21 U.S.C. § 355

Delayed Applicability of Amendment

section 3601(a) of Pub. L. 117–328For delayed applicability of subsection (z) of this section as added by , see Effective Date of 2022 Amendment note below.

Editorial Notes

References in Text

section 264(c) of Pub. L. 104–191section 1320d–2 of Title 42Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (k)(3)(C)(i)(I), (4)(G)(i)(I), is , which is set out as a note under , The Public Health and Welfare.

section 5332 of Title 5The General Schedule, referred to in subsec. (n)(5), is set out under , Government Organization and Employees.

osection 101(c) of Pub. L. 110–85section 379g of this titleSection 101(c) of the Food and Drug Administration Amendments Act of 2007, referred to in subsec. ()(3)(E)(i), is , which is set out as a note under .

Pub. L. 105–115Nov. 21, 1997111 Stat. 2296section 45C of Title 26section 156 of Title 35section 8126 of Title 38section 301 of this titleThe Food and Drug Administration Modernization Act of 1997, referred to in subsec. (v)(1)(A), (2)(A), (4), is , , . Section 125 of the Act amended sections 321, 331, 335a, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381, and 382 of this title, , Internal Revenue Code, , Patents, and , Veterans’ Benefits, repealed sections 356 and 357 of this title, and enacted provisions set out as a note under this section. For complete classification of this Act to the Code, see Short Title of 1997 Amendment note set out under and Tables.

Pub. L. 98–417Sept. 24, 198498 Stat. 1585section 301 of this titleThe Drug Price Competition and Patent Term Restoration Act of 1984, referred to in subsec. (v)(4), is , , . For complete classification of this Act to the Code, see Short Title of 1984 Amendment note set out under and Tables.

Pub. L. 91–513Oct. 27, 197084 Stat. 1242section 801 of this titleThe Controlled Substances Act, referred to in subsec. (x)(1), is title II of , , , which is classified principally to subchapter I (§ 801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under and Tables.

Codification

section 132 of title 41Pub. L. 111–350, § 6(c)Jan. 4, 2011124 Stat. 3854In subsec. (k)(4)(H), “” substituted for “section 4(5) of the Federal Procurement Policy Act” on authority of , , , which Act enacted Title 41, Public Contracts.

Amendments

Pub. L. 119–372025—Subsec. (b)(7). added par. (7).

Pub. L. 117–328, § 3209(a)(1)(A)2022—Subsec. (i)(1)(A). , substituted “nonclinical tests” for “preclinical tests (including tests on animals)”.

Pub. L. 117–328, § 3209(a)(1)(B)Subsec. (i)(2)(B). , substituted “nonclinical tests” for “animal”.

Pub. L. 117–328, § 3222Subsec. (j)(7)(A)(v). , added cl. (v).

Pub. L. 117–328, § 3224Subsec. (j)(10)(A)(i) to (iii). , added cls. (i) to (iii) and struck out former cls. (i) to (iii) which read as follows:

“(i) the application is otherwise eligible for approval under this subsection but for expiration of patent, an exclusivity period, or of a delay in approval described in paragraph (5)(B)(iii), and a revision to the labeling of the listed drug has been approved by the Secretary within 60 days of such expiration;

“(ii) the labeling revision described under clause (i) does not include a change to the ‘Warnings’ section of the labeling;

“(iii) the sponsor of the application under this subsection agrees to submit revised labeling of the drug that is the subject of such application not later than 60 days after the notification of any changes to such labeling required by the Secretary; and”.

Pub. L. 117–328, § 3105(1)Subsec. (u)(1)(A)(ii)(II). , inserted “(other than bioavailability studies)” after “any clinical investigations”.

Pub. L. 117–328, § 3105(2)October 1, 2027December 24, 2022Subsec. (u)(4). , substituted “” for “”.

Pub. L. 117–229December 24, 2022December 17, 2022 substituted “” for “”.

Pub. L. 117–180 substituted “December 17” for “October 1”.

Pub. L. 117–328, § 3601(a)Subsec. (z). , added subsec. (z) relating to diversity action plan for clinical studies.

Pub. L. 117–328, § 3209(a)(2), added subsec. (z) defining nonclinical test.

Pub. L. 116–290, § 2(a)(1)2021—Subsec. (b)(1). , amended par. (1) generally. Prior to amendment, par. (1) related to requirements for filing an application with respect to any drug subject to the provisions of subsec. (a).

Pub. L. 116–290, § 2(b)(1)Subsec. (c)(2). , inserted at beginning “Not later than 30 days after the date of approval of an application submitted under subsection (b), the holder of the approved application shall file with the Secretary the patent number and the expiration date of any patent described in subsection (b)(1)(A)(viii), except that a patent that is identified as claiming a method of using such drug shall be filed only if the patent claims a method of use approved in the application. If a patent described in subsection (b)(1)(A)(viii) is issued after the date of approval of an application submitted under subsection (b), the holder of the approved application shall, not later than 30 days after the date of issuance of the patent, file the patent number and the expiration date of the patent, except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application.”; substituted “described in subsection (b)(1)(A)(viii).” for “which claims the drug for which the application was submitted or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.”; inserted “of the type for which information is required to be submitted in subsection (b)(1)(A)(viii)” after “could not file patent information under subsection (b) because no patent”; and inserted at end “Patent information that is not the type of patent information required by subsection (b)(1)(A)(viii) shall not be submitted under this paragraph.”

Pub. L. 117–9, § 1(a)(1)(A)Subsec. (c)(3)(E). , 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)” wherever appearing.

Pub. L. 116–290, § 2(g)(1), substituted “subsection (b)(1)(A)(i)” for “clause (A) of subsection (b)(1)” wherever appearing.

Pub. L. 117–9, § 1(b)(1)(A)January 1, 1982September 24, 1984Subsec. (c)(3)(E)(i). , struck out cl. (i) which read as follows: “If an application (other than an abbreviated new drug application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), was approved during the period beginning , and ending on , the Secretary may not make the approval of another application for a drug for which the investigations described in subsection (b)(1)(A)(i) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted effective before the expiration of ten years from the date of the approval of the application previously approved under subsection (b).”

Pub. L. 116–290, § 2(g)(2)Subsec. (j)(2)(A)(vi). , substituted “clauses (ii) through (vi) of subsection (b)(1)(A)” for “clauses (B) through (F) of subsection (b)(1)”.

Pub. L. 117–9, § 1(a)(1)(B)Subsec. (j)(5)(F). , 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)” wherever appearing.

Pub. L. 117–9, § 1(b)(1)(B)January 1, 1982September 24, 1984Subsec. (j)(5)(F)(i). , struck out cl. (i) which read as follows: “If an application (other than an abbreviated new drug application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), was approved during the period beginning , and ending on , the Secretary may not make the approval of an application submitted under this subsection which refers to the drug for which the subsection (b) application was submitted effective before the expiration of ten years from the date of the approval of the application under subsection (b).”

Pub. L. 116–290, § 2(b)(2)Subsec. (j)(7)(A)(iii). , struck out “(b) or” before “(c)”.

Pub. L. 116–290, § 2(c)Subsec. (j)(7)(A)(iv). , added cl. (iv).

Pub. L. 116–290, § 2(d)(1)Subsec. (j)(7)(D). , added subpar. (D).

lPub. L. 117–9, § 1(a)(1)(C)(i)section 262 of title 42Subsec. ()(2)(A)(i). , amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: “not later than 30 days after the date of approval of such application for a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or ; and”.

lPub. L. 117–9, § 1(a)(1)(C)(ii)Subsec. ()(2)(A)(ii). , inserted “or biological product” before period at end.

Pub. L. 117–9, § 1(a)(1)(D)section 262 of title 42Subsec. (s). , amended subsec. (s) generally. Prior to amendment, text read as follows: “Prior to the approval of a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or , the Secretary shall—

“(1) refer such drug to a Food and Drug Administration advisory committee for review at a meeting of such advisory committee; or

“(2) if the Secretary does not refer such a drug to a Food and Drug Administration advisory committee prior to the approval of the drug, provide in the action letter on the application for the drug a summary of the reasons why the Secretary did not refer the drug to an advisory committee prior to approval.”

Pub. L. 117–9, § 1(a)(1)(E)Subsec. (u)(1). , in introductory provisions, 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)” and “same active moiety” for “same active ingredient”.

oPub. L. 115–271, § 3041(b)(1)2018—Subsec. ()(4)(A). , substituted “safety or new effectiveness information” for “safety information” in heading and “If the Secretary becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling of the drug” for “If the Secretary becomes aware of new safety information that the Secretary believes should be included in the labeling of the drug” in text. Amendment to heading was executed to reflect the probable intent of Congress, notwithstanding error in text directed to be stricken.

oPub. L. 115–271, § 3041(b)(2)Subsec. ()(4)(B)(i). , inserted “, or new effectiveness information” after “adverse reactions”.

oPub. L. 115–271, § 3041(b)(3)Subsec. ()(4)(C). , substituted “safety or new effectiveness information” for “safety information”.

oPub. L. 115–271, § 3041(b)(4)Subsec. ()(4)(E). , substituted “safety or new effectiveness information” for “safety information”.

Pub. L. 115–52, § 808(1)2017—Subsec. (j)(5)(B)(v). , added cl. (v).

Pub. L. 115–52, § 808(2)Subsec. (j)(5)(D)(iv). , added cl. (iv).

Pub. L. 115–52, § 801Subsec. (j)(11), (12). , added pars. (11) and (12).

Pub. L. 115–52, § 802Subsec. (j)(13). , added par. (13).

Pub. L. 115–52, § 901(a)Pub. L. 114–255, § 3075(a)Subsec. (k)(5). , made technical amendments to directory language of . See 2016 Amendment notes below.

Pub. L. 115–52, § 601Subsec. (u)(4). , substituted “2022” for “2017”.

Pub. L. 115–52, § 706(b)Subsec. (y). , added subsec. (y).

Pub. L. 114–255, § 3031(a)2016—Subsec. (c)(5). , added par. (5).

Pub. L. 114–255, § 3101(a)(2)(B)(i)Subsec. (d). , substituted “marketing approval” for “premarket approval” in last sentence.

Pub. L. 114–255, § 3024(b)Subsec. (i)(4). , substituted “except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings” for “except where it is not feasible or it is contrary to the best interests of such human beings”.

Pub. L. 114–255, § 3075(a)(1)Pub. L. 115–52, § 901(a)(1)Subsec. (k)(5)(A). , as amended by , substituted “screenings” for “, bi-weekly screening”.

Pub. L. 114–255, § 3102(1)(A), inserted “and” after the semicolon.

Pub. L. 114–255, § 3075(a)(2)Pub. L. 115–52, § 901(a)Subsec. (k)(5)(B). , as amended by , substituted “; and” for period at end.

Pub. L. 114–255, § 3102(1)(B)September 27, 2007, (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: “report to Congress not later than 2 year after , on procedures and processes of the Food and Drug Administration for addressing ongoing post market safety issues identified by the Office of Surveillance and Epidemiology and how recommendations of the Office of Surveillance and Epidemiology are handled within the agency; and”.

Pub. L. 114–255, § 3075(a)(3)Pub. L. 115–52, § 901(a)(1)Subsec. (k)(5)(C). , as amended by , added subpar. (C).

Pub. L. 114–255, § 3102(1)(C), redesignated subpar. (C) as (B).

Pub. L. 114–255, § 3101(a)(2)(B)(ii)section 262(k) of title 42Subsec. (q)(5)(A). , substituted “subsection (b)(2) or (j) of this section or ” for “subsection (b)(2) or (j) of the Act or 262(k) of title 42”.

Pub. L. 114–255, § 3075(b)section 262 of title 42Subsec. (r)(2)(D). , substituted “and making publicly available on the Internet website established under paragraph (1) best practices for drug safety surveillance activities for drugs approved under this section or ” for “, by 18 months after approval of a drug or after use of the drug by 10,000 individuals, whichever is later, a summary analysis of the adverse drug reaction reports received for the drug, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number;”.

Pub. L. 114–892015—Subsec. (x). added subsec. (x).

Pub. L. 113–5section 262(k) of title 422013—Subsec. (b)(5)(B). substituted “size—” for “size of clinical trials intended to form the primary basis of an effectiveness claim or, with respect to an applicant for approval of a biological product under , any necessary clinical study or studies.”, added cls. (i) and (ii), and designated last two sentences as concluding provisions.

Pub. L. 112–144, § 9052012—Subsec. (d). , inserted at end “The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and the communication of the benefits and risks of new drugs. Nothing in the preceding sentence shall alter the criteria for evaluating an application for premarket approval of a drug.”

Pub. L. 112–144, § 1135(1)(A)section 262(k) of title 42Subsec. (q)(1)(A). , substituted “subsection (b)(2) or (j) of this section or ” for “subsection (b)(2) or (j)” in introductory provisions.

Pub. L. 112–144, § 1135(1)(B)Subsec. (q)(1)(F). , substituted “150 days” for “180 days” in introductory provisions.

Pub. L. 112–144, § 1135(2)(A)Subsec. (q)(2)(A). , substituted “150” for “180” in heading.

Pub. L. 112–144, § 1135(2)(B)Subsec. (q)(2)(A)(i). , substituted “150-day” for “180-day”.

Pub. L. 112–144, § 1135(3)Subsec. (q)(4). , designated existing provisions as subpar. (A), redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A), and added subpar. (B).

Pub. L. 112–144, § 1135(4)Subsec. (q)(5)(A). , substituted “subsection (b)(2) or (j) of the Act or 262(k) of title 42” for “subsection (b)(2) or (j)”.

Pub. L. 112–144, § 1101(b)Subsec. (u)(1)(A)(ii)(II). , inserted “clinical” after “any”.

Pub. L. 112–144, § 1101(a)Subsec. (u)(4). , substituted “2017” for “2012”.

Pub. L. 112–144, § 1134(a)Subsec. (w). , added subsec. (w).

Pub. L. 111–148, § 7002(d)(1)section 262(k) of title 422010—Subsec. (b)(5)(B). , inserted “or, with respect to an applicant for approval of a biological product under , any necessary clinical study or studies” before period at end of first sentence.

Pub. L. 111–148, § 10609Subsec. (j)(10). , added par. (10).

Pub. L. 111–31section 394 of this title2009—Subsec. (n)(2). made technical amendment to reference in original act which appears in text as reference to .

Pub. L. 110–316, § 3012008—Subsec. (q)(1)(A). , inserted concluding provisions.

Pub. L. 110–379Subsec. (v). added subsec. (v).

Pub. L. 110–85, § 801(b)(3)(B)2007—Subsec. (b)(6). , added par. (6).

Pub. L. 110–85, § 903section 355–1(g)(2)(D) of this titleSubsec. (e). , inserted at end “The Secretary may withdraw the approval of an application submitted under this section, or suspend the approval of such an application, as provided under this subsection, without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug under .”

Pub. L. 110–85, § 801(b)(3)(A)section 282 of title 42Subsec. (i)(4). , inserted at end “The Secretary shall update such regulations to require inclusion in the informed consent documents and process a statement that clinical trial information for such clinical investigation has been or will be submitted for inclusion in the registry data bank pursuant to subsection (j) of .”

Pub. L. 110–85, § 905(a)Subsec. (k)(3), (4). , added pars. (3) and (4).

Pub. L. 110–85, § 921Subsec. (k)(5). , added par. (5).

lPub. L. 110–85, § 916Subsec. (). , designated existing provisions as par. (1), redesignated former pars. (1) to (5) as subpars. (A) to (E), respectively, of par. (1), and added par. (2).

Pub. L. 110–85, § 701(b)Subsec. (n)(4) to (8). , redesignated pars. (5) to (8) as (4) to (7), respectively, and struck out former par. (4) which read as follows: “Each member of a panel shall publicly disclose all conflicts of interest that member may have with the work to be undertaken by the panel. No member of a panel may vote on any matter where the member or the immediate family of such member could gain financially from the advice given to the Secretary. The Secretary may grant a waiver of any conflict of interest requirement upon public disclosure of such conflict of interest if such waiver is necessary to afford the panel essential expertise, except that the Secretary may not grant a waiver for a member of a panel when the member’s own scientific work is involved.”

oPub. L. 110–85, § 901(a)oSubsecs. (), (p). , added subsecs. () and (p).

Pub. L. 110–85, § 914(a)Subsec. (q). , added subsec. (q).

Pub. L. 110–85, § 915Subsec. (r). , added subsec. (r).

Pub. L. 110–85, § 918Subsec. (s). , added subsec. (s).

Pub. L. 110–85, § 920Subsec. (t). , added subsec. (t).

Pub. L. 110–85, § 1113Subsec. (u). , added subsec. (u).

Pub. L. 108–155section 355c of this title2003—Subsec. (b)(1). , in second sentence, substituted “(F)” for “and (F)” and inserted “, and (G) any assessments required under ” before period at end.

Pub. L. 108–173, § 1101(b)(1)(A)Subsec. (b)(3). , added par. (3) and struck out former par. (3) which, in subpar. (A), required an applicant making a certification under par. (2)(A)(iv) to include statement that applicant will give notice to each owner of the patent which is the subject of the certification and to the holder of the approved application, in subpar. (B), directed that notice state that an application has been submitted and include a detailed statement of the applicant’s opinion that the patent is not valid or will not be infringed, and, in subpar. (C), provided that if an application is amended, notice shall be given when the amended application is submitted.

Pub. L. 108–173, § 1101(b)(1)(B)Subsec. (b)(4), (5). , added par. (4) and redesignated former par. (4) as (5).

Pub. L. 108–173, § 1101(b)(2)(A)Subsec. (c)(3). , substituted “by applying the following to each certification made under subsection (b)(2)(A)” for “under the following” in introductory provisions.

Pub. L. 108–173, § 1101(b)(2)(B)(iii)Subsec. (c)(3)(C). , which directed the substitution of “subsection (b)(3)” for “paragraph (3)(B)” in third sentence, could not be executed because such words do not appear. See note below.

Pub. L. 108–173, § 1101(b)(2)(B)(ii)(VI)section 2201 of title 28, in concluding provisions, struck out “Until the expiration of forty-five days from the date the notice made under paragraph (3)(B) is received, no action may be brought under for a declaratory judgment with respect to the patent. Any action brought under such section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business.” after “expediting the action.”

Pub. L. 108–173, § 1101(b)(2)(B)(i), (ii)(I), in first sentence of introductory provisions, substituted “unless, before the expiration of 45 days after the date on which the notice described in subsection (b)(3) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) or subsection (b)(1) before the date on which the application (excluding an amendment or supplement to the application) was submitted” for “unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (3)(B) is received” and, in second sentence of introductory provisions, substituted “subsection (b)(3)” for “paragraph (3)(B)”.

Pub. L. 108–173, § 1101(b)(2)(B)(ii)(II)Subsec. (c)(3)(C)(i). , added cl. (i) and struck out former cl. (i) which read as follows: “if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval may be made effective on the date of the court decision,”.

Pub. L. 108–173, § 1101(b)(2)(B)(ii)(III)section 271(e)(4)(A) of title 35Subsec. (c)(3)(C)(ii). , added cl. (ii) and struck out former cl. (ii) which read as follows: “if before the expiration of such period the court decides that such patent has been infringed, the approval may be made effective on such date as the court orders under , or”.

Pub. L. 108–173, § 1101(b)(2)(B)(ii)(IV)Subsec. (c)(3)(C)(iii). , substituted “as provided in clause (i); or” for “on the date of such court decision.”

Pub. L. 108–173, § 1101(b)(2)(B)(ii)(V)Subsec. (c)(3)(C)(iv). , added cl. (iv).

Pub. L. 108–173, § 1101(b)(2)(C)Subsec. (c)(3)(D), (E). , (D), added subpar. (D) and redesignated former subpar. (D) as (E).

Pub. L. 108–173, § 1101(a)(1)(A)Subsec. (j)(2)(B). , added subpar. (B) and struck out former subpar. (B) which, in cl. (i), required that an applicant making a certification under subpar. (A)(vii)(IV) include in the application a statement that notice would be given to each owner of the patent and the holder of the approved application, in cl. (ii), required that notice would state that an application had been submitted and that it would include a detailed statement of the basis of the applicant’s opinion, and, in cl. (iii), directed that notice of an amended application be given when the amended application had been submitted.

Pub. L. 108–173, § 1101(a)(1)(B)Subsec. (j)(2)(D). , added subpar. (D).

Pub. L. 108–173, § 1101(a)(2)(A)(i)Subsec. (j)(5)(B). , substituted “by applying the following to each certification made under paragraph (2)(A)(vii)” for “under the following” in introductory provisions.

Pub. L. 108–173, § 1101(a)(2)(A)(ii)(II)(ee)section 2201 of title 28Subsec. (j)(5)(B)(iii). , which directed amendment of the second sentence of subsec. (j)(5)(B)(iii) by striking “Until the expiration” and all that follows in the matter after and below subclause (IV), was executed by striking “Until the expiration of forty-five days from the date the notice made under paragraph (2)(B)(i) is received, no action may be brought under , for a declaratory judgment with respect to the patent. Any action brought under section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business.” after “expediting the action.” in concluding provisions, to reflect the probable intent of Congress.

Pub. L. 108–173, § 1101(a)(2)(A)(ii)(I), in introductory provisions, substituted “unless, before the expiration of 45 days after the date on which the notice described in paragraph (2)(B) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under subsection (b)(1) or (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted” for “unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (2)(B)(i) is received”.

Pub. L. 108–173, § 1101(a)(2)(A)(ii)(II)(aa)Subsec. (j)(5)(B)(iii)(I). , added subcl. (I) and struck out former subcl. (I) which read as follows: “if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of the court decision,”.

Pub. L. 108–173, § 1101(a)(2)(A)(ii)(II)(bb)section 271(e)(4)(A) of title 35Subsec. (j)(5)(B)(iii)(II). , added subcl. (II) and struck out former subcl. (II) which read as follows: “if before the expiration of such period the court decides that such patent has been infringed, the approval shall be made effective on such date as the court orders under , or”.

Pub. L. 108–173, § 1101(a)(2)(A)(ii)(II)(cc)Subsec. (j)(5)(B)(iii)(III). , substituted “as provided in subclause (I); or” for “on the date of such court decision.”

Pub. L. 108–173, § 1101(a)(2)(A)(ii)(II)(dd)Subsec. (j)(5)(B)(iii)(IV). , added subcl. (IV).

Pub. L. 108–173, § 1102(a)(1)Subsec. (j)(5)(B)(iv). , added cl. (iv) and struck out former cl. (iv) which read as follows: “If the application contains a certification described in subclause (IV) of paragraph (2)(A)(vii) and is for a drug for which a previous application has been submitted under this subsection continuing such a certification, the application shall be made effective not earlier than one hundred and eighty days after—

“(I) the date the Secretary receives notice from the applicant under the previous application of the first commercial marketing of the drug under the previous application, or

“(II) the date of a decision of a court in an action described in clause (iii) holding the patent which is the subject of the certification to be invalid or not infringed,

whichever is earlier.”

Pub. L. 108–173, § 1101(a)(2)(B)Subsec. (j)(5)(C). , (C), added subpar. (C). Former subpar. (C) redesignated (E).

Pub. L. 108–173, § 1102(a)(2)Subsec. (j)(5)(D). , added subpar. (D).

Pub. L. 108–173, § 1101(a)(2)(B), redesignated subpar. (D) as (F).

Pub. L. 108–173, § 1101(a)(2)(B)Subsec. (j)(5)(E), (F). , redesignated subpars. (C) and (D) as (E) and (F), respectively.

Pub. L. 108–173, § 1103(a)(1)Subsec. (j)(8)(A). , added subpar. (A) and struck out former subpar. (A) which read as follows: “The term ‘bioavailability’ means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action.”

Pub. L. 108–173, § 1103(a)(2)Subsec. (j)(8)(C). , added subpar. (C).

Pub. L. 107–1092002—Subsec. (i)(1)(D). added subpar. (D).

Pub. L. 106–1131999—Subsec. (m). substituted “United States Patent and Trademark Office” for “Patent and Trademark Office of the Department of Commerce”.

Pub. L. 105–115, § 115(b)1997—Subsec. (b)(1). , inserted at end “The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by clause (A).”

Pub. L. 105–115, § 119(a)Subsec. (b)(4). , added par. (4).

Pub. L. 105–115, § 124(a)Subsec. (c)(4). , added par. (4).

Pub. L. 105–115, § 115(a)Subsec. (d). , inserted at end “If the Secretary determines, based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness, the Secretary may consider such data and evidence to constitute substantial evidence for purposes of the preceding sentence.”

Pub. L. 105–115, § 117Subsec. (i). , inserted “(1)” after “(i)”, redesignated former pars. (1) to (3) as subpars. (A) to (C), respectively, of par. (1), added pars. (2) to (4), and struck out closing provisions which read as follows: “Such regulations shall provide that such exemption shall be conditioned upon the manufacturer, or the sponsor of the investigation, requiring that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings. Nothing in this subsection shall be construed to require any clinical investigator to submit directly to the Secretary reports on the investigational use of drugs.”

Pub. L. 105–115, § 119(b)(2)(A)Subsec. (j)(2)(A)(i). , substituted “paragraph (7)” for “paragraph (6)”.

Pub. L. 105–115, § 119(b)(1)(B)Subsec. (j)(3). , added par. (3). Former par. (3) redesignated (4).

Pub. L. 105–115, § 119(b)(1)(A)Subsec. (j)(4). , (2)(B), redesignated par. (3) as (4) and in introductory provisions substituted “paragraph (5)” for “paragraph (4)”. Former par. (4) redesignated (5).

Pub. L. 105–115, § 119(b)(2)(C)Subsec. (j)(4)(I). , substituted “paragraph (6)” for “paragraph (5)”.

Pub. L. 105–115, § 119(b)(1)(A)Subsec. (j)(5), (6). , redesignated pars. (4) and (5) as (5) and (6), respectively. Former par. (6) redesignated (7).

Pub. L. 105–115, § 119(b)(1)(A)Subsec. (j)(7). , (2)(D), redesignated par. (6) as (7) and in subpar. (C) substituted “paragraph (6)” for “paragraph (5)” in two places. Former par. (7) redesignated (8).

Pub. L. 105–115, § 119(b)(1)(A)Subsec. (j)(8), (9). , redesignated pars. (7) and (8) as (8) and (9), respectively.

Pub. L. 105–115, § 120Subsec. (n). , added subsec. (n).

Pub. L. 103–80, § 3(n)(1)(A)1993—Subsec. (j)(6)(A)(ii). , substituted “Secretary” for “Secretry”.

Pub. L. 103–80, § 3(n)(1)(B)Subsec. (j)(6)(A)(iii). , inserted comma after “published by the Secretary”.

Pub. L. 103–80, § 3(n)(2)Provided, howeverSubsec. (k)(1). , substituted “section. Regulations” for “section: , That regulations”.

Pub. L. 102–2821992—Subsec. (j)(8). added par. (8).

Pub. L. 98–417, § 102(b)(1)1984—Subsec. (a). , inserted “or (j)” after “subsection (b)”.

Pub. L. 98–417Subsec. (b). , §§ 102(a)(1), 103(a), designated existing provisions of subsec. (b) as par. (1) thereof and redesignated existing cls. (1) through (6) of such par. (1) as cls. (A) through (F) thereof, respectively, inserted requirement that the applicant file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably by asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug, that the applicant amend the application to include such information if an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, and that upon approval of the application, the Secretary publish the information submitted, and added pars. (2) and (3).

Pub. L. 98–417Subsec. (c). , §§ 102(a)(2), (b)(2), 103(b), designated existing provisions of subsec. (c) as par. (1) thereof and in par. (1) as so designated substituted “subsection (b)” for “this subsection” and redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, and added pars. (2) and (3).

Pub. L. 98–417, § 102(a)(3)(A)Subsec. (d)(6), (7). , added cl. (6) relating to the failure of the application to contain the patent information prescribed by subsec. (b) of this section, and redesignated former cl. (6) as (7).

Pub. L. 98–417, § 102(a)(3)(B)Subsec. (e). , in first sentence, added a new cl. (4) relating to the failure to file the patent information prescribed by subsec. (c) of this section within 30 days after the receipt of written notice from the Secretary specifying the failure to file such information, and redesignated former cl. (4) as (5).

Pub. L. 98–417, § 102(b)(3)section 360(k)(2) of this titlesection 360(j)(2) of this title, (4), in second sentence, inserted in provisions preceding cl. (1) “submitted under subsection (b) or (j)” and in cl. (1) substituted “under subsection (k) or to comply with the notice requirements of ” for “under subsection (j) or to comply with the notice requirements of ”.

Pub. L. 98–417, § 101Subsecs. (j), (k). , added subsec. (j) and redesignated former subsec. (j) as (k).

Pub. L. 98–417, § 102(b)(5)Subsec. (k)(1). , substituted “under subsection (b) or (j)” for “pursuant to this section”.

lPub. L. 98–417, § 104lSubsecs. (), (m). , added subsecs. () and (m).

Pub. L. 92–387section 360(j)(2) of this title1972—Subsec. (e). inserted “or to comply with the notice requirements of ” in cl. (1) of second sentence relating to the maintenance of records.

Pub. L. 87–781, § 104(a)1962—Subsec. (a). , inserted “an approval of” before “an application”.

Pub. L. 87–781, § 102(b)Subsec. (b). , inserted “and whether such drug is effective in use” after “is safe for use”.

Pub. L. 87–781, § 104(b)Subsec. (c). , substituted provisions requiring the Secretary, within 180 days after filing an application, or such additional period as the Secretary and the applicant agree upon, to either approve the application, if meeting the requirements of subsec. (d) of this section, or give notice of opportunity for hearing on question of whether such application is approvable, and providing that if applicant requests hearing in writing within 30 days, the hearing shall begin within 90 days after expiration of said 30 days, unless the Secretary and applicant agree otherwise, that such hearing shall be expedited, and that the Secretary’s order shall be issued within 90 days after date for filing final briefs, for provisions which had an application become effective on the sixtieth day after filing thereof unless prior thereto the Secretary postponed the date by written notice to such time, but not more than 180 days after filing, as the Secretary deemed necessary to study and investigate the application.

Pub. L. 87–781, § 102(c)Subsec. (d). , inserted references to subsec. (c), added cls. (5) and (6), provided that if after notice and opportunity for hearing, the Secretary finds that cls. (1) to (6) do not apply, he shall approve the application, and defined “substantial evidence” as used in this subsection and subsec. (e) of this section.

Pub. L. 87–781, § 102(d)Subsec. (e). , amended subsec. (e) generally, and among other changes, directed the Secretary to withdraw approval of an application if by tests, other scientific data or experience, or new evidence of clinical experience not contained in the application or available at the time of its approval, the drug is shown to be unsafe, or on the basis of new information, there is shown a lack of substantial evidence that the drug has the effect it is represented to have, and provided that if the Secretary, or acting Secretary, finds there is an imminent hazard to the public health, he may suspend approval immediately, notify the applicant, and give him opportunity for an expedited hearing, that the Secretary may withdraw approval if the applicant fails to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain records and make reports, or has refused access to, or copying or verification of such records, or if the Secretary finds on new evidence that the methods, facilities and controls in the manufacturing, processing, and packing are inadequate to assure and preserve the drugs’ identity, strength, quality and purity, and were not made adequate within a reasonable time after receipt of written notice thereof, or finds on new evidence, that the labeling is false or misleading and was not corrected within a reasonable time after receipt of written notice thereof.

Pub. L. 87–781, § 104(c)Subsec. (f). , substituted provisions requiring the Secretary to revoke any previous order under subsecs. (d) or (e) of this section refusing, withdrawing, or suspending approval of an application and to approve such application or reinstate such approval, for provisions which required him to revoke an order refusing effectiveness to an application.

Pub. L. 87–781, § 104(d)(1)section 2112 of title 28section 1254 of title 28February 9, 1893Subsec. (h). , (2), inserted “as provided in ”, and “except that until the filing of the record the Secretary may modify or set aside his order”, substituted “or withdrawing approval of an application under this section” for “to permit the application to become effective, or suspending the effectiveness of the application”, “United States court of appeals for the circuit” for “district court of the United States within any district”, “Court of Appeals for the District of Columbia Circuit” for “District Court for the District of Columbia”, “transmitted by the clerk of the court to” for “served upon”, and “by the Supreme Court of the United States upon certiorari or certification as provided in ” for “as provided in sections 225, 346, and 347 of title 28, as amended, and in section 7, as amended, of the Act entitled ‘An Act to establish a Court of Appeals for the District of Columbia’, approved ”, and eliminated “upon” before “any officer designated”, “a transcript of” before “the record” and “and decree” before “of the court affirming”.

Pub. L. 87–781, § 103(b)Subsec. (i). , inserted “the foregoing subsections of” after “operation of”, and “and effectiveness” after “safety”, and provided that the regulations may condition exemptions upon the submission of reports of preclinical tests to justify the proposed clinical testing, upon the obtaining by the manufacturer or sponsor of the investigation of a new drug of a signed agreement from each of the investigators that patients to whom the drug is administered will be under his supervision or under investigators responsible to him, and that he will not supply such drug to any other investigator, or to clinics, for administration to human beings, or upon the establishment and maintenance of records and reports of data obtained by the investigational use of such drug, as the Secretary finds will enable him to evaluate the safety and effectiveness of such drug, and provided that the regulations shall condition an exemption upon the manufacturer or sponsor of the investigation requiring that experts using such drugs certify that they will inform humans to whom such drugs or any controls connected therewith are administered, or their representatives, and will obtain the consent of such people where feasible and not contrary to the best interests of such people, and that reports on the investigational use of drugs are not required to be submitted directly to the Secretary.

Pub. L. 87–781, § 103(a)Subsec. (j). , added subsec. (j).

Pub. L. 86–5071960—Subsec. (g). inserted “or by certified mail” after “registered mail”.

Statutory Notes and Related Subsidiaries

Effective Date of 2025 Amendment

Pub. L. 119–37, div. F, title V, § 6510Nov. 12, 2025139 Stat. 648

Effective Date of 2022 Amendment

Pub. L. 117–328, div. FF, title III, § 3602(c)Dec. 29, 2022136 Stat. 5863

Effective Date of 2021 Amendment

Pub. L. 116–290, § 2(d)(2)Jan. 5, 2021134 Stat. 4891

Effective Date of 2012 Amendment

Pub. L. 112–144, title XI, § 1134(b)July 9, 2012126 Stat. 1123

Effective Date of 2007 Amendment

Pub. L. 110–85, title VII, § 701(c)Sept. 27, 2007121 Stat. 904

Pub. L. 110–85Sept. 27, 2007section 909 of Pub. L. 110–85section 331 of this titleAmendment by sections 901(a), 903, and 905(a) of effective 180 days after , see , set out as a note under .

Effective Date of 2003 Amendments

Pub. L. 108–173, title XI, § 1101(c)Dec. 8, 2003117 Stat. 2456

Pub. L. 108–173, title XI, § 1102(b)Dec. 8, 2003117 Stat. 2460

Pub. L. 108–155Dec. 3, 2003section 4 of Pub. L. 108–155section 355c of this titleAmendment by effective , except as otherwise provided, see , set out as an Effective Date note under .

Effective Date of 1999 Amendment

Pub. L. 106–113Nov. 29, 1999Pub. L. 106–113section 1 of Title 35Amendment by effective 4 months after , see section 1000(a)(9) [title IV, § 4731] of , set out as a note under , Patents.

Effective Date of 1997 Amendment

Pub. L. 105–115Nov. 21, 1997section 501 of Pub. L. 105–115section 321 of this titleAmendment by effective 90 days after , except as otherwise provided, see , set out as a note under .

Effective Date of 1984 Amendment

Pub. L. 98–417, title I, § 105Sept. 24, 198498 Stat. 1597

Effective Date of 1972 Amendment

Pub. L. 92–387Aug. 16, 1972section 5 of Pub. L. 92–387section 360 of this titleAmendment by effective on first day of sixth month beginning after , see , set out as a note under .

Effective Date of 1962 Amendment

Pub. L. 87–781section 107 of Pub. L. 87–781section 321 of this titleAmendment by effective on first day of seventh calendar month following October 1962, see , set out as a note under .

Pub. L. 110–85Construction of Amendment by

Pub. L. 110–85, title IX, § 905(b)Sept. 27, 2007121 Stat. 949

Pub. L. 102–282Construction of Amendments by

Pub. L. 102–282Pub. L. 102–282section 7 of Pub. L. 102–282section 335a of this titleAmendment by not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by , see , set out as a note under .

Extending Expiration Dates for Certain Drugs

Pub. L. 117–328, div. FF, title II, § 2512(a)Dec. 29, 2022136 Stat. 5804

Antifungal Research and Development

Pub. L. 117–328, div. FF, title III, § 3211Dec. 29, 2022136 Stat. 5825

Guidance on Diversity Action Plans for Clinical Studies

Pub. L. 117–328, div. FF, title III, § 3602(a)Dec. 29, 2022136 Stat. 5861

Annual Summary Report on Progress To Increase Diversity in Clinical Studies

Pub. L. 117–328, div. FF, title III, § 3604Dec. 29, 2022136 Stat. 5864

Facilitating the Use of Real World Evidence

Pub. L. 117–328, div. FF, title III, § 3629Dec. 29, 2022136 Stat. 5891

Clarifying FDA Regulation of Non-Addictive Pain Products

Pub. L. 115–271, title III, § 3001Oct. 24, 2018132 Stat. 3932

Guidance Regarding Reduction in Drug Effectiveness

Pub. L. 115–271, title III, § 3041(c)Oct. 24, 2018132 Stat. 3943

Annual Report on Inspections

Pub. L. 115–52, title IX, § 902Aug. 18, 2017131 Stat. 1077Pub. L. 117–328, div. FF, title III, § 3617Dec. 29, 2022136 Stat. 5876

Report on Patient Experience Drug Development

Pub. L. 114–255, div. A, title III, § 3004Dec. 13, 2016130 Stat. 1085

Novel Clinical Trial Designs

Pub. L. 114–255, div. A, title III, § 3021Dec. 13, 2016130 Stat. 1095

Variations From CGMP Streamlined Approach

Pub. L. 114–255, div. A, title III, § 3038(c)Dec. 13, 2016130 Stat. 1110

FDA Opioid Action Plan

Pub. L. 114–198, title I, § 106(a)July 22, 2016130 Stat. 702

Guidance on Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products

Pub. L. 114–198, title I, § 106(c)July 22, 2016130 Stat. 703

Guidance on Pathogen-Focused Antibacterial Drug Development

Pub. L. 112–144, title VIII, § 806July 9, 2012126 Stat. 1082

Guidance on Abuse-Deterrent Products

Pub. L. 112–144, title XI, § 1122(c)July 9, 2012126 Stat. 1113Pub. L. 114–255, div. A, title III, § 3101(b)(3)(B)Dec. 13, 2016130 Stat. 1156

Extension of Period for First Applicant To Obtain Tentative Approval Without Forfeiting 180-Day-Exclusivity Period

Pub. L. 112–144, title XI, § 1133July 9, 2012126 Stat. 1122

Pub. L. 110–85Effect of Amendments by on Veterinary Medicine

Pub. L. 110–85, title IX, § 907Sept. 27, 2007121 Stat. 950

Pub. L. 108–173Effect of Amendment by on Abbreviated New Drug Applications

Pub. L. 108–173, title XI, § 1103(b)Dec. 8, 2003117 Stat. 2461

Federal Trade Commission Review

Pub. L. 108–173, title XIDec. 8, 2003117 Stat. 2461Pub. L. 115–263, § 3Oct. 10, 2018132 Stat. 3673Pub. L. 115–271, title IV, § 4004Oct. 24, 2018132 Stat. 3960

Report on Patient Access to New Therapeutic Agents for Pediatric Cancer

Pub. L. 107–109, § 15(d)Jan. 4, 2002115 Stat. 1421

Data Requirements for Drugs and Biologics

Pub. L. 105–115, title I, § 118Nov. 21, 1997111 Stat. 2316

Requirements for Review of Approval Procedures and Current Good Manufacturing Practices for Positron Emission Technology

Pub. L. 105–115, title I, § 121(c)Nov. 21, 1997111 Stat. 2321

“Compounded Positron Emission Topography Drug” Defined

Pub. L. 105–115, title I, § 121(e)Nov. 21, 1997111 Stat. 2322

Requirements for Radiopharmaceuticals

Pub. L. 105–115, title I, § 122Nov. 21, 1997111 Stat. 2322

Special Rule

Pub. L. 105–115, title I, § 123(f)Nov. 21, 1997111 Stat. 2324

Transition

Pub. L. 110–379, § 4(b)Oct. 8, 2008122 Stat. 4077

Pub. L. 105–115, title I, § 125(d)Nov. 21, 1997111 Stat. 2326

Termination of Advisory Panels

Jan. 5, 1973Advisory panels established after , to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a panel established by the President or an officer of the Federal Government, such panel is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a panel established by Congress, its duration is otherwise provided for by law. See sections 1001(2) and 1013 of Title 5, Government Organization and Employees.

October 10, 1962Appeals Taken Prior to

Pub. L. 87–781, title I, § 104(d)(3)Oct. 10, 196276 Stat. 785Oct. 10, 1962, , , made amendments to subsec. (h) of this section inapplicable to any appeal taken prior to .

Executive Documents

Transfer of Functions

section 321 of this titleFor 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 .