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<dc:title>117 HR 853 IH: Closing Loopholes for Orphan Drugs Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2021-02-04</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. 853</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20210204">February 4, 2021</action-date><action-desc><sponsor name-id="W000800">Mr. Welch</sponsor> (for himself and <cosponsor name-id="M001180">Mr. McKinley</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 title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title.</official-title></form><legis-body id="H5A3C4BCB8821430CB4CB95E6C99A0C11" style="OLC"> 
<section id="HF2A3F4B4121B429CB4F92B911F93DBBE" 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>Closing Loopholes for Orphan Drugs Act</short-title></quote>.</text></section> <section id="H5B0A076E95D34506849D8EC30693BDF8"><enum>2.</enum><header>Limiting the orphan drug exclusion under 340B drug discount program</header> <subsection id="H40211D83AF484DC7A07ED079F32C3D29"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 340B(e) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/256b">42 U.S.C. 256b(e)</external-xref>) is amended by inserting before the period at the end the following: <quote>when transferred, prescribed, sold, or otherwise used for the rare condition or disease for which such drug is so designated</quote>.</text></subsection> 
<subsection id="H0145D833A4E54B38A77FF307AE8EF566"><enum>(b)</enum><header>Effective date</header><text>The amendment made by subsection (a) shall apply with respect to covered outpatient drugs purchased on or after the date of the enactment of this Act.</text></subsection></section> </legis-body></bill>

