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<dc:title>117 HR 6352 IH: Domain Reform for Unlawful Drug Sellers Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2021-12-30</dc:date>
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<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<distribution-code display="yes">I</distribution-code><congress display="yes">117th CONGRESS</congress><session display="yes">1st Session</session><legis-num display="yes">H. R. 6352</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20211230">December 30, 2021</action-date><action-desc><sponsor name-id="M001180">Mr. McKinley</sponsor> (for himself and <cosponsor name-id="R000515">Mr. Rush</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">To amend the Federal Food, Drug, and Cosmetic Act to provide a process to lock and suspend domain names used to facilitate the online sale of drugs illegally, and for other purposes.</official-title></form><legis-body id="H4A3E3AC3CD354ECB984E9D3C861B6FE8" style="OLC"><section id="HE1178F26BEFE4462B50B62BAB3380CAC" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Domain Reform for Unlawful Drug Sellers Act</short-title></quote> or the <quote><short-title>DRUGS Act</short-title></quote>. </text></section><section id="HB3346A8706684BDAAFF7A5C691FBE01C"><enum>2.</enum><header>Domain names used to facilitate the online sale of drugs illegally</header><subsection id="H247D955FF69245939EEA223B8A40AFC8"><enum>(a)</enum><header>In general</header><text>Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" id="HB38710517AE04335BF2747613C8FFF77" display-inline="no-display-inline"><section id="H9D39E0A7FE4F4C27A4228723D4337B62"><enum>524B.</enum><header>Domain names used to facilitate the online sale of drugs illegally</header><subsection id="H81D1710AC8EF4C308595ED1B0E3D3AAD"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">A registry operator or registrar shall—</text><paragraph id="H25102D3C4F834F02BD0DB48E0903DC7D"><enum>(1)</enum><text display-inline="yes-display-inline">not later than 24 hours after receipt of a notification from a trusted notifier respecting a domain name used to facilitate the online sale of drugs illegally that is under the control of the registry operator or registrar, lock the domain name; and</text></paragraph><paragraph id="HE9911A8112434A3F881B853B7C1D0C70"><enum>(2)</enum><text>not later than 7 days after receipt of such notification, suspend the domain name.</text></paragraph></subsection><subsection id="HD28F8CF51D094310BC251F91AC0C1313"><enum>(b)</enum><header>Notice</header><text>For purposes of subsection (a), a notification shall include, at a minimum—</text><paragraph id="H48B99961290B480AB4877C12196DD89A"><enum>(1)</enum><text>the domain name being reported;</text></paragraph><paragraph id="H886394FA4B744E0CA8F4A3B25830088A"><enum>(2)</enum><text>the date the alleged violations described in subsection (e)(2) were observed;</text></paragraph><paragraph id="H6D7AC3026FF548D7BC02125A3CB48FB4"><enum>(3)</enum><text>a summary of the alleged violations; and</text></paragraph><paragraph id="H913795F2864747AC953DF5ED1FAE6DAA"><enum>(4)</enum><text display-inline="yes-display-inline">a statement that evidence of offering drugs illegally, such as a screenshot, has been retained, and is available to be shared with the registry operator or registrar.</text></paragraph></subsection><subsection id="HE5C3688863714314A8EADA7F147FB59B"><enum>(c)</enum><header>Registrant Appeal</header><paragraph id="H3610625A994E4D60858A04AA9D81FE47"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Any registrant whose domain name is locked and suspended pursuant to subsection (a) may appeal such action to the trusted notifier pursuant to paragraph (2). The domain name shall remain locked and suspended until a final determination of the merits of the appeal has been made.</text></paragraph><paragraph id="HC8639245A5CB4B6E8A582D651E72E1C2"><enum>(2)</enum><header>Appeals</header><subparagraph id="HEAAA692CB66548ED9DAFFF6E67A280E9"><enum>(A)</enum><header>In general</header><text>In bringing such an appeal, the registrant for the locked and suspended domain name may do any of the following:</text><clause id="H946FC0E792D84CE7BC7BDEA7170A50BC"><enum>(i)</enum><text>Contact the applicable registry operator or registrar to request information regarding the business name, or personal name if the trusted notifier is not a business, and the email address, of the trusted notifier who submitted the notification regarding the domain name. </text></clause><clause id="H0D49BA65B8F440B8B0095D3A669975E0"><enum>(ii)</enum><text>Dispute the notification by submitting the following to the applicable trusted notifier:</text><subclause id="HDEFE0079FAB748A0B045DE66B776F0A0"><enum>(I)</enum><text>A copy of the registrant’s pharmacy licenses for all jurisdictions where it offered to ship prescription medicines at the time of the notification where such licensure is legally required in such jurisdiction, or a copy of registrant’s affiliated pharmacy’s licenses for all jurisdictions where the registrant offered to facilitate the shipment of prescription medicines at the time of the notification where such licensure is legally required in such jurisdiction.</text></subclause><subclause id="H49FCBFD686334385AE5C003A41DCB79F"><enum>(II)</enum><text>The license information of the medical practitioner involved in issuing the prescription facilitated in part by the registrant’s domain name where practitioner licensure is legally required in such jurisdiction.</text></subclause></clause></subparagraph><subparagraph id="HBFABB8A708EF4BFE9C59FC604CD1E4CC"><enum>(B)</enum><header>Provision of information</header><text display-inline="yes-display-inline">Within 15 days after receiving a request under subparagraph (A)(i), a registry operator or registrar shall provide the requested information.</text></subparagraph><subparagraph id="H08FD1B734F4443D49CD90A7E81FE425E"><enum>(C)</enum><header>Investigation</header><text>The applicable trusted notifier shall—</text><clause id="H65292821721D4EEB82A7FCFFC5BACFA1"><enum>(i)</enum><text>conduct a reasonable investigation regarding the registrant and its domain name to determine whether notification under subsection (a) was improper; and</text></clause><clause id="HDDDC86BA485F46569801307E75DCA027"><enum>(ii)</enum><text>in conducting such investigation, consider the information provided by the registrant under subparagraph (A).</text></clause></subparagraph><subparagraph id="HFBEC60950B5F4D6C9B677B3313FA3323"><enum>(D)</enum><header>Successful appeal</header><text display-inline="yes-display-inline">If the appeal is successful, the registry operator or registrar shall lift the suspension and unlock the domain name within 15 days.</text></subparagraph></paragraph></subsection><subsection id="HD72DAB589815484F8F9AF7A504F424F7"><enum>(d)</enum><header>Rule of construction</header><text display-inline="yes-display-inline">Nothing in this section prohibits a registry operator or registrar from locking and suspending a domain name used to facilitate the online sale of drugs illegally before receipt of a notification under this section from a trusted notifier.</text></subsection><subsection id="H7B65A913357C4E159252312387061414"><enum>(e)</enum><header>Definitions</header><text>In this section:</text><paragraph id="H4740068FF59649EAA671FFA4B74AB2A7"><enum>(1)</enum><header>Domain name</header><text>The term <quote>domain name</quote> means a name that—</text><subparagraph id="HFCD8FFCD9B6445B69F1F509AD87A889E"><enum>(A)</enum><text>identifies a specific location on the internet that belongs to a particular person; and</text></subparagraph><subparagraph id="H393BC098B51D416FA21A31C515CB50C8"><enum>(B)</enum><text>consists of two or more textual segments separated by dots.</text></subparagraph></paragraph><paragraph id="HC7389D81C6264B7DB69F1E70F3958EBB"><enum>(2)</enum><header>Domain name used to facilitate the online sale of drugs illegally</header><text display-inline="yes-display-inline">The term <quote>domain name used to facilitate the online sale of drugs illegally</quote> means a domain name that identifies a location on the internet the primary or a significant purpose of which is to introduce or deliver for introduction into interstate commerce a drug or controlled substance in violation of this Act or the Controlled Substances Act.</text></paragraph><paragraph id="H5391FCB5FCEE4AF4B21E903ACA2ABEB7" commented="no"><enum>(3)</enum><header>Lock</header><text display-inline="yes-display-inline">The term <quote>lock</quote> means, with respect to a domain name, for the registry operator or registrar to systematically prevent the domain name from being updated, transferred, or deleted during the balance of the registration of the domain name, which may be achieved using domain name registration protocols.</text></paragraph><paragraph id="HFCA2D2A6E83245AABE4978F5C36E51CD"><enum>(4)</enum><header>Prescription drug</header><text>The term <quote>prescription drug</quote> means a drug subject to section 503(b)(1).</text></paragraph><paragraph id="HD309315E7F4946B2AF39A39E9BA0BF83"><enum>(5)</enum><header>Registrar</header><text>The term <quote>registrar</quote> means an organization that—</text><subparagraph id="HAEEC56361F4040418D63265C09D665FA"><enum>(A)</enum><text>manages the registration of domain names; and</text></subparagraph><subparagraph id="HEA029BE86790442C8CCE469820F3303A"><enum>(B)</enum><text>during the registration process—</text><clause id="HEA79B95FCD8440708F59FB89F69DF108"><enum>(i)</enum><text>verifies that the requested domain name meets registry requirements; and</text></clause><clause id="H76C4864418BD4B88941FAEF16E4C4B1F"><enum>(ii)</enum><text>submits the name to the appropriate registry operator.</text></clause></subparagraph></paragraph><paragraph id="H5071D6AFC1484D3594BE2F848452B408"><enum>(6)</enum><header>Registry</header><text>The term <quote>registry</quote> means an authoritative master database of the domain names registered in a top-level domain.</text></paragraph><paragraph id="H356CF5F9C18644C59FAA7741F0C924CB"><enum>(7)</enum><header>Registry operator</header><text>The term <quote>registry operator</quote> means an organization that maintains a registry, including by—</text><subparagraph id="H690D1B28B6A344C6B3CD22503EAB4FE7"><enum>(A)</enum><text>receiving requests from registrars to add, delete, or modify domain names; and</text></subparagraph><subparagraph id="H2D4A562C6B7849EC9831C2FE07989406"><enum>(B)</enum><text>making the requested changes in the registry.</text></subparagraph></paragraph><paragraph id="HE9591BBC82E24D85A4B057E2F000EBC2" commented="no"><enum>(8)</enum><header>Suspend</header><text display-inline="yes-display-inline">The term <quote>suspend</quote> means, with respect to a domain name, for the registry operator or registrar to systematically disable the functionality of the domain name through a hold or suspension during the balance of the registration of the domain name, which may be achieved using domain name registration protocols.</text></paragraph><paragraph id="H4546EED782144FF48311636A3DD9EF8D"><enum>(9)</enum><header>Trusted notifier</header><text>The term <quote>trusted notifier</quote> includes the following (and the designees and agents thereof):</text><subparagraph id="HD1511CFE51744051A3F437352012FC5C"><enum>(A)</enum><text>The Food and Drug Administration.</text></subparagraph><subparagraph id="HC9C77FA53047462A88BEF44C8A81585E"><enum>(B)</enum><text>The Department of Justice, including the Drug Enforcement Administration.</text></subparagraph><subparagraph id="H7F54D576828642159817F6E052FAA9F6"><enum>(C)</enum><text>The Department of Homeland Security.</text></subparagraph><subparagraph id="HCAD70124B3AD463182BACB90E3191FF9"><enum>(D)</enum><text>A State attorney general.</text></subparagraph><subparagraph id="H4037190D6FBE440BBDD339448480A5B1"><enum>(E)</enum><text>A State board of pharmacy.</text></subparagraph><subparagraph id="H8EDDB7EA312041A0BAA4A8D304741A5B"><enum>(F)</enum><text>A nonprofit organization with a membership or governance comprised exclusively of representatives of—</text><clause id="H4214E229C26D45E4986FBB97D50F76BB"><enum>(i)</enum><text>agencies or officials specified in any of subparagraphs (A) through (E); or</text></clause><clause id="H886A6BBF3AC04CA080D386B3C5EF2717"><enum>(ii)</enum><text>similarly positioned (as determined by the Commissioner of Food and Drugs) agencies or officials.</text></clause></subparagraph><subparagraph id="H705714BA89FE4A3C92C6FA94BF44E7A4"><enum>(G)</enum><text>Any entity currently under contract or in a public-private partnership with the Food and Drug Administration or the Drug Enforcement Agency to share information related to online drug sales.</text></subparagraph><subparagraph id="HE7AD6C1BEAC846EFA60F29194C45D841"><enum>(H)</enum><text>Any other entity identified by the Food and Drug Administration as a trusted notifier for purposes of this section, taking into consideration, at minimum, whether the entity—</text><clause id="HE9F102A426FA4C0B8F1781FF7BB8A839"><enum>(i)</enum><text>is registered to do business in the United States;</text></clause><clause id="HB6363812373941EB9951D64B9BCD2853"><enum>(ii)</enum><text display-inline="yes-display-inline">agrees to share notification data, upon request, with the Food and Drug Administration and the Drug Enforcement Agency;</text></clause><clause id="HD0981DDB641B4710ACB986A90DD343DE"><enum>(iii)</enum><text display-inline="yes-display-inline">does not knowingly or with willful ignorance approve or do business with entities that fail to adhere to the regulations of the Food and Drug Administration or the Drug Enforcement Agency; and</text></clause><clause id="HDD6C61D4C39241DEA38EA21EBB3230E5"><enum>(iv)</enum><text>has published on the website of such entity policies and procedures for how the entity will issue notifications under subsection (a).</text></clause></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H15C8DFB2BB8648669B4B8C37A4B18DBE"><enum>(b)</enum><header>Prohibited act</header><text display-inline="yes-display-inline">Section 301 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" id="H42738455174244668496D4C4E9B7887D" display-inline="no-display-inline"><subsection id="HAFFFE46A12F9435DB7D066EA9024A9C4"><enum>(fff)</enum><text display-inline="yes-display-inline">The failure by a registry operator or registrar to lock and suspend any domain name in its control in violation of section 524B.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HD1C15BFA3A834CC8832E3FAB0F44DCCA"><enum>(c)</enum><header>Applicability</header><text>Sections 301(fff) and 524B of the Federal Food, Drug, and Cosmetic Act, as added by this section, shall apply beginning on the date that is 60 days after the date of enactment of this Act.</text></subsection></section></legis-body></bill> 

