Section 342(a)(2) of this title, referred to in subsec. (a)(6), was amended by Pub. L. 104–170, title IV, § 404,
The Controlled Substances Act, referred to in subsec. (q)(1), is title II of Pub. L. 91–513,
2021—Subsec. (c)(2)(F). 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).
2018—Subsec. (b)(4). Pub. L. 115–234 added par. (4).
2016—Subsec. (a)(1)(D). Pub. L. 114–255 added subpar. (D).
2015—Subsec. (q). Pub. L. 114–89 added subsec. (q).
2008—Subsec. (l)(3). Pub. L. 110–316 added par. (3).
2004—Subsec. (a)(1), (2). 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.
Subsec. (b)(3). 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)”.
Subsec. (c)(2)(F)(ii), (iii), (v). 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)”.
Subsec. (d)(4). 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.
Subsec. (d)(5). Pub. L. 108–282, § 102(b)(3), added par. (5).
Subsec. (f). 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)”.
Subsec. (g). Pub. L. 108–282, § 102(b)(5)(M), substituted “this section, or section 360ccc of this title” for “this section”.
Subsec. (i). 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”.
Subsec. (l)(1). Pub. L. 108–282, § 102(b)(5)(O), substituted “subsection (b) or section 360ccc of this title” for “subsection (b)”.
Subsec. (m)(1)(C). 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 section 360ccc–1(h) of this title” for “applicable regulations published pursuant to subsection (i)”.
Subsec. (m)(3). 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.
Subsec. (p)(1), (2)(A). Pub. L. 108–282, § 102(b)(5)(R), (S), substituted “subsection (b)(1) or section 360ccc(a) of this title” for “subsection (b)(1)”.
1999—Subsec. (o). Pub. L. 106–113 substituted “United States Patent and Trademark Office” for “Patent and Trademark Office of the Department of Commerce”.
1998—Subsec. (d)(4)(D)(iii). 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”.
1997—Subsec. (c)(4). Pub. L. 105–115 added par. (4).
1996—Subsec. (a)(1). 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 unless—
“(A) there is in effect an approval of an application filed pursuant to subsection (b) of this section with respect to such use or intended use of such drug, and
“(B) such drug, its labeling, and such use conform to such approved application.
A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed, such consignee—
“(i) is the holder of an approved application under subsection (m) of this section; or
“(ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of an approved application under subsection (m) of this section.”
Subsec. (a)(2). 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)(6) of this title unless—
“(A) there is in effect an approval of an application filed pursuant to subsection (b) of this section with respect to such drugs, as used in such animal feed,
“(B) there is in effect an approval of an application pursuant to subsection (m)(1) of this section with respect to such animal feed, and
“(C) such animal feed, its labeling, and such use conform to the conditions and indications of use published pursuant to subsection (i) of this section and to the application with respect thereto approved under subsection (m) of this section.”
Subsec. (a)(6). Pub. L. 104–250, § 4, added par. (6).
Subsec. (b)(3). Pub. L. 104–250, § 2(d), added par. (3).
Subsec. (c)(2)(F)(ii), (iii). 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 approval” for “essential to the approval”.
Subsec. (c)(2)(F)(v). 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” for “essential to the new approval”.
Subsec. (d)(1)(F). 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 any, exceeds that reasonably required to accomplish the physical or other technical effect for which the drug is intended;”.
Subsec. (d)(3). 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 investigation, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.”
Subsec. (d)(4). Pub. L. 104–250, § 2(c), added par. (4).
Subsec. (i). 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”.
Subsec. (m). 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, such licenses, for provisions relating to application for uses of animal feed containing new animal drug, including required contents, approval, refusal, and withdrawal of approval or suspension of such usage applications, and provisions for record and reporting requirements of such usage applications.
1994—Subsec. (a)(4), (5). Pub. L. 103–396, § 2(a), added pars. (4) and (5).
Subsec. (e)(1)(A). Pub. L. 103–396, § 2(b)(2), inserted before semicolon at end “or the condition of use authorized under subsection (a)(4)(A)”.
Subsec. (l)(1). 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”.
1993—Subsec. (c)(2)(A)(ii). Pub. L. 103–80, § 3(r)(1), inserted “in” after “except as provided”.
Subsec. (c)(2)(F)(i). Pub. L. 103–80, § 3(r)(2), substituted “subparagraph (D)(iii)” for “subparagraph (C)(iii)”.
Subsec. (c)(2)(H)(ii). Pub. L. 103–80, § 3(r)(3), substituted “subclauses” for “subclause” after “bioequivalency information described in” in concluding provisions.
Subsec. (d)(1). Pub. L. 103–80, § 3(r)(4), substituted “subparagraphs (A) through (I)” for “subparagraphs (A) through (G)” in concluding provisions.
Subsec. (n)(1). 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.
1991—Subsec. (e)(1)(B). Pub. L. 102–108 substituted “(I)” for “(H)”.
1988—Subsec. (a)(1)(C). 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 subsection (n) of this section is in effect with respect to such drug.”
Subsec. (b). 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 of any patent which claims new animal drug, to amend application to include such information if patent which claims such drug or method of using such drug is issued after filing date but before approval of application, and to publish such information upon approval.
Subsec. (c). 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).
Subsec. (d)(1). Pub. L. 100–670, § 102(b)(3), substituted “(G)” for “(H)” in last sentence.
Subsec. (d)(1)(G) to (I). Pub. L. 100–670, § 102(b)(2), added subpar. (G) and redesignated former subpars. (G) and (H) as (H) and (I), respectively.
Subsec. (e)(1)(D) to (F). Pub. L. 100–670, § 102(b)(4), added subpar. (D) and redesignated former subpars. (D) and (E) as (E) and (F), respectively.
Subsecs. (n), (o). 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.
Subsec. (p). Pub. L. 100–670, § 104, added subsec. (p).
Amendment by Pub. L. 106–113 effective 4 months after
Amendment by Pub. L. 105–115 effective 90 days after
Pub. L. 103–396, § 2(d),
Pub. L. 100–670, title I, § 108,
Pub. L. 90–399, § 108, “(a) Except as otherwise provided in this section, the amendments made by the foregoing sections [see Short Title of 1968 Amendment note set out under section 301 of this title] shall take effect on the first day of the thirteenth calendar month which begins after the date of enactment of this Act [“(b)(1) As used in this subsection, the term ‘effective date’ means the effective date specified in subsection (a) of this section; the term ‘basic Act’ means the Federal Food, Drug, and Cosmetic Act [this chapter]; and other terms used both in this section and the basic Act shall have the same meaning as they have, or had, at the time referred to in the context, under the basic Act.“(2) Any approval, prior to the effective date, of a new animal drug or of an animal feed bearing or containing a new animal drug, whether granted by approval of a new-drug application, master file, antibiotic regulation, or food additive regulations, shall continue in effect, and shall be subject to change in accordance with the provisions of the basic Act as amended by this Act [see Short Title of 1968 Amendment note set out under section 301 of this title].“(3) In the case of any drug (other than a drug subject to section 512(n) of the basic Act as amended by this Act) [subsection (n) of this section] intended for use in animals other than man which, on “(4) Regulations providing for fees (and advance deposits to cover fees) which on the day preceding the effective date applicable under subsection (a) of this section were in effect pursuant to section 507 of the basic Act [section 357 of this title] shall, except as the Secretary may otherwise prescribe, be deemed to apply also under section 512(n) of the basic Act [subsection (n) of this section], and appropriations of fees (and of advance deposits to cover fees) available for the purposes specified in such section 507 [section 357 of this title] as in effect prior to the effective date shall also be available for the purposes specified in section 512(n) [subsection (n) of this section], including preparatory work or proceedings prior to that date.”
Pub. L. 104–250, § 2(e), “(1) Not later than 6 months after the date of enactment of this Act [“(2) In issuing regulations implementing the amendments made by this Act [see Short Title of 1996 Amendments note set out under section 301 of this title], and in taking an action to review an application for approval of a new animal drug under section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b), or a request for an investigational exemption for a new animal drug under subsection (j) of such section, that is pending or has been submitted prior to the effective date of the regulations, the Secretary shall—“(A) further define the term ‘adequate and well controlled’, as used in subsection (d)(3) of section 512 of such Act, to require that field investigations be designed and conducted in a scientifically sound manner, taking into account practical conditions in the field and differences between field conditions and laboratory conditions;“(B) further define the term ‘substantial evidence’, as defined in subsection (d)(3) of such section, in a manner that encourages the submission of applications and supplemental applications; and“(C) take into account the proposals contained in the citizen petition (FDA Docket No. 91P–0434/CP) jointly submitted by the American Veterinary Medical Association and the Animal Health Institute, dated Until the regulations required by subparagraph (A) are issued, nothing in the regulations published at 21 C.F.R. 514.111(a)(5) (
Pub. L. 103–396, § 2(c),
Pub. L. 100–670, title I, § 103, “(a) The Secretary of Health and Human Services shall promulgate, in accordance with the notice and comment requirements of section 553 of title 5, United States Code, such regulations as may be necessary for the administration of section 512 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b], as amended by sections 101 through 103 of this title, within one year of the date of enactment of this Act [“(b) During the period beginning 60 days after the date of enactment of this Act [
Pub. L. 115–234, title III, § 305, “(a) For purposes of assisting sponsors in incorporating complex adaptive and other novel investigation designs, data from foreign countries, real world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints (referred to in this section as ‘elements of investigations’) into proposed clinical investigation protocols and applications for new animal drugs under sections 512 and 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b; 360ccc), the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall issue guidance addressing the use of such elements of investigations in the development and regulatory review of such new animal drugs.“(b) The guidance under subsection (a) shall address how the Secretary will evaluate the elements of investigations proposed or submitted pursuant to section 512(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act or to meet the commitment under section 571(a)(2)(F) of such Act, and how sponsors of such applications may obtain feedback from the Secretary on technical issues related to such investigations prior to the submission of an application to the Secretary.“(c) Prior to issuing the guidance under subsection (a), the Secretary shall consult with stakeholders, including representatives of regulated industry, consumer groups, academia, veterinarians, and food producers, through a public meeting to be held not later than 1 year after the date of enactment of this Act [“(d) The Secretary shall issue a draft guidance under subsection (a) not later than 1 year after the date of the public meeting under subsection (c), and shall finalize such guidance not later than 1 year after the date on which the public comment period on such draft guidance ends.”
Pub. L. 110–316, title I, § 105(b), (c), “(b) For each new animal drug that is subject to the reporting requirement under section 512(l)(3) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b(l)(3)], as added by subsection (a), and for which an approval of an application filed pursuant to section 512(b) or 571 of such Act [21 U.S.C. 360b(b), 360ccc] is in effect on the date of the enactment of this title [“(c) The reports required under section 512(l)(3) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall be separate from periodic drug experience reports that are required under section 514.80(b)(4) of title 21, Code of Federal Regulations (as in effect on the date of the enactment of this title).”
Pub. L. 104–250, § 2(f),
Pub. L. 104–250, § 6(c),
Pub. L. 100–670, title I, § 106,