---
kind: "section"
citation: "21 U.S.C. § 355h"
title: "21"
title_heading: "Food and Drugs"
number: "355h"
heading: "Regulation of certain nonprescription drugs that are marketed without an approved drug application"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/355h"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §355h. Regulation of certain nonprescription drugs that are marketed without an approved drug application

- (a) **Nonprescription drugs marketed without an approved application—** [Nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1) marketed without an approved [drug](/usc/21/321.md?p=g-1) application under [section 355 of this title](/usc/21/355.md), as of March 27, 2020, shall be treated in accordance with this subsection.
  - (1) **Drugs subject to a final monograph; category I drugs subject to a tentative final monograph—** A [drug](/usc/21/321.md?p=g-1) is deemed to be generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1), not a [new drug](/usc/21/321.md?p=p) under [section 321(p) of this title](/usc/21/321.md?p=p), and not subject to [section 353(b)(1) of this title](/usc/21/353.md?p=b-1), if—
    - (A) the [drug](/usc/21/321.md?p=g-1) is—
      - (i) in conformity with the requirements for [nonprescription](/usc/21/360fff.md?p=5) use of a final monograph issued under part 330 of title 21, Code of Federal Regulations (except as provided in [paragraph (2)](#a-2)), the general requirements for [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1), and conditions or requirements under subsections [(b)](#b), [(c)](#c), and [(k)](#k); and
      - (ii) except as permitted by an order issued under [subsection (b)](#b) or, in the case of a minor change in the [drug](/usc/21/321.md?p=g-1), in conformity with an order issued under [subsection (c)](#c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under [section 321(p)(2) of this title](/usc/21/321.md?p=p-2); or
    - (B) the [drug](/usc/21/321.md?p=g-1) is—
      - (i) classified in category I for safety and effectiveness under a tentative final monograph that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations;
      - (ii) in conformity with the proposed requirements for [nonprescription](/usc/21/360fff.md?p=5) use of such tentative final monograph, any applicable subsequent determination by the [Secretary](/usc/21/321.md?p=d), the general requirements for [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1), and conditions or requirements under subsections [(b)](#b), [(c)](#c), and [(k)](#k); and
      - (iii) except as permitted by an order issued under [subsection (b)](#b) or, in the case of a minor change in the [drug](/usc/21/321.md?p=g-1), in conformity with an order issued under [subsection (c)](#c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under [section 321(p)(2) of this title](/usc/21/321.md?p=p-2).
  - (2) **Treatment of sunscreen drugs—** With respect to [sunscreen](/usc/21/360fff.md?p=9) [drugs](/usc/21/321.md?p=g-1) subject to this section, the applicable requirements in terms of conformity with a final monograph, for purposes of [paragraph (1)(A)(i)](#a-1-A-i), shall be the requirements specified in part [352](/usc/21/352.md) of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and [labeling](/usc/21/321.md?p=m) shall be those specified in section 201.327 of title 21, Code of Federal Regulations.
  - (3) **Category III drugs subject to a tentative final monograph; category I drugs subject to proposed monograph or advance notice of proposed rulemaking—** A [drug](/usc/21/321.md?p=g-1) that is not described in paragraph [(1)](#a-1), [(2)](#a-2), or [(4)](#a-4) is not required to be the subject of an application approved under [section 355 of this title](/usc/21/355.md), and is not subject to [section 353(b)(1) of this title](/usc/21/353.md?p=b-1), if—
    - (A) the [drug](/usc/21/321.md?p=g-1) is—
      - (i) classified in category III for safety or effectiveness in the preamble of a proposed rule establishing a tentative final monograph that is the most recently applicable proposal or determination for such [drug](/usc/21/321.md?p=g-1) issued under part 330 of title 21, Code of Federal Regulations;
      - (ii) in conformity with—
        - (I) the conditions of use, including indication and dosage strength, if any, described for such category III [drug](/usc/21/321.md?p=g-1) in such preamble or in an applicable subsequent proposed rule;
        - (II) the proposed requirements for [drugs](/usc/21/321.md?p=g-1) classified in such tentative final monograph in category I in the most recently proposed rule establishing requirements related to such tentative final monograph and in any final rule establishing requirements that are applicable to the [drug](/usc/21/321.md?p=g-1); and
        - (III) the general requirements for [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1) and conditions or requirements under subsection [(b)](#b) or [(k)](#k); and
      - (iii) in a dosage form that, immediately prior to March 27, 2020, had been used to a material extent and for a material time under [section 321(p)(2) of this title](/usc/21/321.md?p=p-2); or
    - (B) the [drug](/usc/21/321.md?p=g-1) is—
      - (i) classified in category I for safety and effectiveness under a proposed monograph or advance notice of proposed rulemaking that is the most recently applicable proposal or determination for such [drug](/usc/21/321.md?p=g-1) issued under part 330 of title 21, Code of Federal Regulations;
      - (ii) in conformity with the requirements for [nonprescription](/usc/21/360fff.md?p=5) use of such proposed monograph or advance notice of proposed rulemaking, any applicable subsequent determination by the [Secretary](/usc/21/321.md?p=d), the general requirements for [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1), and conditions or requirements under subsection [(b)](#b) or [(k)](#k); and
      - (iii) in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under [section 321(p)(2) of this title](/usc/21/321.md?p=p-2).
  - (4) **Category II drugs deemed new drugs—** A [drug](/usc/21/321.md?p=g-1) that is classified in category II for safety or effectiveness under a tentative final monograph or that is subject to a determination to be not generally recognized as [safe](/usc/21/321.md?p=u) and effective in a proposed rule that is the most recently applicable proposal issued under part 330 of title 21, Code of Federal Regulations, shall be deemed to be a [new drug](/usc/21/321.md?p=p) under [section 321(p) of this title](/usc/21/321.md?p=p), misbranded under [section 352(ee) of this title](/usc/21/352.md?p=ee), and subject to the requirement for an approved [new drug](/usc/21/321.md?p=p) application under [section 355 of this title](/usc/21/355.md) beginning on the day that is 180 calendar days after March 27, 2020, unless, before such day, the [Secretary](/usc/21/321.md?p=d) determines that it is in the interest of public health to extend the period during which the [drug](/usc/21/321.md?p=g-1) may be marketed without such an approved [new drug](/usc/21/321.md?p=p) application.
  - (5) **Drugs not GRASE deemed new drugs—** A [drug](/usc/21/321.md?p=g-1) that the [Secretary](/usc/21/321.md?p=d) has determined not to be generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1) under a final determination issued under part 330 of title 21, Code of Federal Regulations, shall be deemed to be a [new drug](/usc/21/321.md?p=p) under [section 321(p) of this title](/usc/21/321.md?p=p), misbranded under [section 352(ee) of this title](/usc/21/352.md?p=ee), and subject to the requirement for an approved [new drug](/usc/21/321.md?p=p) application under [section 355 of this title](/usc/21/355.md).
  - (6) **Other drugs deemed new drugs—** Except as provided in [subsection (m)](#m), a [drug](/usc/21/321.md?p=g-1) is deemed to be a [new drug](/usc/21/321.md?p=p) under [section 321(p) of this title](/usc/21/321.md?p=p) and misbranded under [section 352(ee) of this title](/usc/21/352.md?p=ee) if the [drug](/usc/21/321.md?p=g-1)—
    - (A) is not subject to [section 353(b)(1) of this title](/usc/21/353.md?p=b-1); and
    - (B) is not described in paragraph [(1)](#a-1), [(2)](#a-2), [(3)](#a-3), [(4)](#a-4), or [(5)](#a-5), or [subsection (b)(1)(B)](#b-1-B).
- (b) **Administrative orders—**
  - (1) **In general—**
    - (A) **Determination—** The [Secretary](/usc/21/321.md?p=d) may, on the initiative of the [Secretary](/usc/21/321.md?p=d) or at the request of one or more requestors, issue an administrative order determining whether there are conditions under which a specific [drug](/usc/21/321.md?p=g-1), a class of [drugs](/usc/21/321.md?p=g-1), or a combination of [drugs](/usc/21/321.md?p=g-1), is determined to be—
      - (i) not subject to [section 353(b)(1) of this title](/usc/21/353.md?p=b-1); and
      - (ii) generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1).
    - (B) **Effect—** A [drug](/usc/21/321.md?p=g-1) or combination of [drugs](/usc/21/321.md?p=g-1) shall be deemed to not require approval under [section 355 of this title](/usc/21/355.md) if such [drug](/usc/21/321.md?p=g-1) or combination of [drugs](/usc/21/321.md?p=g-1)—
      - (i) is determined by the [Secretary](/usc/21/321.md?p=d) to meet the conditions specified in clauses [(i)](#b-1-A-i) and [(ii)](#b-1-A-ii) of subparagraph (A);
      - (ii) is marketed in conformity with an administrative order under this subsection;
      - (iii) meets the general requirements for [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1); and
      - (iv) meets the requirements under subsections [(c)](#c) and [(k)](#k).
    - (C) **Standard—** The [Secretary](/usc/21/321.md?p=d) shall find that a [drug](/usc/21/321.md?p=g-1) is not generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1) if—
      - (i) the evidence shows that the [drug](/usc/21/321.md?p=g-1) is not generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1); or
      - (ii) the evidence is inadequate to show that the [drug](/usc/21/321.md?p=g-1) is generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1).
  - (2) **Administrative orders initiated by the Secretary—**
    - (A) **In general—** In issuing an administrative order under [paragraph (1)](#b-1) upon the [Secretary](/usc/21/321.md?p=d)’s initiative, the [Secretary](/usc/21/321.md?p=d) shall—
      - (i) make reasonable efforts to notify informally, not later than 2 business days before the issuance of the proposed order, the [sponsors](/usc/21/360fff.md?p=8) of [drugs](/usc/21/321.md?p=g-1) who have a listing in effect under [section 360(j) of this title](/usc/21/360.md?p=j) for the [drugs](/usc/21/321.md?p=g-1) or combination of [drugs](/usc/21/321.md?p=g-1) that will be subject to the administrative order;
      - (ii) after any such reasonable efforts of notification—
        - (I) issue a proposed administrative order by publishing it on the website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration and include in such order the reasons for the issuance of such order; and
        - (II) publish a notice of availability of such proposed order in the Federal Register;
      - (iii) except as provided in [subparagraph (B)](#b-2-B), provide for a public comment period with respect to such proposed order of not less than 45 calendar days; and
      - (iv) if, after completion of the proceedings specified in clauses [(i)](#b-2-A-i) through [(iii)](#b-2-A-iii), the [Secretary](/usc/21/321.md?p=d) determines that it is appropriate to issue a final administrative order—
        - (I) issue the final administrative order, together with a detailed statement of reasons, which order shall not take effect until the time for requesting judicial review under [paragraph (3)(D)(ii)](#b-3-D-ii) has expired;
        - (II) publish a notice of such final administrative order in the Federal Register;
        - (III) afford [sponsors](/usc/21/360fff.md?p=8) or requestors of [drugs](/usc/21/321.md?p=g-1) that will be subject to such order the opportunity for formal dispute resolution up to the level of the Director of the Center for [Drug](/usc/21/321.md?p=g-1) Evaluation and Research, which initially must be requested within 45 calendar days of the issuance of the order, and, for subsequent levels of appeal, within 30 calendar days of the prior decision; and
        - (IV) except with respect to [drugs](/usc/21/321.md?p=g-1) described in [paragraph (3)(B)](#b-3-B), upon completion of the formal dispute resolution procedure, inform the [persons](/usc/21/321.md?p=e) which sought such dispute resolution of their right to request a hearing.
    - (B) **Exceptions—** When issuing an administrative order under [paragraph (1)](#b-1) on the [Secretary](/usc/21/321.md?p=d)’s initiative proposing to determine that a [drug](/usc/21/321.md?p=g-1) described in [subsection (a)(3)](#a-3) is not generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1), the [Secretary](/usc/21/321.md?p=d) shall follow the procedures in [subparagraph (A)](#b-2-A), except that—
      - (i) the proposed order shall include notice of—
        - (I) the general categories of data the [Secretary](/usc/21/321.md?p=d) has determined necessary to establish that the [drug](/usc/21/321.md?p=g-1) is generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1); and
        - (II) the format for submissions by interested [persons](/usc/21/321.md?p=e);
      - (ii) the [Secretary](/usc/21/321.md?p=d) shall provide for a public comment period of no less than 180 calendar days with respect to such proposed order, except when the [Secretary](/usc/21/321.md?p=d) determines, for good cause, that a shorter period is in the interest of public health; and
      - (iii) any [person](/usc/21/321.md?p=e) who submits data in such comment period shall include a certification that the [person](/usc/21/321.md?p=e) has submitted all evidence created, obtained, or received by that [person](/usc/21/321.md?p=e) that is both within the categories of data identified in the proposed order and relevant to a determination as to whether the [drug](/usc/21/321.md?p=g-1) is generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1).
  - (3) **Hearings; judicial review—**
    - (A) **In general—** Only a [person](/usc/21/321.md?p=e) who participated in each stage of formal dispute resolution under [subclause (III)](#b-2-A-iv-III) of paragraph (2)(A)(iv) of an administrative order with respect to a [drug](/usc/21/321.md?p=g-1) may request a hearing concerning a final administrative order issued under such paragraph with respect to such [drug](/usc/21/321.md?p=g-1). If a hearing is sought, such [person](/usc/21/321.md?p=e) must submit a request for a hearing, which shall be based solely on information in the administrative record, to the [Secretary](/usc/21/321.md?p=d) not later than 30 calendar days after receiving notice of the final decision of the formal dispute resolution procedure.
    - (B) **No hearing required with respect to orders relating to certain drugs—**
      - (i) **In general—** The [Secretary](/usc/21/321.md?p=d) shall not be required to provide notice and an opportunity for a hearing pursuant to [paragraph (2)(A)(iv)](#b-2-A-iv) if the final administrative order involved relates to a [drug](/usc/21/321.md?p=g-1)—
        - (I) that is described in [subsection (a)(3)(A)](#a-3-A); and
        - (II) with respect to which no human or non-human data studies relevant to the safety or effectiveness of such [drug](/usc/21/321.md?p=g-1) have been submitted to the administrative record since the issuance of the most recent tentative final monograph relating to such [drug](/usc/21/321.md?p=g-1).
      - (ii) **Human data studies and non-human data defined—** In this subparagraph:
        - (I) The term “human data studies” means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies.
        - (II) The term “non-human data” means data from testing other than with human subjects which provides information concerning safety or effectiveness.
    - (C) **Hearing procedures—**
      - (i) **Denial of request for hearing—** If the [Secretary](/usc/21/321.md?p=d) determines that information submitted in a request for a hearing under [subparagraph (A)](#b-3-A) with respect to a final administrative order issued under [paragraph (2)(A)(iv)](#b-2-A-iv) does not identify the existence of a genuine and substantial question of material fact, the [Secretary](/usc/21/321.md?p=d) may deny such request. In making such a determination, the [Secretary](/usc/21/321.md?p=d) may consider only information and data that are based on relevant and reliable scientific principles and methodologies.
      - (ii) **Single hearing for multiple related requests—** If more than one request for a hearing is submitted with respect to the same administrative order under [subparagraph (A)](#b-3-A), the [Secretary](/usc/21/321.md?p=d) may direct that a single hearing be conducted in which all [persons](/usc/21/321.md?p=e) whose hearing requests were granted may participate.
      - (iii) **Presiding officer—** The presiding officer of a hearing requested under [subparagraph (A)](#b-3-A) shall—
        - (I) be designated by the [Secretary](/usc/21/321.md?p=d);
        - (II) not be an employee of the Center for [Drug](/usc/21/321.md?p=g-1) Evaluation and Research; and
        - (III) not have been previously involved in the development of the administrative order involved or proceedings relating to that administrative order.
      - (iv) **Rights of parties to hearing—** The parties to a hearing requested under [subparagraph (A)](#b-3-A) shall have the right to present testimony, including testimony of expert witnesses, and to cross-examine witnesses presented by other parties. Where appropriate, the presiding officer may require that cross-examination by parties representing substantially the same interests be consolidated to promote efficiency and avoid duplication.
      - (v) **Final decision—**
        - (I) At the conclusion of a hearing requested under [subparagraph (A)](#b-3-A), the presiding officer of the hearing shall issue a decision containing findings of fact and conclusions of law. The decision of the presiding officer shall be final.
        - (II) The final decision may not take effect until the period under [subparagraph (D)(ii)](#b-3-D-ii) for submitting a request for judicial review of such decision expires.
    - (D) **Judicial review of final administrative order—**
      - (i) **In general—** The procedures described in [section 355(h) of this title](/usc/21/355.md?p=h) shall apply with respect to judicial review of final administrative orders issued under this subsection in the same manner and to the same extent as such section applies to an order described in such section except that the judicial review shall be taken by filing in an appropriate district court of the United States in lieu of the appellate courts specified in such section.
      - (ii) **Period to submit a request for judicial review—** A [person](/usc/21/321.md?p=e) eligible to request a hearing under this paragraph and seeking judicial review of a final administrative order issued under this subsection shall file such request for judicial review not later than 60 calendar days after the latest of—
        - (I) the date on which notice of such order is published;
        - (II) the date on which a hearing with respect to such order is denied under subparagraph [(B)](#b-3-B) or [(C)(i)](#b-3-C-i);
        - (III) the date on which a final decision is made following a hearing under [subparagraph (C)(v)](#b-3-C-v); or
        - (IV) if no hearing is requested, the date on which the time for requesting a hearing expires.
  - (4) **Expedited procedure with respect to administrative orders initiated by the Secretary—**
    - (A) **Imminent hazard to the public health—**
      - (i) **In general—** In the case of a determination by the [Secretary](/usc/21/321.md?p=d) that a [drug](/usc/21/321.md?p=g-1), class of [drugs](/usc/21/321.md?p=g-1), or combination of [drugs](/usc/21/321.md?p=g-1) subject to this section poses an imminent hazard to the public health, the [Secretary](/usc/21/321.md?p=d), after first making reasonable efforts to notify, not later than 48 hours before issuance of such order under this subparagraph, [sponsors](/usc/21/360fff.md?p=8) who have a listing in effect under [section 360(j) of this title](/usc/21/360.md?p=j) for such [drug](/usc/21/321.md?p=g-1) or combination of [drugs](/usc/21/321.md?p=g-1)—
        - (I) may issue an interim final administrative order for such [drug](/usc/21/321.md?p=g-1), class of [drugs](/usc/21/321.md?p=g-1), or combination of [drugs](/usc/21/321.md?p=g-1) under [paragraph (1)](#b-1), together with a detailed statement of the reasons for such order;
        - (II) shall publish in the Federal Register a notice of availability of any such order; and
        - (III) shall provide for a public comment period of at least 45 calendar days with respect to such interim final order.
      - (ii) **Nondelegation—** The [Secretary](/usc/21/321.md?p=d) may not delegate the authority to issue an interim final administrative order under this subparagraph.
    - (B) **Safety labeling changes—**
      - (i) **In general—** In the case of a determination by the [Secretary](/usc/21/321.md?p=d) that a change in the [labeling](/usc/21/321.md?p=m) of a [drug](/usc/21/321.md?p=g-1), class of [drugs](/usc/21/321.md?p=g-1), or combination of [drugs](/usc/21/321.md?p=g-1) subject to this section is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the [drug](/usc/21/321.md?p=g-1), the [Secretary](/usc/21/321.md?p=d) may—
        - (I) make reasonable efforts to notify informally, not later than 48 hours before the issuance of the interim final order, the [sponsors](/usc/21/360fff.md?p=8) of [drugs](/usc/21/321.md?p=g-1) who have a listing in effect under [section 360(j) of this title](/usc/21/360.md?p=j) for such [drug](/usc/21/321.md?p=g-1) or combination of [drugs](/usc/21/321.md?p=g-1);
        - (II) after reasonable efforts of notification, issue an interim final administrative order in accordance with [paragraph (1)](#b-1) to require such change, together with a detailed statement of the reasons for such order;
        - (III) publish in the Federal Register a notice of availability of such order; and
        - (IV) provide for a public comment period of at least 45 calendar days with respect to such interim final order.
      - (ii) **Content of order—** An interim final order issued under this subparagraph with respect to the [labeling](/usc/21/321.md?p=m) of a [drug](/usc/21/321.md?p=g-1) may provide for new warnings and other information required for [safe](/usc/21/321.md?p=u) use of the [drug](/usc/21/321.md?p=g-1).
    - (C) **Effective date—** An order under subparagraph [(A)](#b-4-A) or [(B)](#b-4-B) shall take effect on a date specified by the [Secretary](/usc/21/321.md?p=d).
    - (D) **Final order—** After the completion of the proceedings in subparagraph [(A)](#b-4-A) or [(B)](#b-4-B), the [Secretary](/usc/21/321.md?p=d) shall—
      - (i) issue a final order in accordance with [paragraph (1)](#b-1);
      - (ii) publish a notice of availability of such final administrative order in the Federal Register; and
      - (iii) afford [sponsors](/usc/21/360fff.md?p=8) of such [drugs](/usc/21/321.md?p=g-1) that will be subject to such an order the opportunity for formal dispute resolution up to the level of the Director of the Center for [Drug](/usc/21/321.md?p=g-1) Evaluation and Research, which must initially be within 45 calendar days of the issuance of the order, and for subsequent levels of appeal, within 30 calendar days of the prior decision.
    - (E) **Hearings—** A [sponsor](/usc/21/360fff.md?p=8) of a [drug](/usc/21/321.md?p=g-1) subject to a final order issued under [subparagraph (D)](#b-4-D) and that participated in each stage of formal dispute resolution under [clause (iii)](#b-4-D-iii) of such subparagraph may request a hearing on such order. The provisions of subparagraphs [(A)](#b-3-A), [(B)](#b-3-B), and [(C)](#b-3-C) of paragraph (3), other than [paragraph (3)(C)(v)(II)](#b-3-C-v-II), shall apply with respect to a hearing on such order in the same manner and to the same extent as such provisions apply with respect to a hearing on an administrative order issued under [paragraph (2)(A)(iv)](#b-2-A-iv).
    - (F) **Timing—**
      - (i) **Final order and hearing—** The [Secretary](/usc/21/321.md?p=d) shall—
        - (I) not later than 6 months after the date on which the comment period closes under subparagraph [(A)](#b-4-A) or [(B)](#b-4-B), issue a final order in accordance with [paragraph (1)](#b-1); and
        - (II) not later than 12 months after the date on which such final order is issued, complete any hearing under [subparagraph (E)](#b-4-E).
      - (ii) **Dispute resolution request—** The [Secretary](/usc/21/321.md?p=d) shall specify in an interim final order issued under subparagraph [(A)](#b-4-A) or [(B)](#b-4-B) such shorter periods for requesting dispute resolution under [subparagraph (D)(iii)](#b-4-D-iii) as are necessary to meet the requirements of this subparagraph.
    - (G) **Judicial review—** A final order issued pursuant to [subparagraph (F)](#b-4-F) shall be subject to judicial review in accordance with [paragraph (3)(D)](#b-3-D).
  - (5) **Administrative order initiated at the request of a requestor—**
    - (A) **In general—** In issuing an administrative order under [paragraph (1)](#b-1) at the request of a requestor with respect to certain [drugs](/usc/21/321.md?p=g-1), classes of [drugs](/usc/21/321.md?p=g-1), or combinations of [drugs](/usc/21/321.md?p=g-1)—
      - (i) the [Secretary](/usc/21/321.md?p=d) shall, after receiving a request under this subparagraph, determine whether the request is sufficiently complete and formatted to permit a substantive review;
      - (ii) if the [Secretary](/usc/21/321.md?p=d) determines that the request is sufficiently complete and formatted to permit a substantive review, the [Secretary](/usc/21/321.md?p=d) shall—
        - (I) file the request; and
        - (II) initiate proceedings with respect to issuing an administrative order in accordance with paragraphs [(2)](#b-2) and [(3)](#b-3); and
      - (iii) except as provided in [paragraph (6)](#b-6), if the [Secretary](/usc/21/321.md?p=d) determines that a request does not meet the requirements for filing or is not sufficiently complete and formatted to permit a substantive review, the requestor may demand that the request be filed over protest, and the [Secretary](/usc/21/321.md?p=d) shall initiate proceedings to review the request in accordance with [paragraph (2)(A)](#b-2-A).
    - (B) **Request to initiate proceedings—**
      - (i) **In general—** A requestor seeking an administrative order under [paragraph (1)](#b-1) with respect to certain [drugs](/usc/21/321.md?p=g-1), classes of [drugs](/usc/21/321.md?p=g-1), or combinations of [drugs](/usc/21/321.md?p=g-1), shall submit to the [Secretary](/usc/21/321.md?p=d) a request to initiate proceedings for such order in the form and manner as specified by the [Secretary](/usc/21/321.md?p=d). Such requestor may submit a request under this subparagraph for the issuance of an administrative order—
        - (I) determining whether a [drug](/usc/21/321.md?p=g-1) is generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1), exempt from [section 353(b)(1) of this title](/usc/21/353.md?p=b-1), and not required to be the subject of an approved application under [section 355 of this title](/usc/21/355.md); or
        - (II) determining whether a change to a condition of use of a [drug](/usc/21/321.md?p=g-1) is generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1), exempt from [section 353(b)(1) of this title](/usc/21/353.md?p=b-1), and not required to be the subject of an approved application under [section 355 of this title](/usc/21/355.md), if, absent such a changed condition of use, such [drug](/usc/21/321.md?p=g-1) is—
          - (aa) generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1) in accordance with subsection [(a)(1)](#a-1), [(a)(2)](#a-2), or an order under this subsection; or
          - (bb) subject to [subsection (a)(3)](#a-3), but only if such requestor initiates such request in conjunction with a request for the [Secretary](/usc/21/321.md?p=d) to determine whether such [drug](/usc/21/321.md?p=g-1) is generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1), which is filed by the [Secretary](/usc/21/321.md?p=d) under [subparagraph (A)(ii)](#b-5-A-ii).
      - (ii) **Exception—** The [Secretary](/usc/21/321.md?p=d) is not required to complete review of a request for a change described in [clause (i)(II)](#b-5-B-i-II) if the [Secretary](/usc/21/321.md?p=d) determines that there is an inadequate basis to find the [drug](/usc/21/321.md?p=g-1) is generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1) under [paragraph (1)](#b-1) and issues a final order announcing that determination.
      - (iii) **Withdrawal—** The requestor may withdraw a request under this paragraph, according to the procedures set forth pursuant to [subsection (d)(2)(B)](#d-2-B). Notwithstanding any other provision of this section, if such request is withdrawn, the [Secretary](/usc/21/321.md?p=d) may cease proceedings under this subparagraph.
    - (C) **Exclusivity—**
      - (i) **In general—** A final administrative order issued in response to a request under this section shall have the effect of authorizing solely the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such order), for a period of 18 months following the effective date of such final order and beginning on the date the requestor may lawfully market such [drugs](/usc/21/321.md?p=g-1) pursuant to the order, to market [drugs](/usc/21/321.md?p=g-1)—
        - (I) incorporating changes described in [clause (ii)](#b-5-C-ii); and
        - (II) subject to the limitations under [clause (iv)](#b-5-C-iv).
      - (ii) **Changes described—** A change described in this clause is a change subject to an order specified in [clause (i)](#b-5-C-i), which—
        - (I) provides for a [drug](/usc/21/321.md?p=g-1) to contain an active ingredient (including any ester or salt of the active ingredient) not previously incorporated in a [drug](/usc/21/321.md?p=g-1) described in [clause (iii)](#b-5-C-iii); or
        - (II) provides for a change in the conditions of use of a [drug](/usc/21/321.md?p=g-1), for which new human data studies conducted or sponsored by the requestor (or for which the requestor has an exclusive right of reference) were essential to the issuance of such order.
      - (iii) **Drugs described—** The [drugs](/usc/21/321.md?p=g-1) described in this clause are [drugs](/usc/21/321.md?p=g-1)—
        - (I) specified in subsection [(a)(1)](#a-1), [(a)(2)](#a-2), or [(a)(3)](#a-3);
        - (II) subject to a final order issued under this section;
        - (III) subject to a [final sunscreen order](/usc/21/360fff.md?p=2) (as defined in [section 360fff(2)(A) of this title](/usc/21/360fff.md?p=2-A)); or
        - (IV) described in [subsection (m)(1)](#m-1), other than [drugs](/usc/21/321.md?p=g-1) subject to an active enforcement action under subchapter III of this chapter.
      - (iv) **Limitations on exclusivity—**
        - (I) **In general—** Only one 18-month period under this subparagraph shall be granted, under each order described in [clause (i)](#b-5-C-i), with respect to changes (to the [drug](/usc/21/321.md?p=g-1) subject to such order) which are either—
          - (aa) changes described in [clause (ii)(I)](#b-5-C-ii-I), relating to active ingredients; or
          - (bb) changes described in [clause (ii)(II)](#b-5-C-ii-II), relating to conditions of use.
        - (II) **No exclusivity allowed—** No exclusivity shall apply to changes to a [drug](/usc/21/321.md?p=g-1) which are—
          - (aa) the subject of a Tier 2 OTC monograph order request (as defined in [section 379j–71 of this title](/usc/21/379j–71.md));
          - (bb) safety-related changes, as defined by the [Secretary](/usc/21/321.md?p=d), or any other changes the [Secretary](/usc/21/321.md?p=d) considers necessary to assure [safe](/usc/21/321.md?p=u) use; or
          - (cc) changes related to methods of testing safety or efficacy.
      - (v) **New human data studies defined—** In this subparagraph, the term “new human data studies” means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies, the results of which—
        - (I) have not been relied on by the [Secretary](/usc/21/321.md?p=d) to support—
          - (aa) a proposed or final determination that a [drug](/usc/21/321.md?p=g-1) described in subclause [(I)](#b-5-C-iii-I), [(II)](#b-5-C-iii-II), or [(III)](#b-5-C-iii-III) of clause (iii) is generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1); or
          - (bb) approval of a [drug](/usc/21/321.md?p=g-1) that was approved under [section 355 of this title](/usc/21/355.md); and
        - (II) do not duplicate the results of another study that was relied on by the [Secretary](/usc/21/321.md?p=d) to support—
          - (aa) a proposed or final determination that a [drug](/usc/21/321.md?p=g-1) described in subclause [(I)](#b-5-C-iii-I), [(II)](#b-5-C-iii-II), or [(III)](#b-5-C-iii-III) of clause (iii) is generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1); or
          - (bb) approval of a [drug](/usc/21/321.md?p=g-1) that was approved under [section 355 of this title](/usc/21/355.md).
      - (vi) **Notification of drug not available for sale—** A requestor that is granted exclusivity with respect to a [drug](/usc/21/321.md?p=g-1) under this subparagraph shall notify the [Secretary](/usc/21/321.md?p=d) in writing within 1 year of the issuance of the final administrative order if the [drug](/usc/21/321.md?p=g-1) that is the subject of such order will not be available for sale within 1 year of the date of issuance of such order. The requestor shall include with such notice the—
        - (I) identity of the [drug](/usc/21/321.md?p=g-1) by established name and by proprietary name, if any;
        - (II) strength of the [drug](/usc/21/321.md?p=g-1);
        - (III) date on which the [drug](/usc/21/321.md?p=g-1) will be available for sale, if known; and
        - (IV) reason for not marketing the [drug](/usc/21/321.md?p=g-1) after issuance of the order.
  - (6) **Information regarding safe nonprescription marketing and use as condition for filing a generally recognized as safe and effective request—**
    - (A) **In general—** In response to a request under this section that a [drug](/usc/21/321.md?p=g-1) described in [subparagraph (B)](#b-6-B) be generally recognized as [safe](/usc/21/321.md?p=u) and effective, the [Secretary](/usc/21/321.md?p=d)—
      - (i) may file such request, if the request includes information specified under [subparagraph (C)](#b-6-C) with respect to [safe](/usc/21/321.md?p=u) [nonprescription](/usc/21/360fff.md?p=5) marketing and use of such [drug](/usc/21/321.md?p=g-1); or
      - (ii) if the request fails to include information specified under [subparagraph (C)](#b-6-C), shall refuse to file such request and require that [nonprescription](/usc/21/360fff.md?p=5) marketing of the [drug](/usc/21/321.md?p=g-1) be pursuant to a [new drug](/usc/21/321.md?p=p) application as described in [subparagraph (D)](#b-6-D).
    - (B) **Drug described—** A [drug](/usc/21/321.md?p=g-1) described in this subparagraph is a [nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1) which contains an active ingredient not previously incorporated in a [drug](/usc/21/321.md?p=g-1)—
      - (i) specified in subsection [(a)(1)](#a-1), [(a)(2)](#a-2), or [(a)(3)](#a-3);
      - (ii) subject to a final order under this section; or
      - (iii) subject to a [final sunscreen order](/usc/21/360fff.md?p=2) (as defined in [section 360fff(2)(A) of this title](/usc/21/360fff.md?p=2-A)).
    - (C) **Information demonstrating prima facie safe nonprescription marketing and use—** Information specified in this subparagraph, with respect to a request described in [subparagraph (A)(i)](#b-6-A-i), is—
      - (i) information sufficient for a prima facie demonstration that the [drug](/usc/21/321.md?p=g-1) subject to such request has a verifiable history of being marketed and safely used by consumers in the United States as a [nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1) under comparable conditions of use;
      - (ii) if the [drug](/usc/21/321.md?p=g-1) has not been previously marketed in the United States as a [nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1), information sufficient for a prima facie demonstration that the [drug](/usc/21/321.md?p=g-1) was marketed and safely used under comparable conditions of marketing and use in a country listed in [section 382(b)(1)(A) of this title](/usc/21/382.md?p=b-1-A) or designated by the [Secretary](/usc/21/321.md?p=d) in accordance with [section 382(b)(1)(B) of this title](/usc/21/382.md?p=b-1-B)—
        - (I) for such period as needed to provide reasonable assurances concerning the [safe](/usc/21/321.md?p=u) [nonprescription](/usc/21/360fff.md?p=5) use of the [drug](/usc/21/321.md?p=g-1); and
        - (II) during such time was subject to sufficient monitoring by a regulatory body considered acceptable by the [Secretary](/usc/21/321.md?p=d) for such monitoring purposes, including for adverse events associated with [nonprescription](/usc/21/360fff.md?p=5) use of the [drug](/usc/21/321.md?p=g-1); or
      - (iii) if the [Secretary](/usc/21/321.md?p=d) determines that information described in clause [(i)](#b-6-C-i) or [(ii)](#b-6-C-ii) is not needed to provide a prima facie demonstration that the [drug](/usc/21/321.md?p=g-1) can be safely marketed and used as a [nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1), such other information the [Secretary](/usc/21/321.md?p=d) determines is sufficient for such purposes.
    - (D) **Marketing pursuant to new drug application—** In the case of a request described in [subparagraph (A)(ii)](#b-6-A-ii), the [drug](/usc/21/321.md?p=g-1) subject to such request may be resubmitted for filing only if—
      - (i) the [drug](/usc/21/321.md?p=g-1) is marketed as a [nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1), under conditions of use comparable to the conditions specified in the request, for such period as the [Secretary](/usc/21/321.md?p=d) determines appropriate (not to exceed 5 consecutive years) pursuant to an application approved under [section 355 of this title](/usc/21/355.md); and
      - (ii) during such period, 1,000,000 retail [packages](/usc/21/360eee.md?p=11-A) of the [drug](/usc/21/321.md?p=g-1), or an equivalent quantity as determined by the [Secretary](/usc/21/321.md?p=d), were distributed for retail sale, as determined in such manner as the [Secretary](/usc/21/321.md?p=d) finds appropriate.
    - (E) **Rule of application—** Except in the case of a request involving a [drug](/usc/21/321.md?p=g-1) described in [section 360fff(9) of this title](/usc/21/360fff.md?p=9), as in effect on January 1, 2017, if the [Secretary](/usc/21/321.md?p=d) refuses to file a request under this paragraph, the requestor may not file such request over protest under [paragraph (5)(A)(iii)](#b-5-A-iii).
  - (7) **Packaging—** An administrative order issued under paragraph [(2)](#b-2), [(4)(A)](#b-4-A), or [(5)](#b-5) may include requirements for the packaging of a [drug](/usc/21/321.md?p=g-1) to encourage use in accordance with [labeling](/usc/21/321.md?p=m). Such requirements may include unit dose packaging, requirements for [products](/usc/21/360eee.md?p=13) intended for use by pediatric populations, requirements to reduce risk of harm from unsupervised ingestion, and other appropriate requirements. This paragraph does not authorize the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration to require standards or testing procedures as described in part 1700 of title 16, Code of Federal Regulations.
  - (8) **Final and tentative final monographs for category I drugs deemed final administrative orders—**
    - (A) **In general—** A final monograph or tentative final monograph described in [subparagraph (B)](#b-8-B) shall be deemed to be a final administrative order under this subsection and may be amended, revoked, or otherwise modified in accordance with the procedures of this subsection.
    - (B) **Monographs described—** For purposes of [subparagraph (A)](#b-8-A), a final monograph or tentative final monograph is described in this subparagraph if it—
      - (i) establishes conditions of use for a [drug](/usc/21/321.md?p=g-1) described in paragraph [(1)](#a-1) or [(2)](#a-2) of subsection (a); and
      - (ii) represents the most recently promulgated version of such conditions, including as modified, in whole or in part, by any proposed or final rule.
    - (C) **Deemed orders include harmonizing technical amendments—** The deemed establishment of a final administrative order under [subparagraph (A)](#b-8-A) shall be construed to include any technical amendments to such order as the [Secretary](/usc/21/321.md?p=d) determines necessary to ensure that such order is appropriately harmonized, in terms of terminology or cross-references, with the applicable provisions of this chapter (and regulations thereunder) and any other orders issued under this section.
- (c) **Procedure for minor changes—**
  - (1) **In general—** Minor changes in the dosage form of a [drug](/usc/21/321.md?p=g-1) that is described in paragraph [(1)](#a-1) or [(2)](#a-2) of subsection (a) or the subject of an order issued under [subsection (b)](#b) may be made by a requestor without the issuance of an order under [subsection (b)](#b) if—
    - (A) the requestor maintains such information as is necessary to demonstrate that the change—
      - (i) will not affect the safety or effectiveness of the [drug](/usc/21/321.md?p=g-1); and
      - (ii) will not materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference [product](/usc/21/360eee.md?p=13); and
    - (B) the change is in conformity with the requirements of an applicable administrative order issued by the [Secretary](/usc/21/321.md?p=d) under [paragraph (3)](#c-3).
  - (2) **Additional information—**
    - (A) **Access to records—** A [sponsor](/usc/21/360fff.md?p=8) shall submit records requested by the [Secretary](/usc/21/321.md?p=d) relating to such a minor change under [section 374(a)(4) of this title](/usc/21/374.md?p=a-4), within 15 business days of receiving such a request, or such longer period as the [Secretary](/usc/21/321.md?p=d) may provide.
    - (B) **Insufficient information—** If the [Secretary](/usc/21/321.md?p=d) determines that the information contained in such records is not sufficient to demonstrate that the change does not affect the safety or effectiveness of the [drug](/usc/21/321.md?p=g-1) or materially affect the extent of absorption or other exposure to the active ingredient, the [Secretary](/usc/21/321.md?p=d)—
      - (i) may so inform the [sponsor](/usc/21/360fff.md?p=8) of the [drug](/usc/21/321.md?p=g-1) in writing; and
      - (ii) if the [Secretary](/usc/21/321.md?p=d) so informs the [sponsor](/usc/21/360fff.md?p=8), shall provide the [sponsor](/usc/21/360fff.md?p=8) of the [drug](/usc/21/321.md?p=g-1) with a reasonable opportunity to provide additional information.
    - (C) **Failure to submit sufficient information—** If the [sponsor](/usc/21/360fff.md?p=8) fails to provide such additional information within a time prescribed by the [Secretary](/usc/21/321.md?p=d), or if the [Secretary](/usc/21/321.md?p=d) determines that such additional information does not demonstrate that the change does not—
      - (i) affect the safety or effectiveness of the [drug](/usc/21/321.md?p=g-1); or
      - (ii) materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference [product](/usc/21/360eee.md?p=13),

      the [drug](/usc/21/321.md?p=g-1) as modified is a [new drug](/usc/21/321.md?p=p) under [section 321(p) of this title](/usc/21/321.md?p=p) and shall be deemed to be misbranded under [section 352(ee) of this title](/usc/21/352.md?p=ee).

  - (3) **Determining whether a change will affect safety or effectiveness—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) shall issue one or more administrative orders specifying requirements for determining whether a minor change made by a [sponsor](/usc/21/360fff.md?p=8) pursuant to this subsection will affect the safety or effectiveness of a [drug](/usc/21/321.md?p=g-1) or materially affect the extent of absorption or other exposure to an active ingredient in the [drug](/usc/21/321.md?p=g-1) in comparison to a suitable reference [product](/usc/21/360eee.md?p=13), together with guidance for applying those orders to specific dosage forms.
    - (B) **Standard practices—** The orders and guidance issued by the [Secretary](/usc/21/321.md?p=d) under [subparagraph (A)](#c-3-A) shall take into account relevant public standards and standard practices for evaluating the quality of [drugs](/usc/21/321.md?p=g-1), and may take into account the special needs of populations, including children.
- (d) **Confidentiality of information submitted to the Secretary—**
  - (1) **In general—** Subject to [paragraph (2)](#d-2), any information, including reports of testing conducted on the [drug](/usc/21/321.md?p=g-1) or [drugs](/usc/21/321.md?p=g-1) involved, that is submitted by a requestor in connection with proceedings on an order under this section (including any minor change under [subsection (c)](#c)) and is a trade secret or confidential information subject to [section 552(b)(4) of title 5](/usc/5/552.md?p=b-4) or [section 1905 of title 18](/usc/18/1905.md) shall not be disclosed to the public unless the requestor consents to that disclosure.
  - (2) **Public availability—**
    - (A) **In general—** Except as provided in [subparagraph (B)](#d-2-B), the [Secretary](/usc/21/321.md?p=d) shall—
      - (i) make any information submitted by a requestor in support of a request under [subsection (b)(5)(A)](#b-5-A) available to the public not later than the date on which the proposed order is issued; and
      - (ii) make any information submitted by any other [person](/usc/21/321.md?p=e) with respect to an order requested (or initiated by the [Secretary](/usc/21/321.md?p=d)) under [subsection (b)](#b), available to the public upon such submission.
    - (B) **Limitations on public availability—** Information described in [subparagraph (A)](#d-2-A) shall not be made public if—
      - (i) the information pertains to pharmaceutical quality information, unless such information is necessary to establish standards under which a [drug](/usc/21/321.md?p=g-1) is generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1);
      - (ii) the information is submitted in a requestor-initiated request, but the requestor withdraws such request, in accordance with withdrawal procedures established by the [Secretary](/usc/21/321.md?p=d), before the [Secretary](/usc/21/321.md?p=d) issues the proposed order;
      - (iii) the [Secretary](/usc/21/321.md?p=d) requests and obtains the information under [subsection (c)](#c) and such information is not submitted in relation to an order under [subsection (b)](#b); or
      - (iv) the information is of the type contained in raw datasets.
- (e) **Updates to drug listing information—** A [sponsor](/usc/21/360fff.md?p=8) who makes a change to a [drug](/usc/21/321.md?p=g-1) subject to this section shall submit updated [drug](/usc/21/321.md?p=g-1) listing information for the [drug](/usc/21/321.md?p=g-1) in accordance with [section 360(j) of this title](/usc/21/360.md?p=j) within 30 calendar days of the date when the [drug](/usc/21/321.md?p=g-1) is first commercially marketed, except that a [sponsor](/usc/21/360fff.md?p=8) who was the order requestor with respect to an order subject to [subsection (b)(5)(C)](#b-5-C) (or a licensee, assignee, or successor in interest of such requestor) shall submit updated [drug](/usc/21/321.md?p=g-1) listing information on or before the date when the [drug](/usc/21/321.md?p=g-1) is first commercially marketed.
- (f) **Approvals under section 355 of this title—** The provisions of this section shall not be construed to preclude a [person](/usc/21/321.md?p=e) from seeking or maintaining the approval of an application for a [drug](/usc/21/321.md?p=g-1) under sections [355(b)(1)](/usc/21/355.md?p=b-1), [355(b)(2)](/usc/21/355.md?p=b-2), and [355(j)](/usc/21/355.md?p=j) of this title. A determination under this section that a [drug](/usc/21/321.md?p=g-1) is not subject to [section 353(b)(1) of this title](/usc/21/353.md?p=b-1), is generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1), and is not a [new drug](/usc/21/321.md?p=p) under [section 321(p) of this title](/usc/21/321.md?p=p) shall constitute a finding that the [drug](/usc/21/321.md?p=g-1) is [safe](/usc/21/321.md?p=u) and effective that may be relied upon for purposes of an application under [section 355(b)(2) of this title](/usc/21/355.md?p=b-2), so that the applicant shall be required to submit for purposes of such application only information needed to support any modification of the [drug](/usc/21/321.md?p=g-1) that is not covered by such determination under this section.
- (g) **Public availability of administrative orders—** The [Secretary](/usc/21/321.md?p=d) shall establish, maintain, update (as determined necessary by the [Secretary](/usc/21/321.md?p=d) but no less frequently than annually), and make publicly available, with respect to orders issued under this section—
  - (1) a repository of each final order and interim final order in effect, including the complete text of the order; and
  - (2) a listing of all orders proposed and under development under [subsection (b)(2)](#b-2), including—
    - (A) a brief description of each such order; and
    - (B) the [Secretary](/usc/21/321.md?p=d)’s expectations, if resources permit, for issuance of proposed orders over a 3-year period.
- (h) **Development advice to sponsors or requestors—** The [Secretary](/usc/21/321.md?p=d) shall establish procedures under which [sponsors](/usc/21/360fff.md?p=8), requestors, or organizations nominated by [sponsors](/usc/21/360fff.md?p=8) or requestors to represent their interests in a proceeding may meet with appropriate officials of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration to obtain advice on the studies and other information necessary to support submissions under this section and other matters relevant to the regulation of [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1) and the development of new [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1) under this section.
- (i) **Participation of multiple sponsors or requestors—** The [Secretary](/usc/21/321.md?p=d) shall establish procedures to facilitate efficient participation by multiple [sponsors](/usc/21/360fff.md?p=8) or requestors in proceedings under this section, including provision for joint meetings with multiple [sponsors](/usc/21/360fff.md?p=8) or requestors or with organizations nominated by [sponsors](/usc/21/360fff.md?p=8) or requestors to represent their interests in a proceeding.
- (j) **Electronic format—** All submissions under this section shall be in electronic format.
- (k) **Effect on existing regulations governing nonprescription drugs—**
  - (1) **Regulations of general applicability to nonprescription drugs—** Except as provided in this subsection, nothing in this section supersedes regulations establishing general requirements for [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1), including regulations of general applicability contained in parts 201, 250, and 330 of title 21, Code of Federal Regulations, or any successor regulations. The [Secretary](/usc/21/321.md?p=d) shall establish or modify such regulations by means of rulemaking in accordance with [section 553 of title 5](/usc/5/553.md).
  - (2) **Regulations establishing requirements for specific nonprescription drugs—**
    - (A) The provisions of section 310.545 of title 21, Code of Federal Regulations, as in effect on the day before March 27, 2020, shall be deemed to be a final order under [subsection (b)](#b).
    - (B) Regulations in effect on the day before March 27, 2020, establishing requirements for specific [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1) marketed pursuant to this section (including such requirements in parts 201 and 250 of title 21, Code of Federal Regulations), shall be deemed to be final orders under [subsection (b)](#b), only as they apply to [drugs](/usc/21/321.md?p=g-1)—
      - (i) subject to paragraph [(1)](#a-1), [(2)](#a-2), [(3)](#a-3), or [(4)](#a-4) of subsection (a); or
      - (ii) otherwise subject to an order under this section.
  - (3) **Withdrawal of regulations—** The [Secretary](/usc/21/321.md?p=d) shall withdraw regulations establishing final monographs and the procedures governing the over-the-counter [drug](/usc/21/321.md?p=g-1) review under part 330 and other relevant parts of [title 21](/usc/21.md), Code of Federal Regulations (as in effect on the day before March 27, 2020), or make technical changes to such regulations to ensure conformity with appropriate terminology and cross references. Notwithstanding subchapter II of [chapter 5](/usc/5/chptI/ch5.md) of title 5, any such withdrawal or technical changes shall be made without public notice and comment and shall be effective upon publication through notice in the Federal Register (or upon such date as specified in such notice).
- (l) **Guidance—** The [Secretary](/usc/21/321.md?p=d) shall issue guidance that specifies—
  - (1) the procedures and principles for formal meetings between the [Secretary](/usc/21/321.md?p=d) and [sponsors](/usc/21/360fff.md?p=8) or requestors for [drugs](/usc/21/321.md?p=g-1) subject to this section;
  - (2) the format and content of data submissions to the [Secretary](/usc/21/321.md?p=d) under this section;
  - (3) the format of electronic submissions to the [Secretary](/usc/21/321.md?p=d) under this section;
  - (4) consolidated proceedings for appeal and the procedures for such proceedings where appropriate; and
  - (5) for minor changes in [drugs](/usc/21/321.md?p=g-1), recommendations on how to comply with the requirements in orders issued under [subsection (c)(3)](#c-3).
- (m) **Rule of construction—**
  - (1) **In general—** This section shall not affect the treatment or status of a [nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1)—
    - (A) that is marketed without an application approved under [section 355 of this title](/usc/21/355.md) as of March 27, 2020;
    - (B) that is not subject to an order issued under this section; and
    - (C) to which paragraph [(1)](#a-1), [(2)](#a-2), [(3)](#a-3), [(4)](#a-4), or [(5)](#a-5) of subsection (a) do not apply.
  - (2) **Treatment of products previously found to be subject to time and extent requirements—**
    - (A) Notwithstanding [subsection (a)](#a), a [drug](/usc/21/321.md?p=g-1) described in [subparagraph (B)](#m-2-B) may only be lawfully marketed, without an application approved under [section 355 of this title](/usc/21/355.md), pursuant to an order issued under this section.
    - (B) A [drug](/usc/21/321.md?p=g-1) described in this subparagraph is a [drug](/usc/21/321.md?p=g-1) which, prior to March 27, 2020, the [Secretary](/usc/21/321.md?p=d) determined in a proposed or final rule to be ineligible for review under the OTC [drug](/usc/21/321.md?p=g-1) review (as such phrase “OTC [drug](/usc/21/321.md?p=g-1) review” was used in section 330.14 of title 21, Code of Federal Regulations, as in effect on the day before March 27, 2020).
  - (3) **Preservation of authority—**
    - (A) Nothing in [paragraph (1)](#m-1) shall be construed to preclude or limit the applicability of any provision of this chapter other than this section.
    - (B) Nothing in [subsection (a)](#a) shall be construed to prohibit the [Secretary](/usc/21/321.md?p=d) from issuing an order under this section finding a [drug](/usc/21/321.md?p=g-1) to be not generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p)(1) of this title](/usc/21/321.md?p=p-1), as the [Secretary](/usc/21/321.md?p=d) determines appropriate.
- (n) **Investigational new drugs—** A [drug](/usc/21/321.md?p=g-1) is not subject to this section if an exemption for investigational use under [section 355(i) of this title](/usc/21/355.md?p=i) is in effect for such [drug](/usc/21/321.md?p=g-1).
- (o) **Inapplicability of Paperwork Reduction Act—** [Chapter 35](/usc/44/chch35.md) of title 44 shall not apply to collections of information made under this section.
- (p) **Inapplicability of notice and comment rulemaking and other requirements—** The requirements of [subsection (b)](#b) shall apply with respect to orders issued under this section instead of the requirements of subchapter II of chapter 5 of title 5.
- (q) **Definitions—** In this section:
  - (1) The term “[nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1)” refers to a [drug](/usc/21/321.md?p=g-1) not subject to the requirements of [section 353(b)(1) of this title](/usc/21/353.md?p=b-1).
  - (2) The term “[sponsor](/usc/21/360fff.md?p=8)” refers to any [person](/usc/21/321.md?p=e) marketing, manufacturing, or processing a [drug](/usc/21/321.md?p=g-1) that—
    - (A) is listed pursuant to [section 360(j) of this title](/usc/21/360.md?p=j); and
    - (B) is or will be subject to an administrative order under this section of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
  - (3) The term “requestor” refers to any [person](/usc/21/321.md?p=e) or group of [persons](/usc/21/321.md?p=e) marketing, manufacturing, processing, or developing a [drug](/usc/21/321.md?p=g-1).
- (r) **Evidence and testing standards for active ingredients for topical administration—**
  - (1) **Evidence and testing standards for active ingredients for topical administration—** The [Secretary](/usc/21/321.md?p=d) shall—
    - (A) in evaluating the generally recognized as [safe](/usc/21/321.md?p=u) and effective status of active ingredients used in [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1) intended for topical administration for purposes of [subsection (a)](#a), utilize standards that allow for the use of real world evidence (as defined in [section 355g(b) of this title](/usc/21/355g.md?p=b)), as appropriate, as part of a comprehensive evaluation of scientific evidence to demonstrate the safety and effectiveness of such active ingredients, to supplement evidence from traditional clinical trials, provided that such standards allow the [Secretary](/usc/21/321.md?p=d) to evaluate whether the benefits of such active ingredients outweigh the risks; and
    - (B) apply [subsection (b)(6)(C)](#b-6-C) to the regulation of active ingredients used in [drugs](/usc/21/321.md?p=g-1) intended for topical administration.
  - (2) **Non-animal testing methods for topical active ingredients—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) shall consider the types of nonclinical tests described in paragraphs [(1)](#r-1) through (4) of the first subsection (z) of [section 355 of this title](/usc/21/355.md) (as inserted by section 3209(a)(2) of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022 (division FF of Public Law 117–328)), or any other alternative to animal testing that the [Secretary](/usc/21/321.md?p=d) determines appropriate, in the consideration of [drugs](/usc/21/321.md?p=g-1) intended for topical administration under this section.
    - (B) **Guidance—** Not later than 1 year after November 12, 2025, the [Secretary](/usc/21/321.md?p=d) shall issue new draft guidance on how [sponsors](/usc/21/360fff.md?p=8) can use nonclinical testing alternatives to animal testing, as appropriate, to meet safety and efficacy standards under this section for [drugs](/usc/21/321.md?p=g-1) intended for topical administration.
  - (3) **Clarification—** Nothing in this subsection shall be construed to alter, supersede, or limit the standards for making determinations of whether a [drug](/usc/21/321.md?p=g-1) is generally recognized as [safe](/usc/21/321.md?p=u) and effective under [section 321(p) of this title](/usc/21/321.md?p=p) or the standards set forth under [section 355 of this title](/usc/21/355.md) for determining the safety and effectiveness of [drugs](/usc/21/321.md?p=g-1).

## Source credit

(June 25, 1938, ch. 675, § 505G, as added Pub. L. 116–136, div. A, title III, § 3851(a), Mar. 27, 2020, 134 Stat. 435; amended Pub. L. 119–37, div. F, title V, §§ 6506(a), 6508, Nov. 12, 2025, 139 Stat. 644, 648.)

## Notes

### Editorial Notes

### Amendments

2025—Subsec. (b)(2)(A)(iv)(III). Pub. L. 119–37, § 6508(b), substituted “sponsors or requestors” for “requestors”.

Subsec. (h). Pub. L. 119–37, § 6508(a), substituted “sponsors, requestors, or organizations nominated by sponsors or requestors to represent their interests in a proceeding” for “sponsors or requestors”.

Subsec. (r). Pub. L. 119–37, § 6506(a), added subsec. (r).

### Statutory Notes and Related Subsidiaries

### Drugs Excluded From the Over-the-Counter Drug Review

Pub. L. 116–136, div. A, title III, § 3853, Mar. 27, 2020, 134 Stat. 454, provided that: In General.—Nothing in this Act [probably should be “this subtitle”, meaning subtitle F (§§ 3851–3862) of title III of div. A of Pub. L. 116–136, enacting this section, section 360fff–8 of this title, and subpart 10 of part C of subchapter VII of this chapter, amending sections 352, 360fff–3, 379j–52, 379r, and 381 of this title, repealing section 360fff–5 of this title, and enacting provisions set out as notes under this section and sections 360fff–3, 360fff–6, 379j–52, and 379j–71 of this title] (or the amendments made by this Act) shall apply to any nonprescription drug (as defined in section 505G(q) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(q)], as added by section 3851 of this subtitle) which was excluded by the Food and Drug Administration from the Over-the-Counter Drug Review in accordance with the paragraph numbered 25 on page 9466 of volume 37 of the Federal Register, published on May 11, 1972. Rule of Construction.—Nothing in this section shall be construed to preclude or limit the applicability of any other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).”

### Treatment of Authority Regarding Finalization of Sunscreen Monograph

Pub. L. 116–136, div. A, title III, § 3854(c), Mar. 27, 2020, 134 Stat. 456, provided that:In general.— Revision of final sunscreen order.—The Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’) shall amend and revise the final administrative order concerning nonprescription sunscreen (referred to in this subsection as the ‘sunscreen order’) for which the content, prior to the date of enactment of this Act [Mar. 27, 2020], was represented by the final monograph for sunscreen drug products set forth in part 352 of title 21, Code of Federal Regulations (as in effect on May 21, 1999). Issuance of revised sunscreen order; effective date.—A revised sunscreen order described in subparagraph (A) shall be— issued in accordance with the procedures described in section 505G(b)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(b)(2)]; issued in proposed form not later than 18 months after the date of enactment of this Act; and issued by the Secretary at least 1 year prior to the effective date of the revised order. Reports.—If a revised sunscreen order issued under paragraph (1) does not include provisions related to the effectiveness of various sun protection factor levels, and does not address all dosage forms known to the Secretary to be used in sunscreens marketed in the United States without a new drug application approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), the Secretary shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the rationale for omission of such provisions from such order, and a plan and timeline to compile any information necessary to address such provisions through such order.”

### Annual Update to Congress on Appropriate Pediatric Indication for Certain OTC Cough and Cold Drugs

Pub. L. 116–136, div. A, title III, § 3855, Mar. 27, 2020, 134 Stat. 457, provided that: In General.—Subject to subsection (c), the Secretary of Health and Human Services shall, beginning not later than 1 year after the date of enactment of this Act [Mar. 27, 2020], annually submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a letter describing the progress of the Food and Drug Administration— in evaluating the cough and cold monograph described in subsection (b) with respect to children under age 6; and as appropriate, revising such cough and cold monograph to address such children through the order process under section 505G(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(b)], as added by section 3851 of this subtitle. Cough and Cold Monograph Described.—The cough and cold monograph described in this subsection consists of the conditions under which nonprescription drugs containing antitussive, expectorant, nasal decongestant, or antihistamine active ingredients (or combinations thereof) are generally recognized as safe and effective, as specified in part 341 of title 21, Code of Federal Regulations (as in effect immediately prior to the date of enactment of this Act), and included in an order deemed to be established under section 505G(b) of the Federal Food, Drug, and Cosmetic Act, as added by section 3851 of this subtitle. Duration of Authority.—The requirement under subsection (a) shall terminate as of the date of a letter submitted by the Secretary of Health and Human Services pursuant to such subsection in which the Secretary indicates that the Food and Drug Administration has completed its evaluation and revised, in a final order, as applicable, the cough and cold monograph as described in subsection (a)(2).”