1.Short title; table of contents
(a)This Act may be cited as the
Fair Pricing for Prescription Drugs
Act
.
(b)The table of contents for this Act is as
follows:
Sec. 1. Short title;
table of contents.
TITLE I—Importation of prescription drugs
Sec. 101. Short title.
Sec. 102. Findings.
Sec. 103. Repeal of certain section regarding importation of
prescription drugs.
Sec. 104. Importation of prescription drugs; waiver of certain
import restrictions.
Sec. 105. Disposition of certain drugs denied admission into
United States.
Sec. 106. Wholesale distribution of drugs; statements regarding
prior sale, purchase, or trade.
Sec. 107. Internet sales of prescription drugs.
Sec. 108. Prohibiting payments to unregistered foreign
pharmacies.
Sec. 109. Importation exemption under Controlled Substances
Import and Export Act.
Sec. 110. Severability.
TITLE II—Negotiation of lower covered part D drug prices on
behalf of Medicare beneficiaries
Sec. 201. Negotiation
of lower covered part D drug prices on behalf of Medicare
beneficiaries.
<enum>I</enum><header display-inline="yes-display-inline">Importation of prescription drugs</header>
<section commented="no" display-inline="no-display-inline" id="idE3FC4E699A9A42C99D2B7DE7B7614E51" section-type="subsequent-section"><enum>101.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This title may be cited as the
<quote>Pharmaceutical Market Access and Drug Safety Act of 2010</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="ID230B31B779614C0C87FA6B4C37E1558B" section-type="subsequent-section"><enum>102.</enum><header display-inline="yes-display-inline">Findings</header><text display-inline="no-display-inline">Congress finds that—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID98A2C1C6485248E78275B5ED1CCC89A1"><enum>(1)</enum><text display-inline="yes-display-inline">Americans unjustly pay up to 5 times more
to fill their prescriptions than consumers in other countries;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1AFF2990C236420599F67B5394FD65DE"><enum>(2)</enum><text display-inline="yes-display-inline">the United States is the largest market for
pharmaceuticals in the world, yet American consumers pay the highest prices for
brand pharmaceuticals in the world;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID3440E3170FA0494FA492E42B8154A4CD"><enum>(3)</enum><text display-inline="yes-display-inline">a prescription drug is neither safe nor
effective to an individual who cannot afford it;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID8F0173BEBB7A49C3B4F500FC547A3207"><enum>(4)</enum><text display-inline="yes-display-inline">allowing and structuring the importation of
prescription drugs to ensure access to safe and affordable drugs approved by
the Food and Drug Administration will provide a level of safety to American
consumers that they do not currently enjoy;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDF835BAB80174402DB5E5E6CCACA2D346"><enum>(5)</enum><text display-inline="yes-display-inline">American consumers spend more than
$200,000,000,000 on prescription drugs every year;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDC7086A94D8044CB0B4C931B29FA0E1DA"><enum>(6)</enum><text display-inline="yes-display-inline">the Congressional Budget Office has found
that the cost of prescription drugs are between 35 to 55 percent less in other
highly developed countries than in the United States; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idFE3997FB94D14CFC8129F39B4A371421"><enum>(7)</enum><text display-inline="yes-display-inline">promoting competitive market pricing would
both contribute to health care savings and allow greater access to therapy,
improving health and saving lives.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="ID51BD1EE543A14136BE750D073F24105F" section-type="subsequent-section"><enum>103.</enum><header display-inline="yes-display-inline">Repeal of certain section regarding
importation of prescription drugs</header><text display-inline="no-display-inline">Chapter VIII of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 381 et seq.) is amended by striking section 804.</text>
</section><section commented="no" display-inline="no-display-inline" id="idA77B134190654DA491735A2D3A47631B" section-type="subsequent-section"><enum>104.</enum><header display-inline="yes-display-inline">Importation of prescription drugs; waiver
of certain import restrictions</header>
<subsection commented="no" display-inline="no-display-inline" id="id6F8458A61E1B4234BF1CA40B392923BA"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Chapter VIII of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 381 et seq.), as amended by section 103, is further amended by
inserting after section 803 the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" display-inline="no-display-inline" id="ID309446E36072489FB648C1EE5CC19866" style="OLC">
<section commented="no" display-inline="no-display-inline" id="ID3FD2A6B5BDB642FD98D4C2002635E80F" section-type="subsequent-section"><enum>804.</enum><header display-inline="yes-display-inline">Commercial and personal importation of
prescription drugs</header>
<subsection commented="no" display-inline="no-display-inline" id="ID881B858AD51946A18FA7DDDA42DAEC50"><enum>(a)</enum><header display-inline="yes-display-inline">Importation of prescription drugs</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID79355180348245FF997A0ADAAAF2DCCB"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In the case of qualifying drugs imported or
offered for import into the United States from registered exporters or by
registered importers—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDC201D8DC88CE41BABDDC906CA8F36A92"><enum>(A)</enum><text display-inline="yes-display-inline">the limitation on importation that is
established in section 801(d)(1) is waived; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDB6C0EBC0397C4665B230C989F169CD6E"><enum>(B)</enum><text display-inline="yes-display-inline">the standards referred to in section 801(a)
regarding admission of the drugs are subject to subsection (g) of this section
(including with respect to qualifying drugs to which section 801(d)(1) does not
apply).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDE7FF5EBAE04B450D83C6AAC5D058F925"><enum>(2)</enum><header display-inline="yes-display-inline">Importers</header><text display-inline="yes-display-inline">A qualifying drug may not be imported under
paragraph (1) unless—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDB171D5E38B824ED1B982F78FDE2EF019"><enum>(A)</enum><text display-inline="yes-display-inline">the drug is imported by a pharmacy, group
of pharmacies, or a wholesaler that is a registered importer; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDDABAFD006C5F4016AC6D83830A5DAFCC"><enum>(B)</enum><text display-inline="yes-display-inline">the drug is imported by an individual for
personal use or for the use of a family member of the individual (not for
resale) from a registered exporter.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID8FEFA46C12D84EE4B9105B11395450D3"><enum>(3)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">This section shall apply only with respect
to a drug that is imported or offered for import into the United States—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDACB94C3FF50E42749162AF5AE1F7877E"><enum>(A)</enum><text display-inline="yes-display-inline">by a registered importer; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDB4E2AC45F61A49D09D50802A85BF2797"><enum>(B)</enum><text display-inline="yes-display-inline">from a registered exporter to an
individual.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDB0D6A53632F548909272F3B665C4FEEC"><enum>(4)</enum><header display-inline="yes-display-inline">Definitions</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID858201A51B1940FB9543C57C62EE412C"><enum>(A)</enum><header display-inline="yes-display-inline">Registered exporter; registered
importer</header><text display-inline="yes-display-inline">For purposes of this
section:</text>
<clause commented="no" display-inline="no-display-inline" id="ID893DEFD0FE234312A242D19241F14171"><enum>(i)</enum><text display-inline="yes-display-inline">The term <term>registered exporter</term>
means an exporter for which a registration under subsection (b) has been
approved and is in effect.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID2C1E3E4A012E4FABB6FAA83D437CB37B"><enum>(ii)</enum><text display-inline="yes-display-inline">The term <term>registered importer</term>
means a pharmacy, group of pharmacies, or a wholesaler for which a registration
under subsection (b) has been approved and is in effect.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDBEE4424B2C0D4989A2CD205BBE2EE90A"><enum>(iii)</enum><text display-inline="yes-display-inline">The term <term>registration
condition</term> means a condition that must exist for a registration under
subsection (b) to be approved.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9E8DE32A1BD544C4B52F4417DD627E32"><enum>(B)</enum><header display-inline="yes-display-inline">Qualifying drug</header><text display-inline="yes-display-inline">For purposes of this section, the term
<term>qualifying drug</term> means a drug for which there is a corresponding
U.S. label drug.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID19E2E6CF2E1648F18EECCBD053AFE28A"><enum>(C)</enum><header display-inline="yes-display-inline">U.S. label drug</header><text display-inline="yes-display-inline">For purposes of this section, the term
<term>U.S. label drug</term> means a prescription drug that—</text>
<clause commented="no" display-inline="no-display-inline" id="IDC7E130E398BD43EFA083105102B6A177"><enum>(i)</enum><text display-inline="yes-display-inline">with respect to a qualifying drug, has the
same active ingredient or ingredients, route of administration, dosage form,
and strength as the qualifying drug;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDE1F3C7ECAB994644A969002A45AA8877"><enum>(ii)</enum><text display-inline="yes-display-inline">with respect to the qualifying drug, is
manufactured by or for the person that manufactures the qualifying drug;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDE49CE5A8E2F7486D9ECECAFE42EC31AA"><enum>(iii)</enum><text display-inline="yes-display-inline">is approved under section 505(c);
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID258F11149F5244D1B5FA9DFA4C34F5B8"><enum>(iv)</enum><text display-inline="yes-display-inline">is not—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID03CCC564E88445A28D12F22D65993568"><enum>(I)</enum><text display-inline="yes-display-inline">a controlled substance, as defined in
section 102 of the <act-name parsable-cite="CSA">Controlled Substances
Act</act-name> (21 U.S.C. 802);</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID2DDA6860F8154EB9B6B66D8944998AFE"><enum>(II)</enum><text display-inline="yes-display-inline">a biological product, as defined in section
351 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>
(42 U.S.C. 262), including—</text>
<item commented="no" display-inline="no-display-inline" id="IDBF8519AC331A402ABA18A4010512C031"><enum>(aa)</enum><text display-inline="yes-display-inline">a therapeutic DNA plasmid product;</text>
</item><item commented="no" display-inline="no-display-inline" id="ID8FE24C2EC46B4E58B26D41EF0DFA21DC"><enum>(bb)</enum><text display-inline="yes-display-inline">a therapeutic synthetic peptide
product;</text>
</item><item commented="no" display-inline="no-display-inline" id="IDA0809459B3354C83B6540B66C4693365"><enum>(cc)</enum><text display-inline="yes-display-inline">a monoclonal antibody product for in vivo
use; and</text>
</item><item commented="no" display-inline="no-display-inline" id="ID3FCBEA59C8EF4025A17CB647562250AB"><enum>(dd)</enum><text display-inline="yes-display-inline">a therapeutic recombinant DNA-derived
product;</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="IDD3C30CC6C6EF450A87C33542399907F6"><enum>(III)</enum><text display-inline="yes-display-inline">an infused drug, including a peritoneal
dialysis solution;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID36B689FDB35846A0BD5D91E33E3A78C7"><enum>(IV)</enum><text display-inline="yes-display-inline">an injected drug;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDEE29E53ED700470BAD541DCE361FFF20"><enum>(V)</enum><text display-inline="yes-display-inline">a drug that is inhaled during
surgery;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID2DD2A9AD9DAA4E6FBCB1B6F5E6684EE2"><enum>(VI)</enum><text display-inline="yes-display-inline">a drug that is the listed drug referred to
in 2 or more abbreviated new drug applications under which the drug is
commercially marketed; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idCB357FDBD66A4607922168DB1DAC61BB"><enum>(VII)</enum><text display-inline="yes-display-inline">a sterile opthlamic drug intended for
topical use on or in the eye.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID19731B1FAC1C472B8E1F0E9CD93F0E53"><enum>(D)</enum><header display-inline="yes-display-inline">Other definitions</header><text display-inline="yes-display-inline">For purposes of this section:</text>
<clause commented="no" display-inline="no-display-inline" id="ID58FBEB9356E54A3894E061C6A87AD1B5"><enum>(i)</enum><subclause commented="no" display-inline="yes-display-inline" id="ID85059805A6334E6FB6D9D3BB54DCF45C"><enum>(I)</enum><text display-inline="yes-display-inline">The term <term>exporter</term> means a
person that is in the business of exporting a drug to individuals in the United
States from Canada or from a permitted country designated by the Secretary
under subclause (II), or that, pursuant to submitting a registration under
subsection (b), seeks to be in such business.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDE0BF09E14C6F4F8B8FC21638D1E0990C" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">The Secretary shall designate a permitted
country under subparagraph (E) (other than Canada) as a country from which an
exporter may export a drug to individuals in the United States if the Secretary
determines that—</text>
<item commented="no" display-inline="no-display-inline" id="ID90D6740774184214BDBC5FF7E2152987"><enum>(aa)</enum><text display-inline="yes-display-inline">the country has statutory or regulatory
standards that are equivalent to the standards in the United States and Canada
with respect to—</text>
<subitem commented="no" display-inline="no-display-inline" id="ID0C2562905BF94D4EB570440FCBD6A7BC"><enum>(AA)</enum><text display-inline="yes-display-inline">the training of pharmacists;</text>
</subitem><subitem commented="no" display-inline="no-display-inline" id="ID15096425D14048FE8B214A2A8821B2B0"><enum>(BB)</enum><text display-inline="yes-display-inline">the practice of pharmacy; and</text>
</subitem><subitem commented="no" display-inline="no-display-inline" id="IDCA8F0730F95D4960ACDD68C07960D215"><enum>(CC)</enum><text display-inline="yes-display-inline">the protection of the privacy of personal
medical information; and</text>
</subitem></item><item commented="no" display-inline="no-display-inline" id="id7C952F05D9DA4D82990E06D5430BD917"><enum>(bb)</enum><text display-inline="yes-display-inline">the importation of drugs to individuals in
the United States from the country will not adversely affect public
health.</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="idDDD2E1CFD8984DB2B9013BABF198B681"><enum>(ii)</enum><text display-inline="yes-display-inline">The term <term>importer</term> means a
pharmacy, a group of pharmacies, or a wholesaler that is in the business of
importing a drug into the United States or that, pursuant to submitting a
registration under subsection (b), seeks to be in such business.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idEB20E2D62E3E4AFFAC0B10D2D9FE8213"><enum>(iii)</enum><text display-inline="yes-display-inline">The term <term>pharmacist</term> means a
person licensed by a State to practice pharmacy, including the dispensing and
selling of prescription drugs.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idDFFF8CCEF4F64891AF80BE2030F1BCB3"><enum>(iv)</enum><text display-inline="yes-display-inline">The term <term>pharmacy</term> means a
person that—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID5B5ECB5D375045159EAFEF080AAEF446"><enum>(I)</enum><text display-inline="yes-display-inline">is licensed by a State to engage in the
business of selling prescription drugs at retail; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID88C41EDDE52C43BAA27D297D45A9DA70"><enum>(II)</enum><text display-inline="yes-display-inline">employs 1 or more pharmacists.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDF6FB45F3D5084737B69DF30874263E7B"><enum>(v)</enum><text display-inline="yes-display-inline">The term <term>prescription drug</term>
means a drug that is described in section 503(b)(1).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDB4431F3A5F61490E9EEB2B9FAAD459BC"><enum>(vi)</enum><text display-inline="yes-display-inline">The term <term>wholesaler</term>—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID97F59B8634664470940F8BA83645B94A"><enum>(I)</enum><text display-inline="yes-display-inline">means a person licensed as a wholesaler or
distributor of prescription drugs in the United States under section
503(e)(2)(A); and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID4CC355F268AE43A5875F18D0DAC00620"><enum>(II)</enum><text display-inline="yes-display-inline">does not include a person authorized to
import drugs under section 801(d)(1).</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDA767207BBAF14864AC6A2BA6317FFE7D"><enum>(E)</enum><header display-inline="yes-display-inline">Permitted country</header><text display-inline="yes-display-inline">The term <term>permitted country</term>
means—</text>
<clause commented="no" display-inline="no-display-inline" id="ID36914DEB996440E592DCD08ECC6714B6"><enum>(i)</enum><text display-inline="yes-display-inline">Australia;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID469D2E7463EF4228A58AF0BF93ADC145"><enum>(ii)</enum><text display-inline="yes-display-inline">Canada;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDD4223DE21C9B4C1E9D4E601AEBCC460E"><enum>(iii)</enum><text display-inline="yes-display-inline">a member country of the European Union, but
does not include a member country with respect to which—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID278D2B43EC4A4CABB2665855CF2BFD99"><enum>(I)</enum><text display-inline="yes-display-inline">the country’s Annex to the Treaty of
Accession to the European Union 2003 includes a transitional measure for the
regulation of human pharmaceutical products that has not expired; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID46726B3412854D07AA53BA634E75A35E"><enum>(II)</enum><text display-inline="yes-display-inline">the Secretary determines that the
requirements described in subclauses (I) and (II) of clause (vii) will not be
met by the date on which such transitional measure for the regulation of human
pharmaceutical products expires;</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID2617C267A37844EE94D773E78AB46024"><enum>(iv)</enum><text display-inline="yes-display-inline">Japan;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID452CBD3E84CB4E00836625CF133350B5"><enum>(v)</enum><text display-inline="yes-display-inline">New Zealand;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID283CD2B337B44EE7BA727A6B7ED95491"><enum>(vi)</enum><text display-inline="yes-display-inline">Switzerland; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID56B4E8FF030C4848A2E292642AF1A8D4"><enum>(vii)</enum><text display-inline="yes-display-inline">a country in which the Secretary determines
the following requirements are met:</text>
<subclause commented="no" display-inline="no-display-inline" id="ID3A831FEFE0A2470588B4DAF9D55B0C6C"><enum>(I)</enum><text display-inline="yes-display-inline">The country has statutory or regulatory
requirements—</text>
<item commented="no" display-inline="no-display-inline" id="ID476B2151E0024D459B9A2360B9BCB106"><enum>(aa)</enum><text display-inline="yes-display-inline">that require the review of drugs for safety
and effectiveness by an entity of the government of the country;</text>
</item><item commented="no" display-inline="no-display-inline" id="ID748B820DD70B4EB1AEDCCBC9E7BBF958"><enum>(bb)</enum><text display-inline="yes-display-inline">that authorize the approval of only those
drugs that have been determined to be safe and effective by experts employed by
or acting on behalf of such entity and qualified by scientific training and
experience to evaluate the safety and effectiveness of drugs on the basis of
adequate and well-controlled investigations, including clinical investigations,
conducted by experts qualified by scientific training and experience to
evaluate the safety and effectiveness of drugs;</text>
</item><item commented="no" display-inline="no-display-inline" id="ID68A7635E565D4A95AFC488DCEF9A49CD"><enum>(cc)</enum><text display-inline="yes-display-inline">that require the methods used in, and the
facilities and controls used for the manufacture, processing, and packing of
drugs in the country to be adequate to preserve their identity, quality,
purity, and strength;</text>
</item><item commented="no" display-inline="no-display-inline" id="ID846EE50A422D4E03921244C24E22F56E"><enum>(dd)</enum><text display-inline="yes-display-inline">for the reporting of adverse reactions to
drugs and procedures to withdraw approval and remove drugs found not to be safe
or effective; and</text>
</item><item commented="no" display-inline="no-display-inline" id="ID914D438D8A824277B0F39033A9B05716"><enum>(ee)</enum><text display-inline="yes-display-inline">that require the labeling and promotion of
drugs to be in accordance with the approval of the drug.</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="ID2791C3E748EE4BF1A04B4F823BE62C76"><enum>(II)</enum><text display-inline="yes-display-inline">The valid marketing authorization system in
the country is equivalent to the systems in the countries described in clauses
(i) through (vi).</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID988031F9794C4352889BFD74149942F9"><enum>(III)</enum><text display-inline="yes-display-inline">The importation of drugs to the United
States from the country will not adversely affect public health.</text>
</subclause></clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDDEED9BE8E20140078F866A04713D9A57"><enum>(b)</enum><header display-inline="yes-display-inline">Registration of importers and
exporters</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDC2995010890549E086E503D8116DA8AD"><enum>(1)</enum><header display-inline="yes-display-inline">Registration of importers and
exporters</header><text display-inline="yes-display-inline">A registration
condition is that the importer or exporter involved (referred to in this
subsection as a <quote>registrant</quote>) submits to the Secretary a
registration containing the following:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDDF41F9429FAC4A8C99105B436B67C85D"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="ID8A269BBDB6F8479B886F346C702DE66C"><enum>(i)</enum><text display-inline="yes-display-inline">In the case of an exporter, the name of the
exporter and an identification of all places of business of the exporter that
relate to qualifying drugs, including each warehouse or other facility owned or
controlled by, or operated for, the exporter.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID5178FCC4E93143F3B0E5362E52CDEC19" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">In the case of an importer, the name of the
importer and an identification of the places of business of the importer at
which the importer initially receives a qualifying drug after importation
(which shall not exceed 3 places of business except by permission of the
Secretary).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5304B4F2E8ED4A7BA0C61D1C399254E2"><enum>(B)</enum><text display-inline="yes-display-inline">Such information as the Secretary
determines to be necessary to demonstrate that the registrant is in compliance
with registration conditions under—</text>
<clause commented="no" display-inline="no-display-inline" id="ID0BF216B083474C4A90F4E23E8FA6ACE3"><enum>(i)</enum><text display-inline="yes-display-inline">in the case of an importer, subsections
(c), (d), (e), (g), and (j) (relating to the sources of imported qualifying
drugs; the inspection of facilities of the importer; the payment of fees;
compliance with the standards referred to in section 801(a); and maintenance of
records and samples); or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID0998A6B72DF44978A1A8B64CFFAE3623"><enum>(ii)</enum><text display-inline="yes-display-inline">in the case of an exporter, subsections
(c), (d), (f), (g), (h), (i), and (j) (relating to the sources of exported
qualifying drugs; the inspection of facilities of the exporter and the marking
of compliant shipments; the payment of fees; and compliance with the standards
referred to in section 801(a); being licensed as a pharmacist; conditions for
individual importation; and maintenance of records and samples).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDB1A1FE3B9BCF41C990080F4FC00EFF9C"><enum>(C)</enum><text display-inline="yes-display-inline">An agreement by the registrant that the
registrant will not under subsection (a) import or export any drug that is not
a qualifying drug.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3188DBFFCF1B4B28A5D7A2778761549F"><enum>(D)</enum><text display-inline="yes-display-inline">An agreement by the registrant to—</text>
<clause commented="no" display-inline="no-display-inline" id="ID8938E3D2FB594796B1B45719CB68B5BB"><enum>(i)</enum><text display-inline="yes-display-inline">notify the Secretary of a recall or
withdrawal of a qualifying drug distributed in a permitted country that the
registrant has exported or imported, or intends to export or import, to the
United States under subsection (a);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID79FEA187A24C4237B099A43D2B31179C"><enum>(ii)</enum><text display-inline="yes-display-inline">provide for the return to the registrant of
such drug; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID97A936DAC33E4374892B064B334D7C2E"><enum>(iii)</enum><text display-inline="yes-display-inline">cease, or not begin, the exportation or
importation of such drug unless the Secretary has notified the registrant that
exportation or importation of such drug may proceed.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDDAC4E39836B34DBA9661F94B05D1D4FB"><enum>(E)</enum><text display-inline="yes-display-inline">An agreement by the registrant to ensure
and monitor compliance with each registration condition, to promptly correct
any noncompliance with such a condition, and to promptly report to the
Secretary any such noncompliance.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID780BF82E848449D1B27BF4FE9AC4D93B"><enum>(F)</enum><text display-inline="yes-display-inline">A plan describing the manner in which the
registrant will comply with the agreement under subparagraph (E).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDF17C8E97D67948D1989B55052A6AE268"><enum>(G)</enum><text display-inline="yes-display-inline">An agreement by the registrant to enforce a
contract under subsection (c)(3)(B) against a party in the chain of custody of
a qualifying drug with respect to the authority of the Secretary under clauses
(ii) and (iii) of that subsection.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7FAED45267FF4A679945B39799BB29A0"><enum>(H)</enum><text display-inline="yes-display-inline">An agreement by the registrant to notify
the Secretary not more than 30 days before the registrant intends to make the
change, of—</text>
<clause commented="no" display-inline="no-display-inline" id="ID1B696A92BABC4B8FBF59185423F553A7"><enum>(i)</enum><text display-inline="yes-display-inline">any change that the registrant intends to
make regarding information provided under subparagraph (A) or (B); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID4C77072B161E4773902346EAB5333AC4"><enum>(ii)</enum><text display-inline="yes-display-inline">any change that the registrant intends to
make in the compliance plan under subparagraph (F).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID664394E29D204B6185509F06ED7B465E"><enum>(I)</enum><text display-inline="yes-display-inline">In the case of an exporter:</text>
<clause commented="no" display-inline="no-display-inline" id="ID1EE881BEB8C94C62AF493CAC50E95644"><enum>(i)</enum><text display-inline="yes-display-inline">An agreement by the exporter that a
qualifying drug will not under subsection (a) be exported to any individual not
authorized pursuant to subsection (a)(2)(B) to be an importer of such
drug.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID82C7B36BECEC4E91B7FDC0BE4B29F41F"><enum>(ii)</enum><text display-inline="yes-display-inline">An agreement to post a bond, payable to the
Treasury of the United States that is equal in value to the lesser of—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID48BCD6945A0A4BE9AB943634F99B7F32"><enum>(I)</enum><text display-inline="yes-display-inline">the value of drugs exported by the exporter
to the United States in a typical 4-week period over the course of a year under
this section; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID8F3625274D9A45C09FEF8158F6325E9D"><enum>(II)</enum><text display-inline="yes-display-inline">$1,000,000.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID57273DE8CF7043688D569DD34F0C9803"><enum>(iii)</enum><text display-inline="yes-display-inline">An agreement by the exporter to comply with
applicable provisions of Canadian law, or the law of the permitted country
designated under subsection (a)(4)(D)(i)(II) in which the exporter is located,
that protect the privacy of personal information with respect to each
individual importing a prescription drug from the exporter under subsection
(a)(2)(B).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID79D5B6C14503443E955D8B21BD53C1EB"><enum>(iv)</enum><text display-inline="yes-display-inline">An agreement by the exporter to report to
the Secretary—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID9B2FB5A3F8C144709D4AA288B25421DE"><enum>(I)</enum><text display-inline="yes-display-inline">not later than August 1 of each fiscal
year, the total price and the total volume of drugs exported to the United
States by the exporter during the 6-month period from January 1 through June 30
of that year; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDC32F6C9EED8F47A1A9F088AFEEA3403F"><enum>(II)</enum><text display-inline="yes-display-inline">not later than January 1 of each fiscal
year, the total price and the total volume of drugs exported to the United
States by the exporter during the previous fiscal year.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3F674C3A45D14668BE79226B21B51FB5"><enum>(J)</enum><text display-inline="yes-display-inline">In the case of an importer, an agreement by
the importer to report to the Secretary—</text>
<clause commented="no" display-inline="no-display-inline" id="IDA3B7FA1526E741A5B9280384A7229D97"><enum>(i)</enum><text display-inline="yes-display-inline">not later than August 1 of each fiscal
year, the total price and the total volume of drugs imported to the United
States by the importer during the 6-month period from January 1 through June 30
of that fiscal year; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID5BBB67BC1F624033875061031DE3D65F"><enum>(ii)</enum><text display-inline="yes-display-inline">not later than January 1 of each fiscal
year, the total price and the total volume of drugs imported to the United
States by the importer during the previous fiscal year.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7EF9203B5CF7404E98EBAD41ABC21FC4"><enum>(K)</enum><text display-inline="yes-display-inline">Such other provisions as the Secretary may
require by regulation to protect the public health while permitting—</text>
<clause commented="no" display-inline="no-display-inline" id="ID3B4A88668C114EB382B910F5FD7164C0"><enum>(i)</enum><text display-inline="yes-display-inline">the importation by pharmacies, groups of
pharmacies, and wholesalers as registered importers of qualifying drugs under
subsection (a); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDFA7DD09767A94485AD8C6B38EB38A8F7"><enum>(ii)</enum><text display-inline="yes-display-inline">importation by individuals of qualifying
drugs under subsection (a).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDAE8BE023AEC1420A9401D6CDBB56F12F"><enum>(2)</enum><header display-inline="yes-display-inline">Approval or disapproval of
registration</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID393F8774EEDD42BF936B86CAD0D71B50"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 90 days after the date on
which a registrant submits to the Secretary a registration under paragraph (1),
the Secretary shall notify the registrant whether the registration is approved
or is disapproved. The Secretary shall disapprove a registration if there is
reason to believe that the registrant is not in compliance with one or more
registration conditions, and shall notify the registrant of such reason. In the
case of a disapproved registration, the Secretary shall subsequently notify the
registrant that the registration is approved if the Secretary determines that
the registrant is in compliance with such conditions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID326804DD032240B8B9A16840897C2873"><enum>(B)</enum><header display-inline="yes-display-inline">Changes in registration
information</header><text display-inline="yes-display-inline">Not later than 30
days after receiving a notice under paragraph (1)(H) from a registrant, the
Secretary shall determine whether the change involved affects the approval of
the registration of the registrant under paragraph (1), and shall inform the
registrant of the determination.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDED5E554523074F40B269D804C9520E86"><enum>(3)</enum><header display-inline="yes-display-inline">Publication of contact information for
registered exporters</header><text display-inline="yes-display-inline">Through
the Internet Web site of the Food and Drug Administration and a toll-free
telephone number, the Secretary shall make readily available to the public a
list of registered exporters, including contact information for the exporters.
Promptly after the approval of a registration submitted under paragraph (1),
the Secretary shall update the Internet Web site and the information provided
through the toll-free telephone number accordingly.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID46FC7FD831534D28A1CBD1EA9388227F"><enum>(4)</enum><header display-inline="yes-display-inline">Suspension and termination</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDDA4A4389CD6C4D98A83710B495C07DB8"><enum>(A)</enum><header display-inline="yes-display-inline">Suspension</header><text display-inline="yes-display-inline">With respect to the effectiveness of a
registration submitted under paragraph (1):</text>
<clause commented="no" display-inline="no-display-inline" id="IDA9E1DC8DEF6440F8893A348D6C601E7F"><enum>(i)</enum><text display-inline="yes-display-inline">Subject to clause (ii), the Secretary may
suspend the registration if the Secretary determines, after notice and
opportunity for a hearing, that the registrant has failed to maintain
substantial compliance with a registration condition.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID8CA2EC99450E4602A4471098C833B515"><enum>(ii)</enum><text display-inline="yes-display-inline">If the Secretary determines that, under
color of the registration, the exporter has exported a drug or the importer has
imported a drug that is not a qualifying drug, or a drug that does not comply
with subsection (g)(2)(A) or (g)(4), or has exported a qualifying drug to an
individual in violation of subsection (i)(2)(F), the Secretary shall
immediately suspend the registration. A suspension under the preceding sentence
is not subject to the provision by the Secretary of prior notice, and the
Secretary shall provide to the registrant an opportunity for a hearing not
later than 10 days after the date on which the registration is
suspended.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID926BC44A62D04EF5BD65752A15F75299"><enum>(iii)</enum><text display-inline="yes-display-inline">The Secretary may reinstate the
registration, whether suspended under clause (i) or (ii), if the Secretary
determines that the registrant has demonstrated that further violations of
registration conditions will not occur.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7723CD07D71742F59649585BB6384996"><enum>(B)</enum><header display-inline="yes-display-inline">Termination</header><text display-inline="yes-display-inline">The Secretary, after notice and opportunity
for a hearing, may terminate the registration under paragraph (1) of a
registrant if the Secretary determines that the registrant has engaged in a
pattern or practice of violating 1 or more registration conditions, or if on 1
or more occasions the Secretary has under subparagraph (A)(ii) suspended the
registration of the registrant. The Secretary may make the termination
permanent, or for a fixed period of not less than 1 year. During the period in
which the registration is terminated, any registration submitted under
paragraph (1) by the registrant, or a person that is a partner in the export or
import enterprise, or a principal officer in such enterprise, and any
registration prepared with the assistance of the registrant or such a person,
has no legal effect under this section.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDAA16FA5685AC4C13B3BC290F3A2D3106"><enum>(5)</enum><header display-inline="yes-display-inline">Default of bond</header><text display-inline="yes-display-inline">A bond required to be posted by an exporter
under paragraph (1)(I)(ii) shall be defaulted and paid to the Treasury of the
United States if, after opportunity for an informal hearing, the Secretary
determines that the exporter has—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDC0C32B5FCD9B4623AE5B16B62DCA44DC"><enum>(A)</enum><text display-inline="yes-display-inline">exported a drug to the United States that
is not a qualifying drug or that is not in compliance with subsection
(g)(2)(A), (g)(4), or (i); or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID4C8556A7786247EF9A07DE0B6037B3C3"><enum>(B)</enum><text display-inline="yes-display-inline">failed to permit the Secretary to conduct
an inspection described under subsection (d).</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID956F61D10A294AB3943116675721DB60"><enum>(c)</enum><header display-inline="yes-display-inline">Sources of qualifying drugs</header><text display-inline="yes-display-inline">A registration condition is that the
exporter or importer involved agrees that a qualifying drug will under
subsection (a) be exported or imported into the United States only if there is
compliance with the following:</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDB1B2DC24547B4D4DAEC8DE4A8C665D1F"><enum>(1)</enum><text display-inline="yes-display-inline">The drug was manufactured in an
establishment—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDC9FD4BBBB32040DF919C7207E6D7DFC4"><enum>(A)</enum><text display-inline="yes-display-inline">required to register under subsection (h)
or (i) of section 510; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDDBD1B68C534E47999F456FF8D02F9380"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="ID5FC497A0BFFC4AF99049A6424A35E994"><enum>(i)</enum><text display-inline="yes-display-inline">inspected by the Secretary; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDA6E95B6F9B254C3E9BD79BB1202CD4AA" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">for which the Secretary has elected to rely
on a satisfactory report of a good manufacturing practice inspection of the
establishment from a permitted country whose regulatory system the Secretary
recognizes as equivalent under a mutual recognition agreement, as provided for
under section 510(i)(3), section 803, or part 26 of title 21, Code of Federal
Regulations (or any corresponding successor rule or regulation).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID359D01319E334C1598CA68175A69B767"><enum>(2)</enum><text display-inline="yes-display-inline">The establishment is located in any
country, and the establishment manufactured the drug for distribution in the
United States or for distribution in 1 or more of the permitted countries
(without regard to whether in addition the drug is manufactured for
distribution in a foreign country that is not a permitted country).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID6779AC11BA7949168F6C6E547FC56659"><enum>(3)</enum><text display-inline="yes-display-inline">The exporter or importer obtained the
drug—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID11900CF89A174368A92F9BEA3F94E0D1"><enum>(A)</enum><text display-inline="yes-display-inline">directly from the establishment; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID85A42D4FB09A452881CD2055067A8056"><enum>(B)</enum><text display-inline="yes-display-inline">directly from an entity that, by contract
with the exporter or importer—</text>
<clause commented="no" display-inline="no-display-inline" id="ID05E86D1DEFEB4595A1EBA074937F4E02"><enum>(i)</enum><text display-inline="yes-display-inline">provides to the exporter or importer a
statement (in such form and containing such information as the Secretary may
require) that, for the chain of custody from the establishment, identifies each
prior sale, purchase, or trade of the drug (including the date of the
transaction and the names and addresses of all parties to the
transaction);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID9543F1BC415D4FD9828886D983B731FE"><enum>(ii)</enum><text display-inline="yes-display-inline">agrees to permit the Secretary to inspect
such statements and related records to determine their accuracy;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID499A8323C8684DD095CF457CDBB03DDA"><enum>(iii)</enum><text display-inline="yes-display-inline">agrees, with respect to the qualifying
drugs involved, to permit the Secretary to inspect warehouses and other
facilities, including records, of the entity for purposes of determining
whether the facilities are in compliance with any standards under this Act that
are applicable to facilities of that type in the United States; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID56D56EC07D6149889A9BC5060195FA11"><enum>(iv)</enum><text display-inline="yes-display-inline">has ensured, through such contractual
relationships as may be necessary, that the Secretary has the same authority
regarding other parties in the chain of custody from the establishment that the
Secretary has under clauses (ii) and (iii) regarding such entity.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID92E6B7F1F69C441998550637C6A72DCC"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="ID084B45D9C7BD43F886A02EEB7673D087"><enum>(A)</enum><text display-inline="yes-display-inline">The foreign country from which the importer
will import the drug is a permitted country; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5AB77E01B492496798325CD141F691A9" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">The foreign country from which the exporter
will export the drug is the permitted country in which the exporter is
located.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID84CC9F3E6A6C4A2CBB111A102DE10D86"><enum>(5)</enum><text display-inline="yes-display-inline">During any period in which the drug was not
in the control of the manufacturer of the drug, the drug did not enter any
country that is not a permitted country.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID33938E414EE24CB6B8E644182CDF1D26"><enum>(6)</enum><text display-inline="yes-display-inline">The exporter or importer retains a sample
of each lot of the drug for testing by the Secretary.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID4B7E17B2EE59434EB0302AC25D9FB270"><enum>(d)</enum><header display-inline="yes-display-inline">Inspection of facilities; marking of
shipments</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID25C16B841C4543E7983087865895A09F"><enum>(1)</enum><header display-inline="yes-display-inline">Inspection of facilities</header><text display-inline="yes-display-inline">A registration condition is that, for the
purpose of assisting the Secretary in determining whether the exporter involved
is in compliance with all other registration conditions—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID1D255406840D46AC8DD8AFC76263C398"><enum>(A)</enum><text display-inline="yes-display-inline">the exporter agrees to permit the
Secretary—</text>
<clause commented="no" display-inline="no-display-inline" id="IDBA700837CFCF43D4AFB902F3751B12A2"><enum>(i)</enum><text display-inline="yes-display-inline">to conduct onsite inspections, including
monitoring on a day-to-day basis, of places of business of the exporter that
relate to qualifying drugs, including each warehouse or other facility owned or
controlled by, or operated for, the exporter;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID2DA7EE1F2E6941E8A7928D506CDB2BAD"><enum>(ii)</enum><text display-inline="yes-display-inline">to have access, including on a day-to-day
basis, to—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID4FAD5410EBCB4EE1BE9B3A1F543AD9DC"><enum>(I)</enum><text display-inline="yes-display-inline">records of the exporter that relate to the
export of such drugs, including financial records; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID3A4D764FDFAA4DBA8271696FFE510AB0"><enum>(II)</enum><text display-inline="yes-display-inline">samples of such drugs;</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDA9DCB9ECD8B04C67BC0197F84B874BA7"><enum>(iii)</enum><text display-inline="yes-display-inline">to carry out the duties described in
paragraph (3); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDC6C852BF6D1745A1805D77183B4E9378"><enum>(iv)</enum><text display-inline="yes-display-inline">to carry out any other functions determined
by the Secretary to be necessary regarding the compliance of the exporter;
and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDF92FC68A13F14C32A81B1E54509B9E7A"><enum>(B)</enum><text display-inline="yes-display-inline">the Secretary has assigned 1 or more
employees of the Secretary to carry out the functions described in this
subsection for the Secretary randomly, but not less than 12 times annually, on
the premises of places of businesses referred to in subparagraph (A)(i), and
such an assignment remains in effect on a continuous basis.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID6F644BF664D14E41B84436E3621BC361"><enum>(2)</enum><header display-inline="yes-display-inline">Marking of compliant
shipments</header><text display-inline="yes-display-inline">A registration
condition is that the exporter involved agrees to affix to each shipping
container of qualifying drugs exported under subsection (a) such markings as
the Secretary determines to be necessary to identify the shipment as being in
compliance with all registration conditions. Markings under the preceding
sentence shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID6507BF0DF3B24F148266628270CF1617"><enum>(A)</enum><text display-inline="yes-display-inline">be designed to prevent affixation of the
markings to any shipping container that is not authorized to bear the markings;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID64D32AD92EA3404F8BBA4C1E44C025BD"><enum>(B)</enum><text display-inline="yes-display-inline">include anticounterfeiting or
track-and-trace technologies, taking into account the economic and technical
feasibility of those technologies.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID6E8E77BFDEB34381A209540B7592F3B1"><enum>(3)</enum><header display-inline="yes-display-inline">Certain duties relating to
exporters</header><text display-inline="yes-display-inline">Duties of the
Secretary with respect to an exporter include the following:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID6B85CAB01E9548C5A4138B9C1D9D4F84"><enum>(A)</enum><text display-inline="yes-display-inline">Inspecting, randomly, but not less than 12
times annually, the places of business of the exporter at which qualifying
drugs are stored and from which qualifying drugs are shipped.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7210C98EB7DF47DB93E6DE6F3D629B94"><enum>(B)</enum><text display-inline="yes-display-inline">During the inspections under subparagraph
(A), verifying the chain of custody of a statistically significant sample of
qualifying drugs from the establishment in which the drug was manufactured to
the exporter, which shall be accomplished or supplemented by the use of
anticounterfeiting or track-and-trace technologies, taking into account the
economic and technical feasibility of those technologies, except that a drug
that lacks such technologies from the point of manufacture shall not for that
reason be excluded from importation by an exporter.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDD86636B3486A43DBB9EF6003CF92EA2C"><enum>(C)</enum><text display-inline="yes-display-inline">Randomly reviewing records of exports to
individuals for the purpose of determining whether the drugs are being imported
by the individuals in accordance with the conditions under subsection (i). Such
reviews shall be conducted in a manner that will result in a statistically
significant determination of compliance with all such conditions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID539FE8C7CD3144F7BDAADA16A8F82EEC"><enum>(D)</enum><text display-inline="yes-display-inline">Monitoring the affixing of markings under
paragraph (2).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID593E5BE0ECBB4F4DA87BC46BB5CF1472"><enum>(E)</enum><text display-inline="yes-display-inline">Inspecting as the Secretary determines is
necessary the warehouses and other facilities, including records, of other
parties in the chain of custody of qualifying drugs.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID8D6DE468E81748CBAE2FC53BDC3749E2"><enum>(F)</enum><text display-inline="yes-display-inline">Determining whether the exporter is in
compliance with all other registration conditions.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID7705EBCBFAB9467D90F9CD7BEB9BEFE8"><enum>(4)</enum><header display-inline="yes-display-inline">Prior notice of shipments</header><text display-inline="yes-display-inline">A registration condition is that, not less
than 8 hours and not more than 5 days in advance of the time of the importation
of a shipment of qualifying drugs, the importer involved agrees to submit to
the Secretary a notice with respect to the shipment of drugs to be imported or
offered for import into the United States under subsection (a). A notice under
the preceding sentence shall include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID0A78C13F47844F278CA371696A788190"><enum>(A)</enum><text display-inline="yes-display-inline">the name and complete contact information
of the person submitting the notice;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0C0D2052B47542AF9F3C6AC0CA287D93"><enum>(B)</enum><text display-inline="yes-display-inline">the name and complete contact information
of the importer involved;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0EFA2723D17B417F858ABB9E64BB1C72"><enum>(C)</enum><text display-inline="yes-display-inline">the identity of the drug, including the
established name of the drug, the quantity of the drug, and the lot number
assigned by the manufacturer;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1440C2C5672C44198AD12E9E929403E3"><enum>(D)</enum><text display-inline="yes-display-inline">the identity of the manufacturer of the
drug, including the identity of the establishment at which the drug was
manufactured;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDAEF00B3DB79940C3ADD210A501227943"><enum>(E)</enum><text display-inline="yes-display-inline">the country from which the drug is
shipped;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID793A31A99BDE42728F1159AABCD2E6E3"><enum>(F)</enum><text display-inline="yes-display-inline">the name and complete contact information
for the shipper of the drug;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1841AE62183B4FFB8976F0F8DFB301D4"><enum>(G)</enum><text display-inline="yes-display-inline">anticipated arrival information, including
the port of arrival and crossing location within that port, and the date and
time;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDF5B8BF52E7CE4F408E4A5C8831964D1D"><enum>(H)</enum><text display-inline="yes-display-inline">a summary of the chain of custody of the
drug from the establishment in which the drug was manufactured to the
importer;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7C0CFA0FCECB41978B829B30D798F4E5"><enum>(I)</enum><text display-inline="yes-display-inline">a declaration as to whether the Secretary
has ordered that importation of the drug from the permitted country cease under
subsection (g)(2)(C) or (D); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDAA063C40EC8D49A88CB6943058CD3ED4"><enum>(J)</enum><text display-inline="yes-display-inline">such other information as the Secretary may
require by regulation.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDD625FBD2045F4527B83F4DC52FBB3B8F"><enum>(5)</enum><header display-inline="yes-display-inline">Marking of compliant
shipments</header><text display-inline="yes-display-inline">A registration
condition is that the importer involved agrees, before wholesale distribution
(as defined in section 503(e)) of a qualifying drug that has been imported
under subsection (a), to affix to each container of such drug such markings or
other technology as the Secretary determines necessary to identify the shipment
as being in compliance with all registration conditions, except that the
markings or other technology shall not be required on a drug that bears
comparable, compatible markings or technology from the manufacturer of the
drug. Markings or other technology under the preceding sentence shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDF02B8B0B73D94171B09EC61B908ED7C3"><enum>(A)</enum><text display-inline="yes-display-inline">be designed to prevent affixation of the
markings or other technology to any container that is not authorized to bear
the markings; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID038179724CCD48E4B73B06E3CACA5A8A"><enum>(B)</enum><text display-inline="yes-display-inline">shall include anticounterfeiting or
track-and-trace technologies, taking into account the economic and technical
feasibility of such technologies.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDEFF60D8A49804F41B002BC17EF1D5D35"><enum>(6)</enum><header display-inline="yes-display-inline">Certain duties relating to
importers</header><text display-inline="yes-display-inline">Duties of the
Secretary with respect to an importer include the following:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID458512CF6B674F6F97F36CF3CBD0603D"><enum>(A)</enum><text display-inline="yes-display-inline">Inspecting, randomly, but not less than 12
times annually, the places of business of the importer at which a qualifying
drug is initially received after importation.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDE5718A0C93AC4E0899FEA155B0235489"><enum>(B)</enum><text display-inline="yes-display-inline">During the inspections under subparagraph
(A), verifying the chain of custody of a statistically significant sample of
qualifying drugs from the establishment in which the drug was manufactured to
the importer, which shall be accomplished or supplemented by the use of
anticounterfeiting or track-and-trace technologies, taking into account the
economic and technical feasibility of those technologies, except that a drug
that lacks such technologies from the point of manufacture shall not for that
reason be excluded from importation by an importer.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3DE9E22F108C4331910D34A5F17FF0F7"><enum>(C)</enum><text display-inline="yes-display-inline">Reviewing notices under paragraph
(4).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID8D505DA584884CBB8F4D6749B4C92C41"><enum>(D)</enum><text display-inline="yes-display-inline">Inspecting as the Secretary determines is
necessary the warehouses and other facilities, including records of other
parties in the chain of custody of qualifying drugs.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5FA577FC2C6746B2AAB3FBDC4138284F"><enum>(E)</enum><text display-inline="yes-display-inline">Determining whether the importer is in
compliance with all other registration conditions.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID997C87182793416EAB3179B6BBB4F4A6"><enum>(e)</enum><header display-inline="yes-display-inline">Importer fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDF3AF1A58A9AC4A8CB0DE0621D6C04D7F"><enum>(1)</enum><header display-inline="yes-display-inline">Registration fee</header><text display-inline="yes-display-inline">A registration condition is that the
importer involved pays to the Secretary a fee of $10,000 due on the date on
which the importer first submits the registration to the Secretary under
subsection (b).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDBEE7EBFBBFC3416C9123C5E54B052CE8"><enum>(2)</enum><header display-inline="yes-display-inline">Inspection
fee</header><text display-inline="yes-display-inline">A registration condition
is that the importer involved pays a fee to the Secretary in accordance with
this subsection. Such fee shall be paid not later than October 1 and April 1 of
each fiscal year in the amount provided for under paragraph (3).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID995318B86A7F42598A1B9E21E90E1C78"><enum>(3)</enum><header display-inline="yes-display-inline">Amount of inspection fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID0A8543A9A8D040ACAA68DC80E8254ACC"><enum>(A)</enum><header display-inline="yes-display-inline">Aggregate total of fees</header><text display-inline="yes-display-inline">Not later than 30 days before the start of
each fiscal year, the Secretary, in consultation with the Secretary of Homeland
Security and the Secretary of the Treasury, shall establish an aggregate total
of fees to be collected under paragraph (2) for importers for that fiscal year
that is sufficient, and not more than necessary, to pay the costs for that
fiscal year of administering this section with respect to registered importers,
including the costs associated with—</text>
<clause commented="no" display-inline="no-display-inline" id="IDFEE802E7101647339EB6C58AAA958FFA"><enum>(i)</enum><text display-inline="yes-display-inline">inspecting the facilities of registered
importers, and of other entities in the chain of custody of a qualifying drug
as necessary, under subsection (d)(6);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDF602388C898E4E249C213A87E52DBB52"><enum>(ii)</enum><text display-inline="yes-display-inline">developing, implementing, and operating
under such subsection an electronic system for submission and review of the
notices required under subsection (d)(4) with respect to shipments of
qualifying drugs under subsection (a) to assess compliance with all
registration conditions when such shipments are offered for import into the
United States; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID0E7C09082F574B729B465AAD7D277754"><enum>(iii)</enum><text display-inline="yes-display-inline">inspecting such shipments as necessary,
when offered for import into the United States to determine if such a shipment
should be refused admission under subsection (g)(5).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDA8AC6917D25D4AA882FB1F18A7075975"><enum>(B)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Subject to subparagraph (C), the aggregate
total of fees collected under paragraph (2) for a fiscal year shall not exceed
2.5 percent of the total price of qualifying drugs imported during that fiscal
year into the United States by registered importers under subsection
(a).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6DCD360C31924A429D338868FCA8D669"><enum>(C)</enum><header display-inline="yes-display-inline">Total price of drugs</header>
<clause commented="no" display-inline="no-display-inline" id="IDC8FD30AD971348759EF1324BBF08C468"><enum>(i)</enum><header display-inline="yes-display-inline">Estimate</header><text display-inline="yes-display-inline">For the purposes of complying with the
limitation described in subparagraph (B) when establishing under subparagraph
(A) the aggregate total of fees to be collected under paragraph (2) for a
fiscal year, the Secretary shall estimate the total price of qualifying drugs
imported into the United States by registered importers during that fiscal year
by adding the total price of qualifying drugs imported by each registered
importer during the 6-month period from January 1 through June 30 of the
previous fiscal year, as reported to the Secretary by each registered importer
under subsection (b)(1)(J).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDBB9CFCC52DEF493B82214F75BA95BF46"><enum>(ii)</enum><header display-inline="yes-display-inline">Calculation</header><text display-inline="yes-display-inline">Not later than March 1 of the fiscal year
that follows the fiscal year for which the estimate under clause (i) is made,
the Secretary shall calculate the total price of qualifying drugs imported into
the United States by registered importers during that fiscal year by adding the
total price of qualifying drugs imported by each registered importer during
that fiscal year, as reported to the Secretary by each registered importer
under subsection (b)(1)(J).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDBCB2AE0977904F049FC794DA9C4D6413"><enum>(iii)</enum><header display-inline="yes-display-inline">Adjustment</header><text display-inline="yes-display-inline">If the total price of qualifying drugs
imported into the United States by registered importers during a fiscal year as
calculated under clause (ii) is less than the aggregate total of fees collected
under paragraph (2) for that fiscal year, the Secretary shall provide for a
pro-rata reduction in the fee due from each registered importer on April 1 of
the subsequent fiscal year so that the limitation described in subparagraph (B)
is observed.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2C446A18968A4EE09421815E08A1D0B1"><enum>(D)</enum><header display-inline="yes-display-inline">Individual importer fee</header><text display-inline="yes-display-inline">Subject to the limitation described in
subparagraph (B), the fee under paragraph (2) to be paid on October 1 and April
1 by an importer shall be an amount that is proportional to a reasonable
estimate by the Secretary of the semiannual share of the importer of the volume
of qualifying drugs imported by importers under subsection (a).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDC81FF58464F941A8BEFBE0F83978AE8D"><enum>(4)</enum><header display-inline="yes-display-inline">Use of fees</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDBE754EC830BA46CF8FFEE350032239E8"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subject to appropriations Acts, fees
collected by the Secretary under paragraphs (1) and (2) shall be credited to
the appropriation account for salaries and expenses of the Food and Drug
Administration until expended (without fiscal year limitation), and the
Secretary may, in consultation with the Secretary of Homeland Security and the
Secretary of the Treasury, transfer some proportion of such fees to the
appropriation account for salaries and expenses of the Bureau of Customs and
Border Protection until expended (without fiscal year limitation).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDF65248550EDB4A6B8FFBCDA8A6800EE0"><enum>(B)</enum><header display-inline="yes-display-inline">Sole purpose</header><text display-inline="yes-display-inline">Fees collected by the Secretary under
paragraphs (1) and (2) are only available to the Secretary and, if transferred,
to the Secretary of Homeland Security, and are for the sole purpose of paying
the costs referred to in paragraph (3)(A).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID860AC212830B482DB12B644E299E4361"><enum>(5)</enum><header display-inline="yes-display-inline">Collection of fees</header><text display-inline="yes-display-inline">In any case where the Secretary does not
receive payment of a fee assessed under paragraph (1) or (2) within 30 days
after it is due, such fee shall be treated as a claim of the United States
Government subject to subchapter II of chapter 37 of title 31, United States
Code.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID0786B1EF14994477B5413BBCAE9EAAB8"><enum>(f)</enum><header display-inline="yes-display-inline">Exporter fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID767C26CC4A7E4925B8AA4473CA0D1740"><enum>(1)</enum><header display-inline="yes-display-inline">Registration fee</header><text display-inline="yes-display-inline">A registration condition is that the
exporter involved pays to the Secretary a fee of $10,000 due on the date on
which the exporter first submits that registration to the Secretary under
subsection (b).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID3905B8730136434BBFB7360483337AEB"><enum>(2)</enum><header display-inline="yes-display-inline">Inspection
fee</header><text display-inline="yes-display-inline">A registration condition
is that the exporter involved pays a fee to the Secretary in accordance with
this subsection. Such fee shall be paid not later than October 1 and April 1 of
each fiscal year in the amount provided for under paragraph (3).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID678767416B004C93A0939FD007EF9617"><enum>(3)</enum><header display-inline="yes-display-inline">Amount of inspection fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID5C6D335A50A64C0D9965C9921D18DFEB"><enum>(A)</enum><header display-inline="yes-display-inline">Aggregate total of fees</header><text display-inline="yes-display-inline">Not later than 30 days before the start of
each fiscal year, the Secretary, in consultation with the Secretary of Homeland
Security and the Secretary of the Treasury, shall establish an aggregate total
of fees to be collected under paragraph (2) for exporters for that fiscal year
that is sufficient, and not more than necessary, to pay the costs for that
fiscal year of administering this section with respect to registered exporters,
including the costs associated with—</text>
<clause commented="no" display-inline="no-display-inline" id="ID7857B7A7F7D840739714D5D65FE0051B"><enum>(i)</enum><text display-inline="yes-display-inline">inspecting the facilities of registered
exporters, and of other entities in the chain of custody of a qualifying drug
as necessary, under subsection (d)(3);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID10E2F1BE655A48B29F749529B36A9C06"><enum>(ii)</enum><text display-inline="yes-display-inline">developing, implementing, and operating
under such subsection a system to screen marks on shipments of qualifying drugs
under subsection (a) that indicate compliance with all registration conditions,
when such shipments are offered for import into the United States; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDB7D7001954BF4175B6565A1641C494D1"><enum>(iii)</enum><text display-inline="yes-display-inline">screening such markings, and inspecting
such shipments as necessary, when offered for import into the United States to
determine if such a shipment should be refused admission under subsection
(g)(5).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5DDAC6157FB44770ADFAFB10926A9E8C"><enum>(B)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Subject to subparagraph (C), the aggregate
total of fees collected under paragraph (2) for a fiscal year shall not exceed
2.5 percent of the total price of qualifying drugs imported during that fiscal
year into the United States by registered exporters under subsection
(a).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID82666CF994884C90B9357308B420A533"><enum>(C)</enum><header display-inline="yes-display-inline">Total price of drugs</header>
<clause commented="no" display-inline="no-display-inline" id="ID4CE13ED2BF3741D7AC34CFF92AA67A61"><enum>(i)</enum><header display-inline="yes-display-inline">Estimate</header><text display-inline="yes-display-inline">For the purposes of complying with the
limitation described in subparagraph (B) when establishing under subparagraph
(A) the aggregate total of fees to be collected under paragraph (2) for a
fiscal year, the Secretary shall estimate the total price of qualifying drugs
imported into the United States by registered exporters during that fiscal year
by adding the total price of qualifying drugs exported by each registered
exporter during the 6-month period from January 1 through June 30 of the
previous fiscal year, as reported to the Secretary by each registered exporter
under subsection (b)(1)(I)(iv).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDC26A5D5C48A344FCB2B2A4BE7E0931CA"><enum>(ii)</enum><header display-inline="yes-display-inline">Calculation</header><text display-inline="yes-display-inline">Not later than March 1 of the fiscal year
that follows the fiscal year for which the estimate under clause (i) is made,
the Secretary shall calculate the total price of qualifying drugs imported into
the United States by registered exporters during that fiscal year by adding the
total price of qualifying drugs exported by each registered exporter during
that fiscal year, as reported to the Secretary by each registered exporter
under subsection (b)(1)(I)(iv).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID3584D1977E704D6EA5C2A96E928B9DBF"><enum>(iii)</enum><header display-inline="yes-display-inline">Adjustment</header><text display-inline="yes-display-inline">If the total price of qualifying drugs
imported into the United States by registered exporters during a fiscal year as
calculated under clause (ii) is less than the aggregate total of fees collected
under paragraph (2) for that fiscal year, the Secretary shall provide for a
pro-rata reduction in the fee due from each registered exporter on April 1 of
the subsequent fiscal year so that the limitation described in subparagraph (B)
is observed.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDC45DF0D815834A019E686FFA483F565C"><enum>(D)</enum><header display-inline="yes-display-inline">Individual exporter fee</header><text display-inline="yes-display-inline">Subject to the limitation described in
subparagraph (B), the fee under paragraph (2) to be paid on October 1 and April
1 by an exporter shall be an amount that is proportional to a reasonable
estimate by the Secretary of the semiannual share of the exporter of the volume
of qualifying drugs exported by exporters under subsection (a).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDF4FAD563095A40DBB0C4C209909228AF"><enum>(4)</enum><header display-inline="yes-display-inline">Use of fees</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID729A24E666384C8980B652A866208802"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subject to appropriations Acts, fees
collected by the Secretary under paragraphs (1) and (2) shall be credited to
the appropriation account for salaries and expenses of the Food and Drug
Administration until expended (without fiscal year limitation), and the
Secretary may, in consultation with the Secretary of Homeland Security and the
Secretary of the Treasury, transfer some proportion of such fees to the
appropriation account for salaries and expenses of the Bureau of Customs and
Border Protection until expended (without fiscal year limitation).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID77A345ADF32C4B9EAC8751A0FE747CA4"><enum>(B)</enum><header display-inline="yes-display-inline">Sole purpose</header><text display-inline="yes-display-inline">Fees collected by the Secretary under
paragraphs (1) and (2) are only available to the Secretary and, if transferred,
to the Secretary of Homeland Security, and are for the sole purpose of paying
the costs referred to in paragraph (3)(A).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDD6A63CE1A9D04E75B99D0EAD52D9E8B8"><enum>(5)</enum><header display-inline="yes-display-inline">Collection of fees</header><text display-inline="yes-display-inline">In any case where the Secretary does not
receive payment of a fee assessed under paragraph (1) or (2) within 30 days
after it is due, such fee shall be treated as a claim of the United States
Government subject to subchapter II of chapter 37 of title 31, United States
Code.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID4B01F0B6133B4FD9A9049AC5C985F282"><enum>(g)</enum><header display-inline="yes-display-inline">Compliance with Section
<enum-in-header>801(a)</enum-in-header></header>
<paragraph commented="no" display-inline="no-display-inline" id="IDEB89B825C9E949F680B8564B16AFFAF3"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A registration condition is that each
qualifying drug exported under subsection (a) by the registered exporter
involved or imported under subsection (a) by the registered importer involved
is in compliance with the standards referred to in section 801(a) regarding
admission of the drug into the United States, subject to paragraphs (2), (3),
and (4).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID71975237FC234658B7EC0591B957846C"><enum>(2)</enum><header display-inline="yes-display-inline">Section 505; approval status</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID2B9CE27998CB4A9FA6CB792DF36CA75A"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A qualifying drug that is imported or
offered for import under subsection (a) shall comply with the conditions
established in the approved application under section 505(b) for the U.S. label
drug as described under this subsection.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7ED196AAE245487098C8D144B4EE4EA0"><enum>(B)</enum><header display-inline="yes-display-inline">Notice by manufacturer; general
provisions</header>
<clause commented="no" display-inline="no-display-inline" id="IDD1910B654A174288AEA28ED4440AF3AF"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The person that manufactures a qualifying
drug that is, or will be, introduced for commercial distribution in a permitted
country shall in accordance with this paragraph submit to the Secretary a
notice that—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDDE0738D7576548F98EA191E81AB8FE42"><enum>(I)</enum><text display-inline="yes-display-inline">includes each difference in the qualifying
drug from a condition established in the approved application for the U.S.
label drug beyond—</text>
<item commented="no" display-inline="no-display-inline" id="IDD2B776D833FB4D3BAAFA997C2EA5FF7B"><enum>(aa)</enum><text display-inline="yes-display-inline">the variations provided for in the
application; and</text>
</item><item commented="no" display-inline="no-display-inline" id="ID54ADA72D867E49B1BC7CE38BEA2EF21D"><enum>(bb)</enum><text display-inline="yes-display-inline">any difference in labeling (except
ingredient labeling); or</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="IDA2DF23B0F525484A818D7D223EA5200D"><enum>(II)</enum><text display-inline="yes-display-inline">States that there is no difference in the
qualifying drug from a condition established in the approved application for
the U.S. label drug beyond—</text>
<item commented="no" display-inline="no-display-inline" id="IDAF28774A9A1A47AA9ABDE3BD74F08420"><enum>(aa)</enum><text display-inline="yes-display-inline">the variations provided for in the
application; and</text>
</item><item commented="no" display-inline="no-display-inline" id="IDC32CEFCFD91640F7A4E7156B91AE1235"><enum>(bb)</enum><text display-inline="yes-display-inline">any difference in labeling (except
ingredient labeling).</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDDB1EDB0A7DBF4343BDC456CF6FD247A9"><enum>(ii)</enum><header display-inline="yes-display-inline">Information in notice</header><text display-inline="yes-display-inline">A notice under clause (i)(I) shall include
the information that the Secretary may require under section 506A, any
additional information the Secretary may require (which may include data on
bioequivalence if such data are not required under section 506A), and, with
respect to the permitted country that approved the qualifying drug for
commercial distribution, or with respect to which such approval is sought,
include the following:</text>
<subclause commented="no" display-inline="no-display-inline" id="IDA8F4215AA87446AFA021531C34FA44A5"><enum>(I)</enum><text display-inline="yes-display-inline">The date on which the qualifying drug with
such difference was, or will be, introduced for commercial distribution in the
permitted country.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDC8902493E4A44453B498F15F8EFE5A85"><enum>(II)</enum><text display-inline="yes-display-inline">Information demonstrating that the person
submitting the notice has also notified the government of the permitted country
in writing that the person is submitting to the Secretary a notice under clause
(i)(I), which notice describes the difference in the qualifying drug from a
condition established in the approved application for the U.S. label
drug.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDB359B9FCEB93439E980A9E274774E037"><enum>(III)</enum><text display-inline="yes-display-inline">The information that the person submitted
or will submit to the government of the permitted country for purposes of
obtaining approval for commercial distribution of the drug in the country
which, if in a language other than English, shall be accompanied by an English
translation verified to be complete and accurate, with the name, address, and a
brief statement of the qualifications of the person that made the
translation.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDA0F7658E98444A26A9433F9B8E02E0E1"><enum>(iii)</enum><header display-inline="yes-display-inline">Certifications</header><text display-inline="yes-display-inline">The chief executive officer and the chief
medical officer of the manufacturer involved shall each certify in the notice
under clause (i) that—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID64D4B0BADA204706856E68CF6A830E17"><enum>(I)</enum><text display-inline="yes-display-inline">the information provided in the notice is
complete and true; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDD4E573E542B74222AF43A733315559BA"><enum>(II)</enum><text display-inline="yes-display-inline">a copy of the notice has been provided to
the Federal Trade Commission and to the State attorneys general.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID670E778EF21D4D90AF1872FB40415EBE"><enum>(iv)</enum><header display-inline="yes-display-inline">Fee</header><text display-inline="yes-display-inline">If a notice submitted under clause (i)
includes a difference that would, under section 506A, require the submission of
a supplemental application if made as a change to the U.S. label drug, the
person that submits the notice shall pay to the Secretary a fee in the same
amount as would apply if the person were paying a fee pursuant to section
736(a)(1)(A)(ii). Subject to appropriations Acts, fees collected by the
Secretary under the preceding sentence are available only to the Secretary and
are for the sole purpose of paying the costs of reviewing notices submitted
under clause (i).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID48FDF50CCA374BF9B0BDB0055566DAC4"><enum>(v)</enum><header display-inline="yes-display-inline">Timing of submission of notices</header>
<subclause commented="no" display-inline="no-display-inline" id="ID13B0F03898294D27922DAAB3F687297B"><enum>(I)</enum><header display-inline="yes-display-inline">Prior approval notices</header><text display-inline="yes-display-inline">A notice under clause (i) to which
subparagraph (C) applies shall be submitted to the Secretary not later than 120
days before the qualifying drug with the difference is introduced for
commercial distribution in a permitted country, unless the country requires
that distribution of the qualifying drug with the difference begin less than
120 days after the country requires the difference.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID6BD2516C15114BD692DA807ED4692021"><enum>(II)</enum><header display-inline="yes-display-inline">Other approval notices</header><text display-inline="yes-display-inline">A notice under clause (i) to which
subparagraph (D) applies shall be submitted to the Secretary not later than the
day on which the qualifying drug with the difference is introduced for
commercial distribution in a permitted country.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDC24668F2D85140509BC15B94545AD775"><enum>(III)</enum><header display-inline="yes-display-inline">Other notices</header><text display-inline="yes-display-inline">A notice under clause (i) to which
subparagraph (E) applies shall be submitted to the Secretary on the date that
the qualifying drug is first introduced for commercial distribution in a
permitted country and annually thereafter.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID74FD1F83A56F4E529C08BE537D9BDFB0"><enum>(vi)</enum><header display-inline="yes-display-inline">Review by Secretary</header>
<subclause commented="no" display-inline="no-display-inline" id="ID9B9CE452560646E590E986E250FFDE12"><enum>(I)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In this paragraph, the difference in a
qualifying drug that is submitted in a notice under clause (i) from the U.S.
label drug shall be treated by the Secretary as if it were a manufacturing
change to the U.S. label drug under section 506A.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDB2843EED62B247F283D53189DBB16EB9"><enum>(II)</enum><header display-inline="yes-display-inline">Standard of review</header><text display-inline="yes-display-inline">Except as provided in subclause (III), the
Secretary shall review and approve or disapprove the difference in a notice
submitted under clause (i), if required under section 506A, using the safe and
effective standard for approving or disapproving a manufacturing change under
section 506A.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID627FE5B2604F42A8AED0F7693FADAF35"><enum>(III)</enum><header display-inline="yes-display-inline">Bioequivalence</header><text display-inline="yes-display-inline">If the Secretary would approve the
difference in a notice submitted under clause (i) using the safe and effective
standard under section 506A and if the Secretary determines that the qualifying
drug is not bioequivalent to the U.S. label drug, the Secretary shall—</text>
<item commented="no" display-inline="no-display-inline" id="IDC56BAEC220A148C89B48669714459AD6"><enum>(aa)</enum><text display-inline="yes-display-inline">include in the labeling provided under
paragraph (3) a prominent advisory that the qualifying drug is safe and
effective but is not bioequivalent to the U.S. label drug if the Secretary
determines that such an advisory is necessary for health care practitioners and
patients to use the qualifying drug safely and effectively; or</text>
</item><item commented="no" display-inline="no-display-inline" id="ID348296E252DD403EBDBBB185B2B98699"><enum>(bb)</enum><text display-inline="yes-display-inline">decline to approve the difference if the
Secretary determines that the availability of both the qualifying drug and the
U.S. label drug would pose a threat to the public health.</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="ID62E52D3C501B44F785B9572641C2CE6D"><enum>(IV)</enum><header display-inline="yes-display-inline">Review by the Secretary</header><text display-inline="yes-display-inline">The Secretary shall review and approve or
disapprove the difference in a notice submitted under clause (i), if required
under section 506A, not later than 120 days after the date on which the notice
is submitted.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID90E0056566264282A05DEF9953F5C2D7"><enum>(V)</enum><header display-inline="yes-display-inline">Establishment inspection</header><text display-inline="yes-display-inline">If review of such difference would require
an inspection of the establishment in which the qualifying drug is
manufactured—</text>
<item commented="no" display-inline="no-display-inline" id="ID38770BAE9E3B4226BB3938CF8654538A"><enum>(aa)</enum><text display-inline="yes-display-inline">such inspection by the Secretary shall be
authorized; and</text>
</item><item commented="no" display-inline="no-display-inline" id="IDF7A2CFBFA8A14015BD60FF3A70DCA230"><enum>(bb)</enum><text display-inline="yes-display-inline">the Secretary may rely on a satisfactory
report of a good manufacturing practice inspection of the establishment from a
permitted country whose regulatory system the Secretary recognizes as
equivalent under a mutual recognition agreement, as provided under section
510(i)(3), section 803, or part 26 of title 21, Code of Federal Regulations (or
any corresponding successor rule or regulation).</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID646653EA1A7B409293D0D0955DA18D21"><enum>(vii)</enum><header display-inline="yes-display-inline">Publication of information on
notices</header>
<subclause commented="no" display-inline="no-display-inline" id="ID2100A5EB0A4D4840A1636F28E59F6DD7"><enum>(I)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Through the Internet Web site of the Food
and Drug Administration and a toll-free telephone number, the Secretary shall
readily make available to the public a list of notices submitted under clause
(i).</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDFE61E463AD834A058226BC37D779B80A"><enum>(II)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">The list under subclause (I) shall include
the date on which a notice is submitted and whether—</text>
<item commented="no" display-inline="no-display-inline" id="IDD6D4AF41901649E8A950E2C67BCA994B"><enum>(aa)</enum><text display-inline="yes-display-inline">a notice is under review;</text>
</item><item commented="no" display-inline="no-display-inline" id="ID5C72435E29A043CD8C8275BB90D7B0C5"><enum>(bb)</enum><text display-inline="yes-display-inline">the Secretary has ordered that importation
of the qualifying drug from a permitted country cease; or</text>
</item><item commented="no" display-inline="no-display-inline" id="ID7EF7F5B5D11B4D66B60760DE8DACDA97"><enum>(cc)</enum><text display-inline="yes-display-inline">the importation of the drug is permitted
under subsection (a).</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="ID190EA990B4F24A20A42FDD7E36E7CF0D"><enum>(III)</enum><header display-inline="yes-display-inline">Update</header><text display-inline="yes-display-inline">The Secretary shall promptly update the
Internet Web site with any changes to the list.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5AE492B48E2E4AC78D827E8E2161B073"><enum>(C)</enum><header display-inline="yes-display-inline">Notice; drug difference requiring prior
approval</header><text display-inline="yes-display-inline">In the case of a
notice under subparagraph (B)(i) that includes a difference that would, under
section 506A(c) or (d)(3)(B)(i), require the approval of a supplemental
application before the difference could be made to the U.S. label drug the
following shall occur:</text>
<clause commented="no" display-inline="no-display-inline" id="IDC50AE691ABB8474291DB25D283CA20C2"><enum>(i)</enum><text display-inline="yes-display-inline">Promptly after the notice is submitted, the
Secretary shall notify registered exporters, registered importers, the Federal
Trade Commission, and the State attorneys general that the notice has been
submitted with respect to the qualifying drug involved.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID9F5D28B5AB714190B9A208F9AFC1571D"><enum>(ii)</enum><text display-inline="yes-display-inline">If the Secretary has not made a
determination whether such a supplemental application regarding the U.S. label
drug would be approved or disapproved by the date on which the qualifying drug
involved is to be introduced for commercial distribution in a permitted
country, the Secretary shall—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDC075E61F59834A63BCBA1E58574D2FDA"><enum>(I)</enum><text display-inline="yes-display-inline">order that the importation of the
qualifying drug involved from the permitted country not begin until the
Secretary completes review of the notice; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID5C1BBE681640411284A7168A8CB2488A"><enum>(II)</enum><text display-inline="yes-display-inline">promptly notify registered exporters,
registered importers, the Federal Trade Commission, and the State attorneys
general of the order.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDCBBBEB571604425195756F17FD6E49E9"><enum>(iii)</enum><text display-inline="yes-display-inline">If the Secretary determines that such a
supplemental application regarding the U.S. label drug would not be approved,
the Secretary shall—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID5105D525C60C49AF8C7AC6E6CF920173"><enum>(I)</enum><text display-inline="yes-display-inline">order that the importation of the
qualifying drug involved from the permitted country cease, or provide that an
order under clause (ii), if any, remains in effect;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID8DA5CE99DC9C4CEBB1DC13B55620632A"><enum>(II)</enum><text display-inline="yes-display-inline">notify the permitted country that approved
the qualifying drug for commercial distribution of the determination;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDA47F8E1EEBEA4E4C89E664C718269CED"><enum>(III)</enum><text display-inline="yes-display-inline">promptly notify registered exporters,
registered importers, the Federal Trade Commission, and the State attorneys
general of the determination.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDF3DDB8D4AD5944B78D58B199BC4B34A0"><enum>(iv)</enum><text display-inline="yes-display-inline">If the Secretary determines that such a
supplemental application regarding the U.S. label drug would be approved, the
Secretary shall—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDD339AEB4359D4A1B9B59EE8C8D8561A4"><enum>(I)</enum><text display-inline="yes-display-inline">vacate the order under clause (ii), if
any;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID8A4F2D2194EC434CBE7CF084C2A73195"><enum>(II)</enum><text display-inline="yes-display-inline">consider the difference to be a variation
provided for in the approved application for the U.S. label drug;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID3F7F474806D34FAC8510AFE7A3E7DA25"><enum>(III)</enum><text display-inline="yes-display-inline">permit importation of the qualifying drug
under subsection (a); and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID1DC50E8F10C44798B61C2861A83F0474"><enum>(IV)</enum><text display-inline="yes-display-inline">promptly notify registered exporters,
registered importers, the Federal Trade Commission, and the State attorneys
general of the determination.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9BFE4E6384DA4BE1B3489CE98754F040"><enum>(D)</enum><header display-inline="yes-display-inline">Notice; drug difference not requiring prior
approval</header><text display-inline="yes-display-inline">In the case of a
notice under subparagraph (B)(i) that includes a difference that would, under
section 506A(d)(3)(B)(ii), not require the approval of a supplemental
application before the difference could be made to the U.S. label drug the
following shall occur:</text>
<clause commented="no" display-inline="no-display-inline" id="IDFE2833DDBFA24C9EB380BA81047CC0DA"><enum>(i)</enum><text display-inline="yes-display-inline">During the period in which the notice is
being reviewed by the Secretary, the authority under this subsection to import
the qualifying drug involved continues in effect.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID14FFB0C3CE5848EDB0AAE5180FA11BF8"><enum>(ii)</enum><text display-inline="yes-display-inline">If the Secretary determines that such a
supplemental application regarding the U.S. label drug would not be approved,
the Secretary shall—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID1EFE1D2582FE4631AA0926A2E533FB92"><enum>(I)</enum><text display-inline="yes-display-inline">order that the importation of the
qualifying drug involved from the permitted country cease;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDD6DCFD02F70547C78159648005B223EB"><enum>(II)</enum><text display-inline="yes-display-inline">notify the permitted country that approved
the qualifying drug for commercial distribution of the determination;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID8719373C714C4539930D96FE77C4A2B0"><enum>(III)</enum><text display-inline="yes-display-inline">promptly notify registered exporters,
registered importers, the Federal Trade Commission, and the State attorneys
general of the determination.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDA11E5673FDBF4D2B96F10B1A84142777"><enum>(iii)</enum><text display-inline="yes-display-inline">If the Secretary determines that such a
supplemental application regarding the U.S. label drug would be approved, the
difference shall be considered to be a variation provided for in the approved
application for the U.S. label drug.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDBC3092283D244765A3B20EDD8999E015"><enum>(E)</enum><header display-inline="yes-display-inline">Notice; drug difference not requiring
approval; no difference</header><text display-inline="yes-display-inline">In
the case of a notice under subparagraph (B)(i) that includes a difference for
which, under section 506A(d)(1)(A), a supplemental application would not be
required for the difference to be made to the U.S. label drug, or that states
that there is no difference, the Secretary—</text>
<clause commented="no" display-inline="no-display-inline" id="ID9A4A097FC7F34ACE832492837A022F76"><enum>(i)</enum><text display-inline="yes-display-inline">shall consider such difference to be a
variation provided for in the approved application for the U.S. label
drug;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDBBB56D14505A47579FADF571A81DF5A2"><enum>(ii)</enum><text display-inline="yes-display-inline">may not order that the importation of the
qualifying drug involved cease; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID852D386BD3F342D4ADF8B7B0DD201CBA"><enum>(iii)</enum><text display-inline="yes-display-inline">shall promptly notify registered exporters
and registered importers.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID4F8DE68A8BBD45EA81A15A57CEB7661A"><enum>(F)</enum><header display-inline="yes-display-inline">Differences in active ingredient, route of
administration, dosage form, or strength</header>
<clause commented="no" display-inline="no-display-inline" id="IDB5870115C87B40FABA6C3F10290BB262"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A person who manufactures a drug approved
under section 505(b) shall submit an application under section 505(b) for
approval of another drug that is manufactured for distribution in a permitted
country by or for the person that manufactures the drug approved under section
505(b) if—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID82341C169FBF4E569AC2DF45B4162679"><enum>(I)</enum><text display-inline="yes-display-inline">there is no qualifying drug in commercial
distribution in permitted countries whose combined population represents at
least 50 percent of the total population of all permitted countries with the
same active ingredient or ingredients, route of administration, dosage form,
and strength as the drug approved under section 505(b); and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID14B4647439B84D988C6D413315FECBC2"><enum>(II)</enum><text display-inline="yes-display-inline">each active ingredient of the other drug is
related to an active ingredient of the drug approved under section 505(b), as
defined in clause (v).</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID6E0262940A27423EB3A26F63522BF924"><enum>(ii)</enum><header display-inline="yes-display-inline">Application under Section
<enum-in-header>505(b)</enum-in-header></header><text display-inline="yes-display-inline">The application under section 505(b)
required under clause (i) shall—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDE4BB0F69B77F4CE49EBC0F79C40C4AD7"><enum>(I)</enum><text display-inline="yes-display-inline">request approval of the other drug for the
indication or indications for which the drug approved under section 505(b) is
labeled;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDB62D9B34F96540059CFBD6C5E08B8BAB"><enum>(II)</enum><text display-inline="yes-display-inline">include the information that the person
submitted to the government of the permitted country for purposes of obtaining
approval for commercial distribution of the other drug in that country, which
if in a language other than English, shall be accompanied by an English
translation verified to be complete and accurate, with the name, address, and a
brief statement of the qualifications of the person that made the
translation;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID7635E1B2E24248A8852AD700862D236C"><enum>(III)</enum><text display-inline="yes-display-inline">include a right of reference to the
application for the drug approved under section 505(b); and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDBD76D607BE914FEDAD0FE034FF8D90BA"><enum>(IV)</enum><text display-inline="yes-display-inline">include such additional information as the
Secretary may require.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID95622C3AAB6646E587BEE3E856486035"><enum>(iii)</enum><header display-inline="yes-display-inline">Timing of submission of
application</header><text display-inline="yes-display-inline">An application
under section 505(b) required under clause (i) shall be submitted to the
Secretary not later than the day on which the information referred to in clause
(ii)(II) is submitted to the government of the permitted country.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID41E2BCF3CC1A4EBCB0E073D9F230522A"><enum>(iv)</enum><header display-inline="yes-display-inline">Notice of decision on
application</header><text display-inline="yes-display-inline">The Secretary
shall promptly notify registered exporters, registered importers, the Federal
Trade Commission, and the State attorneys general of a determination to approve
or to disapprove an application under section 505(b) required under clause
(i).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID15FFA49487594572BECF80ED389FFE5C"><enum>(v)</enum><header display-inline="yes-display-inline">Related active ingredients</header><text display-inline="yes-display-inline">For purposes of clause (i)(II), 2 active
ingredients are related if they are—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDC732886DF5B2480385A96330801F3647"><enum>(I)</enum><text display-inline="yes-display-inline">the same; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDA32F64090F9646FCAFE5D26E541D3322"><enum>(II)</enum><text display-inline="yes-display-inline">different salts, esters, or complexes of
the same moiety.</text>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDAF699952774247BEAAA31973C6CC41EB"><enum>(3)</enum><header display-inline="yes-display-inline">Section 502; labeling</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID0FDBF00F89D74B8C86E92BAB5A3D6854"><enum>(A)</enum><header display-inline="yes-display-inline">Importation by registered importer</header>
<clause commented="no" display-inline="no-display-inline" id="ID3F0FA1D90FE34D6C90CD96EAE5B6EBBB"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In the case of a qualifying drug that is
imported or offered for import by a registered importer, such drug shall be
considered to be in compliance with section 502 and the labeling requirements
under the approved application for the U.S. label drug if the qualifying drug
bears—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID6039A0BBF4F74AC8BBB55CB48DAC8706"><enum>(I)</enum><text display-inline="yes-display-inline">a copy of the labeling approved for the
U.S. label drug under section 505, without regard to whether the copy bears any
trademark involved;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDED528DB9750C4A30A2428974865B9C4C"><enum>(II)</enum><text display-inline="yes-display-inline">the name of the manufacturer and location
of the manufacturer;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID601AE86D14E14F438B59AE42AAAAC747"><enum>(III)</enum><text display-inline="yes-display-inline">the lot number assigned by the
manufacturer;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDF8A92A8D64FF47AEB81253776CE0CA83"><enum>(IV)</enum><text display-inline="yes-display-inline">the name, location, and registration number
of the importer; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID6451FF62C61D44E9A7977C83DEB23B70"><enum>(V)</enum><text display-inline="yes-display-inline">the National Drug Code number assigned to
the qualifying drug by the Secretary.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID25CB57E07F5041D79F03B867E267F207"><enum>(ii)</enum><header display-inline="yes-display-inline">Request for copy of the
labeling</header><text display-inline="yes-display-inline">The Secretary shall
provide such copy to the registered importer involved, upon request of the
importer.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID8DB38A1162B345219DB5D451A827FCCF"><enum>(iii)</enum><header display-inline="yes-display-inline">Requested labeling</header><text display-inline="yes-display-inline">The labeling provided by the Secretary
under clause (ii) shall—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID3CEA7DB6B0E84BABA14F1F99EF7514BF"><enum>(I)</enum><text display-inline="yes-display-inline">include the established name, as defined in
section 502(e)(3), for each active ingredient in the qualifying drug;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID86D14056889342BE9851032621040505"><enum>(II)</enum><text display-inline="yes-display-inline">not include the proprietary name of the
U.S. label drug or any active ingredient thereof;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID17CAF0AE62C446A6822F4BEBAE6720B6"><enum>(III)</enum><text display-inline="yes-display-inline">if required under paragraph
(2)(B)(vi)(III), a prominent advisory that the qualifying drug is safe and
effective but not bioequivalent to the U.S. label drug; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID393580A9468B4092BCE0145440593BC4"><enum>(IV)</enum><text display-inline="yes-display-inline">if the inactive ingredients of the
qualifying drug are different from the inactive ingredients for the U.S. label
drug, include—</text>
<item commented="no" display-inline="no-display-inline" id="IDD6A06A42EC6740D2A3145BBE1B82576F"><enum>(aa)</enum><text display-inline="yes-display-inline">a prominent notice that the ingredients of
the qualifying drug differ from the ingredients of the U.S. label drug and that
the qualifying drug must be dispensed with an advisory to people with allergies
about this difference and a list of ingredients; and</text>
</item><item commented="no" display-inline="no-display-inline" id="IDA1C31699099943879AE1D99F15FCC095"><enum>(bb)</enum><text display-inline="yes-display-inline">a list of the ingredients of the qualifying
drug as would be required under section 502(e).</text>
</item></subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID39036F5D2F584539BBF43534800444D5"><enum>(B)</enum><header display-inline="yes-display-inline">Importation by individual</header>
<clause commented="no" display-inline="no-display-inline" id="IDC2801F2D1CCF44D2A8F1654789081C5F"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In the case of a qualifying drug that is
imported or offered for import by a registered exporter to an individual, such
drug shall be considered to be in compliance with section 502 and the labeling
requirements under the approved application for the U.S. label drug if the
packaging and labeling of the qualifying drug complies with all applicable
regulations promulgated under sections 3 and 4 of the Poison Prevention
Packaging Act of 1970 (15 U.S.C. 1471 et seq.) and the labeling of the
qualifying drug includes—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID6770405009E54834A6304149571236DB"><enum>(I)</enum><text display-inline="yes-display-inline">directions for use by the consumer;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDD0DC07D368E34DE8B33831281F25C2B9"><enum>(II)</enum><text display-inline="yes-display-inline">the lot number assigned by the
manufacturer;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID96756545D8F64ADDA2BBEEF73E17208C"><enum>(III)</enum><text display-inline="yes-display-inline">the name and registration number of the
exporter;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID99149BCB2567482590FD9E89E31F4477"><enum>(IV)</enum><text display-inline="yes-display-inline">if required under paragraph
(2)(B)(vi)(III), a prominent advisory that the drug is safe and effective but
not bioequivalent to the U.S. label drug;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID4DA12763CCA24E3A8D2F074DE8ED86EE"><enum>(V)</enum><text display-inline="yes-display-inline">if the inactive ingredients of the drug are
different from the inactive ingredients for the U.S. label drug—</text>
<item commented="no" display-inline="no-display-inline" id="IDF7615B4281A44B1C9B88C8BF46E9F412"><enum>(aa)</enum><text display-inline="yes-display-inline">a prominent advisory that persons with an
allergy should check the ingredient list of the drug because the ingredients of
the drug differ from the ingredients of the U.S. label drug; and</text>
</item><item commented="no" display-inline="no-display-inline" id="ID3F2ACEA680D24DEA8BC008DB97AF75F0"><enum>(bb)</enum><text display-inline="yes-display-inline">a list of the ingredients of the drug as
would be required under section 502(e); and</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="ID402D04C1801C47BEB3EA0FFE494424A1"><enum>(VI)</enum><text display-inline="yes-display-inline">a copy of any special labeling that would
be required by the Secretary had the U.S. label drug been dispensed by a
pharmacist in the United States, without regard to whether the special labeling
bears any trademark involved.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id83CD825CBA3E40449EB7F8F91E1C2541"><enum>(ii)</enum><header display-inline="yes-display-inline">Packaging</header><text display-inline="yes-display-inline">A qualifying drug offered for import to an
individual by an exporter under this section that is packaged in a unit-of-use
container (as those items are defined in the United States Pharmacopeia and
National Formulary) shall not be repackaged, provided that—</text>
<subclause commented="no" display-inline="no-display-inline" id="idCECAF43D34A2434297046FC7C91D9C1F"><enum>(I)</enum><text display-inline="yes-display-inline">the packaging complies with all applicable
regulations under sections 3 and 4 of the Poison Prevention Packaging Act of
1970 (15 U.S.C. 1471 et seq.); or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id3CD9BE683DEB40EFBA827F66C8DE69C8"><enum>(II)</enum><text display-inline="yes-display-inline">the consumer consents to waive the
requirements of such Act, after being informed that the packaging does not
comply with such Act and that the exporter will provide the drug in packaging
that is compliant at no additional cost.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID45BBE2A6BC3A4D11B5DA86744F79EBBC"><enum>(iii)</enum><header display-inline="yes-display-inline">Request for copy of special labeling and
ingredient list</header><text display-inline="yes-display-inline">The Secretary
shall provide to the registered exporter involved a copy of the special
labeling, the advisory, and the ingredient list described under clause (i),
upon request of the exporter.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID8AD60E1DD8BE4C1F85AC67ED418F7BA6"><enum>(iv)</enum><header display-inline="yes-display-inline">Requested labeling and ingredient
list</header><text display-inline="yes-display-inline">The labeling and
ingredient list provided by the Secretary under clause (iii) shall—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID748994FF6701464D92CFE8E6EC665551"><enum>(I)</enum><text display-inline="yes-display-inline">include the established name, as defined in
section 502(e)(3), for each active ingredient in the drug; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID90DF311B5C4043E3A7DF977154B57A6D"><enum>(II)</enum><text display-inline="yes-display-inline">not include the proprietary name of the
U.S. label drug or any active ingredient thereof.</text>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4E8D43110F5C401B90DFB7FE435E6D99"><enum>(4)</enum><header display-inline="yes-display-inline">Section 501; adulteration</header><text display-inline="yes-display-inline">A qualifying drug that is imported or
offered for import under subsection (a) shall be considered to be in compliance
with section 501 if the drug is in compliance with subsection (c).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDE9F3A61F1A1B472387D564E13E377FD9"><enum>(5)</enum><header display-inline="yes-display-inline">Standards for refusing
admission</header><text display-inline="yes-display-inline">A drug exported
under subsection (a) from a registered exporter or imported by a registered
importer may be refused admission into the United States if 1 or more of the
following applies:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID3F5ED036D53140FA94B65EE999EC67B5"><enum>(A)</enum><text display-inline="yes-display-inline">The drug is not a qualifying drug.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDB337968453FB41FDA7C3BA85ED53440D"><enum>(B)</enum><text display-inline="yes-display-inline">A notice for the drug required under
paragraph (2)(B) has not been submitted to the Secretary.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9A44DE3B87ED4534A5CC8DA6C35B4300"><enum>(C)</enum><text display-inline="yes-display-inline">The Secretary has ordered that importation
of the drug from the permitted country cease under paragraph (2) (C) or
(D).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDEB55EC812D1145EC87883A8D5FABB444"><enum>(D)</enum><text display-inline="yes-display-inline">The drug does not comply with paragraph (3)
or (4).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDF5D938A7BF3545BA8A48CBE4640A1159"><enum>(E)</enum><text display-inline="yes-display-inline">The shipping container appears damaged in a
way that may affect the strength, quality, or purity of the drug.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDFE69C81BF6CD4DF5A48BF5F65E2FF9E7"><enum>(F)</enum><text display-inline="yes-display-inline">The Secretary becomes aware that—</text>
<clause commented="no" display-inline="no-display-inline" id="ID8480697E986E4AC1967992BF6B76355A"><enum>(i)</enum><text display-inline="yes-display-inline">the drug may be counterfeit;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDFF9C3BD2E82842D4BD26FCD853046B07"><enum>(ii)</enum><text display-inline="yes-display-inline">the drug may have been prepared, packed, or
held under insanitary conditions; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID1689C0944ED7404499DB31D03F1DB0BF"><enum>(iii)</enum><text display-inline="yes-display-inline">the methods used in, or the facilities or
controls used for, the manufacturing, processing, packing, or holding of the
drug do not conform to good manufacturing practice.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5F10B866F279436591C0B82A17969ED1"><enum>(G)</enum><text display-inline="yes-display-inline">The Secretary has obtained an injunction
under section 302 that prohibits the distribution of the drug in interstate
commerce.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID8F7BD432EB8A46B0812C45999AC82D98"><enum>(H)</enum><text display-inline="yes-display-inline">The Secretary has under section 505(e)
withdrawn approval of the drug.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDD2561153CF984870A8C68EF80EF77AFB"><enum>(I)</enum><text display-inline="yes-display-inline">The manufacturer of the drug has instituted
a recall of the drug.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDEF2380120FE244E5AFEA0AA75FD399CB"><enum>(J)</enum><text display-inline="yes-display-inline">If the drug is imported or offered for
import by a registered importer without submission of a notice in accordance
with subsection (d)(4).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7736510443F846F387C0B85575817D2E"><enum>(K)</enum><text display-inline="yes-display-inline">If the drug is imported or offered for
import from a registered exporter to an individual and 1 or more of the
following applies:</text>
<clause commented="no" display-inline="no-display-inline" id="IDF025BF2CFF6B4D32B43513B7F2531E59"><enum>(i)</enum><text display-inline="yes-display-inline">The shipping container for such drug does
not bear the markings required under subsection (d)(2).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID1172931698034F098B5B5AD5E6CAE820"><enum>(ii)</enum><text display-inline="yes-display-inline">The markings on the shipping container
appear to be counterfeit.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDDFA6441B35544C6CB65364604A468D54"><enum>(iii)</enum><text display-inline="yes-display-inline">The shipping container or markings appear
to have been tampered with.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID706620D78CCA45D7AD81759177D48D31"><enum>(h)</enum><header display-inline="yes-display-inline">Exporter licensure in permitted
country</header><text display-inline="yes-display-inline">A registration
condition is that the exporter involved agrees that a qualifying drug will be
exported to an individual only if the Secretary has verified that—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID278203F6729B45A281CD8250759E026F"><enum>(1)</enum><text display-inline="yes-display-inline">the exporter is authorized under the law of
the permitted country in which the exporter is located to dispense prescription
drugs; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID7FA007CE7F534E5FBBDF8C88D6758F0B"><enum>(2)</enum><text display-inline="yes-display-inline">the exporter employs persons that are
licensed under the law of the permitted country in which the exporter is
located to dispense prescription drugs in sufficient number to dispense safely
the drugs exported by the exporter to individuals, and the exporter assigns to
those persons responsibility for dispensing such drugs to individuals.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID4370C533001C44A0A21107C476691F00"><enum>(i)</enum><header display-inline="yes-display-inline">Individuals; conditions for
importation</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDA2B7BE0CE8D1474DB24F1B0389E997EB"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">For purposes of subsection (a)(2)(B), the
importation of a qualifying drug by an individual is in accordance with this
subsection if the following conditions are met:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDC17E053C06534219883A351D26671D51"><enum>(A)</enum><text display-inline="yes-display-inline">The drug is accompanied by a copy of a
prescription for the drug, which prescription—</text>
<clause commented="no" display-inline="no-display-inline" id="ID3BEB937CBB484E52AEB79AE71D1D14FD"><enum>(i)</enum><text display-inline="yes-display-inline">is valid under applicable Federal and State
laws; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDDE238F39A4684891B57BBF8D8CF43F98"><enum>(ii)</enum><text display-inline="yes-display-inline">was issued by a practitioner who, under the
law of a State of which the individual is a resident, or in which the
individual receives care from the practitioner who issues the prescription, is
authorized to administer prescription drugs.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2B256310D16646F79DC681CECC5C0E77"><enum>(B)</enum><text display-inline="yes-display-inline">The drug is accompanied by a copy of the
documentation that was required under the law or regulations of the permitted
country in which the exporter is located, as a condition of dispensing the drug
to the individual.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID88AED1674BD444E18F7DF4A96A2168DC"><enum>(C)</enum><text display-inline="yes-display-inline">The copies referred to in subparagraphs
(A)(i) and (B) are marked in a manner sufficient—</text>
<clause commented="no" display-inline="no-display-inline" id="IDA1AEBB9CBF1B48A98664E7D22DD2CDF9"><enum>(i)</enum><text display-inline="yes-display-inline">to indicate that the prescription, and the
equivalent document in the permitted country in which the exporter is located,
have been filled; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID498CAD1D28314C3AB6980AB90DBFC710"><enum>(ii)</enum><text display-inline="yes-display-inline">to prevent a duplicative filling by another
pharmacist.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDC732ABDBA18E49FD9E4DBA3983E07189"><enum>(D)</enum><text display-inline="yes-display-inline">The individual has provided to the
registered exporter a complete list of all drugs used by the individual for
review by the individuals who dispense the drug.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID575D19830C1247B19EE077C65838C236"><enum>(E)</enum><text display-inline="yes-display-inline">The quantity of the drug does not exceed a
90-day supply.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6F2B143AE3A0446788FA67E7E5D46960"><enum>(F)</enum><text display-inline="yes-display-inline">The drug is not an ineligible subpart H
drug. For purposes of this section, a prescription drug is an <quote>ineligible
subpart H drug</quote> if the drug was approved by the Secretary under subpart
H of part 314 of title 21, Code of Federal Regulations (relating to accelerated
approval), with restrictions under section 520 of such part to assure safe use,
and the Secretary has published in the Federal Register a notice that the
Secretary has determined that good cause exists to prohibit the drug from being
imported pursuant to this subsection.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDBC3643903FC946B4852030BE2FBC9BDE"><enum>(2)</enum><header display-inline="yes-display-inline">Notice regarding drug refused
admission</header><text display-inline="yes-display-inline">If a registered
exporter ships a drug to an individual pursuant to subsection (a)(2)(B) and the
drug is refused admission to the United States, a written notice shall be sent
to the individual and to the exporter that informs the individual and the
exporter of such refusal and the reason for the refusal.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID374357AB2D644223807B8608FB3400F4"><enum>(j)</enum><header display-inline="yes-display-inline">Maintenance of records and samples</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID155A077A507C4BA1A65BA9AD0D0AF7A8"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A registration condition is that the
importer or exporter involved shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDC0AFCF0A91B84E478088DAAA5502732B"><enum>(A)</enum><text display-inline="yes-display-inline">maintain records required under this
section for not less than 2 years; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6E6A87EC77B647078170C61EF6C2EDC7"><enum>(B)</enum><text display-inline="yes-display-inline">maintain samples of each lot of a
qualifying drug required under this section for not more than 2 years.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID2643B41B2B00470582A869A28D59B9D1"><enum>(2)</enum><header display-inline="yes-display-inline">Place of record maintenance</header><text display-inline="yes-display-inline">The records described under paragraph (1)
shall be maintained—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID906CF4403E0F49D58D9DB5182D951CB8"><enum>(A)</enum><text display-inline="yes-display-inline">in the case of an importer, at the place of
business of the importer at which the importer initially receives the
qualifying drug after importation; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDFFA6F6B311184F64822D8257B8541D54"><enum>(B)</enum><text display-inline="yes-display-inline">in the case of an exporter, at the facility
from which the exporter ships the qualifying drug to the United States.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID656055BCE25D429BAB9B17CCDA3FB718"><enum>(k)</enum><header display-inline="yes-display-inline">Drug recalls</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID5BF189DB205D4EDBB6793A02E38D5CA6"><enum>(1)</enum><header display-inline="yes-display-inline">Manufacturers</header><text display-inline="yes-display-inline">A person that manufactures a qualifying
drug imported from a permitted country under this section shall promptly inform
the Secretary—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDF07B208BD7224FD0AAE3BCB8488DC8E8"><enum>(A)</enum><text display-inline="yes-display-inline">if the drug is recalled or withdrawn from
the market in a permitted country;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDA1FBD7C989B04D848086545E7D88AD78"><enum>(B)</enum><text display-inline="yes-display-inline">how the drug may be identified, including
lot number; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDF3EFCA5430C64A9082170193116E7738"><enum>(C)</enum><text display-inline="yes-display-inline">the reason for the recall or
withdrawal.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID3D1F033FC8D8418597AA49125F77EB41"><enum>(2)</enum><header display-inline="yes-display-inline">Secretary</header><text display-inline="yes-display-inline">With respect to each permitted country, the
Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDCDAD20BC91BE42E6BD198BD2102BBE1E"><enum>(A)</enum><text display-inline="yes-display-inline">enter into an agreement with the government
of the country to receive information about recalls and withdrawals of
qualifying drugs in the country; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID29C253675A744D639AC1EEE43D8A276C"><enum>(B)</enum><text display-inline="yes-display-inline">monitor recalls and withdrawals of
qualifying drugs in the country using any information that is available to the
public in any media.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID528FE626B5824D859527BE15B38146DB"><enum>(3)</enum><header display-inline="yes-display-inline">Notice</header><text display-inline="yes-display-inline">The Secretary may notify, as appropriate,
registered exporters, registered importers, wholesalers, pharmacies, or the
public of a recall or withdrawal of a qualifying drug in a permitted
country.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDF1F1041E48FA4D6FB31F61B39D6DBFD9"><enum>(l)</enum><header display-inline="yes-display-inline">Drug labeling and packaging</header>
<paragraph commented="no" display-inline="no-display-inline" id="idC6CD60002E8645A593E5AF7D8F4F7CEA"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">When a qualifying drug that is imported
into the United States by an importer under subsection (a) is dispensed by a
pharmacist to an individual, the pharmacist shall provide that the packaging
and labeling of the drug complies with all applicable regulations promulgated
under sections 3 and 4 of the Poison Prevention Packaging Act of 1970 (15
U.S.C. 1471 et seq.) and shall include with any other labeling provided to the
individual the following:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDFA326C1613EB430C893D1B69D4643271"><enum>(A)</enum><text display-inline="yes-display-inline">The lot number assigned by the
manufacturer.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDB5C12C14A05840D09BE4F2ED93C03314"><enum>(B)</enum><text display-inline="yes-display-inline">The name and registration number of the
importer.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6FC64810E8E84E7E87B4E0B91EADE119"><enum>(C)</enum><text display-inline="yes-display-inline">If required under paragraph (2)(B)(vi)(III)
of subsection (g), a prominent advisory that the drug is safe and effective but
not bioequivalent to the U.S. label drug.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDB23757324E44403780B2C0A00BAAE3C3"><enum>(D)</enum><text display-inline="yes-display-inline">If the inactive ingredients of the drug are
different from the inactive ingredients for the U.S. label drug—</text>
<clause commented="no" display-inline="no-display-inline" id="IDEBD71C768CBD4B05A581F3FCEF0055B3"><enum>(i)</enum><text display-inline="yes-display-inline">a prominent advisory that persons with
allergies should check the ingredient list of the drug because the ingredients
of the drug differ from the ingredients of the U.S. label drug; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID911A0221859340EBB49E8D851F1C0DB8"><enum>(ii)</enum><text display-inline="yes-display-inline">a list of the ingredients of the drug as
would be required under section 502(e).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF3ECB940DCB34D07965666B9EA6094A1"><enum>(2)</enum><header display-inline="yes-display-inline">Packaging</header><text display-inline="yes-display-inline">A qualifying drug that is packaged in a
unit-of-use container (as those terms are defined in the United States
Pharmacopeia and National Formulary) shall not be repackaged, provided
that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id0CE6FDA8B0F446FB816AB48542494E07"><enum>(A)</enum><text display-inline="yes-display-inline">the packaging complies with all applicable
regulations under sections 3 and 4 of the Poison Prevention Packaging Act of
1970 (15 U.S.C. 1471 et seq.); or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id42B6E6BB9FC047F3A9F3717B5E8B85D9"><enum>(B)</enum><text display-inline="yes-display-inline">the consumer consents to waive the
requirements of such Act, after being informed that the packaging does not
comply with such Act and that the pharmacist will provide the drug in packaging
that is compliant at no additional cost.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID920D46F3EFD7474087F9E86ED5728EA6"><enum>(m)</enum><header display-inline="yes-display-inline">Charitable contributions</header><text display-inline="yes-display-inline">Notwithstanding any other provision of this
section, this section does not authorize the importation into the United States
of a qualifying drug donated or otherwise supplied for free or at nominal cost
by the manufacturer of the drug to a charitable or humanitarian organization,
including the United Nations and affiliates, or to a government of a foreign
country.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDC89CF2CE7F6E4FA59AE471F3C953A713"><enum>(n)</enum><header display-inline="yes-display-inline">Unfair and discriminatory Acts and
practices</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDB3CA6A3CA1324605804361AA3725424B"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">It is unlawful for a manufacturer, directly
or indirectly (including by being a party to a licensing agreement or other
agreement), to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDE958D16B60084DB993A6263425CA54D9"><enum>(A)</enum><text display-inline="yes-display-inline">discriminate by charging a higher price for
a prescription drug sold to a registered exporter or other person in a
permitted country that exports a qualifying drug to the United States under
this section than the price that is charged, inclusive of rebates or other
incentives to the permitted country or other person, to another person that is
in the same country and that does not export a qualifying drug into the United
States under this section;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID60E154D1EAA04C2CA7DCC779BEFFA89D"><enum>(B)</enum><text display-inline="yes-display-inline">discriminate by charging a higher price for
a prescription drug sold to a registered importer or other person that
distributes, sells, or uses a qualifying drug imported into the United States
under this section than the price that is charged to another person in the
United States that does not import a qualifying drug under this section, or
that does not distribute, sell, or use such a drug;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2C8D01C1EB4E4CAD8DFDD4A524031766"><enum>(C)</enum><text display-inline="yes-display-inline">discriminate by denying, restricting, or
delaying supplies of a prescription drug to a registered exporter or other
person in a permitted country that exports a qualifying drug to the United
States under this section or to a registered importer or other person that
distributes, sells, or uses a qualifying drug imported into the United States
under this section;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID4590EE89528B4D3F9EB5C16E7B2853D4"><enum>(D)</enum><text display-inline="yes-display-inline">discriminate by publicly, privately, or
otherwise refusing to do business with a registered exporter or other person in
a permitted country that exports a qualifying drug to the United States under
this section or with a registered importer or other person that distributes,
sells, or uses a qualifying drug imported into the United States under this
section;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDD4F17F7EF0ED4044A6C2AF150CFB3B00"><enum>(E)</enum><text display-inline="yes-display-inline">knowingly fail to submit a notice under
subsection (g)(2)(B)(i), knowingly fail to submit such a notice on or before
the date specified in subsection (g)(2)(B)(v) or as otherwise required under
subsection (e) (3), (4), and (5) of section 104 of the Pharmaceutical Market
Access and Drug Safety Act of 2010, knowingly submit such a notice that makes a
materially false, fictitious, or fraudulent statement, or knowingly fail to
provide promptly any information requested by the Secretary to review such a
notice;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID510394677272452A8548A2A1027CF9E3"><enum>(F)</enum><text display-inline="yes-display-inline">knowingly fail to submit an application
required under subsection (g)(2)(F), knowingly fail to submit such an
application on or before the date specified in subsection (g)(2)(F)(ii),
knowingly submit such an application that makes a materially false, fictitious,
or fraudulent statement, or knowingly fail to provide promptly any information
requested by the Secretary to review such an application;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDB72736FB8C5141CA8378452796225867"><enum>(G)</enum><text display-inline="yes-display-inline">cause there to be a difference (including a
difference in active ingredient, route of administration, dosage form,
strength, formulation, manufacturing establishment, manufacturing process, or
person that manufactures the drug) between a prescription drug for distribution
in the United States and the drug for distribution in a permitted
country;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID717FF36B9C534E599A54FA958849E70A"><enum>(H)</enum><text display-inline="yes-display-inline">refuse to allow an inspection authorized
under this section of an establishment that manufactures a qualifying drug that
is, or will be, introduced for commercial distribution in a permitted
country;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7E5BE94FD72C41AAB80A95CD7934DEBD"><enum>(I)</enum><text display-inline="yes-display-inline">fail to conform to the methods used in, or
the facilities used for, the manufacturing, processing, packing, or holding of
a qualifying drug that is, or will be, introduced for commercial distribution
in a permitted country to good manufacturing practice under this Act;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDB7DAC2D35065497C8C473EFF152867B1"><enum>(J)</enum><text display-inline="yes-display-inline">become a party to a licensing agreement or
other agreement related to a qualifying drug that fails to provide for
compliance with all requirements of this section with respect to such
drug;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID91909B39A61B4BCBAB57BB871CDF28A3"><enum>(K)</enum><text display-inline="yes-display-inline">enter into a contract that restricts,
prohibits, or delays the importation of a qualifying drug under this
section;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDCA3B51F9F9B3434CAD12EE3959E5439E"><enum>(L)</enum><text display-inline="yes-display-inline">engage in any other action to restrict,
prohibit, or delay the importation of a qualifying drug under this section;
or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID869F1D4ED73C4FB7B9DE0CD35B9E54B3"><enum>(M)</enum><text display-inline="yes-display-inline">engage in any other action that the Federal
Trade Commission determines to discriminate against a person that engages or
attempts to engage in the importation of a qualifying drug under this
section.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE41453FEF9D24168BC917CE240F92527"><enum>(2)</enum><header display-inline="yes-display-inline">Referral of potential
violations</header><text display-inline="yes-display-inline">The Secretary
shall promptly refer to the Federal Trade Commission each potential violation
of subparagraph (E), (F), (G), (H), or (I) of paragraph (1) that becomes known
to the Secretary.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDBB09ECA47A2A4EBCBC39AF03FBECE180"><enum>(3)</enum><header display-inline="yes-display-inline">Affirmative defense</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDB0C81C9BCBB74A3686C3126A4E8F13BA"><enum>(A)</enum><header display-inline="yes-display-inline">Discrimination</header><text display-inline="yes-display-inline">It shall be an affirmative defense to a
charge that a manufacturer has discriminated under subparagraph (A), (B), (C),
(D), or (M) of paragraph (1) that the higher price charged for a prescription
drug sold to a person, the denial, restriction, or delay of supplies of a
prescription drug to a person, the refusal to do business with a person, or
other discriminatory activity against a person, is not based, in whole or in
part, on—</text>
<clause commented="no" display-inline="no-display-inline" id="IDB71416640BA34FD0829EA7E2B471D501"><enum>(i)</enum><text display-inline="yes-display-inline">the person exporting or importing a
qualifying drug into the United States under this section; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID58BA3F8BD1194594861F146988CCC21F"><enum>(ii)</enum><text display-inline="yes-display-inline">the person distributing, selling, or using
a qualifying drug imported into the United States under this section.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3E78C67B77944F55AED321FF01E77C73"><enum>(B)</enum><header display-inline="yes-display-inline">Drug differences</header><text display-inline="yes-display-inline">It shall be an affirmative defense to a
charge that a manufacturer has caused there to be a difference described in
subparagraph (G) of paragraph (1) that—</text>
<clause commented="no" display-inline="no-display-inline" id="ID06F34B3182D345AF88C73FFCEC5FA653"><enum>(i)</enum><text display-inline="yes-display-inline">the difference was required by the country
in which the drug is distributed;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDDF5D98EDB58148EB9101D641A48295E9"><enum>(ii)</enum><text display-inline="yes-display-inline">the Secretary has determined that the
difference was necessary to improve the safety or effectiveness of the
drug;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDCF68B0C276D84B7E950AAE0B857C47DE"><enum>(iii)</enum><text display-inline="yes-display-inline">the person manufacturing the drug for
distribution in the United States has given notice to the Secretary under
subsection (g)(2)(B)(i) that the drug for distribution in the United States is
not different from a drug for distribution in permitted countries whose
combined population represents at least 50 percent of the total population of
all permitted countries; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID5DF5CAFA8C124BFFACF1AA1539C5F2A3"><enum>(iv)</enum><text display-inline="yes-display-inline">the difference was not caused, in whole or
in part, for the purpose of restricting importation of the drug into the United
States under this section.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDA45D7E781B2A4A3E97CAF5ABE3FF535F"><enum>(4)</enum><header display-inline="yes-display-inline">Effect of subsection</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID5098697F5DAD467FA212B66C5F9AB540"><enum>(A)</enum><header display-inline="yes-display-inline">Sales in other countries</header><text display-inline="yes-display-inline">This subsection applies only to the sale or
distribution of a prescription drug in a country if the manufacturer of the
drug chooses to sell or distribute the drug in the country. Nothing in this
subsection shall be construed to compel the manufacturer of a drug to
distribute or sell the drug in a country.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDC22B229E7D2A49EF95835487629CDABD"><enum>(B)</enum><header display-inline="yes-display-inline">Discounts to insurers, health plans,
pharmacy benefit managers, and covered entities</header><text display-inline="yes-display-inline">Nothing in this subsection shall be
construed to—</text>
<clause commented="no" display-inline="no-display-inline" id="IDE4A0EFBECF344265AF8E4E82E81AF1BC"><enum>(i)</enum><text display-inline="yes-display-inline">prevent or restrict a manufacturer of a
prescription drug from providing discounts to an insurer, health plan, pharmacy
benefit manager in the United States, or covered entity in the drug discount
program under section 340B of the <act-name parsable-cite="PHSA">Public Health
Service Act</act-name> (42 U.S.C. 256b) in return for inclusion of the drug on
a formulary;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDC85CB29B17E54FB79B96997D8E205737"><enum>(ii)</enum><text display-inline="yes-display-inline">require that such discounts be made
available to other purchasers of the prescription drug; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDBB760B21F9654CA7B5CD14002FEFDDB9"><enum>(iii)</enum><text display-inline="yes-display-inline">prevent or restrict any other measures
taken by an insurer, health plan, or pharmacy benefit manager to encourage
consumption of such prescription drug.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9C09698E7BD746C4B3A6D047E3A05FFF"><enum>(C)</enum><header display-inline="yes-display-inline">Charitable contributions</header><text display-inline="yes-display-inline">Nothing in this subsection shall be
construed to—</text>
<clause commented="no" display-inline="no-display-inline" id="IDB6E285B6BAB94BDE9B320C0E60D2D851"><enum>(i)</enum><text display-inline="yes-display-inline">prevent a manufacturer from donating a
prescription drug, or supplying a prescription drug at nominal cost, to a
charitable or humanitarian organization, including the United Nations and
affiliates, or to a government of a foreign country; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDDE101AB8E2F240C2B7A497BD0BBE1043"><enum>(ii)</enum><text display-inline="yes-display-inline">apply to such donations or supplying of a
prescription drug.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID82F1EABEF6C1424E82A69F95B398EB20"><enum>(5)</enum><header display-inline="yes-display-inline">Enforcement</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDAA2D22C6C4C449CD9DC36845A7DE8E3C"><enum>(A)</enum><header display-inline="yes-display-inline">Unfair or deceptive Act or
practice</header><text display-inline="yes-display-inline">A violation of this
subsection shall be treated as a violation of a rule defining an unfair or
deceptive act or practice prescribed under section 18(a)(1)(B) of the
<act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name> (15
U.S.C. 57a(a)(1)(B)).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7A5BAD682B434F7C90EB46715C90E58F"><enum>(B)</enum><header display-inline="yes-display-inline">Actions by the commission</header><text display-inline="yes-display-inline">The Federal Trade Commission—</text>
<clause commented="no" display-inline="no-display-inline" id="ID3FE652BA253A4DD48F952531A75E136B"><enum>(i)</enum><text display-inline="yes-display-inline">shall enforce this subsection in the same
manner, by the same means, and with the same jurisdiction, powers, and duties
as though all applicable terms and provisions of the
<act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name> (15
U.S.C. 41 et seq.) were incorporated into and made a part of this section;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID32AB20F57001458CBB6776A91F8947C6"><enum>(ii)</enum><text display-inline="yes-display-inline">may seek monetary relief threefold the
damages sustained, in addition to any other remedy available to the Federal
Trade Commission under the <act-name parsable-cite="FTCA">Federal Trade
Commission Act</act-name> (15 U.S.C. 41 et seq.).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID33D4AD83FF7848C79784C6AD0FEDA4A2"><enum>(6)</enum><header display-inline="yes-display-inline">Actions by States</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDEF27844036D340299495F733AFA261AF"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header>
<clause commented="no" display-inline="no-display-inline" id="IDF014B2DAD84E451DBD5813ACAA7DD6E9"><enum>(i)</enum><header display-inline="yes-display-inline">Civil actions</header><text display-inline="yes-display-inline">In any case in which the attorney general
of a State has reason to believe that an interest of the residents of that
State have been adversely affected by any manufacturer that violates paragraph
(1), the attorney general of a State may bring a civil action on behalf of the
residents of the State, and persons doing business in the State, in a district
court of the United States of appropriate jurisdiction to—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDC6B1BAABBC004B6498F0CC54FBCF9D27"><enum>(I)</enum><text display-inline="yes-display-inline">enjoin that practice;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID4405808ACF044324B08F53D43B848029"><enum>(II)</enum><text display-inline="yes-display-inline">enforce compliance with this
subsection;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDF1897699C1FB4DDA9D7AC7D1D2DE9745"><enum>(III)</enum><text display-inline="yes-display-inline">obtain damages, restitution, or other
compensation on behalf of residents of the State and persons doing business in
the State, including threefold the damages; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDC648902245BB488A80075BEB333FA872"><enum>(IV)</enum><text display-inline="yes-display-inline">obtain such other relief as the court may
consider to be appropriate.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID135C7ECC7CA2459B8B89610F3296298E"><enum>(ii)</enum><header display-inline="yes-display-inline">Notice</header>
<subclause commented="no" display-inline="no-display-inline" id="ID4E2C21B6246A4616A3DDA99008D3730C"><enum>(I)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Before filing an action under clause (i),
the attorney general of the State involved shall provide to the Federal Trade
Commission—</text>
<item commented="no" display-inline="no-display-inline" id="IDE339C0C4EEC2409CB5B907AD12A3A9E5"><enum>(aa)</enum><text display-inline="yes-display-inline">written notice of that action; and</text>
</item><item commented="no" display-inline="no-display-inline" id="ID1EC3740BB0E440669A97E5DB3C54C278"><enum>(bb)</enum><text display-inline="yes-display-inline">a copy of the complaint for that
action.</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="IDABD7005DB88147378AC15011576E0BCF"><enum>(II)</enum><header display-inline="yes-display-inline">Exemption</header><text display-inline="yes-display-inline">Subclause (I) shall not apply with respect
to the filing of an action by an attorney general of a State under this
paragraph, if the attorney general determines that it is not feasible to
provide the notice described in that subclause before filing of the action. In
such case, the attorney general of a State shall provide notice and a copy of
the complaint to the Federal Trade Commission at the same time as the attorney
general files the action.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDCA96844ED8404271AE80F10AE990BE92"><enum>(B)</enum><header display-inline="yes-display-inline">Intervention</header>
<clause commented="no" display-inline="no-display-inline" id="ID9957A7B122694A7EA8A5A1195C86CFD0"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">On receiving notice under subparagraph
(A)(ii), the Federal Trade Commission shall have the right to intervene in the
action that is the subject of the notice.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDE2C8E8F327FA4F6C881496F60C84E22D"><enum>(ii)</enum><header display-inline="yes-display-inline">Effect of intervention</header><text display-inline="yes-display-inline">If the Federal Trade Commission intervenes
in an action under subparagraph (A), it shall have the right—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID4E423DB407524E97BEC21EF8EA627A80"><enum>(I)</enum><text display-inline="yes-display-inline">to be heard with respect to any matter that
arises in that action; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID893B9F8B4B9940A2B8A04947F7B5CBF2"><enum>(II)</enum><text display-inline="yes-display-inline">to file a petition for appeal.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5C021B8B65F3478D8E7646A806CF90D7"><enum>(C)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">For purposes of bringing any civil action
under subparagraph (A), nothing in this subsection shall be construed to
prevent an attorney general of a State from exercising the powers conferred on
the attorney general by the laws of that State to—</text>
<clause commented="no" display-inline="no-display-inline" id="IDD646FA371C1D4ABDA782446E4804F6F5"><enum>(i)</enum><text display-inline="yes-display-inline">conduct investigations;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDD0DFD4F5B2B742DBBD546094DF7B0FDB"><enum>(ii)</enum><text display-inline="yes-display-inline">administer oaths or affirmations; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID99639AEC2E0A44BA95084E0B95E870D7"><enum>(iii)</enum><text display-inline="yes-display-inline">compel the attendance of witnesses or the
production of documentary and other evidence.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7D2CB49845224C4982B6FCF744CC344C"><enum>(D)</enum><header display-inline="yes-display-inline">Actions by the commission</header><text display-inline="yes-display-inline">In any case in which an action is
instituted by or on behalf of the Federal Trade Commission for a violation of
paragraph (1), a State may not, during the pendency of that action, institute
an action under subparagraph (A) for the same violation against any defendant
named in the complaint in that action.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3B6EC79C8EAA4133BA49446733366031"><enum>(E)</enum><header display-inline="yes-display-inline">Venue</header><text display-inline="yes-display-inline">Any action brought under subparagraph (A)
may be brought in the district court of the United States that meets applicable
requirements relating to venue under section 1391 of title 28, United States
Code.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDEC9AACEB130C45928A408BE8306D8AFE"><enum>(F)</enum><header display-inline="yes-display-inline">Service of process</header><text display-inline="yes-display-inline">In an action brought under subparagraph
(A), process may be served in any district in which the defendant—</text>
<clause commented="no" display-inline="no-display-inline" id="ID80BAA594FC814D4A99CA8C567C614C61"><enum>(i)</enum><text display-inline="yes-display-inline">is an inhabitant; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID012701F5B9AD4014A4559B49FB0E9F32"><enum>(ii)</enum><text display-inline="yes-display-inline">may be found.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID70DFC4D863934A56A2B29D9489664166"><enum>(G)</enum><header display-inline="yes-display-inline">Measurement of damages</header><text display-inline="yes-display-inline">In any action under this paragraph to
enforce a cause of action under this subsection in which there has been a
determination that a defendant has violated a provision of this subsection,
damages may be proved and assessed in the aggregate by statistical or sampling
methods, by the computation of illegal overcharges or by such other reasonable
system of estimating aggregate damages as the court in its discretion may
permit without the necessity of separately proving the individual claim of, or
amount of damage to, persons on whose behalf the suit was brought.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0DA10338DCD94E4D824B935775569726"><enum>(H)</enum><header display-inline="yes-display-inline">Exclusion on duplicative
relief</header><text display-inline="yes-display-inline">The district court
shall exclude from the amount of monetary relief awarded in an action under
this paragraph brought by the attorney general of a State any amount of
monetary relief which duplicates amounts which have been awarded for the same
injury.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID373AA165AB8F45569DEDF35FFEA736DD"><enum>(7)</enum><header display-inline="yes-display-inline">Effect on antitrust laws</header><text display-inline="yes-display-inline">Nothing in this subsection shall be
construed to modify, impair, or supersede the operation of the antitrust laws.
For the purpose of this subsection, the term <term>antitrust laws</term> has
the meaning given it in the first section of the <act-name parsable-cite="CLAY">Clayton Act</act-name>, except that it includes section 5
of the <act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name>
to the extent that such section 5 applies to unfair methods of
competition.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID5A9D61CC585148AA8FD48DE32F6FC272"><enum>(8)</enum><header display-inline="yes-display-inline">Manufacturer</header><text display-inline="yes-display-inline">In this subsection, the term
<term>manufacturer</term> means any entity, including any affiliate or licensee
of that entity, that is engaged in—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID4C817B4F38CB4AFDB5A487449524179C"><enum>(A)</enum><text display-inline="yes-display-inline">the production, preparation, propagation,
compounding, conversion, or processing of a prescription drug, either directly
or indirectly by extraction from substances of natural origin, or independently
by means of chemical synthesis, or by a combination of extraction and chemical
synthesis; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6C32E9FADF884F5F89E021EB9B2D407D"><enum>(B)</enum><text display-inline="yes-display-inline">the packaging, repackaging, labeling,
relabeling, or distribution of a prescription
drug.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDEDE7F8F368EE491582030D423C66B8C5"><enum>(b)</enum><header display-inline="yes-display-inline">Prohibited Acts</header><text display-inline="yes-display-inline">The <act-name parsable-cite="FFDCA">Federal
Food, Drug, and Cosmetic Act</act-name> is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID8517332672D940D48C2C0F374BE13907"><enum>(1)</enum><text display-inline="yes-display-inline">in section 301 (21 U.S.C. 331), by striking
paragraph (aa) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="ID2DC7C4537E034C92B7D5F2A739C0199C" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id231387ECFB634F3D8ACEA898C11B0A4D"><enum>(aa)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id6EA74560F9994126934E470FE0228AE3"><enum>(1)</enum><text display-inline="yes-display-inline">The sale or trade by a pharmacist, or by a
business organization of which the pharmacist is a part, of a qualifying drug
that under section 804(a)(2)(A) was imported by the pharmacist, other
than—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id2C4D962739084DB6B68F6764B155647F" indent="up1"><enum>(A)</enum><text display-inline="yes-display-inline">a
sale at retail made pursuant to dispensing the drug to a customer of the
pharmacist or organization; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id78D73A4D89074904BDA7CF95EBA3F976" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">a
sale or trade of the drug to a pharmacy or a wholesaler registered to import
drugs under section 804.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2CFF3FA7060048ACBF2506B964F6C6F1" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">The sale or trade by an individual of a
qualifying drug that under section 804(a)(2)(B) was imported by the
individual.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF60001D0EB004C08A606A1F0981B2ACA" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">The making of a materially false,
fictitious, or fraudulent statement or representation, or a material omission,
in a notice under clause (i) of section 804(g)(2)(B) or in an application
required under section 804(g)(2)(F), or the failure to submit such a notice or
application.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4C510A02C03B4B199D26DE9BB8DDA541" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">The importation of a drug in violation of a
registration condition or other requirement under section 804, the
falsification of any record required to be maintained, or provided to the
Secretary, under such section, or the violation of any registration condition
or other requirement under such
section.</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID47418579B52D422BB0D288784D6B2F96"><enum>(2)</enum><text display-inline="yes-display-inline">in section 303(a) (21 U.S.C. 333(a)), by
striking paragraph (6) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="ID6EA58B3CC6F5441FADB870C5BECD6B36" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="ID84C090A527C745A18F6FB4AC41738106" indent="up1"><enum>(6)</enum><text display-inline="yes-display-inline">Notwithstanding subsection (a), any person
that knowingly violates section 301(i) (2) or (3) or section 301(aa)(4) shall
be imprisoned not more than 10 years, or fined in accordance with title 18,
United States Code, or
both.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID45372B47605F48B690D9B39CF7A042FA"><enum>(c)</enum><header display-inline="yes-display-inline">Amendment of certain provisions</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID24F2163DEF3345F78DEB16E054643ECD"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 801 of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 381) is amended by striking subsection (g) and inserting the
following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" display-inline="no-display-inline" id="IDFDC783AECA364CB987B528B0EC1BAB43" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="ID4D620477605448C6BC81E55FA606F64D"><enum>(g)</enum><text display-inline="yes-display-inline">With respect to a prescription drug that is
imported or offered for import into the United States by an individual who is
not in the business of such importation, that is not shipped by a registered
exporter under section 804, and that is refused admission under subsection (a),
the Secretary shall notify the individual that—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDC60D06484E524693A83D9A299D4C6BC9"><enum>(1)</enum><text display-inline="yes-display-inline">the drug has been refused admission because
the drug was not a lawful import under section 804;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID3A9E20D47D404BD4B68A86C697F6B7EE"><enum>(2)</enum><text display-inline="yes-display-inline">the drug is not otherwise subject to a
waiver of the requirements of subsection (a);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID052740FFB7574D02AFF09822DD7D84D2"><enum>(3)</enum><text display-inline="yes-display-inline">the individual may under section 804
lawfully import certain prescription drugs from exporters registered with the
Secretary under section 804; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID45E3FA1806424CCB836A752CB4FC1E75"><enum>(4)</enum><text display-inline="yes-display-inline">the individual can find information about
such importation, including a list of registered exporters, on the Internet Web
site of the Food and Drug Administration or through a toll-free telephone
number required under section
804.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID21949B394C5D4B6CA5B0F47564F36E3B"><enum>(2)</enum><header display-inline="yes-display-inline">Establishment registration</header><text display-inline="yes-display-inline">Section 510(i) of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 360(i)) is amended in paragraph (1) by inserting after <quote>import
into the United States</quote> the following: <quote>, including a drug that
is, or may be, imported or offered for import into the United States under
section 804,</quote>.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID28B5EEADAF4D4E29A052479C33A2CE10"><enum>(3)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendments made by
this subsection shall take effect on the date that is 90 days after the date of
enactment of this Act.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID26EF669298534FB6840FF726772662DB"><enum>(d)</enum><header display-inline="yes-display-inline">Exhaustion</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID6D092A8CC58C44F89B16F069982FE79B"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 271 of title 35, United States
Code, is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID6CE34D4D5C464284A9722251EFB0BC8E"><enum>(A)</enum><text display-inline="yes-display-inline">by redesignating subsections (h) and (i) as
(i) and (j), respectively; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDE288553774834F328F912B6FC4DF187E"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting after subsection (g) the
following:</text>
<quoted-block display-inline="no-display-inline" id="ID3432FF7B985B45E98CA8010DAB3F6042" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="ID69CA5CA37DB24441BFE2837B7148ABB2"><enum>(h)</enum><text display-inline="yes-display-inline">It shall not be an act of infringement to
use, offer to sell, or sell within the United States or to import into the
United States any patented invention under section 804 of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
that was first sold abroad by or under authority of the owner or licensee of
such
patent.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDBEEFD143DCD44C628C8E164BFE4CBAB1"><enum>(2)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">Nothing in the amendment made by paragraph
(1) shall be construed to affect the ability of a patent owner or licensee to
enforce their patent, subject to such amendment.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID417999FF678B4258AD37096A8F9FE06D"><enum>(e)</enum><header display-inline="yes-display-inline">Effect of Section
<enum-in-header>804</enum-in-header></header>
<paragraph commented="no" display-inline="no-display-inline" id="ID49A11BFFB3104785A6B5C3CC5F50AAF0"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 804 of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>, as added by subsection (a), shall permit the importation of
qualifying drugs (as defined in such section 804) into the United States
without regard to the status of the issuance of implementing
regulations—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID02A5B28522F449B29A2DF1BA21FDC5FA"><enum>(A)</enum><text display-inline="yes-display-inline">from exporters registered under such
section 804 on the date that is 90 days after the date of enactment of this
Act; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID03ECF5B2E10D429C9621E8379BCF02ED"><enum>(B)</enum><text display-inline="yes-display-inline">from permitted countries, as defined in
such section 804, by importers registered under such section 804 on the date
that is 1 year after the date of enactment of this Act.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDD4E9B81D04AB4F5085C2B865E82E88B3"><enum>(2)</enum><header display-inline="yes-display-inline">Review of registration by certain
exporters</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID009CE89C347E49ACB30B49BBD103CD06"><enum>(A)</enum><header display-inline="yes-display-inline">Review priority</header><text display-inline="yes-display-inline">In the review of registrations submitted
under subsection (b) of such section 804, registrations submitted by entities
in Canada that are significant exporters of prescription drugs to individuals
in the United States as of the date of enactment of this Act will have priority
during the 90-day period that begins on such date of enactment.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDBAF2352920914405868300A60490F119"><enum>(B)</enum><header display-inline="yes-display-inline">Period for review</header><text display-inline="yes-display-inline">During such 90-day period, the reference in
subsection (b)(2)(A) of such section 804 to 90 days (relating to approval or
disapproval of registrations) is, as applied to such entities, deemed to be 30
days.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID72F1AC71474B4C01B142C358F3C700D5"><enum>(C)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">That an exporter in Canada exports, or has
exported, prescription drugs to individuals in the United States on or before
the date that is 90 days after the date of enactment of this Act shall not
serve as a basis, in whole or in part, for disapproving a registration under
such section 804 from the exporter.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDB33AD014A5CE4F05A4FD36AC83A71432"><enum>(D)</enum><header display-inline="yes-display-inline">First year limit on number of
exporters</header><text display-inline="yes-display-inline">During the 1-year
period beginning on the date of enactment of this Act, the Secretary of Health
and Human Services (referred to in this section as the
<quote>Secretary</quote>) may limit the number of registered exporters under
such section 804 to not less than 50, so long as the Secretary gives priority
to those exporters with demonstrated ability to process a high volume of
shipments of drugs to individuals in the United States.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID534F529B739E49FE9B9F70E5A8EF4739"><enum>(E)</enum><header display-inline="yes-display-inline">Second year limit on number of
exporters</header><text display-inline="yes-display-inline">During the 1-year
period beginning on the date that is 1 year after the date of enactment of this
Act, the Secretary may limit the number of registered exporters under such
section 804 to not less than 100, so long as the Secretary gives priority to
those exporters with demonstrated ability to process a high volume of shipments
of drugs to individuals in the United States.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6BA04586A2464F54BA04C749E7C80797"><enum>(F)</enum><header display-inline="yes-display-inline">Further limit on number of
exporters</header><text display-inline="yes-display-inline">During any 1-year
period beginning on a date that is 2 or more years after the date of enactment
of this Act, the Secretary may limit the number of registered exporters under
such section 804 to not less than 25 more than the number of such exporters
during the previous 1-year period, so long as the Secretary gives priority to
those exporters with demonstrated ability to process a high volume of shipments
of drugs to individuals in the United States.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID67E5D3E1CA0840248838EDA75074E507"><enum>(3)</enum><header display-inline="yes-display-inline">Limits on number of importers</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDDE06E13595B34EDD84E86FA49122D549"><enum>(A)</enum><header display-inline="yes-display-inline">First year limit on number of
importers</header><text display-inline="yes-display-inline">During the 1-year
period beginning on the date that is 1 year after the date of enactment of this
Act, the Secretary may limit the number of registered importers under such
section 804 to not less than 100 (of which at least a significant number shall
be groups of pharmacies, to the extent feasible given the applications
submitted by such groups), so long as the Secretary gives priority to those
importers with demonstrated ability to process a high volume of shipments of
drugs imported into the United States.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDFA7975178DC9474B8843C74F9BB41EAF"><enum>(B)</enum><header display-inline="yes-display-inline">Second year limit on number of
importers</header><text display-inline="yes-display-inline">During the 1-year
period beginning on the date that is 2 years after the date of enactment of
this Act, the Secretary may limit the number of registered importers under such
section 804 to not less than 200 (of which at least a significant number shall
be groups of pharmacies, to the extent feasible given the applications
submitted by such groups), so long as the Secretary gives priority to those
importers with demonstrated ability to process a high volume of shipments of
drugs into the United States.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID892D488FB680419C98CB155A632386C4"><enum>(C)</enum><header display-inline="yes-display-inline">Further limit on number of
importers</header><text display-inline="yes-display-inline">During any 1-year
period beginning on a date that is 3 or more years after the date of enactment
of this Act, the Secretary may limit the number of registered importers under
such section 804 to not less than 50 more (of which at least a significant
number shall be groups of pharmacies, to the extent feasible given the
applications submitted by such groups) than the number of such importers during
the previous 1-year period, so long as the Secretary gives priority to those
importers with demonstrated ability to process a high volume of shipments of
drugs to the United States.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4F62EF3A20FB40DFB4643AC65342A2C5"><enum>(4)</enum><header display-inline="yes-display-inline">Notices for drugs for import from
Canada</header><text display-inline="yes-display-inline">The notice with
respect to a qualifying drug introduced for commercial distribution in Canada
as of the date of enactment of this Act that is required under subsection
(g)(2)(B)(i) of such section 804 shall be submitted to the Secretary not later
than 30 days after the date of enactment of this Act if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDEF13C53B8E1047BCBD93533511BCB4FD"><enum>(A)</enum><text display-inline="yes-display-inline">the U.S. label drug (as defined in such
section 804) for the qualifying drug is 1 of the 100 prescription drugs with
the highest dollar volume of sales in the United States based on the 12
calendar month period most recently completed before the date of enactment of
this Act; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3C8C43800AC447FE896329240D18FB39"><enum>(B)</enum><text display-inline="yes-display-inline">the notice is a notice under subsection
(g)(2)(B)(i)(II) of such section 804.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4815DC1199EB403EB13E50D7218F80C5"><enum>(5)</enum><header display-inline="yes-display-inline">Notice for drugs for import from other
countries</header><text display-inline="yes-display-inline">The notice with
respect to a qualifying drug introduced for commercial distribution in a
permitted country other than Canada as of the date of enactment of this Act
that is required under subsection (g)(2)(B)(i) of such section 804 shall be
submitted to the Secretary not later than 180 days after the date of enactment
of this Act if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID7F7130B12F0B4B9B8393B108DEAC5E10"><enum>(A)</enum><text display-inline="yes-display-inline">the U.S. label drug for the qualifying drug
is 1 of the 100 prescription drugs with the highest dollar volume of sales in
the United States based on the 12 calendar month period that is first completed
on the date that is 120 days after the date of enactment of this Act; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDF4B30B0F84104910B8B8C1130CDC05E3"><enum>(B)</enum><text display-inline="yes-display-inline">the notice is a notice under subsection
(g)(2)(B)(i)(II) of such section 804.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4FFA2B73DA3E4E8096BD7F9243F9D225"><enum>(6)</enum><header display-inline="yes-display-inline">Notice for other drugs for import</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID8E7F30F07DA948DC896EC68F63F4FD0D"><enum>(A)</enum><header display-inline="yes-display-inline">Guidance on submission dates</header><text display-inline="yes-display-inline">The Secretary shall by guidance establish a
series of submission dates for the notices under subsection (g)(2)(B)(i) of
such section 804 with respect to qualifying drugs introduced for commercial
distribution as of the date of enactment of this Act and that are not required
to be submitted under paragraph (4) or (5).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDCA721A23AD6F453098F44F075D1D74A3"><enum>(B)</enum><header display-inline="yes-display-inline">Consistent and efficient use of
resources</header><text display-inline="yes-display-inline">The Secretary shall
establish the dates described under subparagraph (A) so that such notices
described under subparagraph (A) are submitted and reviewed at a rate that
allows consistent and efficient use of the resources and staff available to the
Secretary for such reviews. The Secretary may condition the requirement to
submit such a notice, and the review of such a notice, on the submission by a
registered exporter or a registered importer to the Secretary of a notice that
such exporter or importer intends to import such qualifying drug to the United
States under such section 804.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0889A45A3CD44F7297F5C83F7354BBBA"><enum>(C)</enum><header display-inline="yes-display-inline">Priority for drugs with higher
sales</header><text display-inline="yes-display-inline">The Secretary shall
establish the dates described under subparagraph (A) so that the Secretary
reviews the notices described under such subparagraph with respect to
qualifying drugs with higher dollar volume of sales in the United States before
the notices with respect to drugs with lower sales in the United States.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDAE0626285C49465C8BCE91CAB1D2E00F"><enum>(7)</enum><header display-inline="yes-display-inline">Notices for drugs approved after effective
date</header><text display-inline="yes-display-inline">The notice required
under subsection (g)(2)(B)(i) of such section 804 for a qualifying drug first
introduced for commercial distribution in a permitted country (as defined in
such section 804) after the date of enactment of this Act shall be submitted to
and reviewed by the Secretary as provided under subsection (g)(2)(B) of such
section 804, without regard to paragraph (4), (5), or (6).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID35DAC34EBB82449F9FECDBE6158CD7B5"><enum>(8)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Beginning with the first full fiscal year
after the date of enactment of this Act, not later than 90 days after the end
of each fiscal year during which the Secretary reviews a notice referred to in
paragraph (4), (5), or (6), the Secretary shall submit a report to Congress
concerning the progress of the Food and Drug Administration in reviewing the
notices referred to in paragraphs (4), (5), and (6).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDFBC0C33A4ABE49769A1BCADF1BB43114"><enum>(9)</enum><header display-inline="yes-display-inline">User fees</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID0795003A788341DCA2A41720E9A64D5E"><enum>(A)</enum><header display-inline="yes-display-inline">Exporters</header><text display-inline="yes-display-inline">When establishing an aggregate total of
fees to be collected from exporters under subsection (f)(2) of such section
804, the Secretary shall, under subsection (f)(3)(C)(i) of such section 804,
estimate the total price of drugs imported under subsection (a) of such section
804 into the United States by registered exporters during the first fiscal year
in which this title takes effect to be an amount equal to the amount which
bears the same ratio to $1,000,000,000 as the number of days in such fiscal
year during which this title is effective bears to 365.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID561929F729D744BD98C06F8FF66B949B"><enum>(B)</enum><header display-inline="yes-display-inline">Importers</header><text display-inline="yes-display-inline">When establishing an aggregate total of
fees to be collected from importers under subsection (e)(2) of such section
804, the Secretary shall, under subsection (e)(3)(C)(i) of such section 804,
estimate the total price of drugs imported under subsection (a) of such section
804 into the United States by registered importers during—</text>
<clause commented="no" display-inline="no-display-inline" id="ID92A5655173FD4A3DB6F4B25BDA5792D5"><enum>(i)</enum><text display-inline="yes-display-inline">the first fiscal year in which this title
takes effect to be an amount equal to the amount which bears the same ratio to
$1,000,000,000 as the number of days in such fiscal year during which this
title is effective bears to 365; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDAB9CD7FED5DE43969340AA9543EB4FB5"><enum>(ii)</enum><text display-inline="yes-display-inline">the second fiscal year in which this title
is in effect to be $3,000,000,000.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID157876643BED43DA991DFC929E9DC221"><enum>(C)</enum><header display-inline="yes-display-inline">Second year adjustment</header>
<clause commented="no" display-inline="no-display-inline" id="ID6955351C625C4255B8E3EE0844AFAD81"><enum>(i)</enum><header display-inline="yes-display-inline">Reports</header><text display-inline="yes-display-inline">Not later than February 20 of the second
fiscal year in which this title is in effect, registered importers shall report
to the Secretary the total price and the total volume of drugs imported to the
United States by the importer during the 4-month period from October 1 through
January 31 of such fiscal year.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID610A61F86A9F4D71BDA6F9A2D14FB93B"><enum>(ii)</enum><header display-inline="yes-display-inline">Reestimate</header><text display-inline="yes-display-inline">Notwithstanding subsection (e)(3)(C)(ii) of
such section 804 or subparagraph (B), the Secretary shall reestimate the total
price of qualifying drugs imported under subsection (a) of such section 804
into the United States by registered importers during the second fiscal year in
which this title is in effect. Such reestimate shall be equal to—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID5C2880F089BD4BB7916CCA5CB81452EC"><enum>(I)</enum><text display-inline="yes-display-inline">the total price of qualifying drugs
imported by each importer as reported under clause (i); multiplied by</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID9072CECAD0AE480382DED84214575C43"><enum>(II)</enum><text display-inline="yes-display-inline">3.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDD42A783BD1ED4C1EA70D9765D49D7E67"><enum>(iii)</enum><header display-inline="yes-display-inline">Adjustment</header><text display-inline="yes-display-inline">The Secretary shall adjust the fee due on
April 1 of the second fiscal year in which this title is in effect, from each
importer so that the aggregate total of fees collected under subsection (e)(2)
for such fiscal year does not exceed the total price of qualifying drugs
imported under subsection (a) of such section 804 into the United States by
registered importers during such fiscal year as reestimated under clause
(ii).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC6BC8E2AAF0144D19053E48819BAC5D1"><enum>(D)</enum><header display-inline="yes-display-inline">Failure to pay fees</header><text display-inline="yes-display-inline">Notwithstanding any other provision of this
section, the Secretary may prohibit a registered importer or exporter that is
required to pay user fees under subsection (e) or (f) of such section 804 and
that fails to pay such fees within 30 days after the date on which it is due,
from importing or offering for importation a qualifying drug under such section
804 until such fee is paid.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2AE96FFFF25440FD8FA6435191457D74"><enum>(E)</enum><header display-inline="yes-display-inline">Annual report</header>
<clause commented="no" display-inline="no-display-inline" id="ID514B74DD411D48E088932F76FB0DAB49"><enum>(i)</enum><header display-inline="yes-display-inline">Food and Drug Administration</header><text display-inline="yes-display-inline">Not later than 180 days after the end of
each fiscal year during which fees are collected under subsection (e), (f), or
(g)(2)(B)(iv) of such section 804, the Secretary shall prepare and submit to
the House of Representatives and the Senate a report on the implementation of
the authority for such fees during such fiscal year and the use, by the Food
and Drug Administration, of the fees collected for the fiscal year for which
the report is made and credited to the Food and Drug Administration.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID598830ADA3F04BD8905016380BF39782"><enum>(ii)</enum><header display-inline="yes-display-inline">Customs and border control</header><text display-inline="yes-display-inline">Not later than 180 days after the end of
each fiscal year during which fees are collected under subsection (e) or (f) of
such section 804, the Secretary of Homeland Security, in consultation with the
Secretary of the Treasury, shall prepare and submit to the House of
Representatives and the Senate a report on the use, by the Bureau of Customs
and Border Protection, of the fees, if any, transferred by the Secretary to the
Bureau of Customs and Border Protection for the fiscal year for which the
report is made.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id14AA613477564352BCB8C036B5E46286"><enum>(10)</enum><header display-inline="yes-display-inline">Special rule regarding importation by
individuals</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id9EAC0237A3A44BB9BA0F20E9C34F5848"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Notwithstanding any provision of this title
(or an amendment made by this title), the Secretary shall expedite the
designation of any additional countries from which an individual may import a
qualifying drug into the United States under such section 804 if any action
implemented by the Government of Canada has the effect of limiting or
prohibiting the importation of qualifying drugs into the United States from
Canada.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idFCD960C7A6F843D88CBA38FA989DF126"><enum>(B)</enum><header display-inline="yes-display-inline">Timing and criteria</header><text display-inline="yes-display-inline">The Secretary shall designate such
additional countries under subparagraph (A)—</text>
<clause commented="no" display-inline="no-display-inline" id="id958740709CAA462B828DE71FF2D79779"><enum>(i)</enum><text display-inline="yes-display-inline">not later than 6 months after the date of
the action by the Government of Canada described under such subparagraph;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idCA53D36A6B514145942F400CE1FC9FE8"><enum>(ii)</enum><text display-inline="yes-display-inline">using the criteria described under
subsection (a)(4)(D)(i)(II) of such section 804.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDF551245FCA1D4798BC30096506C9FEEA"><enum>(f)</enum><header display-inline="yes-display-inline">Implementation of Section
<enum-in-header>804</enum-in-header></header>
<paragraph commented="no" display-inline="no-display-inline" id="ID7DE21F5828524BE2977B0CDA625F6D25"><enum>(1)</enum><header display-inline="yes-display-inline">Interim rule</header><text display-inline="yes-display-inline">The Secretary may promulgate an interim
rule for implementing section 804 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>, as added
by subsection (a) of this section.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID945809C415FD48C4A18AE67AE3322F50"><enum>(2)</enum><header display-inline="yes-display-inline">No notice of proposed
rulemaking</header><text display-inline="yes-display-inline">The interim rule
described under paragraph (1) may be developed and promulgated by the Secretary
without providing general notice of proposed rulemaking.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDF1FA44FC556B4EA79FA9B6EFD27FA95D"><enum>(3)</enum><header display-inline="yes-display-inline">Final rule</header><text display-inline="yes-display-inline">Not later than 1 year after the date on
which the Secretary promulgates an interim rule under paragraph (1), the
Secretary shall, in accordance with procedures under section 553 of title 5,
United States Code, promulgate a final rule for implementing such section 804,
which may incorporate by reference provisions of the interim rule provided for
under paragraph (1), to the extent that such provisions are not
modified.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDD159A99A7A684C06AA6C5485C8096FD0"><enum>(g)</enum><header display-inline="yes-display-inline">Consumer education</header><text display-inline="yes-display-inline">The Secretary shall carry out activities
that educate consumers—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDBD80008964204A7BBDF5179D331512AD"><enum>(1)</enum><text display-inline="yes-display-inline">with regard to the availability of
qualifying drugs for import for personal use from an exporter registered with
and approved by the Food and Drug Administration under section 804 of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>, as added by this section, including information on how to
verify whether an exporter is registered and approved by use of the Internet
Web site of the Food and Drug Administration and the toll-free telephone number
required by this title;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDF49EE0D2AA1B4AAA978778C0AC627FF4"><enum>(2)</enum><text display-inline="yes-display-inline">that drugs that consumers attempt to import
from an exporter that is not registered with and approved by the Food and Drug
Administration can be seized by the United States Customs Service and
destroyed, and that such drugs may be counterfeit, unapproved, unsafe, or
ineffective;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD92E88BF2C86463A994A77DF9DB99A1A"><enum>(3)</enum><text display-inline="yes-display-inline">with regard to the suspension and
termination of any registration of a registered importer or exporter under such
section 804; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID5A6343A483A2440E911F1E0629191DE2"><enum>(4)</enum><text display-inline="yes-display-inline">with regard to the availability at domestic
retail pharmacies of qualifying drugs imported under such section 804 by
domestic wholesalers and pharmacies registered with and approved by the Food
and Drug Administration.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID0CE3BCE5AB644AFABD53B45594D5C977"><enum>(h)</enum><header display-inline="yes-display-inline">Effect on administration
practices</header><text display-inline="yes-display-inline">Notwithstanding any
provision of this title (and the amendments made by this title), the practices
and policies of the Food and Drug Administration and Bureau of Customs and
Border Protection, in effect on January 1, 2004, with respect to the
importation of prescription drugs into the United States by an individual, on
the person of such individual, for personal use, shall remain in effect.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id81FC2F8343A6427996C56C8F16215E5F"><enum>(i)</enum><header display-inline="yes-display-inline">Report to Congress</header><text display-inline="yes-display-inline">The Federal Trade Commission shall, on an
annual basis, submit to Congress a report that describes any action taken
during the period for which the report is being prepared to enforce the
provisions of section 804(n) of the Federal Food, Drug, and Cosmetic Act (as
added by this title), including any pending investigations or civil actions
under such section.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="ID811EBDFE2365427EB22EA69F8AFF79A5" section-type="subsequent-section"><enum>105.</enum><header display-inline="yes-display-inline">Disposition of certain drugs denied
admission into United States</header>
<subsection commented="no" display-inline="no-display-inline" id="IDEB5C9ECFDF49462EBF5E1456E1128D41"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Chapter VIII of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 381 et seq.), as amended by section 104, is further amended by
adding at the end the following section:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" display-inline="no-display-inline" id="ID0C5DF90289494C79814A05091048BB29" style="OLC">
<section commented="no" display-inline="no-display-inline" id="ID662BB921E5974A619ECB4EF0F6A79CAD" section-type="subsequent-section"><enum>805.</enum><header display-inline="yes-display-inline">Disposition of certain drugs denied
admission</header>
<subsection commented="no" display-inline="no-display-inline" id="ID4DA088F7111A4A8EB793126FF9BBE8BA"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary of Homeland Security shall
deliver to the Secretary a shipment of drugs that is imported or offered for
import into the United States if—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDF0E930946366473C941DEBEF1B5EF79E"><enum>(1)</enum><text display-inline="yes-display-inline">the shipment has a declared value of less
than $10,000; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDC08AE3A669D6405DA89975CCA3896DE1"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="IDB152C24466224BB5A187DC285402C2C4"><enum>(A)</enum><text display-inline="yes-display-inline">the shipping container for such drugs does
not bear the markings required under section 804(d)(2); or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID67F9C8D0D98D43BB8EB701C3427856DA" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">the Secretary has requested delivery of
such shipment of drugs.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDC18CBA9B7B0E4A7DAE70A9792277DDF2"><enum>(b)</enum><header display-inline="yes-display-inline">No bond or export</header><text display-inline="yes-display-inline">Section 801(b) does not authorize the
delivery to the owner or consignee of drugs delivered to the Secretary under
subsection (a) pursuant to the execution of a bond, and such drugs may not be
exported.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID4942D589D2EA412984913C504E12AD0E"><enum>(c)</enum><header display-inline="yes-display-inline">Destruction of violative
shipment</header><text display-inline="yes-display-inline">The Secretary shall
destroy a shipment of drugs delivered by the Secretary of Homeland Security to
the Secretary under subsection (a) if—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDC555262C17C24B71BD1E1CE0BB34DBF9"><enum>(1)</enum><text display-inline="yes-display-inline">in the case of drugs that are imported or
offered for import from a registered exporter under section 804, the drugs are
in violation of any standard described in section 804(g)(5); or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID05AE7AD558904919AA9DC1610E3CBDBE"><enum>(2)</enum><text display-inline="yes-display-inline">in the case of drugs that are not imported
or offered for import from a registered exporter under section 804, the drugs
are in violation of a standard referred to in section 801(a) or
801(d)(1).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID7C26B2FBD320415A9BBCBD61C6DD76A9"><enum>(d)</enum><header display-inline="yes-display-inline">Certain procedures</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID007F297FC4894BA4AEEB331EAC6FF74C"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The delivery and destruction of drugs under
this section may be carried out without notice to the importer, owner, or
consignee of the drugs except as required by section 801(g) or section
804(i)(2). The issuance of receipts for the drugs, and recordkeeping activities
regarding the drugs, may be carried out on a summary basis.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDD029DA00489843C3BD3AA1C93520094F"><enum>(2)</enum><header display-inline="yes-display-inline">Objective of procedures</header><text display-inline="yes-display-inline">Procedures promulgated under paragraph (1)
shall be designed toward the objective of ensuring that, with respect to
efficiently utilizing Federal resources available for carrying out this
section, a substantial majority of shipments of drugs subject to described in
subsection (c) are identified and destroyed.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID829BE754C57B4D3CB3B141AFAF66533E"><enum>(e)</enum><header display-inline="yes-display-inline">Evidence exception</header><text display-inline="yes-display-inline">Drugs may not be destroyed under subsection
(c) to the extent that the Attorney General of the United States determines
that the drugs should be preserved as evidence or potential evidence with
respect to an offense against the United States.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDCD492B638CE94555B264A0BF4FCEE7A6"><enum>(f)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">This section may not be construed as having
any legal effect on applicable law with respect to a shipment of drugs that is
imported or offered for import into the United States and has a declared value
equal to or greater than
$10,000.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID4AE645B8549E44DAB163A7B14B7B2EE0"><enum>(b)</enum><header display-inline="yes-display-inline">Procedures</header><text display-inline="yes-display-inline">Procedures for carrying out section 805 of
the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>, as added by subsection (a), shall be established not later than
90 days after the date of the enactment of this Act.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID33D676839A8A4DB1B1FD634F8A766962"><enum>(c)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendments made by
this section shall take effect on the date that is 90 days after the date of
enactment of this Act.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="ID7A4967C5D3FB43449E3CD4845982CB86" section-type="subsequent-section"><enum>106.</enum><header display-inline="yes-display-inline">Wholesale distribution of drugs; statements
regarding prior sale, purchase, or trade</header>
<subsection commented="no" display-inline="no-display-inline" id="ID35D9D803AE2C44DEB9C5219FBA320F48"><enum>(a)</enum><header display-inline="yes-display-inline">Striking of exemptions; applicability to
registered exporters</header><text display-inline="yes-display-inline">Section
503(e) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name> (21 U.S.C. 353(e)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDBE72EF25A50A4B4C9601D9C807996652"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID3AEA8987D166492AA795F75F14BAA69B"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>and who is not the
manufacturer or an authorized distributor of record of such
drug</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID15DF4AA624AE4E74AD6BECA1F6FFAC52"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>to an authorized
distributor of record or</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3C9FCB86C8CB484888EF32E707B39011"><enum>(C)</enum><text display-inline="yes-display-inline">by striking subparagraph (B) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="IDE916BDE28D85422A8A0D9301C0F41A0C" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="ID2619AA1209714D2FBD8C641C79B1747C" indent="up2"><enum>(B)</enum><text display-inline="yes-display-inline">The fact that a drug subject to subsection
(b) is exported from the United States does not with respect to such drug
exempt any person that is engaged in the business of the wholesale distribution
of the drug from providing the statement described in subparagraph (A) to the
person that receives the drug pursuant to the export of the drug.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDCA1A4D5C0DCB4BE1B45E4BF850BD2B9D" indent="up2"><enum>(C)</enum><clause commented="no" display-inline="yes-display-inline" id="ID787615C4A53E4BA0B92B967A49FF83DB"><enum>(i)</enum><text display-inline="yes-display-inline">The Secretary shall by regulation establish
requirements that supersede subparagraph (A) (referred to in this subparagraph
as <quote>alternative requirements</quote>) to identify the chain of custody of
a drug subject to subsection (b) from the manufacturer of the drug throughout
the wholesale distribution of the drug to a pharmacist who intends to sell the
drug at retail if the Secretary determines that the alternative requirements,
which may include standardized anti-counterfeiting or track-and-trace
technologies, will identify such chain of custody or the identity of the
discrete package of the drug from which the drug is dispensed with equal or
greater certainty to the requirements of subparagraph (A), and that the
alternative requirements are economically and technically feasible.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID05A2F9041C55456396960A3CC75E83F4" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">When the Secretary promulgates a final rule
to establish such alternative requirements, the final rule in addition shall,
with respect to the registration condition established in clause (i) of section
804(c)(3)(B), establish a condition equivalent to the alternative requirements,
and such equivalent condition may be met in lieu of the registration condition
established in such clause
(i).</text>
</clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID6CC6C6E463544E0E9C79A2E5DD80D396"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)(A), by adding at the end
the following: <quote>The preceding sentence may not be construed as having any
applicability with respect to a registered exporter under section 804.</quote>;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1D6442BB7C5E4A92A476A888588D7E15"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (3), by striking <quote>and
subsection (d)—</quote> in the matter preceding subparagraph (A) and all that
follows through <quote>the term <term>wholesale distribution</term>
means</quote> in subparagraph (B) and inserting the following: <quote>and
subsection (d), the term <term>wholesale distribution</term>
means</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDBCE645B1C21D443EBD65BBDC97F405AF"><enum>(b)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">Section 503(d) of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 353(d)) is amended by adding at the end the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" display-inline="no-display-inline" id="IDF3F342344FE348528F749B33A4DEFD7D" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="ID532A423F419D4F2CAF7A106AFCFAB657" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">Each manufacturer of a drug subject to
subsection (b) shall maintain at its corporate offices a current list of the
authorized distributors of record of such drug.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID6724042EDC9442E5A443327CB952A8B4" indent="up1"><enum>(5)</enum><text display-inline="yes-display-inline">For purposes of this subsection, the term
<term>authorized distributors of record</term> means those distributors with
whom a manufacturer has established an ongoing relationship to distribute such
manufacturer’s
products.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID04252AEDE39045CCBB324E8F3C71213E"><enum>(c)</enum><header display-inline="yes-display-inline">Effective date</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID888606AC2BF340ED93013C869CDF0391"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The amendments made by paragraphs (1) and
(3) of subsection (a) and by subsection (b) shall take effect on January 1,
2012.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID197FEE8D61E74EEFA7165A1F7D86E25D"><enum>(2)</enum><header display-inline="yes-display-inline">Drugs imported by registered importers
under Section 804</header><text display-inline="yes-display-inline">Notwithstanding paragraph (1), the
amendments made by paragraphs (1) and (3) of subsection (a) and by subsection
(b) shall take effect on the date that is 90 days after the date of enactment
of this Act with respect to qualifying drugs imported under section 804 of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>, as added by section 104.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDFAB50F6BA18E4B22B21FA461EEE5EC6D"><enum>(3)</enum><header display-inline="yes-display-inline">Effect with respect to registered
exporters</header><text display-inline="yes-display-inline">The amendment made
by subsection (a)(2) shall take effect on the date that is 90 days after the
date of enactment of this Act.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDBDBE97C9A12342CEA21C541F64ABFB19"><enum>(4)</enum><header display-inline="yes-display-inline">Alternative requirements</header><text display-inline="yes-display-inline">The Secretary shall issue regulations to
establish the alternative requirements, referred to in the amendment made by
subsection (a)(1), that take effect not later than January 1, 2012.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID828B7916ED094663BA494886B44F1BF5"><enum>(5)</enum><header display-inline="yes-display-inline">Intermediate requirements</header><text display-inline="yes-display-inline">The Secretary shall by regulation require
the use of standardized anti-counterfeiting or track-and-trace technologies on
prescription drugs at the case and pallet level effective not later than 1 year
after the date of enactment of this Act.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6D3F599452F64540A121721FF1A62CC1"><enum>(6)</enum><header display-inline="yes-display-inline">Additional requirements</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idDF6098E18DE540048B9973F94D449F4E"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Notwithstanding any other provision of this
section, the Secretary shall, not later than 18 months after the date of
enactment of this Act, require that the packaging of any prescription drug
incorporates—</text>
<clause commented="no" display-inline="no-display-inline" id="id860A8883E244474F830AE8978DEDC839"><enum>(i)</enum><text display-inline="yes-display-inline">a standardized numerical identifier unique
to each package of such drug, applied at the point of manufacturing and
repackaging (in which case the numerical identifier shall be linked to the
numerical identifier applied at the point of manufacturing); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idAF2AB634C5C14E4DB5E72B4D24D53995"><enum>(ii)</enum><subclause commented="no" display-inline="yes-display-inline" id="idC739E8AEDA8C465CB662AEA4A139697B"><enum>(I)</enum><text display-inline="yes-display-inline">overt optically variable
counterfeit-resistant technologies that—</text>
<item commented="no" display-inline="no-display-inline" id="id3C91EAD645FF4AB69ED9B7B713AFAC59" indent="up1"><enum>(aa)</enum><text display-inline="yes-display-inline">are visible to the naked eye, providing for
visual identification of product authenticity without the need for readers,
microscopes, lighting devices, or scanners;</text>
</item><item commented="no" display-inline="no-display-inline" id="idEDA54D2A5CDA426095E2DA1797573C30" indent="up1"><enum>(bb)</enum><text display-inline="yes-display-inline">are similar to that used by the Bureau of
Engraving and Printing to secure United States currency;</text>
</item><item commented="no" display-inline="no-display-inline" id="idFA8A20D9CE9C4AC991F0DD3C6E92A609" indent="up1"><enum>(cc)</enum><text display-inline="yes-display-inline">are manufactured and distributed in a
highly secure, tightly controlled environment; and</text>
</item><item commented="no" display-inline="no-display-inline" id="id290C167948A2456DA4DFA3309B80B3D8" indent="up1"><enum>(dd)</enum><text display-inline="yes-display-inline">incorporate additional layers of nonvisible
convert security features up to and including forensic capability, as described
in subparagraph (B); or</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="id499E2482B2114B07ADBEB04BC59EE7F7" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">technologies that have a function of
security comparable to that described in subclause (I), as determined by the
Secretary.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD06735EA2BDD43C4BDC9D3ED6843AAA4"><enum>(B)</enum><header display-inline="yes-display-inline">Standards for packaging</header><text display-inline="yes-display-inline">For the purpose of making it more difficult
to counterfeit the packaging of drugs subject to this paragraph, the
manufacturers of such drugs shall incorporate the technologies described in
subparagraph (A) into at least 1 additional element of the physical packaging
of the drugs, including blister packs, shrink wrap, package labels, package
seals, bottles, and boxes.</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="IDD470091DFC3C4DBA8FE507D014677D9D" section-type="subsequent-section"><enum>107.</enum><header display-inline="yes-display-inline">Internet sales of prescription
drugs</header>
<subsection commented="no" display-inline="no-display-inline" id="ID579473DD5D6B402B93B4D44B464591EE"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Chapter V of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 351 et seq.) is amended by inserting after section 503B the
following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" display-inline="no-display-inline" id="IDCBC4A75CBC3B47D7B3FC33CCCC49C64A" style="OLC">
<section commented="no" display-inline="no-display-inline" id="IDB96FED5EB177430292D0A2BBA43FEDB4" section-type="subsequent-section"><enum>503C.</enum><header display-inline="yes-display-inline">Internet sales of prescription
drugs</header>
<subsection commented="no" display-inline="no-display-inline" id="ID92F8798D49FC45089F300B55C830C35E"><enum>(a)</enum><header display-inline="yes-display-inline">Requirements regarding information on
Internet site</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID8C4DE8E9974546C6931436C7171C0A8A"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A person may not dispense a prescription
drug pursuant to a sale of the drug by such person if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID59E8871D704C47A6AF151115B4BB32B9"><enum>(A)</enum><text display-inline="yes-display-inline">the purchaser of the drug submitted the
purchase order for the drug, or conducted any other part of the sales
transaction for the drug, through an Internet site;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDAC16A1B55EB944BE914573AC9827DC09"><enum>(B)</enum><text display-inline="yes-display-inline">the person dispenses the drug to the
purchaser by mailing or shipping the drug to the purchaser; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDFE231A7E217E46DDA857F15FF56CED53"><enum>(C)</enum><text display-inline="yes-display-inline">such site, or any other Internet site used
by such person for purposes of sales of a prescription drug, fails to meet each
of the requirements specified in paragraph (2), other than a site or pages on a
site that—</text>
<clause commented="no" display-inline="no-display-inline" id="IDA444076479BA4CE4BA4E5FC7EC0A5CAF"><enum>(i)</enum><text display-inline="yes-display-inline">are not intended to be accessed by
purchasers or prospective purchasers; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID2FE483ED8AC2489891E85E8C22345EB2"><enum>(ii)</enum><text display-inline="yes-display-inline">provide an Internet information location
tool within the meaning of section 231(e)(5) of the
<act-name parsable-cite="CA34">Communications Act of 1934</act-name> (47 U.S.C.
231(e)(5)).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID9CDBA0FB4B1543219E9109699B626954"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">With respect to an Internet site, the
requirements referred to in subparagraph (C) of paragraph (1) for a person to
whom such paragraph applies are as follows:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDCCD3E56B22E5402D8678887C09517CA1"><enum>(A)</enum><text display-inline="yes-display-inline">Each page of the site shall include either
the following information or a link to a page that provides the following
information:</text>
<clause commented="no" display-inline="no-display-inline" id="ID7CD5BF1F1E334A2CA1A141A30C928A42"><enum>(i)</enum><text display-inline="yes-display-inline">The name of such person.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID14C0C75C09724FB285D9F9E7D8B5A9D0"><enum>(ii)</enum><text display-inline="yes-display-inline">Each State in which the person is
authorized by law to dispense prescription drugs.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID39656903D7964F2FBE18A2E7DDD39715"><enum>(iii)</enum><text display-inline="yes-display-inline">The address and telephone number of each
place of business of the person with respect to sales of prescription drugs
through the Internet, other than a place of business that does not mail or ship
prescription drugs to purchasers.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID3FE6F7D07DD44E68A7724EF3925B086B"><enum>(iv)</enum><text display-inline="yes-display-inline">The name of each individual who serves as a
pharmacist for prescription drugs that are mailed or shipped pursuant to the
site, and each State in which the individual is authorized by law to dispense
prescription drugs.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDF3353C8CCA8E47FA98140CABCC9E6B51"><enum>(v)</enum><text display-inline="yes-display-inline">If the person provides for medical
consultations through the site for purposes of providing prescriptions, the
name of each individual who provides such consultations; each State in which
the individual is licensed or otherwise authorized by law to provide such
consultations or practice medicine; and the type or types of health professions
for which the individual holds such licenses or other authorizations.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID8C586A6D51CE4567B7150F2671798867"><enum>(B)</enum><text display-inline="yes-display-inline">A link to which paragraph (1) applies shall
be displayed in a clear and prominent place and manner, and shall include in
the caption for the link the words <quote>licensing and contact
information</quote>.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID216ECC955F594320ADB282CE35E5AE21"><enum>(b)</enum><header display-inline="yes-display-inline">Internet sales without appropriate medical
relationships</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID32B9DC1A11C24A2AB17A3F373FC0269B"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided in paragraph (2), a
person may not dispense a prescription drug, or sell such a drug, if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID79018EAF2B9849D5A3644C4F57DCFEB3"><enum>(A)</enum><text display-inline="yes-display-inline">for purposes of such dispensing or sale,
the purchaser communicated with the person through the Internet;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDEB2AE0C4AABB46709B5BDEF6F2770D34"><enum>(B)</enum><text display-inline="yes-display-inline">the patient for whom the drug was dispensed
or purchased did not, when such communications began, have a prescription for
the drug that is valid in the United States;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID52B377F9B9034339897B3D4DD91C2FFB"><enum>(C)</enum><text display-inline="yes-display-inline">pursuant to such communications, the person
provided for the involvement of a practitioner, or an individual represented by
the person as a practitioner, and the practitioner or such individual issued a
prescription for the drug that was purchased;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDBB12293497154684AE3F1AA31E5F541B"><enum>(D)</enum><text display-inline="yes-display-inline">the person knew, or had reason to know,
that the practitioner or the individual referred to in subparagraph (C) did
not, when issuing the prescription, have a qualifying medical relationship with
the patient; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDE3AAAACFC7394B579B3B2FB37CD0BBCF"><enum>(E)</enum><text display-inline="yes-display-inline">the person received payment for the
dispensing or sale of the drug.</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">For purposes of subparagraph (E),
payment is received if money or other valuable consideration is
received.</continuation-text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDFEC54C81E86B446EAE2B83A7F84B698C"><enum>(2)</enum><header display-inline="yes-display-inline">Exceptions</header><text display-inline="yes-display-inline">Paragraph (1) does not apply to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDF360BEFC44CF4236AD882B8952746611"><enum>(A)</enum><text display-inline="yes-display-inline">the dispensing or selling of a prescription
drug pursuant to telemedicine practices sponsored by—</text>
<clause commented="no" display-inline="no-display-inline" id="IDA054798B8DF049469092061CE61B88A0"><enum>(i)</enum><text display-inline="yes-display-inline">a hospital that has in effect a provider
agreement under title XVIII of the <act-name parsable-cite="SSA">Social
Security Act</act-name> (relating to the Medicare program); or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDE168CD9098F74EC9856BFCA2E673D080"><enum>(ii)</enum><text display-inline="yes-display-inline">a group practice that has not fewer than
100 physicians who have in effect provider agreements under such title;
or</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID99D0ADBE7D8D49B097C7B8CB37C677D1"><enum>(B)</enum><text display-inline="yes-display-inline">the dispensing or selling of a prescription
drug pursuant to practices that promote the public health, as determined by the
Secretary by regulation.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID05173D41893F48AFAEEE7E8AFCA3FAA7"><enum>(3)</enum><header display-inline="yes-display-inline">Qualifying medical relationship</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDA5377D8C480942FBB570DBEBB40D150F"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">With respect to issuing a prescription for
a drug for a patient, a practitioner has a qualifying medical relationship with
the patient for purposes of this section if—</text>
<clause commented="no" display-inline="no-display-inline" id="ID40591F110C2040A0AD64D878F1197113"><enum>(i)</enum><text display-inline="yes-display-inline">at least one in-person medical evaluation
of the patient has been conducted by the practitioner; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID38C77D43615F4362B6F256EC0213B1CE"><enum>(ii)</enum><text display-inline="yes-display-inline">the practitioner conducts a medical
evaluation of the patient as a covering practitioner.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7740DFDEB87041A79A5FD093FEBFF2CF"><enum>(B)</enum><header display-inline="yes-display-inline">In-person medical evaluation</header><text display-inline="yes-display-inline">A medical evaluation by a practitioner is
an in-person medical evaluation for purposes of this section if the
practitioner is in the physical presence of the patient as part of conducting
the evaluation, without regard to whether portions of the evaluation are
conducted by other health professionals.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID5FC15C5F5EE241F095068B3386E368F2"><enum>(C)</enum><header display-inline="yes-display-inline">Covering practitioner</header><text display-inline="yes-display-inline">With respect to a patient, a practitioner
is a covering practitioner for purposes of this section if the practitioner
conducts a medical evaluation of the patient at the request of a practitioner
who has conducted at least one in-person medical evaluation of the patient and
is temporarily unavailable to conduct the evaluation of the patient. A
practitioner is a covering practitioner without regard to whether the
practitioner has conducted any in-person medical evaluation of the patient
involved.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4D458285760B47C38C00BDAEEF8B98A8"><enum>(4)</enum><header display-inline="yes-display-inline">Rules of construction</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDF401C9CE40124BF9A8B4BBCAF85D683C"><enum>(A)</enum><header display-inline="yes-display-inline">Individuals represented as
practitioners</header><text display-inline="yes-display-inline">A person who is
not a practitioner (as defined in subsection (e)(1)) lacks legal capacity under
this section to have a qualifying medical relationship with any patient.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID444B70FC98554B15B4D1B1E623C2CA54"><enum>(B)</enum><header display-inline="yes-display-inline">Standard practice of pharmacy</header><text display-inline="yes-display-inline">Paragraph (1) may not be construed as
prohibiting any conduct that is a standard practice in the practice of
pharmacy.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDE83BAFBB806B4B248A3D0889C6C2F994"><enum>(C)</enum><header display-inline="yes-display-inline">Applicability of requirements</header><text display-inline="yes-display-inline">Paragraph (3) may not be construed as
having any applicability beyond this section, and does not affect any State
law, or interpretation of State law, concerning the practice of
medicine.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID2752852352464FC4989CBFFCA4A20635"><enum>(c)</enum><header display-inline="yes-display-inline">Actions by States</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID870C4E220C8545ACB7468F9CB961D11C"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Whenever an attorney general of any State
has reason to believe that the interests of the residents of that State have
been or are being threatened or adversely affected because any person has
engaged or is engaging in a pattern or practice that violates section 301(l),
the State may bring a civil action on behalf of its residents in an appropriate
district court of the United States to enjoin such practice, to enforce
compliance with such section (including a nationwide injunction), to obtain
damages, restitution, or other compensation on behalf of residents of such
State, to obtain reasonable attorneys fees and costs if the State prevails in
the civil action, or to obtain such further and other relief as the court may
deem appropriate.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDCECD7D8C5FCD4047890EAF52A6CB30F5"><enum>(2)</enum><header display-inline="yes-display-inline">Notice</header><text display-inline="yes-display-inline">The State shall serve prior written notice
of any civil action under paragraph (1) or (5)(B) upon the Secretary and
provide the Secretary with a copy of its complaint, except that if it is not
feasible for the State to provide such prior notice, the State shall serve such
notice immediately upon instituting such action. Upon receiving a notice
respecting a civil action, the Secretary shall have the right—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID235974EEC89F4D8C9F7C9A1ED8DC3752"><enum>(A)</enum><text display-inline="yes-display-inline">to intervene in such action;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0CB02F6A5CE84D9FB2BCEB05FC346B2D"><enum>(B)</enum><text display-inline="yes-display-inline">upon so intervening, to be heard on all
matters arising therein; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2A81E43F0E00491792A47F5DB211E979"><enum>(C)</enum><text display-inline="yes-display-inline">to file petitions for appeal.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID3CFE585166FD49DD8D7ED2D9F7B0149C"><enum>(3)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">For purposes of bringing any civil action
under paragraph (1), nothing in this chapter shall prevent an attorney general
of a State from exercising the powers conferred on the attorney general by the
laws of such State to conduct investigations or to administer oaths or
affirmations or to compel the attendance of witnesses or the production of
documentary and other evidence.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID0EF563B33220472080205BB9D5A564EA"><enum>(4)</enum><header display-inline="yes-display-inline">Venue; service of process</header><text display-inline="yes-display-inline">Any civil action brought under paragraph
(1) in a district court of the United States may be brought in the district in
which the defendant is found, is an inhabitant, or transacts business or
wherever venue is proper under section 1391 of title 28, United States Code.
Process in such an action may be served in any district in which the defendant
is an inhabitant or in which the defendant may be found.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID5075AA51547C4481BCF241CFCD8030B2"><enum>(5)</enum><header display-inline="yes-display-inline">Actions by other State officials</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDD790D111D37C41C0B3EE3D5CFA06C41C"><enum>(A)</enum><text display-inline="yes-display-inline">Nothing contained in this section shall
prohibit an authorized State official from proceeding in State court on the
basis of an alleged violation of any civil or criminal statute of such
State.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1EC13719BC7E48559593B1B7209A3711"><enum>(B)</enum><text display-inline="yes-display-inline">In addition to actions brought by an
attorney general of a State under paragraph (1), such an action may be brought
by officers of such State who are authorized by the State to bring actions in
such State on behalf of its residents.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID32024C443A5044689C5413A3731AD41C"><enum>(d)</enum><header display-inline="yes-display-inline">Effect of Section</header><text display-inline="yes-display-inline">This section shall not apply to a person
that is a registered exporter under section 804.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDE6B40A3647AA432C9CE5A137016B3758"><enum>(e)</enum><header display-inline="yes-display-inline">General definitions</header><text display-inline="yes-display-inline">For purposes of this section:</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID37D641A6527341C18D0A6545AA8E2674"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>practitioner</term> means a
practitioner referred to in section 503(b)(1) with respect to issuing a written
or oral prescription.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1E568E2D2C1342A58024B2341417F91C"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>prescription drug</term>
means a drug that is described in section 503(b)(1).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID605D30F2238E42EE9020E2D2A6EE1CE5"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>qualifying medical
relationship</term>, with respect to a practitioner and a patient, has the
meaning indicated for such term in subsection (b).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID3934E0912E7549C1A6AC9A4351658F80"><enum>(f)</enum><header display-inline="yes-display-inline">Internet-Related definitions</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDA2D2217FA408431DA87E0344F57595BA"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">For purposes of this section:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID46A4EBFB9A5D420ABF9144A4B94F0FDD"><enum>(A)</enum><text display-inline="yes-display-inline">The term <term>Internet</term> means
collectively the myriad of computer and telecommunications facilities,
including equipment and operating software, which comprise the interconnected
world-wide network of networks that employ the transmission control
protocol/Internet protocol, or any predecessor or successor protocols to such
protocol, to communicate information of all kinds by wire or radio.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID847B096313784178BAE8093476026A75"><enum>(B)</enum><text display-inline="yes-display-inline">The term <term>link</term>, with respect to
the Internet, means one or more letters, words, numbers, symbols, or graphic
items that appear on a page of an Internet site for the purpose of serving,
when activated, as a method for executing an electronic command—</text>
<clause commented="no" display-inline="no-display-inline" id="IDB04607F041E14C719EDAB4A3DF4059EB"><enum>(i)</enum><text display-inline="yes-display-inline">to move from viewing one portion of a page
on such site to another portion of the page;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDD6B8A78BF7BC456A8C649E009B27EF44"><enum>(ii)</enum><text display-inline="yes-display-inline">to move from viewing one page on such site
to another page on such site; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID575C90F28D1B4593B0F9481AA2E53DA9"><enum>(iii)</enum><text display-inline="yes-display-inline">to move from viewing a page on one Internet
site to a page on another Internet site.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0EF4542EE9814E94970C02AE91866CDD"><enum>(C)</enum><text display-inline="yes-display-inline">The term <term>page</term>, with respect to
the Internet, means a document or other file accessed at an Internet
site.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDE3BC817B65B14CB1B52B5B26BBAFCC41"><enum>(D)</enum><clause commented="no" display-inline="yes-display-inline" id="IDE4B1DF4EDA2E4FC39A2542A9067FDF85"><enum>(i)</enum><text display-inline="yes-display-inline">The terms <term>site</term> and
<term>address</term>, with respect to the Internet, mean a specific location on
the Internet that is determined by Internet Protocol numbers. Such term
includes the domain name, if any.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDD7230825A42D4502A024115BAF428A10" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">The term <term>domain name</term> means a
method of representing an Internet address without direct reference to the
Internet Protocol numbers for the address, including methods that use
designations such as <quote>.com</quote>, <quote>.edu</quote>,
<quote>.gov</quote>, <quote>.net</quote>, or <quote>.org</quote>.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID1F247C4E995A4A509BC2040ED79A346C" indent="up1"><enum>(iii)</enum><text display-inline="yes-display-inline">The term <term>Internet Protocol
numbers</term> includes any successor protocol for determining a specific
location on the Internet.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDEBA52DCCE0BF460FBBB0C2225069FC66"><enum>(2)</enum><header display-inline="yes-display-inline">Authority of Secretary</header><text display-inline="yes-display-inline">The Secretary may by regulation modify any
definition under paragraph (1) to take into account changes in
technology.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID63A3C413DBBC435183E1CF4AFD711CA6"><enum>(g)</enum><header display-inline="yes-display-inline">Interactive computer service;
advertising</header><text display-inline="yes-display-inline">No provider of an
interactive computer service, as defined in section 230(f)(2) of the
<act-name parsable-cite="CA34">Communications Act of 1934</act-name> (47 U.S.C.
230(f)(2)), or of advertising services shall be liable under this section for
dispensing or selling prescription drugs in violation of this section on
account of another person’s selling or dispensing such drugs, provided that the
provider of the interactive computer service or of advertising services does
not own or exercise corporate control over such
person.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID75E2989C7FF3423DA2E10CE00106B6DB"><enum>(b)</enum><header display-inline="yes-display-inline">Inclusion as prohibited Act</header><text display-inline="yes-display-inline">Section 301 of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 331) is amended by inserting after paragraph (k) the
following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" display-inline="no-display-inline" id="ID5B5A00A4EE0246C4B475877499C96820" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="IDE14728FDD32649AB885E5AF7151800DF"><enum>(l)</enum><text display-inline="yes-display-inline">The dispensing or selling of a prescription
drug in violation of section
503C.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID9521E240389E43079A2F5B1ED0430124"><enum>(c)</enum><header display-inline="yes-display-inline">Internet sales of prescription drugs;
consideration by Secretary of practices and procedures for certification of
legitimate businesses</header><text display-inline="yes-display-inline">In
carrying out section 503C of the <act-name parsable-cite="FFDCA">Federal Food,
Drug, and Cosmetic Act</act-name> (as added by subsection (a) of this section),
the Secretary of Health and Human Services shall take into consideration the
practices and procedures of public or private entities that certify that
businesses selling prescription drugs through Internet sites are legitimate
businesses, including practices and procedures regarding disclosure formats and
verification programs.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDA5E095FA5B514E878DFB6FEB0E74663D"><enum>(d)</enum><header display-inline="yes-display-inline">Reports regarding Internet-Related
violations of Federal and State laws on dispensing of drugs</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDB7BDBD3D8ACD452B8E87F0D76407A07E"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services
(referred to in this subsection as the <quote>Secretary</quote>) shall,
pursuant to the submission of an application meeting the criteria of the
Secretary, make an award of a grant or contract to the National Clearinghouse
on Internet Prescribing (operated by the Federation of State Medical Boards)
for the purpose of—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID34D51C5504144450B5BBD5C8B984F76E"><enum>(A)</enum><text display-inline="yes-display-inline">identifying Internet sites that appear to
be in violation of Federal or State laws concerning the dispensing of
drugs;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDB812BE4375C947BAB5FCB2076124C78A"><enum>(B)</enum><text display-inline="yes-display-inline">reporting such sites to State medical
licensing boards and State pharmacy licensing boards, and to the Attorney
General and the Secretary, for further investigation; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID61FF604DB2104CE1A29ACF2173D8A0CF"><enum>(C)</enum><text display-inline="yes-display-inline">submitting, for each fiscal year for which
the award under this subsection is made, a report to the Secretary describing
investigations undertaken with respect to violations described in subparagraph
(A).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID008E2AD0E3994BAF84C30FDFC32A10BF"><enum>(2)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">For the
purpose of carrying out paragraph (1), there is authorized to be appropriated
$100,000 for each of the first 3 fiscal years in which this section is in
effect.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID5824C73110844473B6DB7894D6441949"><enum>(e)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendments made by
subsections (a) and (b) take effect 90 days after the date of enactment of this
Act, without regard to whether a final rule to implement such amendments has
been promulgated by the Secretary of Health and Human Services under section
701(a) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>. The preceding sentence may not be construed as affecting the
authority of such Secretary to promulgate such a final rule.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id43FAA6C1FD744106AB715B3487097A12" section-type="subsequent-section"><enum>108.</enum><header display-inline="yes-display-inline">Prohibiting payments to unregistered
foreign pharmacies</header>
<subsection commented="no" display-inline="no-display-inline" id="idEE116BDBA3844D248613DF1688EEB544"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 303 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id160872B2B9134C6EA5C651682C76E75C" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="ID91a04745e0b44893ac6e4bc8a5b4b12c"><enum>(h)</enum><header display-inline="yes-display-inline">Restricted transactions</header>
<paragraph commented="no" display-inline="no-display-inline" id="id2A4D2FC9B53B4574863E8C384852B35C"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The introduction of restricted transactions
into a payment system or the completion of restricted transactions using a
payment system is prohibited.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5B12D2A5567945F09DCF23D209338856"><enum>(2)</enum><header display-inline="yes-display-inline">Payment system</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id911D0F81E85F473A8C4C8F1E430BF223"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The term <quote>payment system</quote>
means a system used by a person described in subparagraph (B) to effect a
credit transaction, electronic fund transfer, or money transmitting service
that may be used in connection with, or to facilitate, a restricted
transaction, and includes—</text>
<clause commented="no" display-inline="no-display-inline" id="idA197921812CD4EC5A84877A4A252B500"><enum>(i)</enum><text display-inline="yes-display-inline">a credit card system;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idBBE490B2F672480E9F7D8CAA5B331329"><enum>(ii)</enum><text display-inline="yes-display-inline">an international, national, regional, or
local network used to effect a credit transaction, an electronic fund transfer,
or a money transmitting service; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id79F4F18E831441FA842E79F3BC0CD142"><enum>(iii)</enum><text display-inline="yes-display-inline">any other system that is centrally managed
and is primarily engaged in the transmission and settlement of credit
transactions, electronic fund transfers, or money transmitting services.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id76FB7B1986F84CE2886185652603C99D"><enum>(B)</enum><header display-inline="yes-display-inline">Persons described</header><text display-inline="yes-display-inline">A person referred to in subparagraph (A)
is—</text>
<clause commented="no" display-inline="no-display-inline" id="id0FE382D1DE15478DAE7D6958DDF982B6"><enum>(i)</enum><text display-inline="yes-display-inline">a creditor;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id336E87C14BE8450AB4DF533AE18FCF82"><enum>(ii)</enum><text display-inline="yes-display-inline">a credit card issuer;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id17A2F5FDBA684D35B32DB2C233E46CF2"><enum>(iii)</enum><text display-inline="yes-display-inline">a financial institution;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id60891DB46CC143579C0DAE4E711DE5B0"><enum>(iv)</enum><text display-inline="yes-display-inline">an operator of a terminal at which an
electronic fund transfer may be initiated;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id1A5D5F59FBD44225BF0281CF6DC6DCC5"><enum>(v)</enum><text display-inline="yes-display-inline">a money transmitting business; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idD9A04D4EA41E4D16B603CDB78C184792"><enum>(vi)</enum><text display-inline="yes-display-inline">a participant in an international,
national, regional, or local network used to effect a credit transaction,
electronic fund transfer, or money transmitting service.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC7FEA1B46E27423DA8579DA698A3FEE8"><enum>(3)</enum><header display-inline="yes-display-inline">Restricted transaction</header><text display-inline="yes-display-inline">The term <quote>restricted
transaction</quote> means a transaction or transmittal, on behalf of an
individual who places an unlawful drug importation request to any person
engaged in the operation of an unregistered foreign pharmacy, of—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idB1B0DCB1D19842FBAEA7FA2FB5FDFC12"><enum>(A)</enum><text display-inline="yes-display-inline">credit, or the proceeds of credit, extended
to or on behalf of the individual for the purpose of the unlawful drug
importation request (including credit extended through the use of a credit
card);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6B503EB8866941799E77F5F93C78F897"><enum>(B)</enum><text display-inline="yes-display-inline">an electronic fund transfer or funds
transmitted by or through a money transmitting business, or the proceeds of an
electronic fund transfer or money transmitting service, from or on behalf of
the individual for the purpose of the unlawful drug importation request;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id723E5DCB899A4D27ABBFF8914B6A3050"><enum>(C)</enum><text display-inline="yes-display-inline">a check, draft, or similar instrument which
is drawn by or on behalf of the individual for the purpose of the unlawful drug
importation request and is drawn on or payable at or through any financial
institution; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9131F4FC14984B908CD1C99B2F997705"><enum>(D)</enum><text display-inline="yes-display-inline">the proceeds of any other form of financial
transaction (identified by the Board by regulation) that involves a financial
institution as a payor or financial intermediary on behalf of or for the
benefit of the individual for the purpose of the unlawful drug importation
request.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC55DAA5D555041308A0471A9CD79209B"><enum>(4)</enum><header display-inline="yes-display-inline">Unlawful drug importation
request</header><text display-inline="yes-display-inline">The term
<quote>unlawful drug importation request</quote> means the request, or
transmittal of a request, made to an unregistered foreign pharmacy for a
prescription drug by mail (including a private carrier), facsimile, phone, or
electronic mail, or by a means that involves the use, in whole or in part, of
the Internet.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id87807FE7C02040439DEB1C49B52E2597"><enum>(5)</enum><header display-inline="yes-display-inline">Unregistered foreign pharmacy</header><text display-inline="yes-display-inline">The term <quote>unregistered foreign
pharmacy</quote> means a person in a country other than the United States that
is not a registered exporter under section 804.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id610EE588535D4206969343065AA9D1CA"><enum>(6)</enum><header display-inline="yes-display-inline">Other definitions</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idA7E03FA874EF4E44BF3B44064EAF185C"><enum>(A)</enum><header display-inline="yes-display-inline">Credit; creditor; credit card</header><text display-inline="yes-display-inline">The terms <quote>credit</quote>,
‘creditor’, and <quote>credit card</quote> have the meanings given the terms in
section 103 of the Truth in Lending Act (15 U.S.C. 1602).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB683910E34B2425FA9DE575D75F4F4B1"><enum>(B)</enum><header display-inline="yes-display-inline">Access device; electronic fund
transfer</header><text display-inline="yes-display-inline">The terms
<quote>access device</quote> and <quote>electronic fund
transfer</quote>—</text>
<clause commented="no" display-inline="no-display-inline" id="id5D8744E547094B69846201AA7C1F6242"><enum>(i)</enum><text display-inline="yes-display-inline">have the meaning given the term in section
903 of the Electronic Fund Transfer Act (15 U.S.C. 1693a); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id11A2DBC70B9A436B8536654D2543B9E8"><enum>(ii)</enum><text display-inline="yes-display-inline">the term <quote>electronic fund
transfer</quote> also includes any fund transfer covered under Article 4A of
the Uniform Commercial Code, as in effect in any State.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3BCAFF2BB286430EBA7A85618B432F33"><enum>(C)</enum><header display-inline="yes-display-inline">Financial institution</header><text display-inline="yes-display-inline">The term <quote>financial
institution</quote>—</text>
<clause commented="no" display-inline="no-display-inline" id="id1D0AD0355E3048ECA01C054A0D803818"><enum>(i)</enum><text display-inline="yes-display-inline">has the meaning given the term in section
903 of the Electronic Transfer Fund Act (15 U.S.C. 1693a); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idEE524280F6D94E2C83457182A9BF2FEA"><enum>(ii)</enum><text display-inline="yes-display-inline">includes a financial institution (as
defined in section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809)).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF80DE3BEA4814B84A8CA323F22B66AC1"><enum>(D)</enum><header display-inline="yes-display-inline">Money transmitting business; money
transmitting service</header><text display-inline="yes-display-inline">The
terms <quote>money transmitting business</quote> and <quote>money transmitting
service</quote> have the meaning given the terms in section 5330(d) of title
31, United States Code.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB6187FF36A414264931F0850123ABCC2"><enum>(E)</enum><header display-inline="yes-display-inline">Board</header><text display-inline="yes-display-inline">The term <quote>Board</quote> means the
Board of Governors of the Federal Reserve System.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id651518061B1D4B308F2F2491CA2384EB"><enum>(7)</enum><header display-inline="yes-display-inline">Policies and procedures required to prevent
restricted transactions</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id852FA52BB12349098750F71751F59AF8"><enum>(A)</enum><header display-inline="yes-display-inline">Regulations</header><text display-inline="yes-display-inline">The Board shall promulgate regulations
requiring—</text>
<clause commented="no" display-inline="no-display-inline" id="id9706DCCF28E14C05BCE3C7A27CCC6FA8"><enum>(i)</enum><text display-inline="yes-display-inline">an operator of a credit card system;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id3296FA4B964940E6BA3D0771D3DF5623"><enum>(ii)</enum><text display-inline="yes-display-inline">an operator of an international, national,
regional, or local network used to effect a credit transaction, an electronic
fund transfer, or a money transmitting service;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id7C84CFE0E7C04922A9525D2AB533F284"><enum>(iii)</enum><text display-inline="yes-display-inline">an operator of any other payment system
that is centrally managed and is primarily engaged in the transmission and
settlement of credit transactions, electronic transfers or money transmitting
services where at least one party to the transaction or transfer is an
individual; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idA411595A11644FD7ABDAFA5F87ED5151"><enum>(iv)</enum><text display-inline="yes-display-inline">any other person described in paragraph
(2)(B) and specified by the Board in such regulations,</text>
</clause><continuation-text commented="no" continuation-text-level="subparagraph">to establish policies and
procedures that are reasonably designed to prevent the introduction of a
restricted transaction into a payment system or the completion of a restricted
transaction using a payment system.</continuation-text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id64C6991E28EE4529B19E766588CEE394"><enum>(B)</enum><header display-inline="yes-display-inline">Requirements for policies and
procedures</header><text display-inline="yes-display-inline">In promulgating
regulations under subparagraph (A), the Board shall—</text>
<clause commented="no" display-inline="no-display-inline" id="id13DA5B64A91C4A8899401D016CA1901D"><enum>(i)</enum><text display-inline="yes-display-inline">identify types of policies and procedures,
including nonexclusive examples, that shall be considered to be reasonably
designed to prevent the introduction of restricted transactions into a payment
system or the completion of restricted transactions using a payment system;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id43AE51DC440344FF9804C412CEB11498"><enum>(ii)</enum><text display-inline="yes-display-inline">to the extent practicable, permit any
payment system, or person described in paragraph (2)(B), as applicable, to
choose among alternative means of preventing the introduction or completion of
restricted transactions.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8B741CB062E94DE2BE063EFF64E7D7A0"><enum>(C)</enum><header display-inline="yes-display-inline">No liability for blocking or refusing to
honor restricted transaction</header>
<clause commented="no" display-inline="no-display-inline" id="idDA0994CE2F8242949EA8BE6441E88311"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A payment system, or a person described in
paragraph (2)(B) that is subject to a regulation issued under this subsection,
and any participant in such payment system that prevents or otherwise refuses
to honor transactions in an effort to implement the policies and procedures
required under this subsection or to otherwise comply with this subsection
shall not be liable to any party for such action.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idE4E5D24D2BB849FE853CF7D16592299F"><enum>(ii)</enum><header display-inline="yes-display-inline">Compliance</header><text display-inline="yes-display-inline">A person described in paragraph (2)(B)
meets the requirements of this subsection if the person relies on and complies
with the policies and procedures of a payment system of which the person is a
member or in which the person is a participant, and such policies and
procedures of the payment system comply with the requirements of the
regulations promulgated under subparagraph (A).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB20188344AD94D858C93E973AB69310B"><enum>(D)</enum><header display-inline="yes-display-inline">Enforcement</header>
<clause commented="no" display-inline="no-display-inline" id="idBDC1F7767966487AB9101BBED85EB65C"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">This section shall be enforced by the
Federal functional regulators and the Federal Trade Commission under applicable
law in the manner provided in section 505(a) of the Gramm-Leach-Bliley Act (15
U.S.C. 6805(a)).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id27D1813E8A5A46B49538001FECE22CBB"><enum>(ii)</enum><header display-inline="yes-display-inline">Factors to be considered</header><text display-inline="yes-display-inline">In considering any enforcement action under
this subsection against a payment system or person described in paragraph
(2)(B), the Federal functional regulators and the Federal Trade Commission
shall consider the following factors:</text>
<subclause commented="no" display-inline="no-display-inline" id="id1D831976ACDE4721A5787C703058660C"><enum>(I)</enum><text display-inline="yes-display-inline">The extent to which the payment system or
person knowingly permits restricted transactions.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idDA767204412849B3977082F23B75252A"><enum>(II)</enum><text display-inline="yes-display-inline">The history of the payment system or person
in connection with permitting restricted transactions.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id0E5370923EB04158A91717E565DEF359"><enum>(III)</enum><text display-inline="yes-display-inline">The extent to which the payment system or
person has established and is maintaining policies and procedures in compliance
with regulations prescribed under this subsection.</text>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF0A93997E8AA461FAE2D3B96F9E72464"><enum>(8)</enum><header display-inline="yes-display-inline">Transactions permitted</header><text display-inline="yes-display-inline">A payment system, or a person described in
paragraph (2)(B) that is subject to a regulation issued under this subsection,
is authorized to engage in transactions with foreign pharmacies in connection
with investigating violations or potential violations of any rule or
requirement adopted by the payment system or person in connection with
complying with paragraph (7). A payment system, or such a person, and its
agents and employees shall not be found to be in violation of, or liable under,
any Federal, State or other law by virtue of engaging in any such
transaction.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA2D5430BF0EF493B8501C7218AD700BB"><enum>(9)</enum><header display-inline="yes-display-inline">Relation to State laws</header><text display-inline="yes-display-inline">No requirement, prohibition, or liability
may be imposed on a payment system, or a person described in paragraph (2)(B)
that is subject to a regulation issued under this subsection, under the laws of
any State with respect to any payment transaction by an individual because the
payment transaction involves a payment to a foreign pharmacy.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD4A4C21354D948DA9D7B6DBFE5CDA867"><enum>(10)</enum><header display-inline="yes-display-inline">Timing of requirements</header><text display-inline="yes-display-inline">A payment system, or a person described in
paragraph (2)(B) that is subject to a regulation issued under this subsection,
must adopt policies and procedures reasonably designed to comply with any
regulations required under paragraph (7) within 60 days after such regulations
are issued in final
form.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id5B6FE23C26314981B6CC328FB4E95B59"><enum>(b)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendment made by
this section shall take effect on the day that is 90 days after the date of
enactment of this Act.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id3A93F9C8FF82427A9853828DA232724C"><enum>(c)</enum><header display-inline="yes-display-inline">Implementation</header><text display-inline="yes-display-inline">The Board of Governors of the Federal
Reserve System shall promulgate regulations as required by subsection (h)(7) of
section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), as
added by subsection (a), not later than 90 days after the date of enactment of
this Act.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="ID44323B23202841D0BF0C3B3D465583C8" section-type="subsequent-section"><enum>109.</enum><header display-inline="yes-display-inline">Importation exemption under Controlled
Substances Import and Export Act</header><text display-inline="no-display-inline">Section 1006(a)(2) of the Controlled
Substances Import and Export Act (21 U.S.C. 956(a)(2)) is amended by striking
<quote>not import the controlled substance into the United States in an amount
that exceeds 50 dosage units of the controlled substance.</quote> and inserting
<quote>import into the United States not more than 10 dosage units combined of
all such controlled substances.</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="id77EFAF8A4FF14D8CBF48E6E32F743B00" section-type="subsequent-section"><enum>110.</enum><header display-inline="yes-display-inline">Severability</header><text display-inline="no-display-inline">If any provision of this title, an amendment
by this title, or the application of such provision or amendment to any person
or circumstance is held to be unconstitutional, the remainder of this title,
the amendments made by this title, and the application of the provisions of
such to any person or circumstance shall not affected thereby.</text>
</section><enum>II</enum><header display-inline="yes-display-inline">Negotiation of lower covered part D drug
prices on behalf of Medicare beneficiaries</header>
<section commented="no" display-inline="no-display-inline" id="HA812C80A6E8442AC999967086D96D6A6" section-type="subsequent-section"><enum>201.</enum><header display-inline="yes-display-inline">Negotiation of lower covered part D drug
prices on behalf of Medicare beneficiaries</header>
<subsection commented="no" display-inline="no-display-inline" id="HEC1F58FD32744FFA9D1826A1203499CA"><enum>(a)</enum><header display-inline="yes-display-inline">Negotiation by Secretary</header><text display-inline="yes-display-inline">Section 1860D–11 of the Social Security Act
(42 U.S.C. 1395w–111) is amended by striking subsection (i) (relating to
noninterference) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="HA925AF3AC289463B9D4AB3797D1487FC" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HC151D361C79C4891AFF204240CA36BFE"><enum>(i)</enum><header display-inline="yes-display-inline">Negotiation of Lower Drug Prices</header>
<paragraph commented="no" display-inline="no-display-inline" id="HB550ADAE5CFF411BAB6BA0ADFD7BEC55"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law,
the Secretary shall negotiate with pharmaceutical manufacturers the prices
(including discounts, rebates, and other price concessions) that may be charged
to PDP sponsors and MA organizations for covered part D drugs for part D
eligible individuals who are enrolled under a prescription drug plan or under
an MA–PD plan.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2891009F84B94A209701EBE1F997DEA8"><enum>(2)</enum><header display-inline="yes-display-inline">No change in rules for formularies</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H29EF1C35F05444D7963083EEF48AF266"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Nothing in paragraph (1) shall be construed
to authorize the Secretary to establish or require a particular
formulary.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD8C2D6B0C2894EFBB05759BA97FC77FE"><enum>(B)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">Subparagraph (A) shall not be construed as
affecting the Secretary’s authority to ensure appropriate and adequate access
to covered part D drugs under prescription drug plans and under MA–PD plans,
including compliance of such plans with formulary requirements under section
1860D–4(b)(3).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC08797AA56104DCFA669821915B4E471"><enum>(3)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">Nothing in this subsection shall be
construed as preventing the sponsor of a prescription drug plan, or an
organization offering an MA–PD plan, from obtaining a discount or reduction of
the price for a covered part D drug below the price negotiated under paragraph
(1).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1B96E6F931AB412EBEB24B2CBD99B4EF"><enum>(4)</enum><header display-inline="yes-display-inline">Semi-annual reports to
congress</header><text display-inline="yes-display-inline">Not later than June
1, 2011, and every 6 months thereafter, the Secretary shall submit to the
Committees on Ways and Means, Energy and Commerce, and Oversight and Government
Reform of the House of Representatives and the Committee on Finance of the
Senate a report on negotiations conducted by the Secretary to achieve lower
prices for Medicare beneficiaries, and the prices and price discounts achieved
by the Secretary as a result of such
negotiations.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HEEC312A3FEBA4C21A371F000743D9AAD"><enum>(b)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendment made by
subsection (a) shall take effect on the date of the enactment of this Act and
shall first apply to negotiations and prices for plan years beginning on
January 1, 2011.</text>
</subsection></section>