub. L. 104–250, §6(b), amended subsec. (m) generally, substituting provisions relating to application for feed mill licenses, including approval, refusal, revocation, and suspension of such licenses, and provisions for record and reporting requirements for, as well as exemption from, … Law text · (m)

1994

• Pub. L. 103–396, §2(a), added pars. (4) and (5). · (a), (5)
• Pub. L. 103–396, §2(b)(2), inserted before semicolon at end "or the condition of use authorized under subsection (a)(4)(A)". · (e)
• Pub. L. 103–396, §2(b)(3), substituted "relating to experience, including experience with uses authorized under subsection (a)(4)(A)," for "relating to experience". · (l)

1993

• Pub. L. 103–80, §3(r)(1), inserted "in" after "except as provided". · (c)
• Pub. L. 103–80, §3(r)(2), substituted "subparagraph (D)(iii)" for "subparagraph (C)(iii)". · (c)
• Pub. L. 103–80, §3(r)(3), substituted "subclauses" for "subclause" after "bioequivalency information described in" in concluding provisions. · (c)
• Pub. L. 103–80, §3(r)(4), substituted "subparagraphs (A) through (I)" for "subparagraphs (A) through (G)" in concluding provisions. · (d)
• Pub. L. 103–80, §3(r)(5), substituted "section 321(v) of this title" for "section 321(w) of this title" in subpars. (B)(ii)(II) and (C)(ii)(I) and substituted "through (I)" for "through (H)" in concluding provisions. · (n)

1991

• Pub. L. 102–108 substituted "(I)" for "(H)". · (e)

1988

• Pub. L. 100–670, §107(a)(2), struck out subpar. (C) which read as follows: "in the case of a new animal drug subject to subsection (n) of this section and not exempted therefrom by regulations it is from a batch with respect to which a certificate or release issued pursuant to su… · (a)
• Pub. L. 100–670, §§101(a), 102(a), designated existing provisions as par. (1), redesignated cls. (1) to (8) as cls. (A) to (H), respectively, added par. (2), and inserted provisions at end of par. (1) which require applicant to file with application, patent number and expiration date o… · (b)
• Pub. L. 100–670, §§101(c), 102(b)(1), designated existing provisions as par. (1), redesignated cls. (1) and (2) as cls. (A) and (B), respectively, and added pars. (2) and (3). · (c)
• Pub. L. 100–670, §102(b)(3), substituted "(G)" for "(H)" in last sentence. · (d)
• Pub. L. 100–670, §102(b)(2), added subpar. (G) and redesignated former subpars. (G) and (H) as (H) and (I), respectively. · (d)
• Pub. L. 100–670, §102(b)(4), added subpar. (D) and redesignated former subpars. (D) and (E) as (E) and (F), respectively. · (e)
• Pub. L. 100–670, §101(b), added subsecs. (n) and (o) and struck out former subsec. (n) which related to certification of new drugs containing penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, and release prior to certification. · (n), (o)
• Pub. L. 100–670, §104, added subsec. (p). · (p)