Sec. 101. Regulation of certain nonprescription drugs that are marketed without an approved drug application
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Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505F of such Act ( 21 U.S.C. 355g ) the following: Nonprescription drugs marketed without an approved drug application under section 505, as of the date of the enactment of this section, shall be treated in accordance with this subsection. A drug is deemed to be generally recognized as safe and effective under section 201(p)(1), not a new drug under section 201(p), and not subject to section 503(b)(1), if— the drug is— in conformity with the requirements for nonprescription use of a final monograph issued under part 330 of title 21, Code of Federal Regulations (except as provided in paragraph (2)), the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and except as permitted by an order issued under subsection
(b)or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to the date of the enactment of this section, has been used to a material extent and for a material time under section 201(p)(2); or the drug is— 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; in conformity with the proposed requirements for nonprescription use of such tentative final monograph, any applicable subsequent determination by the Secretary, the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and except as permitted by an order issued under subsection
(b)or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to the date of the enactment of this section, has been used to a material extent and for a material time under section 201(p)(2). With respect to sunscreen drugs subject to this section, the applicable requirements in terms of conformity with a final monograph, for purposes of paragraph (1)(A)(i), shall be the requirements specified in part 352 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 shall be those specified in section 201.327 of title 21, Code of Federal Regulations. A drug that is not described in paragraph (1), (2), or
(4)is not required to be the subject of an application approved under section 505, and is not subject to section 503(b)(1), if— the drug is— 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 issued under part 330 of title 21, Code of Federal Regulations; in conformity with— the conditions of use, including indication and dosage strength, if any, described for such category III drug in such preamble or in an applicable subsequent proposed rule; the proposed requirements for drugs 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; and the general requirements for nonprescription drugs and conditions or requirements under subsection
(b)or (k); and in a dosage form that, immediately prior to the date of the enactment of this section, had been used to a material extent and for a material time under section 201(p)(2); or the drug is— 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 issued under part 330 of title 21, Code of Federal Regulations; in conformity with the requirements for nonprescription use of such proposed monograph or advance notice of proposed rulemaking, any applicable subsequent determination by the Secretary, the general requirements for nonprescription drugs, and conditions or requirements under subsection
(b)or (k); and in a dosage form that, immediately prior to the date of the enactment of this section, has been used to a material extent and for a material time under section 201(p)(2). A drug 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 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 under section 201(p), misbranded under section 502(ee), and subject to the requirement for an approved new drug application under section 505 beginning on the day that is 180 calendar days after the date of the enactment of this section, unless, before such day, the Secretary determines that it is in the interest of public health to extend the period during which the drug may be marketed without such an approved new drug application. A drug that the Secretary has determined not to be generally recognized as safe and effective under section 201(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 under section 201(p), misbranded under section 502(ee), and subject to the requirement for an approved new drug application under section 505. Except as provided in subsection (m), a drug is deemed to be a new drug under section 201(p) and misbranded under section 502(ee) if the drug— is not subject to section 503(b)(1); and is not described in paragraph (1), (2), (3), (4), or (5), or subsection (b)(1)(B). The Secretary may, on the initiative of the Secretary or at the request of one or more requestors, issue an administrative order determining whether there are conditions under which a specific drug, a class of drugs, or a combination of drugs, is determined to be— not subject to section 503(b)(1); and generally recognized as safe and effective under section 201(p)(1). A drug or combination of drugs shall be deemed to not require approval under section 505 if such drug or combination of drugs— is determined by the Secretary to meet the conditions specified in clauses
(i)and
(ii)of subparagraph (A); is marketed in conformity with an administrative order under this subsection; meets the general requirements for nonprescription drugs; and meets the requirements under subsections
(c)and (k). The Secretary shall find that a drug is not generally recognized as safe and effective under section 201(p)(1) if— the evidence shows that the drug is not generally recognized as safe and effective under section 201(p)(1); or the evidence is inadequate to show that the drug is generally recognized as safe and effective under section 201(p)(1). In issuing an administrative order under paragraph
(1)upon the Secretary’s initiative, the Secretary shall— make reasonable efforts to notify informally, not later than 2 business days before the issuance of the proposed order, the sponsors of drugs who have a listing in effect under section 510(j) for the drugs or combination of drugs that will be subject to the administrative order; after any such reasonable efforts of notification— issue a proposed administrative order by publishing it on the website of the Food and Drug Administration and include in such order the reasons for the issuance of such order; and publish a notice of availability of such proposed order in the Federal Register; except as provided in subparagraph (B), provide for a public comment period with respect to such proposed order of not less than 45 calendar days; and if, after completion of the proceedings specified in clauses
(i)through (iii), the Secretary determines that it is appropriate to issue a final administrative order— 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) has expired; publish a notice of such final administrative order in the Federal Register; afford requestors of drugs 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 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 except with respect to drugs described in paragraph (3)(B), upon completion of the formal dispute resolution procedure, inform the persons which sought such dispute resolution of their right to request a hearing. When issuing an administrative order under paragraph
(1)on the Secretary’s initiative proposing to determine that a drug described in subsection (a)(3) is not generally recognized as safe and effective under section 201(p)(1), the Secretary shall follow the procedures in subparagraph (A), except that— the proposed order shall include notice of— the general categories of data the Secretary has determined necessary to establish that the drug is generally recognized as safe and effective under section 201(p)(1); and the format for submissions by interested persons; the Secretary shall provide for a public comment period of no less than 180 calendar days with respect to such proposed order, except when the Secretary determines, for good cause, that a shorter period is in the interest of public health; and any person who submits data in such comment period shall include a certification that the person has submitted all evidence created, obtained, or received by that person that is both within the categories of data identified in the proposed order and relevant to a determination as to whether the drug is generally recognized as safe and effective under section 201(p)(1). Only a person who participated in each stage of formal dispute resolution under subclause
(III)of paragraph (2)(A)(iv) of an administrative order with respect to a drug may request a hearing concerning a final administrative order issued under such paragraph with respect to such drug. If a hearing is sought, such person must submit a request for a hearing, which shall be based solely on information in the administrative record, to the Secretary not later than 30 calendar days after receiving notice of the final decision of the formal dispute resolution procedure. The Secretary shall not be required to provide notice and an opportunity for a hearing pursuant to paragraph (2)(A)(iv) if the final administrative order involved relates to a drug— that is described in subsection (a)(3)(A); and with respect to which no human or non-human data studies relevant to the safety or effectiveness of such drug have been submitted to the administrative record since the issuance of the most recent tentative final monograph relating to such drug. In this subparagraph: The term human data studies means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies. The term non-human data means data from testing other than with human subjects which provides information concerning safety or effectiveness. If the Secretary determines that information submitted in a request for a hearing under subparagraph
(A)with respect to a final administrative order issued under paragraph (2)(A)(iv) does not identify the existence of a genuine and substantial question of material fact, the Secretary may deny such request. In making such a determination, the Secretary may consider only information and data that are based on relevant and reliable scientific principles and methodologies. If more than one request for a hearing is submitted with respect to the same administrative order under subparagraph (A), the Secretary may direct that a single hearing be conducted in which all persons whose hearing requests were granted may participate. The presiding officer of a hearing requested under subparagraph
(A)shall— be designated by the Secretary; not be an employee of the Center for Drug Evaluation and Research; and not have been previously involved in the development of the administrative order involved or proceedings relating to that administrative order. The parties to a hearing requested under subparagraph
(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. At the conclusion of a hearing requested under subparagraph (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. The final decision may not take effect until the period under subparagraph (D)(ii) for submitting a request for judicial review of such decision expires. The procedures described in section 505(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. A person 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— the date on which notice of such order is published; the date on which a hearing with respect to such order is denied under subparagraph
(B)or (C)(i); the date on which a final decision is made following a hearing under subparagraph (C)(v); or if no hearing is requested, the date on which the time for requesting a hearing expires. In the case of a determination by the Secretary that a drug, class of drugs, or combination of drugs subject to this section poses an imminent hazard to the public health, the Secretary, after first making reasonable efforts to notify, not later than 48 hours before issuance of such order under this subparagraph, sponsors who have a listing in effect under section 510(j) for such drug or combination of drugs— may issue an interim final administrative order for such drug, class of drugs, or combination of drugs under paragraph (1), together with a detailed statement of the reasons for such order; shall publish in the Federal Register a notice of availability of any such order; and shall provide for a public comment period of at least 45 calendar days with respect to such interim final order. The Secretary may not delegate the authority to issue an interim final administrative order under this subparagraph. In the case of a determination by the Secretary that a change in the labeling of a drug, class of drugs, or combination of drugs 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, the Secretary may— make reasonable efforts to notify informally, not later than 48 hours before the issuance of the interim final order, the sponsors of drugs who have a listing in effect under section 510(j) for such drug or combination of drugs; after reasonable efforts of notification, issue an interim final administrative order in accordance with paragraph
(1)to require such change, together with a detailed statement of the reasons for such order; publish in the Federal Register a notice of availability of such order; and provide for a public comment period of at least 45 calendar days with respect to such interim final order. An interim final order issued under this subparagraph with respect to the labeling of a drug may provide for new warnings and other information required for safe use of the drug. An order under subparagraph
(A)or
(B)shall take effect on a date specified by the Secretary. After the completion of the proceedings in subparagraph
(A)or (B), the Secretary shall— issue a final order in accordance with paragraph (1); publish a notice of availability of such final administrative order in the Federal Register; and afford sponsors of such drugs 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 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. A sponsor of a drug subject to a final order issued under subparagraph
(D)and that participated in each stage of formal dispute resolution under clause
(iii)of such subparagraph may request a hearing on such order. The provisions of subparagraphs (A), (B), and
(C)of paragraph (3), other than paragraph (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). The Secretary shall— not later than 6 months after the date on which the comment period closes under subparagraph
(A)or (B), issue a final order in accordance with paragraph (1); and not later than 12 months after the date on which such final order is issued, complete any hearing under subparagraph (E). The Secretary shall specify in an interim final order issued under subparagraph
(A)or
(B)such shorter periods for requesting dispute resolution under subparagraph (D)(iii) as are necessary to meet the requirements of this subparagraph. A final order issued pursuant to subparagraph
(F)shall be subject to judicial review in accordance with paragraph (3)(D). In issuing an administrative order under paragraph
(1)at the request of a requestor with respect to certain drugs, classes of drugs, or combinations of drugs— the Secretary shall, after receiving a request under this subparagraph, determine whether the request is sufficiently complete and formatted to permit a substantive review; if the Secretary determines that the request is sufficiently complete and formatted to permit a substantive review, the Secretary shall— file the request; and initiate proceedings with respect to issuing an administrative order in accordance with paragraphs
(2)and (3); and except as provided in paragraph (6), if the Secretary 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 shall initiate proceedings to review the request in accordance with paragraph (2)(A). A requestor seeking an administrative order under paragraph
(1)with respect to certain drugs, classes of drugs, or combinations of drugs, shall submit to the Secretary a request to initiate proceedings for such order in the form and manner as specified by the Secretary. Such requestor may submit a request under this subparagraph for the issuance of an administrative order— determining whether a drug is generally recognized as safe and effective under section 201(p)(1), exempt from section 503(b)(1), and not required to be the subject of an approved application under section 505; or determining whether a change to a condition of use of a drug is generally recognized as safe and effective under section 201(p)(1), exempt from section 503(b)(1), and not required to be the subject of an approved application under section 505, if, absent such a changed condition of use, such drug is— generally recognized as safe and effective under section 201(p)(1) in accordance with subsection (a)(1), (a)(2), or an order under this subsection; or subject to subsection (a)(3), but only if such requestor initiates such request in conjunction with a request for the Secretary to determine whether such drug is generally recognized as safe and effective under section 201(p)(1), which is filed by the Secretary under subparagraph (A)(ii). The Secretary is not required to complete review of a request for a change described in clause (i)(II) if the Secretary determines that there is an inadequate basis to find the drug is generally recognized as safe and effective under section 201(p)(1) under paragraph
(1)and issues a final order announcing that determination. The requestor may withdraw a request under this paragraph, according to the procedures set forth pursuant to subsection (d)(2)(B). Notwithstanding any other provision of this section, if such request is withdrawn, the Secretary may cease proceedings under this subparagraph. 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 pursuant to the order, to market drugs— incorporating changes described in clause (ii); and subject to the limitations under clause (iv). A change described in this clause is a change subject to an order specified in clause (i), which— provides for a drug to contain an active ingredient (including any ester or salt of the active ingredient) not previously incorporated in a drug described in clause (iii); or provides for a change in the conditions of use of a drug, 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. The drugs described in this clause are drugs— specified in subsection (a)(1), (a)(2), or (a)(3); subject to a final order issued under this section; subject to a final sunscreen order (as defined in section 586(2)(A)); or described in subsection (m)(1), other than drugs subject to an active enforcement action under chapter III of this Act. Only one 18-month period under this subparagraph shall be granted, under each order described in clause (i), with respect to changes (to the drug subject to such order) which are either— changes described in clause (ii)(I), relating to active ingredients; or changes described in clause (ii)(II), relating to conditions of use. No exclusivity shall apply to changes to a drug which are— the subject of a Tier 2 OTC monograph order request (as defined in section 744L); safety-related changes, as defined by the Secretary, or any other changes the Secretary considers necessary to assure safe use; or changes related to methods of testing safety or efficacy. 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— have not been relied on by the Secretary to support— a proposed or final determination that a drug described in subclause (I), (II), or
(III)of clause
(iii)is generally recognized as safe and effective under section 201(p)(1); or approval of a drug that was approved under section 505; and do not duplicate the results of another study that was relied on by the Secretary to support— a proposed or final determination that a drug described in subclause (I), (II), or
(III)of clause
(iii)is generally recognized as safe and effective under section 201(p)(1); or approval of a drug that was approved under section 505. A requestor that is granted exclusivity with respect to a drug under this subparagraph shall notify the Secretary in writing within 1 year of the issuance of the final administrative order if the drug 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— identity of the drug by established name and by proprietary name, if any; strength of the drug; date on which the drug will be available for sale, if known; and reason for not marketing the drug after issuance of the order. In response to a request under this section that a drug described in subparagraph
(B)be generally recognized as safe and effective, the Secretary— may file such request, if the request includes information specified under subparagraph
(C)with respect to safe nonprescription marketing and use of such drug; or if the request fails to include information specified under subparagraph (C), shall refuse to file such request and require that nonprescription marketing of the drug be pursuant to a new drug application as described in subparagraph (D). A drug described in this subparagraph is a nonprescription drug which contains an active ingredient not previously incorporated in a drug— specified in subsection (a)(1), (a)(2), or (a)(3); subject to a final order under this section; or subject to a final sunscreen order (as defined in section 586(2)(A)). Information specified in this subparagraph, with respect to a request described in subparagraph (A)(i), is— information sufficient for a prima facie demonstration that the drug subject to such request has a verifiable history of being marketed and safely used by consumers in the United States as a nonprescription drug under comparable conditions of use; if the drug has not been previously marketed in the United States as a nonprescription drug, information sufficient for a prima facie demonstration that the drug was marketed and safely used under comparable conditions of marketing and use in a country listed in section 802(b)(1)(A) or designated by the Secretary in accordance with section 802(b)(1)(B)— for such period as needed to provide reasonable assurances concerning the safe nonprescription use of the drug; and during such time was subject to sufficient monitoring by a regulatory body considered acceptable by the Secretary for such monitoring purposes, including for adverse events associated with nonprescription use of the drug; or if the Secretary determines that information described in clause
(i)or
(ii)is not needed to provide a prima facie demonstration that the drug can be safely marketed and used as a nonprescription drug, such other information the Secretary determines is sufficient for such purposes. In the case of a request described in subparagraph (A)(ii), the drug subject to such request may be resubmitted for filing only if— the drug is marketed as a nonprescription drug, under conditions of use comparable to the conditions specified in the request, for such period as the Secretary determines appropriate (not to exceed 5 consecutive years) pursuant to an application approved under section 505; and during such period, 1,000,000 retail packages of the drug, or an equivalent quantity as determined by the Secretary, were distributed for retail sale, as determined in such manner as the Secretary finds appropriate. Except in the case of a request involving a drug described in section 586(9), as in effect on January 1, 2017, if the Secretary refuses to file a request under this paragraph, the requestor may not file such request over protest under paragraph (5)(A)(iii). An administrative order issued under paragraph (2), (4)(A), or
(5)may include requirements for the packaging of a drug to encourage use in accordance with labeling. Such requirements may include unit dose packaging, requirements for products 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 and Drug Administration to require standards or testing procedures as described in part 1700 of title 16, Code of Federal Regulations. A final monograph or tentative final monograph described in subparagraph
(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. For purposes of subparagraph (A), a final monograph or tentative final monograph is described in this subparagraph if it— establishes conditions of use for a drug described in paragraph
(1)or
(2)of subsection (a); and represents the most recently promulgated version of such conditions, including as modified, in whole or in part, by any proposed or final rule. The deemed establishment of a final administrative order under subparagraph
(A)shall be construed to include any technical amendments to such order as the Secretary determines necessary to ensure that such order is appropriately harmonized, in terms of terminology or cross-references, with the applicable provisions of this Act (and regulations thereunder) and any other orders issued under this section. Minor changes in the dosage form of a drug that is described in paragraph
(1)or
(2)of subsection
(a)or the subject of an order issued under subsection
(b)may be made by a requestor without the issuance of an order under subsection
(b)if— the requestor maintains such information as is necessary to demonstrate that the change— will not affect the safety or effectiveness of the drug; and will not materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product; and the change is in conformity with the requirements of an applicable administrative order issued by the Secretary under paragraph (3). A sponsor shall submit records requested by the Secretary relating to such a minor change under section 704(a)(4), within 15 business days of receiving such a request, or such longer period as the Secretary may provide. If the Secretary 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 or materially affect the extent of absorption or other exposure to the active ingredient, the Secretary— may so inform the sponsor of the drug in writing; and if the Secretary so informs the sponsor, shall provide the sponsor of the drug with a reasonable opportunity to provide additional information. If the sponsor fails to provide such additional information within a time prescribed by the Secretary, or if the Secretary determines that such additional information does not demonstrate that the change does not— affect the safety or effectiveness of the drug; or materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product, the drug as modified is a new drug under section 201(p) and shall be deemed to be misbranded under section 502(ee). The Secretary shall issue one or more administrative orders specifying requirements for determining whether a minor change made by a sponsor pursuant to this subsection will affect the safety or effectiveness of a drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product, together with guidance for applying those orders to specific dosage forms. The orders and guidance issued by the Secretary under subparagraph
(A)shall take into account relevant public standards and standard practices for evaluating the quality of drugs, and may take into account the special needs of populations, including children. Subject to paragraph (2), any information, including reports of testing conducted on the drug or drugs involved, that is submitted by a requestor in connection with proceedings on an order under this section (including any minor change under subsection (c)) and is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code, shall not be disclosed to the public unless the requestor consents to that disclosure. Except as provided in subparagraph (B), the Secretary shall— make any information submitted by a requestor in support of a request under subsection (b)(5)(A) available to the public not later than the date on which the proposed order is issued; and make any information submitted by any other person with respect to an order requested (or initiated by the Secretary) under subsection (b), available to the public upon such submission. Information described in subparagraph
(A)shall not be made public if— the information pertains to pharmaceutical quality information, unless such information is necessary to establish standards under which a drug is generally recognized as safe and effective under section 201(p)(1); the information is submitted in a requestor-initiated request, but the requestor withdraws such request, in accordance with withdrawal procedures established by the Secretary, before the Secretary issues the proposed order; the Secretary requests and obtains the information under subsection
(c)and such information is not submitted in relation to an order under subsection (b); or the information is of the type contained in raw datasets. A sponsor who makes a change to a drug subject to this section shall submit updated drug listing information for the drug in accordance with section 510(j) within 30 calendar days of the date when the drug is first commercially marketed, except that a sponsor who was the order requestor with respect to an order subject to subsection (b)(5)(C) (or a licensee, assignee, or successor in interest of such requestor) shall submit updated drug listing information on or before the date when the drug is first commercially marketed. The provisions of this section shall not be construed to preclude a person from seeking or maintaining the approval of an application for a drug under sections 505(b)(1), 505(b)(2), and 505(j). A determination under this section that a drug is not subject to section 503(b)(1), is generally recognized as safe and effective under section 201(p)(1), and is not a new drug under section 201(p) shall constitute a finding that the drug is safe and effective that may be relied upon for purposes of an application under section 505(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 that is not covered by such determination under this section. The Secretary shall establish, maintain, update (as determined necessary by the Secretary but no less frequently than annually), and make publicly available, with respect to orders issued under this section— a repository of each final order and interim final order in effect, including the complete text of the order; and a listing of all orders proposed and under development under subsection (b)(2), including— a brief description of each such order; and the Secretary’s expectations, if resources permit, for issuance of proposed orders over a 3-year period. The Secretary shall establish procedures under which sponsors or requestors may meet with appropriate officials of the Food and Drug 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 drugs and the development of new nonprescription drugs under this section. The Secretary shall establish procedures to facilitate efficient participation by multiple sponsors or requestors in proceedings under this section, including provision for joint meetings with multiple sponsors or requestors or with organizations nominated by sponsors or requestors to represent their interests in a proceeding. All submissions under this section shall be in electronic format. Except as provided in this subsection, nothing in this section supersedes regulations establishing general requirements for nonprescription drugs, 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 shall establish or modify such regulations by means of rulemaking in accordance with section 553 of title 5, United States Code. The provisions of section 310.545 of title 21, Code of Federal Regulations, as in effect on the day before the date of the enactment of this section, shall be deemed to be a final order under subsection (b). Regulations in effect on the day before the date of the enactment of this section, establishing requirements for specific nonprescription drugs 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), only as they apply to drugs— subject to paragraph (1), (2), (3), or
(4)of subsection (a); or otherwise subject to an order under this section. The Secretary shall withdraw regulations establishing final monographs and the procedures governing the over-the-counter drug review under part 330 and other relevant parts of title 21, Code of Federal Regulations (as in effect on the day before the date of the enactment of this section), or make technical changes to such regulations to ensure conformity with appropriate terminology and cross references. Notwithstanding subchapter II of chapter 5 of title 5, United States Code, 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). The Secretary shall issue guidance that specifies— the procedures and principles for formal meetings between the Secretary and sponsors or requestors for drugs subject to this section; the format and content of data submissions to the Secretary under this section; the format of electronic submissions to the Secretary under this section; consolidated proceedings for appeal and the procedures for such proceedings where appropriate; and for minor changes in drugs, recommendations on how to comply with the requirements in orders issued under subsection (c)(3). This section shall not affect the treatment or status of a nonprescription drug— that is marketed without an application approved under section 505 as of the date of the enactment of this section; that is not subject to an order issued under this section; and to which paragraph (1), (2), (3), (4), or
(5)of subsection
(a)do not apply. Notwithstanding subsection (a), a drug described in subparagraph
(B)may only be lawfully marketed, without an application approved under section 505, pursuant to an order issued under this section. A drug described in this subparagraph is a drug which, prior to the date of the enactment of this section, the Secretary determined in a proposed or final rule to be ineligible for review under the OTC drug review (as such phrase OTC drug review was used in section 330.14 of title 21, Code of Federal Regulations, as in effect on the day before the date of the enactment of this section). Nothing in paragraph
(1)shall be construed to preclude or limit the applicability of any provision of this Act other than this section. Nothing in subsection
(a)shall be construed to prohibit the Secretary from issuing an order under this section finding a drug to be not generally recognized as safe and effective under section 201(p)(1), as the Secretary determines appropriate. A drug is not subject to this section if an exemption for investigational use under section 505(i) is in effect for such drug. Chapter 35 of title 44, United States Code, shall not apply to collections of information made under this section. The requirements of subsection
(b)shall apply with respect to orders issued under this section instead of the requirements of subchapter II of chapter 5 of title 5, United States Code. In this section: The term nonprescription drug refers to a drug not subject to the requirements of section 503(b)(1). The term sponsor refers to any person marketing, manufacturing, or processing a drug that— is listed pursuant to section 510(j); and is or will be subject to an administrative order under this section of the Food and Drug Administration. The term requestor refers to any person or group of persons marketing, manufacturing, processing, or developing a drug. . Not later than 4 years after the date of enactment of this Act, the Comptroller General of the United States shall submit a study to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate addressing the effectiveness and overall impact of exclusivity under section 505G of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), and section 586C of such Act ( 21 U.S.C. 360fff–3 ), including the impact of such exclusivity on consumer access. Such study shall include— an analysis of the impact of exclusivity under such section 505G for nonprescription drug products, including— the number of nonprescription drug products that were granted exclusivity and the indication for which the nonprescription drug products were determined to be generally recognized as safe and effective; whether the exclusivity for such drug products was granted for— a new active ingredient (including any ester or salt of the active ingredient); or changes in the conditions of use of a drug, for which new human data studies conducted or sponsored by the requestor were essential; whether, and to what extent, the exclusivity impacted the requestor’s or sponsor’s decision to develop the drug product; an analysis of the implementation of the exclusivity provision in such section 505G, including— the resources used by the Food and Drug Administration; the impact of such provision on innovation, as well as research and development in the nonprescription drug market; the impact of such provision on competition in the nonprescription drug market; the impact of such provision on consumer access to nonprescription drug products; the impact of such provision on the prices of nonprescription drug products; and whether the administrative orders initiated by requestors under such section 505G have been sufficient to encourage the development of nonprescription drug products that would likely not be otherwise developed, or developed in as timely a manner; and whether the administrative orders initiated by requestors under such section 505G have been sufficient incentive to encourage innovation in the nonprescription drug market; and an analysis of the impact of exclusivity under such section 586C for sunscreen ingredients, including— the number of sunscreen ingredients that were granted exclusivity and the specific ingredient that was determined to be generally recognized as safe and effective; whether, and to what extent, the exclusivity impacted the requestor’s or sponsor’s decision to develop the sunscreen ingredient; whether, and to what extent, the sunscreen ingredient granted exclusivity had previously been available outside of the United States; an analysis of the implementation of the exclusivity provision in such section 586C, including— the resources used by the Food and Drug Administration; the impact of such provision on innovation, as well as research and development in the sunscreen market; the impact of such provision on competition in the sunscreen market; the impact of such provision on consumer access to sunscreen products; the impact of such provision on the prices of sunscreen products; and whether the administrative orders initiated by requestors under such section 505G have been utilized by sunscreen ingredient sponsors and whether such process has been sufficient to encourage the development of sunscreen ingredients that would likely not be otherwise developed, or developed in as timely a manner; and whether the administrative orders initiated by requestors under such section 586C have been sufficient incentive to encourage innovation in the sunscreen market. Section 751(d)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379r(d)(1) ) is amended— in the matter preceding subparagraph (A)— by striking final regulation promulgated and inserting final order under section 505G ; and by striking and not misbranded ; and in subparagraph (A), by striking regulation in effect and inserting regulation or order in effect .
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- 21 USC 360fff–3
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Sec. 101
Regulation of certain nonprescription drugs that are marketed without an approved drug application
Cite21 USC 360fff–3
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