1.This Act may be cited as the &short-title1;
.
<enum>I</enum><header>IMPROVEMENT OF MEDICARE PRESCRIPTION DRUG BENEFITS</header>
<section id="HC47115C9FF764019AD25B714779D2100"><enum>101.</enum><header>Permitting the negotiation of fair prices for medicare prescription drugs on behalf of medicare beneficiaries</header>
<subsection id="HD8E606C2F6B7499BAEF5F783E726A278"><enum></enum><text>Section 1860D–11 of the Social Security Act, as added by section 101(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>), is amended by striking subsection (i) (relating to noninterference) and by inserting the following:</text>
<quoted-block style="OLC" id="H81238C10426940CAA61200BCD62E38D7" display-inline="no-display-inline">
<subsection id="H4E7A4B52D13047E5001C3B5B1D27CFD2"><enum>(i)</enum><header>Authority to negotiate prices with manufacturers</header><text>In order to ensure that beneficiaries enrolled under prescription drug plans, MA–PD plans, and qualified retiree prescription drug plans pay the lowest possible price, the Secretary shall have authority similar to that of the Secretary of Veterans Affairs, Secretary of Defense, and the heads of other Federal agencies and departments that purchase prescription drugs in bulk to negotiate contracts with manufacturers of covered part D drugs, consistent with the requirements and in furtherance of the goals of providing quality care and containing costs under this part.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section>
<section id="H6D2A9FC279364C0896D681154FEFC724" section-type="subsequent-section"><enum>102.</enum><header>Elimination of gap in coverage of prescription drug benefits</header>
<subsection id="H59E793939DC54828BD994EC642131C5"><enum>(a)</enum><header>In general</header><text>Section 1860D–2(b) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(b)</external-xref>), as added by section 101(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>), is amended by striking paragraph (3) and inserting the following:</text>
<quoted-block act-name="Social" id="H4D1CD5B1F6CF4F4780827EF44D06C27F">
<paragraph id="HA01FDE03A0DF4BA8B5C2E8E77DCC3B05"><enum>(3)</enum><text>Repealed.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="H7957BF0516E24C21A4ED941FB548F47"><enum>(b)</enum><header>Conforming amendments</header>
<paragraph id="H20586CFF15FB40D589F579C6A400E7A0"><enum>(1)</enum><text>Section 1860D–2 of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102</external-xref>) is amended—</text>
<subparagraph id="H0A2ED4E7EBDC443FB25864BD7D2D2165"><enum>(A)</enum><text>in subsection (a)(2)(A)(i)(I), by striking <quote>, or an increase in the initial coverage limit with respect to covered part D drugs</quote>;</text></subparagraph>
<subparagraph id="HF3630FF8DB074ECC8174A21ED538A849"><enum>(B)</enum><text>in subsection (b)(2)(A), by striking <quote>and up to the initial coverage limit under paragraph (3)</quote>;</text></subparagraph>
<subparagraph id="HB8974779D6D44F1D904EE9CCE8EFD5C"><enum>(C)</enum><text>in subsection (b)(4)(C)(i)—</text>
<clause id="H82BF1DFEC049407F87F5F6E5A58745EC"><enum>(i)</enum><text>by striking the comma after <quote>paragraph (1)</quote> and inserting <quote>and</quote>; and</text></clause>
<clause id="HDDD15E4E489546DE86BB50D67805FB60"><enum>(ii)</enum><text>by striking <quote>, and for amounts for which benefits are not provided because of the application of the initial coverage limit described in paragraph (3)</quote>;</text></clause></subparagraph>
<subparagraph id="HE0FA89599A254E70B4A1B7ABC71A01"><enum>(D)</enum><text>in subsection (c)(1), by striking subparagraph (C); and</text></subparagraph>
<subparagraph id="H07941CCC597B4A5FB5B1E8B85DA7AEAD"><enum>(E)</enum><text>in subsection (d)(1)(A), by striking <quote>or an initial coverage limit (described in subsection (b)(3))</quote>.</text></subparagraph></paragraph>
<paragraph id="HE7B39E05831F4EAE84CEB63B6733AD61"><enum>(2)</enum><text>Section 1860D–4(a)(4)(B) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-104">42 U.S.C. 1395w–104(a)(4)(B)</external-xref>) is amended to read as follows:</text>
<quoted-block id="H117A6786819C4A9D8C9C2CBA579CFEF1">
<subparagraph id="HB480AA20F36D4A3EA0BE70C775300002"><enum>(B)</enum><text>when prescription drug benefits are provided under this part, a notice of the benefits in relation to the annual out-of-pocket threshold for the current year.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H04C33C248666453F89EAAD96FDD09C5E"><enum>(3)</enum>
<subparagraph id="HE2DE21D729F842D68BF4FBE00F4C0EF" display-inline="yes-display-inline"><enum>(A)</enum><text>Section 1860D–14(a) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-114">42 U.S.C. 1395w–114(a)</external-xref>) is amended—</text>
<clause id="H2E35F506F3DE4955B2EBEE68E1BC0091" indent="up1"><enum>(i)</enum><text>in paragraph (1), by striking subparagraph (C) and redesignating subparagraphs (D) and (E) as subparagraphs (C) and (D), respectively;</text></clause>
<clause id="H1C584EF3454249299104548E341C3E58" indent="up1"><enum>(ii)</enum><text>in paragraph (2), by striking subparagraph (C) and redesignating subparagraphs (D) and (E) as subparagraphs (C) and (D), respectively; and</text></clause>
<clause id="HF06B41F127AA4C60B930A0C50533FC8" indent="up1"><enum>(iii)</enum><text>in paragraph (4)(A) in the matter preceding clause (i), by striking <quote>paragraph (1)(D)(ii)</quote> and inserting <quote>paragraph (1)(C)(ii)</quote>.</text></clause></subparagraph>
<subparagraph id="H917784628AA44981882936F23003DC21" indent="up1"><enum>(B)</enum><text>Section 1860D–14(c)(1) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-114">42 U.S.C. 1395w–114(c)(1)</external-xref>) is amended in the second sentence by striking <quote>subsections (a)(1)(D) and (a)(2)(E)</quote> and inserting <quote>subsections (a)(1)(C) and (a)(2)(D)</quote>.</text></subparagraph>
<subparagraph id="HEEDB227BB3E04872987BA0A5EC10A776" indent="up1"><enum>(C)</enum><text>Section 1860D–15(e)(1)(B) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-115">42 U.S.C. 1395w–115(e)(1)(B)</external-xref>) is amended by striking <quote>paragraphs (1)(D) and (2)(E)</quote> and inserting <quote>paragraphs (1)(C) and (2)(D)</quote>.</text></subparagraph></paragraph>
<paragraph id="H7E8FA0A9C5174EC7B546DCC72ECA20B2"><enum>(4)</enum>
<subparagraph id="H85A58F2E2F3542C4A4767F006E92A9F" display-inline="yes-display-inline"><enum>(A)</enum><text>Section 1860D–41(a)(6) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-151">42 U.S.C. 1395w–151(a)(6)</external-xref>) is amended by striking paragraph (6) and redesignating paragraphs (7) through (18) as paragraphs (6) through (17), respectively.</text></subparagraph>
<subparagraph id="H4D3026C9DA6641E1AE82A7CA79D26C4F" indent="up1"><enum>(B)</enum><text>Section 1860D–1(a)(1)(A) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-101">42 U.S.C. 1395w–101(a)(1)(A)</external-xref>) is amended by striking <quote>1860D–41(a)(14)</quote> and inserting <quote>1860D–41(a)(13)</quote>.</text></subparagraph></paragraph></subsection>
<subsection id="H92AA840CEB734B2F88613849E2021428"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall take effect as if included in the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public law 108–173).</text></subsection></section>
<enum>II</enum><header>Importation of Prescription Drugs</header>
<section section-type="subsequent-section" id="H0BE83EE54BA34310AD52818BD4845219"><enum>201.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Pharmaceutical Market Access Act of 2004</quote>. </text></section>
<section id="H8299F4EB384746CBBC4BCCFA2198EC78"><enum>202.</enum><header>Importation of prescription drugs</header>
<subsection id="HD895F0302C2842209D4137BE8B45A9F1"><enum>(a)</enum><header>Nullification of certain amendments made by Public Law <enum-in-header>108-173</enum-in-header></header><text>The Federal Food, Drug, and Cosmetic Act is amended—</text>
<paragraph id="HDD311168E91946BE87CA90517735B173"><enum>(1)</enum><text>in section 804 (<external-xref legal-doc="usc" parsable-cite="usc/21/384">21 U.S.C. 384</external-xref>), by amending the section to read as if section 1121(a) of <external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref> had not been enacted;</text> </paragraph>
<paragraph id="HE6A6BFF3422942178140F7F3A693D978"><enum>(2)</enum><text>in section 301 (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>), by amending the section to read as if section 1121(b)(1) of <external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref> had not been enacted; and</text> </paragraph>
<paragraph id="H03FFED7B5AA5415A8B0087CFC779E775"><enum>(3)</enum><text>in section 303 (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333</external-xref>), by amending the section to read as if section 1121(b)(2) of <external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref> had not been enacted.</text> </paragraph></subsection>
<subsection id="HA1DBC8BDBEAE420E9706236EB7FF3EC4"><enum>(b)</enum><header>Importation of prescription drugs</header><text>Section 804 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/384">21 U.S.C. 384</external-xref>), as amended by subsection (a)(1) of this section, is amended—</text>
<paragraph id="H6DABE5FDB4A84429A47094BEBE373EE2"><enum>(1)</enum><text>in subsection (a)—</text>
<subparagraph id="HFEB6D8362D704422B9254BB417D9F105"><enum>(A)</enum><text>by striking <quote>The Secretary</quote> and inserting <quote>Not later than 180 days after the date of the enactment of the &short-title2;, the Secretary</quote>; and</text></subparagraph>
<subparagraph id="H131160667D1C4D35AE639015A2E468AF"><enum>(B)</enum><text>by striking <quote>pharmacists and wholesalers</quote> and inserting <quote>pharmacists, wholesalers, and qualifying individuals</quote>;</text></subparagraph></paragraph>
<paragraph id="HDE5961E0864348D985E35700C52E9DB"><enum>(2)</enum><text>in subsection (b)—</text>
<subparagraph id="HF0A4414D69694CC895D45B4DE98DBC13"><enum>(A)</enum><text>by amending paragraph (1) to read as follows:</text>
<quoted-block id="HDB2CE7D3912F44219995C7E6CDA4900">
<paragraph id="HDCFDFB9036F846679447B5F935BA64C3"><enum>(1)</enum><text>require that each covered product imported pursuant to such subsection complies with sections 501, 502, and 505, and other applicable requirements of this Act; and</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph>
<subparagraph id="H66B3D0D25D22401880002EE9198F851B"><enum>(B)</enum><text>in paragraph (2), by striking <quote>, including subsection (d); and</quote> and inserting a period; and</text></subparagraph>
<subparagraph id="HB671C4B264C443B3B94BF40847A1A891"><enum>(C)</enum><text>by striking paragraph (3);</text></subparagraph></paragraph>
<paragraph id="HC74CE0FF5C7C47B4BC3DA0B526FF19A9"><enum>(3)</enum><text>in subsection (c), by inserting <quote>by pharmacists and wholesalers (but not qualifying individuals)</quote> after <quote>importation of covered products</quote>;</text></paragraph>
<paragraph id="H39F48257507A46F9819FEABF0029D1D9"><enum>(4)</enum><text>in subsection (d)—</text>
<subparagraph id="H6CE13B73E81D4BB589079D77AD26E953"><enum>(A)</enum><text>by striking paragraphs (3) and (10);</text></subparagraph>
<subparagraph id="H3E79A114811845039C013B690099B99E"><enum>(B)</enum><text>in paragraph (5), by striking <quote>, including the professional license number of the importer, if any</quote>;</text></subparagraph>
<subparagraph id="H65E915F9DA7646BEA68E5684DAF0E200"><enum>(C)</enum><text>in paragraph (6)—</text>
<clause id="HB283EE814D8B4D51A7742DFE3C572E82"><enum>(i)</enum><text>in subparagraph (C), by inserting <quote>(if required under subsection (e))</quote> before the period;</text></clause>
<clause id="H81CBC4BBAAD144F2BC36A0D8FA75B317"><enum>(ii)</enum><text>in subparagraph (D), by inserting <quote>(if required under subsection (e))</quote> before the period; and</text></clause>
<clause id="HA3876173B436496CB3ABEA54EDAA737"><enum>(iii)</enum><text>in subparagraph (E), by striking <quote>labeling</quote>;</text></clause></subparagraph>
<subparagraph id="H16410B8B3861464E9E9803885C00C5F8"><enum>(D)</enum><text>in paragraph (7)—</text>
<clause id="H1F19E184AFEC44EF819FAC78B82FADA"><enum>(i)</enum><text>in subparagraph (A), by inserting <quote>(if required under subsection (e))</quote> before the period; and</text></clause>
<clause id="H7570E62CAAE94BF39DE2556693E12546"><enum>(ii)</enum><text>by amending subparagraph (B) to read as follows:</text>
<quoted-block id="H25360D6A3E464D249B2D37726C00CEE6">
<subparagraph id="HEEEA2F56833B482498B7FBC4EE55137C"><enum>(B)</enum><text>Certification from the importer or manufacturer of such product that the product meets all requirements of this Act.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph>
<subparagraph id="H25AE73A4B057415193AE8F13C88F133"><enum>(E)</enum><text>by redesignating paragraphs (4) through (9) as paragraphs (3) through (8), respectively;</text></subparagraph></paragraph>
<paragraph id="HE87F35E8378C4EAF926C60285616F446"><enum>(5)</enum><text>by amending subsection (e) to read as follows:</text>
<quoted-block id="H387929922EC24B15A59059DCC7D1BE1">
<subsection id="H9F84956E394149F08FD4FE94478AC58"><enum>(e)</enum><header>Testing</header>
<paragraph id="HD0E66BFEB1D04FE288FDEBD4BECD29F3"><enum>(1)</enum><header>In general</header><text>Subject to paragraph (2), regulations under subsection (a) shall require that testing referred to in paragraphs (5) through (7) of subsection (d) be conducted by the importer of the covered product, unless the covered product is a prescription drug subject to the requirements of section 505C for counterfeit-resistant technologies.</text></paragraph>
<paragraph id="H308F7C3A3F9C42B698BDA600A400F544"><enum>(2)</enum><header>Exception</header><text>The testing requirements of paragraphs (5) through (7) of subsection (d) shall not apply to an importer unless the importer is a wholesaler.</text></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph>
<paragraph id="HCBD20270761F4F739F14BC4C00AC46A4"><enum>(6)</enum><text>in subsection (f), by striking <quote>or designated by the Secretary, subject to such limitations as the Secretary determines to be appropriate to protect the public health</quote>;</text></paragraph>
<paragraph id="H01088012FF7B4AA2A3B94235FAF515D"><enum>(7)</enum><text>in subsection (g)—</text>
<subparagraph id="H6AA1D644BBDF4CFC811FFBB4CE73A7B6"><enum>(A)</enum><text>by striking <quote>counterfeit or</quote>; and</text></subparagraph>
<subparagraph id="H4C2C8651082A4878A4B553E5D0164100"><enum>(B)</enum><text>by striking <quote>and the Secretary determines that the public is adequately protected from counterfeit and violative covered products being imported pursuant to subsection (a)</quote>;</text></subparagraph></paragraph>
<paragraph id="H4E754D80FAD9495792242E93DE3E6DBE"><enum>(8)</enum><text>in subsection (i)(1)—</text>
<subparagraph id="HBB0F77C4D1714E49819D6C7000CC4BBB"><enum>(A)</enum><text>by amending subparagraph (A) to read as follows:</text>
<quoted-block id="H80F6493A45F940B58B744EEA174128F7">
<subparagraph id="HD58F736EE3B342C7A5D973F21744D200"><enum>(A)</enum><header>In general</header><text>The Secretary shall conduct, or contract with an entity to conduct, a study on the imports permitted pursuant to subsection (a), including consideration of the information received under subsection (d). In conducting such study, the Secretary or entity shall evaluate the compliance of importers with regulations under subsection (a), and the incidence of shipments pursuant to such subsection, if any, that have been determined to be misbranded or adulterated, and determine how such compliance contrasts with the incidence of shipments of prescription drugs transported within the United States that have been determined to be misbranded or adulterated.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph>
<subparagraph id="H6E0D430131FF43608137C8F643CA888C"><enum>(B)</enum><text>in subparagraph (B), by striking <quote>Not later than 2 years after the effective date of final regulations under subsection (a),</quote> and inserting <quote>Not later than 18 months after the date of the enactment of the &short-title2;,</quote>;</text></subparagraph></paragraph>
<paragraph id="HE45ED15CD2024B419F3BDCE89B1F63DB"><enum>(9)</enum><text>in subsection (k)(2)—</text>
<subparagraph id="H3945A65E72284577A9BC739F5C1DB5E"><enum>(A)</enum><text>by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively; and</text></subparagraph>
<subparagraph id="HE16357F879DA4AF1A54B35E2B3BBB89B"><enum>(B)</enum><text>by inserting after subparagraph (C) the following:</text>
<quoted-block id="H2EEBC2E373514012BE543BA189AA8528">
<subparagraph id="H0D81807D47B7432FB6FA7C00ED77B75F"><enum>(D)</enum><text>The term <term>qualifying individual</term> means an individual who is not a pharmacist or a wholesaler.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="HA72ECCE1C43642B5BB3CCA19A05C24D4"><enum>(10)</enum><text>by striking subsections (l) and (m).</text></paragraph></subsection></section>
<section id="H03561B3E0E6C4E8C95E7EE0084A3EF34"><enum>203.</enum><header>Use of counterfeit-resistant technologies to prevent counterfeiting</header>
<subsection id="H832A233B6D9C475DA87311A9AAC12CCF"><enum>(a)</enum><header>Misbranding</header><text>Section 502 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C. 352</external-xref>; deeming drugs and devices to be misbranded) is amended by adding at the end the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="HBA4C8A77EBDD487C8944DD08A23D6C3E">
<subsection id="H07B0164AB56440B4980000A38CEB00EA"><enum>(w)</enum><text>If it is a drug subject to section 503(b), unless the packaging of such drug complies with the requirements of section 505C for counterfeit-resistant technologies.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="H5F3AA80CB27A4BB0AA6CE700F688E679"><enum>(b)</enum><header>Requirements</header><text>Title V of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351 et seq.</external-xref>) is amended by inserting after section 505B the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="HE7815CFAA18E4BCFB624168F4C3FBD79">
<section id="H02C17A0619764011AC00B3BAA2C1F1C5"><enum>505C.</enum><header>Counterfeit-resistant technologies</header>
<subsection id="H8F15492DBD1B4767B089BE03647F6CA1"><enum>(a)</enum><header>Incorporation of counterfeit-resistant technologies into prescription drug packaging</header><text>The Secretary shall require that the packaging of any drug subject to section 503(b) incorporate—</text>
<paragraph id="H8E6129A872CF4947B2008D045BB9026C"><enum>(1)</enum><text>overt optically variable counterfeit-resistant technologies that are described in subsection (b) and comply with the standards of subsection (c); or</text></paragraph>
<paragraph id="H02725A94EC61468A00FC77F1DAC4002D"><enum>(2)</enum><text>technologies that have an equivalent function of security, as determined by the Secretary.</text></paragraph></subsection>
<subsection id="H9E612DE6950F4228968C4177BFCD6DBC"><enum>(b)</enum><header>Eligible technologies</header><text>Technologies described in this subsection—</text>
<paragraph id="H8F29139166DF4689BE041F63DD397FFE"><enum>(1)</enum><text>shall be visible to the naked eye, providing for visual identification of product authenticity without the need for readers, microscopes, lighting devices, or scanners;</text></paragraph>
<paragraph id="HE7912A13964A455B003B384F9E9B69FC"><enum>(2)</enum><text>shall be similar to that used by the Bureau of Engraving and Printing to secure United States currency;</text></paragraph>
<paragraph id="H8318B1CB42D845C300024F0000A65859"><enum>(3)</enum><text>shall be manufactured and distributed in a highly secure, tightly controlled environment; and</text></paragraph>
<paragraph id="HFEE653CC9CAF4C2C004EF61133AD5D00"><enum>(4)</enum><text>should incorporate additional layers of non-visible covert security features up to and including forensic capability.</text></paragraph></subsection>
<subsection id="H73591F7CE6FC487CBD8B411B295CDF09"><enum>(c)</enum><header>Standards for packaging</header>
<paragraph id="HA768B28589464F789967B240DB9BC194"><enum>(1)</enum><header>Multiple elements</header><text>For the purpose of making it more difficult to counterfeit the packaging of drugs subject to section 503(b), manufacturers of the drugs shall incorporate the technologies described in subsection (b) into multiple elements of the physical packaging of the drugs, including blister packs, shrink wrap, package labels, package seals, bottles, and boxes.</text></paragraph>
<paragraph id="H37092DA1CA5E4CA48D7023F8B84EC57"><enum>(2)</enum><header>Labeling of shipping container</header><text>Shipments of drugs described in subsection (a) shall include a label on the shipping container that incorporates the technologies described in subsection (b), so that officials inspecting the packages will be able to determine the authenticity of the shipment. Chain of custody procedures shall apply to such labels and shall include procedures applicable to contractual agreements for the use and distribution of the labels, methods to audit the use of the labels, and database access for the relevant governmental agencies for audit or verification of the use and distribution of the labels.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section>