1.This Act may be cited as the
Drug Safety Enhancement Act of
2011
.
2.The table of contents
for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Title I—Prevention
Sec. 101. Registration of producers of drugs; applicable
fee.
Sec. 102. Drug supply quality and safety.
Sec. 103. Inspection of producers of drugs.
Sec. 104. Prohibition against delaying, limiting, or refusing
inspection.
Sec. 105. Clarification of inspection authority related to BIMO
and IRB inspections.
Sec. 106. Notification, nondistribution, and recall of
adulterated or misbranded drug products.
Sec. 107. Notification.
Title II—Response
Sec. 201. Administrative detention.
Sec. 202. Destruction of adulterated, misbranded, or
counterfeit drugs offered for import.
Sec. 203. Criminal penalties.
Sec. 204. Civil penalties.
Sec. 205. Seizure.
Sec. 206. Asset forfeiture.
Title III—Importation and Exportation
Sec. 301. Documentation for admissibility of
imports.
Sec. 302. Registration for commercial importers;
fee.
Sec. 303. Registration for customs brokers.
Sec. 304. Exportation certificate program.
Sec. 305. Extraterritorial jurisdiction.
Sec. 306. Dedicated foreign inspectorate.
Title IV—Miscellaneous
Sec. 401. Unique identification number for establishments,
importers, and customs brokers.
Sec. 402. Country of origin labeling.
Sec. 403. False or misleading reporting to FDA.
Sec. 404. Subpoena authority.
Sec. 405. Whistleblower protections.
Sec. 406. Rule of construction.
<enum>I</enum><header>Prevention</header>
<section id="HF989385EE5D449A2AB4E78B32AB9B6D7"><enum>101.</enum><header>Registration of
producers of drugs; applicable fee</header>
<subsection commented="no" id="HE55AD647FF324F078DA3A7D93DD5B1F1"><enum>(a)</enum><header>Foreign
registrants</header>
<paragraph commented="no" id="HD26031C664ED495388E8C5861ACB7098"><enum>(1)</enum><header>Misbranding</header><text>Section
502(o) of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 352(o)) is
amended by inserting <quote>if it is a drug and was manufactured, prepared,
propagated, compounded, or processed in an establishment not duly registered
under section 510(i),</quote> after <quote>not duly registered under section
510,</quote>.</text>
</paragraph><paragraph commented="no" id="H33BB8D6CFA9E49D69EF219C64170D1C6"><enum>(2)</enum><header>Application</header><text>The
amendment made by paragraph (1) applies only with respect to registration
(including failure to register) under section 510 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360) occurring on or after the date of the
enactment of this Act.</text>
</paragraph></subsection><subsection commented="no" id="HE4224C168C364C9490B7B1EC6485CA3C"><enum>(b)</enum><header>Excipient
manufacturers</header>
<paragraph commented="no" id="H34835D6D61D14D599DA15E0C5C0FC8D1"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">Not later than 6
months after the date of the enactment of this Act, the Secretary of Health and
Human Services shall revise section 207.10 of title 21, Code of Federal
Regulations, and such other regulations as may be necessary to require owners
and operators of establishments that engage in the manufacture, preparation,
propagation, compounding, or processing of an excipient of a drug to register
such establishments under section 510 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360).</text>
</paragraph><paragraph commented="no" id="H0C71A12D9CDB4DA383013D5E39E56AFB"><enum>(2)</enum><header>Application</header><text display-inline="yes-display-inline">The revisions to regulations under
paragraph (1) shall apply with respect to the manufacture, preparation,
propagation, compounding, or processing of an excipient of a drug on or after
the date that is 18 months after the date of the enactment of this Act.</text>
</paragraph></subsection><subsection commented="no" id="HD47E4D6498744EE187D1655E4019CF50"><enum>(c)</enum><header>Drug listing
elements and frequency</header>
<paragraph id="HF74256369FF84198BD1BA810C2A61ED3"><enum>(1)</enum><header>In
general</header><text>Sections 510(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(j)) is amended—</text>
<subparagraph commented="no" id="H8B7497E5BF674FC2B7A86C8190BB2C62"><enum>(A)</enum><text>in paragraph (1),
by amending subparagraph (C) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HD0C2ABACA18E4765BF1A726081EF9A61" style="OLC">
<subparagraph commented="no" id="H73E7801ACF654FBCBF82299A0B53D541" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">in
the case of any drug contained in an applicable list which is described in
subparagraph (A) or (B), a qualitative and quantitative listing of each of its
active and other ingredients, and any other information that the Secretary
finds is necessary to carry out the purposes of this Act;
and</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" id="HC4AD5D3C089E4B3E8E683241716A47AA"><enum>(B)</enum><text>in paragraph (2),
in the matter preceding subparagraph (A), by inserting <quote>, unless
otherwise specified by the Secretary</quote> after <quote>once during the month
of December of each year</quote>.</text>
</subparagraph></paragraph><paragraph id="H0CF7066DF399409DBC16313C9D6DE489"><enum>(2)</enum><header>Application</header><text>The
amendments made by paragraph (1) apply with respect to the filing of a list
under section 510(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360(j)) that occurs on or after the date that is 6 months after the date of the
enactment of this Act.</text>
</paragraph></subsection><subsection id="H1BD6324B572E4B7EBF5DF63D1540245E"><enum>(d)</enum><header>Suspension and
cancellation of registration</header><text>Section 510 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360j) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HA41DA598649D442E9B2A93C4B819F1EE" style="OLC">
<subsection id="H961E8EE70E084FC49ADBEB11303D9F5D"><enum>(q)</enum><header>Suspension and
cancellation of registration</header><text display-inline="yes-display-inline">With respect to any registration under this
section attributable to the manufacture, preparation, propagation, compounding,
or processing of a drug:</text>
<paragraph id="H43D1DFF60240411099CF2E0AC3A81C01"><enum>(1)</enum><header>Suspension of
registration</header>
<subparagraph id="HBBFD8555E264496285D3AFDD11019974"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">Registration under
this section is subject to suspension upon a finding by the Secretary, after
notice and an opportunity for an informal hearing, of—</text>
<clause id="H572CF0AD915246C1AA1ADF41E3DCB5C5"><enum>(i)</enum><text>a
violation of this Act; or</text>
</clause><clause id="H099C4F60590E4185B5539F03DEC7BCBB"><enum>(ii)</enum><text display-inline="yes-display-inline">the knowing or repeated making of an
inaccurate or incomplete statement or submission of information relating to the
manufacture, preparation, propagation, compounding, processing, or importing of
a drug.</text>
</clause></subparagraph><subparagraph id="H6756884D8351414CBDCA52379A030856"><enum>(B)</enum><header>Request</header><text>Any
person or establishment whose registration is suspended under subparagraph (A)
may request that the Secretary vacate the suspension when such person or
establishment has corrected the violation that is the basis for such
suspension.</text>
</subparagraph><subparagraph id="HCF3F2AAE7DB840A193E696CB777E4257"><enum>(C)</enum><header>Vacating of
suspension</header><text>If the Secretary determines that adequate reasons do
not exist to continue the suspension of a registration under subparagraph (A),
the Secretary shall vacate such suspension.</text>
</subparagraph></paragraph><paragraph id="H9741D908249F411A88A60B38390D2F8A"><enum>(2)</enum><header>Cancellation of
registration</header>
<subparagraph id="HFB0E39134C2E4C94A3FC69D084FDB2D2"><enum>(A)</enum><header>In
general</header><text>Not earlier than 10 days after providing the notice under
subparagraph (B), the Secretary may cancel a registration if the Secretary
determines that—</text>
<clause id="HA5229FF00C134D4486FD7E731F02A31A"><enum>(i)</enum><text>such registration
was not updated in accordance with this section or contains false, incomplete,
or inaccurate information; or</text>
</clause><clause id="HAE3451B7613B451389E69442E6651934"><enum>(ii)</enum><text>the fee required
under section 736C for such registration has not been paid within 30 days after
the date due.</text>
</clause></subparagraph><subparagraph id="H3D316BD3B43F4A14A20660E5A51373FF"><enum>(B)</enum><header>Notice of
cancellation</header><text>Before cancelling the registration of a person or
establishment under this section, the Secretary shall give notice to the person
or establishment of the Secretary’s intent to cancel the registration and the
basis for such cancellation.</text>
</subparagraph><subparagraph id="HFAF721B85BEE439CA66F6CE54A781B4C"><enum>(C)</enum><header>Timely update or
correction</header><text>If a registration is adequately updated or corrected
no later than 7 days after notice is provided under subparagraph (B) with
respect to the registration, the Secretary shall not cancel such registration.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H5EA531DADBF84B72A8E08BDC26D2A37B"><enum>(e)</enum><header>Registration
fee</header>
<paragraph id="H07CFE83EDC0248CB819BF6A362902D6F"><enum>(1)</enum><header>Establishment</header><text>Part
2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379g et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HC0AA129EE32E458880D2CD21936B3407" style="OLC">
<section id="H83A08D9143864C6FA1BFBE5B97AB0362"><enum>736C.</enum><header>Registration
fee</header>
<subsection id="HDA697F9B97744F11B54EB367029F3F61"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">In the case of any
registration under section 510 that is attributable to the manufacture,
preparation, propagation, compounding, processing, or importing of a drug, the
Secretary shall assess and collect an annual fee for such registration to
defray the increase in the costs of drug safety activities.</text>
</subsection><subsection id="H2ADDB21F5CB0411EBB07F022C9B2872A"><enum>(b)</enum><header>Payable
date</header><text>A fee under this section shall be payable—</text>
<paragraph id="H7A388BF9A9DA4B9EA37E96229FDFB611"><enum>(1)</enum><text>for a facility
that was not registered under section 510 for the preceding fiscal year, on the
date of registration; and</text>
</paragraph><paragraph id="HC38DDE93DD5641A6B04BD09ECC9734BD"><enum>(2)</enum><text>for any other
facility—</text>
<subparagraph id="H6AEE54E603C84F9988F77F991766CEFE"><enum>(A)</enum><text>for fiscal year
2012, not later than the sooner of 90 days after the date of the enactment of
this section or December 31, 2011; and</text>
</subparagraph><subparagraph id="HC0E7B56A1B4E46B6B3698FA1CAAA471D"><enum>(B)</enum><text>for a subsequent
fiscal year, not later than December 31 of such fiscal year.</text>
</subparagraph></paragraph></subsection><subsection id="H6D3344F2EA9F41F08139D45F66899613"><enum>(c)</enum><header>Fee
amounts</header>
<paragraph id="H4C834A71D34841E69EC0F47037563CE6"><enum>(1)</enum><header>Total revenue
amount</header>
<subparagraph id="HF1A25BA3A8394600A90CA0EDFEEA9D17"><enum>(A)</enum><header>Initial
year</header><text display-inline="yes-display-inline">For fiscal year 2012,
fees under subsection (a) shall, except as provided in subsections (f) and (g),
be established to generate a total revenue amount that is equal to the increase
in the costs of drug safety activities (as estimated by the Secretary) for such
fiscal year.</text>
</subparagraph><subparagraph id="H0C1F2C5869D2432DB037905E3089E314"><enum>(B)</enum><header>Subsequent
years</header><text display-inline="yes-display-inline">For each of fiscal
years 2013 through 2016, fees under subsection (a) shall, except as provided in
subsections (f) and (g), be the total revenue amount for fiscal year 2012, as
adjusted under subsection (d).</text>
</subparagraph></paragraph><paragraph id="HAA64638E00274DADB8CABA2C01927740"><enum>(2)</enum><header>Annual fee
setting</header><text>For fiscal year 2012 and each subsequent fiscal year, the
Secretary shall establish registration fees under subsection (a)—</text>
<subparagraph id="H7D51E863846B4224B3A4589B3D287D18"><enum>(A)</enum><text>based on the total
revenue amount applicable under paragraph (1); and</text>
</subparagraph><subparagraph id="HF074A27A344A458FB4C1D7B7871B792A"><enum>(B)</enum><text>taking into
consideration the difference in costs of inspections between foreign and
domestic establishments.</text>
</subparagraph></paragraph><paragraph id="H2FA91F0AE4904E98A2C63B56D0B7DA50"><enum>(3)</enum><header>Transmission to
Congress</header><text>Not later than 60 days before the start of fiscal year
2012 and each subsequent fiscal year, the Secretary shall transmit to the
Congress—</text>
<subparagraph id="H21C1A99AAF704F87BF85119C6C40506A"><enum>(A)</enum><text>the total revenue
amount for the upcoming fiscal year, as applicable under paragraph (1);
and</text>
</subparagraph><subparagraph id="H69AF1D320F8B4B27948BA7F9297869C8"><enum>(B)</enum><text>the registration
fees for such year, as established under paragraph (2).</text>
</subparagraph></paragraph></subsection><subsection id="H029AE81238D44015B41E2D3D2E4C9265"><enum>(d)</enum><header>Inflation
adjustment</header><text>For fiscal year 2013 and subsequent fiscal years, the
fee amount under subsection (c) shall be adjusted by the Secretary by notice,
published in the Federal Register, for the respective fiscal year to reflect
the greater of—</text>
<paragraph id="H9AE89A0C75AD4A1A90F2DE8C4D2A2D72"><enum>(1)</enum><text>the total
percentage change that occurred in the Consumer Price Index for all urban
consumers (all items; United States city average) for the 12-month period
ending June 30 preceding the fiscal year for which fees are being established;</text>
</paragraph><paragraph id="H27370AE1FF8D46108C58949184621F7C"><enum>(2)</enum><text>the total
percentage change for the previous fiscal year in basic pay under the General
Schedule in accordance with section 5332 of title 5, United States Code, as
adjusted by any locality-based comparability payment pursuant to section 5304
of such title for Federal employees stationed in the District of Columbia; or</text>
</paragraph><paragraph id="H979B05197907417FBABAD771121877B0"><enum>(3)</enum><text>the average annual
change in the cost, per full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits paid with respect to
such positions for the first 5 years of the preceding 6 fiscal years.</text>
</paragraph><continuation-text continuation-text-level="subsection">The
adjustment made each fiscal year under this subsection will be added on a
compounded basis to the sum of all adjustments made each fiscal year after
fiscal year 2011 under this subsection.</continuation-text></subsection><subsection id="H795A81BF5B634043B01603C5AE490A99"><enum>(e)</enum><header>Fee waiver or
reduction</header><text>The Secretary may grant to a person a waiver from, or a
reduction of, one or more fees under this section if the Secretary finds
that—</text>
<paragraph id="H3F8536C144D34B55BA85068920FEB210"><enum>(1)</enum><text>such waiver or
reduction is necessary to protect the public health; or</text>
</paragraph><paragraph id="HFC9455FA4D5C49C89B9D11FDCF72B2A0"><enum>(2)</enum><text>the assessment of
the fee would impose significant financial hardship because of limited
resources available to such person or other circumstances.</text>
</paragraph></subsection><subsection id="H8CA0149A38E848FBA0C54B19E9272300"><enum>(f)</enum><header>Limitations</header>
<paragraph id="H03C43CC63D9F4D8F82A0DA646852AA26"><enum>(1)</enum><header>In
general</header><text>Fees under subsection (a) shall be refunded for a fiscal
year beginning after fiscal year 2012 unless appropriations for salaries and
expenses of the Food and Drug Administration for such fiscal year (excluding
the amount of fees appropriated for such fiscal year) are equal to or greater
than the amount of appropriations for the salaries and expenses of the Food and
Drug Administration for the fiscal year 2012 (excluding the amount of fees
appropriated for such fiscal year) adjusted in the same manner that fee amounts
are adjusted under subsection (d).</text>
</paragraph><paragraph id="HEA9F04AACD7E4EEE9A6963C60E4A1EE3"><enum>(2)</enum><header>Authority</header><text>If
the Secretary does not assess fees under subsection (a) during any portion of a
fiscal year because of paragraph (1) and if at a later date in such fiscal year
the Secretary may assess such fees, the Secretary may assess and collect such
fees, without any modification in the rate, for registration under section 510
at any time in such fiscal year.</text>
</paragraph></subsection><subsection id="HA4BA36A23F9F458B9022616365634AE7"><enum>(g)</enum><header>Crediting and
availability of fees</header>
<paragraph id="HA22E259F9122493C992D3F794F20EEF2"><enum>(1)</enum><header>In
general</header><text>Fees authorized under subsection (a) shall be collected
and available for obligation only to the extent and in the amount provided in
advance in appropriations Acts. Such fees are authorized to remain available
until expended. Such sums as may be necessary may be transferred from the Food
and Drug Administration salaries and expenses appropriation account without
fiscal year limitation to such appropriation account for salaries and expenses
with such fiscal year limitation.</text>
</paragraph><paragraph id="H26FCE4630C3B42C7981B6DBAB179B7C4"><enum>(2)</enum><header>Collections and
appropriations acts</header><text>The fees authorized by this section—</text>
<subparagraph id="H24FAF375F22F4AA1B1EF3C0A157C188E"><enum>(A)</enum><text>shall be retained
in each fiscal year in an amount not to exceed the amount specified in
appropriations Acts, or otherwise made available for obligation, for such
fiscal year; and</text>
</subparagraph><subparagraph id="H16915C7988494B99A0DBF75B9E12D9FD"><enum>(B)</enum><text>shall only be
collected and available to defray the costs of drug safety activities.</text>
</subparagraph></paragraph><paragraph id="H9B3EFE17A9434E24AE7E49D270F00741"><enum>(3)</enum><header>Authorization of
appropriations</header><text>For each of the fiscal years 2012 through 2016,
there are authorized to be appropriated for fees under this section such sums
as may be necessary.</text>
</paragraph></subsection><subsection id="HBB4059D0CB254998A3B0CBE4A4F60B27"><enum>(h)</enum><header>Collection of
unpaid fees</header><text>In any case in which the Secretary does not receive
payment of a fee assessed under subsection (a) 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>
</subsection><subsection id="H43737001E0AD400A954026A4BE70C3EC"><enum>(i)</enum><header>Construction</header><text>This
section may not be construed to require that the number of full-time equivalent
positions in the Department of Health and Human Services, for officers,
employers, and advisory committees not engaged in drug safety activities, be
reduced to offset the number of officers, employees, and advisory committees so
engaged.</text>
</subsection><subsection id="H0A5ABB1F0A1C4C0F821A19A7750937A5"><enum>(j)</enum><header>Annual fiscal
reports</header><text>Beginning with fiscal year 2013, not later than 120 days
after the end of each fiscal year for which fees are collected under this
section, the Secretary shall prepare and submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of 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 such fiscal year.</text>
</subsection><subsection id="HEF772ADBDA3843C78AC46AF736A15CC3"><enum>(k)</enum><header>Relation to
other fees</header><text>Fees assessed and collected under this section are in
addition to other fees assessed and collected under this Act with respect to
the same person or establishment.</text>
</subsection><subsection id="H9510800590DA4D059A0B39935524AAAC"><enum>(l)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph id="H7E70242FE12046E0A13ECCD3AA1E692C"><enum>(1)</enum><text>The term
<term>costs of drug safety activities</term> means the expenses incurred in
connection with drug safety activities for—</text>
<subparagraph id="H24E41E1985224F21B71F1875C2F99B4C"><enum>(A)</enum><text>officers and
employees of the Food and Drug Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to such officers,
employees, and committees and to contracts with such contractors;</text>
</subparagraph><subparagraph id="HE134812DA0FB4BD3A4FAD1D129565ABC"><enum>(B)</enum><text>laboratory space;</text>
</subparagraph><subparagraph id="H7315ED53D2B44EA88368426F72839CBE"><enum>(C)</enum><text>management of
information, and the acquisition, maintenance, and repair of information
technology resources;</text>
</subparagraph><subparagraph id="HE29C561EE6E7401C88ADCC40540161B4"><enum>(D)</enum><text>leasing,
maintenance, renovation, and repair of facilities and acquisition, maintenance,
and repair of fixtures, furniture, scientific equipment, and other necessary
materials and supplies; and</text>
</subparagraph><subparagraph id="H068E442B7900492C8973F287861E6618"><enum>(E)</enum><text>collecting fees
under this section and accounting for resources allocated for drug safety
activities.</text>
</subparagraph></paragraph><paragraph id="HFBA7878510A3431D87F293DA3C636802"><enum>(2)</enum><text>The term
<term>drug safety activities</term> means activities related to compliance by
persons and establishments registered under section 510 with the requirements
of this Act relating to drugs (including research related to and the
development of standards (such as performance standards and preventive
controls), risk assessments, hazard analyses, inspection planning and
inspections, third-party inspections, compliance review and enforcement, import
review, information technology support, test development, product sampling,
risk communication, and administrative detention).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H0EE30BF4FD284F17A261DDC11ECDD160"><enum>(2)</enum><header>Transitional
provisions</header>
<subparagraph id="HD385434A16864594A9BAD8434A11A155"><enum>(A)</enum><header>First imposition
of fees</header><text>The Secretary of Health and Human Services shall first
impose the fee established under section 736C of the Federal Food, Drug, and
Cosmetic Act, as added by paragraph (1), for fiscal years beginning with fiscal
year 2012.</text>
</subparagraph><subparagraph id="H05921742B1744A749A89D35535CC4063"><enum>(B)</enum><header>Sunset
date</header><text>Section 736C of the Federal Food, Drug, and Cosmetic Act, as
added by paragraph (1), does not authorize the assessment or collection of a
fee for registration under section 510 of such Act (21 U.S.C. 360) occurring
after fiscal year 2016.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="H8C6A788C7CD14C3295EFF43F8201AE5A"><enum>(f)</enum><header>Modification of
registration form</header><text>Not later than 180 days after the date of the
enactment of this Act, the Secretary of Health and Human Services shall modify
the registration forms under section 510 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350d) to comply with the amendments made by this
section.</text>
</subsection></section><section id="H4A12E0174013484695345715AB74C675"><enum>102.</enum><header>Drug supply
quality and safety</header>
<subsection id="HA6B979C728294923B2B9280CEB744B3D"><enum>(a)</enum><header>Definitions</header><text>Section
201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HDED1F2C80CAE45F0825993C66576BAA1" style="OLC">
<paragraph id="H7DA6EF2A07F04BC596239D8E78985066" indent="up1"><enum>(3)</enum><text>In the case of a drug, the term
<term>component</term> includes—</text>
<subparagraph id="H792DC091BCEE4309A6B38893CB21A3C6"><enum>(A)</enum><text>any active ingredient or bulk drug
substance;</text>
</subparagraph><subparagraph id="HEA7D52AEF11745B4A32C87D72BD5D466"><enum>(B)</enum><text>any inactive ingredient;</text>
</subparagraph><subparagraph id="H5C3626224F02406EB89011BDBE623099"><enum>(C)</enum><text>any intermediate of an active
ingredient, inactive ingredient, or bulk drug substance, whether or not it
appears in the finished product and whether or not derived from any chemical,
human, animal, plant, or other material; and</text>
</subparagraph><subparagraph id="HECD7269785FB4FBA81A40E9FD7D76628"><enum>(D)</enum><text>any original source material for
components specified in clauses (A), (B), and (C) whether or not the original
source material—</text>
<clause id="H01BC8C1956884D188494BD11B48A2F1E"><enum>(i)</enum><text>appears in the finished product;
and</text>
</clause><clause id="H135B05B22E7E48D3AEB1F0F70C0D1ABB"><enum>(ii)</enum><text>is derived from any chemical,
human, animal, plant, or other
material.</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HF00A14EBA76B49D69E2B9E5FF3CE1129"><enum>(b)</enum><header>Effective
quality systems</header>
<paragraph id="H9F182FA83B174B879D3168B953A38020"><enum>(1)</enum><header>Prohibited
acts</header>
<subparagraph id="HC36CB3CF905C4316B03BCCCCA7B127D3"><enum>(A)</enum><header>Recordkeeping</header><text>Section
301(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)) is
amended—</text>
<clause id="H69D2F63DCB1442F09838562C8BE53D04"><enum>(i)</enum><text>by
inserting <quote>503C,</quote> after <quote>417(g),</quote>; and</text>
</clause><clause id="H7924B9CCA5CF41189163B8A2CEC24DAD"><enum>(ii)</enum><text>by
inserting <quote>503C,</quote> after <quote>417,</quote>.</text>
</clause></subparagraph><subparagraph id="H1CA8EDFCAC23467BB432E522DE843742"><enum>(B)</enum><header>Adulteration</header><text display-inline="yes-display-inline">Section 501 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H298525AF64B148A4B53E155B2EE4A4BD" style="OLC">
<subsection id="HBF107402E2564B17AB69B51E4EBE43A9"><enum>(j)</enum><text display-inline="yes-display-inline">If it is a drug that was manufactured (as
defined in section 503C) by a manufacturer that is or was at the time of such
manufacture in violation of section 503C because of the failure to have in
effect or implement an effective quality system in accordance with such
section.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="H1855C53FC0974353814E0B905D331FC9"><enum>(2)</enum><header>System
requirements</header><text>The Federal Food, Drug, and Cosmetic Act is amended
by inserting after section 503B (21 U.S.C. 353b) the following:</text>
<quoted-block display-inline="no-display-inline" id="HDF7731DF76B1452D9367796AC650924E" style="OLC">
<section id="H18C6FBA37DEE4D30A9CE1FEBA42758F4"><enum>503C.</enum><header>Effective
quality system for drug manufacturers</header>
<subsection id="H8AE5BFDBAADD4659A5102A0FBA151E7E"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Each manufacturer of
a drug required to be registered under section 510 shall have in effect and
implement an effective quality system.</text>
</subsection><subsection id="H7767168ED43649228B58224A7A494F90"><enum>(b)</enum><header>System
requirements</header><text>An effective quality system applicable to a
manufacturer of a drug under subsection (a) shall require each of the
following:</text>
<paragraph id="HA5DF5CB1F2594F5587E88A5D27146B19"><enum>(1)</enum><header>Management
responsibility</header><text>The manufacturer shall ensure that—</text>
<subparagraph id="H6453F21A79FB4858852773DC3586E8F1"><enum>(A)</enum><text>adequate resources
are provided to ensure compliance with current good manufacturing
practice;</text>
</subparagraph><subparagraph id="H61600837D6534FD9B38941A2C2185FB3"><enum>(B)</enum><text>procedures are
established and maintained to ensure timely communication of product quality
issues to appropriate levels of management, including executive
management;</text>
</subparagraph><subparagraph id="HE563847FED2E436CABAE9ECA4976168A"><enum>(C)</enum><text>periodic reviews
of process performance, product quality, and other elements of the quality
system are conducted;</text>
</subparagraph><subparagraph id="HFB34B0EB79814FD3825FE32F5C8E495C"><enum>(D)</enum><text>the periodic
reviews under subparagraph (C) are evaluated by executive management to
determine any appropriate action; and</text>
</subparagraph><subparagraph id="H02E43C0F527B4CD2927ECB11C50C2440"><enum>(E)</enum><text>the integrity of
data, records, and regulatory submissions, including with respect to accuracy,
veracity, and validity, is maintained.</text>
</subparagraph></paragraph><paragraph id="HF5CD7A51F48741C7B1F2EB595B0BEFB0"><enum>(2)</enum><header>Quality
responsibility</header>
<subparagraph id="H5F6094B57A034D7AA18D8B34B68E88B0"><enum>(A)</enum><header>Internal,
independent unit</header><text>The manufacturer shall establish and maintain an
internal, independent unit with the authority to ensure that all operations
related to manufacturing drugs, including those performed by another person,
are appropriately designed, approved, conducted, monitored, and corrected in
compliance with current good manufacturing practice.</text>
</subparagraph><subparagraph id="H3183AE552B354EF094E87A284F19CCDB"><enum>(B)</enum><header>Procedures</header><text>The
manufacturer shall establish and maintain procedures to ensure that—</text>
<clause id="H90482926D26A4BDEB704D1C9BCB4651C"><enum>(i)</enum><text>any discrepancy
related to manufacturing a drug (including the discrepancy’s causes) is
promptly identified, investigated, and corrected, the recurrence of the
discrepancy is prevented, and any corrective or preventive action is verified
or validated to ensure that such action is effective and does not adversely
affect the drug; and</text>
</clause><clause id="H9947CAB966EC439BB468259ED90A39F2"><enum>(ii)</enum><text>ongoing reviews
of all data related to manufacturing a drug are conducted to identify trends
that might affect product quality and timely actions are performed to prevent
any adverse effect on product safety, identity, quality, strength, or purity.</text>
</clause></subparagraph></paragraph><paragraph id="H0ADC1C88AEE84CCD8911BC87FBAB029D"><enum>(3)</enum><header>Risk
management</header><text>The manufacturer shall establish and maintain risk
management procedures that ensure effective risk assessment, control, and
communication. The risk assessment procedures shall ensure that all factors
throughout the supply chain that may reasonably be expected to indicate a risk
to the safety, identity, quality, strength, purity, or security of any drug
manufactured by that manufacturer are identified, starting with factors
relating to origin of all components including the original source materials;
information relating to all such factors is continuously gathered, monitored,
and evaluated; and new factors are promptly identified.</text>
</paragraph><paragraph id="HF4B22929F145427B9E307AF85783C436"><enum>(4)</enum><header>Supply Chain
Management</header>
<subparagraph id="HAF735C73B9C145109F54FE441F1F61F3"><enum>(A)</enum><header>In
general</header><text>The manufacturer shall establish and maintain procedures
that ensure the safety, identity, quality, strength, purity, and security of
all drugs and other materials used by that manufacturer. The supply chain
procedures shall address the entire supply chain from original source materials
used in the manufacture of the drug to the manufacturer. The supply chain
procedures shall ensure that there is adequate followup, which shall include no
longer receiving any source materials or drugs from, or using operations
conducted by, any person who fails to implement timely corrections for supply
chain management practices or other applicable requirements under this Act or
sections 351 or 361 of the Public Health Service Act.</text>
</subparagraph><subparagraph id="H24462A10DB064C64B09B66E3FA90EDAE"><enum>(B)</enum><header>Procedures</header><text>Supply
chain management procedures under subparagraph (A) shall include—</text>
<clause id="H980B5B4EA8DE47338FA79C61844C546E"><enum>(i)</enum><text>acceptance and
rejection criteria for each component that ensures that such component is
appropriate for its intended use and that include, unless not feasible using
current technology, a sufficient impurity profile for each component, including
each component that is naturally derived, except that the requirements of this
clause shall not apply to any component of a licensed biological product unless
required under the license issued for such product under section 351 of the
Public Health Service Act or under paragraph (5);</text>
</clause><clause id="H1F75F83742044661A4EBD06D692E20B8"><enum>(ii)</enum><text>onsite audits,
performed by qualified individuals, of each person that supplies a drug or
conducts operations related to manufacturing, before such person begins initial
supply or operation and at an appropriate frequency to assess the continued
compliance of such person with the manufacturer’s supply chain practices and
with the applicable requirements under this Act and sections 351 and 361 of the
Public Health Service Act;</text>
</clause><clause id="HCC1734273BD049919AA3316D7375E147"><enum>(iii)</enum><text>requirements for
a quality agreement with any person who supplies a drug or conducts operations
related to manufacturing a drug which addresses all applicable current good
manufacturing practice requirements;</text>
</clause><clause id="H681D8F77CF144E7AAB70F361311E546A"><enum>(iv)</enum><text>the sharing of
manufacturing information by any person who supplies a drug or conducts
operations related to manufacturing, including timely notification concerning
any change to, discrepancy in, or defect in, materials or operations related to
manufacturing, along with adequate information about such change, discrepancy,
or defect;</text>
</clause><clause id="H8E4C6A8A00064A16BD8AD0ADFAE5C5D2"><enum>(v)</enum><text>when supplying any
drug to another manufacturer, provision of a certificate of analysis for each
batch and lot that includes complete source, manufacturing, and test
information and results; and</text>
</clause><clause id="HC1A016FC56C74EA9BFAC809982488088"><enum>(vi)</enum><text>methods, which
shall include acceptance and rejection criteria, adequate—</text>
<subclause id="HADC121C314B04CDEB2045DEF44724AAE"><enum>(I)</enum><text display-inline="yes-display-inline">to detect, or exclude the possibility of,
the presence of any substance that may reasonably be expected to indicate a
risk to safety, identity, quality, strength, purity, or security; and</text>
</subclause><subclause id="H6FEF74740CCF4E0F9F24B84DBAC83604"><enum>(II)</enum><text display-inline="yes-display-inline">to detect, or exclude the possibility of,
other risks to safety, identity, quality, strength, purity, or security.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="HED01460C6AEC4B8186C89EC078B52A8C"><enum>(5)</enum><header>Methods</header>
<subparagraph id="HADD32B4329BD47FF8B9DA569209BD84D"><enum>(A)</enum><header>In
general</header><text>Each manufacturer shall establish and maintain procedures
that ensure—</text>
<clause commented="no" id="H11295F52671B4B579B0DB40AD83AA993"><enum>(i)</enum><text>periodic
evaluation and, where necessary, prompt revision of methods, including
acceptance and rejection criteria, to ensure the safety, identity, quality,
strength, purity, and security of each drug manufactured by such manufacturer,
or component used in the manufacture of such drug;</text>
</clause><clause commented="no" id="HB353AD294BFB437E88C8B7690950675C"><enum>(ii)</enum><text>when any new risk
is identified—</text>
<subclause commented="no" id="H20976CF87B544E96B072B321E7362A90"><enum>(I)</enum><text>adoption of
appropriate revised or new methods; and</text>
</subclause><subclause commented="no" id="HCFD0089C0CFC4505B4AE5FAF5478DBF6"><enum>(II)</enum><text>evaluation of
every batch and lot of drug using such revised methods; and</text>
</subclause></clause><clause commented="no" id="H49175E6C082E4A768F507B696DBEFFBF"><enum>(iii)</enum><text>if required, an
application is submitted for timely approval by the Secretary of the revised or
new methods under section 505, 506A, 512, or 571 of this Act or section 351 of
the Public Health Service Act.</text>
</clause></subparagraph><subparagraph id="H480D1D5C897E44B9A29BE5AD31C568BE"><enum>(B)</enum><header>Determination of
risk</header><text display-inline="yes-display-inline">Each evaluation and
revision under subparagraph (A)(i) shall be based on a determination of
risk.</text>
</subparagraph><subparagraph id="H0AC0106C6E6F47278536FA5E5B1C2FCE"><enum>(C)</enum><header>Notification
regarding revised method</header><text>Each manufacturer of a drug shall
promptly notify the Secretary and the appropriate body charged with revision of
an official compendium of any revised method for such drug and its rationale.
Such notification shall be made in such form and manner as the Secretary shall
prescribe by regulation.</text>
</subparagraph><subparagraph id="HE6CF44D8933B4DD7BF1774A099A980E7"><enum>(D)</enum><header>Orders regarding
revised or new methods</header><text>If the Secretary determines that a revised
or new method, including acceptance and rejection criteria, is appropriate for
the safety, identity, quality, strength, purity, or security of any drug, the
Secretary may by letter order any manufacturer of such drug to promptly—</text>
<clause id="H6C931CE7EB214D04A185AFF1CDAC7ABF"><enum>(i)</enum><text>revise any method,
or adopt any new method, and any related acceptance and rejection criteria for
such drug; and</text>
</clause><clause id="H1E057BFCC7354F34BDA74E05CCF1874E"><enum>(ii)</enum><text>implement such
revised or new method and any related acceptance and rejection criteria.</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="HD7E7020E350C4F4C8A9251A1C165D801"><enum>(6)</enum><header>Records</header>
<subparagraph commented="no" id="H480A3CFF51834EEB9F0A668B0A0781EF"><enum>(A)</enum><header>In
general</header><text>Each manufacturer shall maintain adequate,
contemporaneous records (which may be electronic) to document conformity with
requirements under this section. Such records shall be accurate, indelible, and
legible. Each manufacturer shall establish and maintain a procedure to ensure
the identification, storage, protection, retrieval, retention, and disposition
of such records.</text>
</subparagraph><subparagraph commented="no" id="H61B3ECC6EE7A46239088574A27A51CAC"><enum>(B)</enum><header>Maintenance of
records; inspection</header><text>Each manufacturer shall maintain records
under subparagraph (A) for at least 2 years from the date of the expiration
date of the drug involved and make such records readily available for
inspection by the Secretary. Such records or copies thereof shall be subject to
photocopying or other means of reproduction as part of such inspection. Each
manufacturer shall provide to the Secretary these records or copies thereof in
a timely manner, upon verbal or written request by an officer or employee duly
designated by the Secretary.</text>
</subparagraph></paragraph><paragraph id="H9F35C3189ABE4E10A7FA58F500AB8CB0"><enum>(7)</enum><header>Additional
provisions</header><text>If the Secretary determines that provisions in
addition to those described in paragraphs (1) through (6) would be appropriate
to provide additional assurance of the safety, identity, quality, strength,
purity, or security of any drug, the Secretary may promulgate such provisions
by regulation.</text>
</paragraph></subsection><subsection id="H58449BA2C26D41F486F4C043F84696CC"><enum>(c)</enum><header>Exemptions and
variances</header><text display-inline="yes-display-inline">Any person subject
to any requirement prescribed pursuant to this section may petition the
Secretary for an exemption or variance from such requirement. Such a petition
shall be submitted to the Secretary in such form and manner as the Secretary
shall prescribe by regulation. If, when granting a request for exemption or
variance under this subsection, the Secretary determines that it is appropriate
to apply the exemption or variance to more than one manufacturer, the Secretary
shall publish a notice of the exemption or variance in the Federal
Register.</text>
</subsection><subsection id="H16AB3FE110E0480AA0D8B91D87C271C2"><enum>(d)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph id="H3847DDC1C0B243799A669A7C52E797D8"><enum>(1)</enum><text>The term
<term>manufacturer</term> means any person who manufactures a drug.</text>
</paragraph><paragraph id="H37B5FFAFBB674CA3B5E66A7944C09743"><enum>(2)</enum><text>The terms
<term>manufacture</term>, <term>manufacturing</term>, or
<term>manufactured</term> include preparation, processing, packing, or
holding.</text>
</paragraph><paragraph id="HC06ED7423B9A4552B91FB1AC7172621E"><enum>(3)</enum><text>The term
<term>establish and maintain</term> means adequately—</text>
<subparagraph id="H02056C36DF9F4A9790CB7853CCE93F63"><enum>(A)</enum><text>define, document
(by paper or electronically), implement, and follow; and</text>
</subparagraph><subparagraph id="HE453D43B1859421EA547B7B1738965D5"><enum>(B)</enum><text>review and, as
needed, revise on an ongoing
basis.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="HDC083E165ABC4ED3BF0FE6B26B508C84"><enum>(3)</enum><header>Application</header><text display-inline="yes-display-inline">The requirements of section 503C of the
Federal Food, Drug, and Cosmetic Act, as added by paragraph (2), apply
beginning on the date that is 2 years after the date of the enactment of this
Act.</text>
</paragraph></subsection><subsection id="HD43B0D5EEB994DCDB55BCFACE762E3FA"><enum>(c)</enum><header>Documentation of
supply chain</header>
<paragraph id="HF79A62832FDC4869AD17CF2F0DC2B6CF"><enum>(1)</enum><header>In
general</header><text>Section 510 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j), as amended, is further amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H69FCFDFA6D8E4B929F0D661BD3BD4003" style="OLC">
<subsection id="H6949E2A191BF4D819CA75BC3484ACA23"><enum>(r)</enum><header>Documentation of
supply chain</header><text>Each establishment required to be registered under
this section for the manufacture, preparation, propagation, compounding, or
processing of a drug, shall maintain and provide to the Secretary, upon
request, adequate information, in electronic form, establishing—</text>
<paragraph id="H3A7D0C0EC19D444B95FBE61E4E83E10C"><enum>(1)</enum><text>where the drug,
including its raw materials, was produced, including all preceding producers,
manufacturers, distributors, and shippers; and</text>
</paragraph><paragraph id="H86AE7E6E153D4A528396E4C8033F8E06"><enum>(2)</enum><text>that the drug, its
ingredients, and its raw materials were manufactured, prepared, propagated,
compounded, processed, distributed, shipped, warehoused, brokered, imported,
and conveyed under conditions that ensure the identity, strength, quality, and
purity of the drug.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H8471B01977D940F080F2CD8489697E8C"><enum>(2)</enum><header>Application</header><text>The
amendment made by paragraph (1) applies beginning on the date that is 2 years
after the date of the enactment of this Act.</text>
</paragraph></subsection></section><section commented="no" id="H71CFECA1D84742238ECA09F102EA4AB6"><enum>103.</enum><header>Inspection of
producers of drugs</header>
<subsection commented="no" id="HEEB60A59821D4782850AC21523B3CDDB"><enum>(a)</enum><header>Inspection</header><text>Subsection
(h) of section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360)
is amended—</text>
<paragraph commented="no" id="HB56A17A20058453299F7365BFFE4D33C"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>(h)</quote> and
inserting <quote>(h)(1)</quote>; and</text>
</paragraph><paragraph id="H97321287C2574D10B1B939E55599CAF0"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HF7E34DAE36894E57BA39805D54D4F6B7" style="OLC">
<paragraph id="H8949B98794154B5CBAC07D7D662F4D87" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">Notwithstanding paragraph (1), every
establishment engaged in the manufacture, propagation, compounding, or
processing of a drug that is a finished dosage form or an active pharmaceutical
ingredient shall be inspected pursuant to section 704 by one or more officers
or employees duly designated by the Secretary—</text>
<subparagraph id="HB6FAEFA857004E2FAE4DC23755674E2D"><enum>(A)</enum><text>at least once in the 2-year period
beginning with the date of registration of such establishment pursuant to this
section and at least once in every successive 2-year period thereafter;
or</text>
</subparagraph><subparagraph id="HA1A4A5A9767F443EBD9FCA2461F88648"><enum>(B)</enum><text display-inline="yes-display-inline">at
least once in the 4-year period beginning with the date of registration of such
establishment pursuant to this section and at least once in every successive
4-year period thereafter, if the Secretary determines that sufficient
information about the type of product produced in the establishment, inspection
history, compliance history, and such additional factors as the Secretary
determines by guidance, exists to assess risk and to establish a risk-based
inspection schedule.</text>
</subparagraph></paragraph><paragraph id="HB59BEEA5055F467FB399C19F6B3F0686" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">The Secretary shall conduct an inspection
of a drug establishment when the establishment begins to manufacture, prepare,
propagate, compound, or process a drug that is a finished dosage form or active
pharmaceutical ingredient before the drug is introduced into interstate
commerce if the active ingredient is new to the drug product or the drug has
undergone a major change requiring prior approval by the Secretary of a
supplement to an application submitted under section 505. Notwithstanding the
preceding sentence, the Secretary may opt against conducting such an inspection
if the Secretary determines, based on the inspection history of the
establishment, that such an inspection is not necessary to verify the data
contained in the application (or supplement to the application) submitted under
section 505, ensure compliance with current good manufacturing practices, or
otherwise ensure the safety of the drug or ingredient.</text>
</paragraph><paragraph id="HC3D35BA8AFC54140B95CA0297035C7BD" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">The Secretary may inspect, pursuant to
section 704, every establishment engaged in the manufacture, propagation,
compounding, or processing of an excipient of a drug to the same extent as the
Secretary is authorized to inspect an establishment engaged in the manufacture,
propagation, compounding, or processing of any other drug.</text>
</paragraph><paragraph id="HB1CC626D89C947BB84E2FA29614F347A" indent="up1"><enum>(5)</enum><text display-inline="yes-display-inline">Nothing in this subsection shall be
construed as limiting the authority of the Secretary to conduct inspections of
establishments under any other provision of the Act.</text>
</paragraph><paragraph id="H3B28BCE77FE142B8A7DD9E924B3ADF31" indent="up1"><enum>(6)</enum><text display-inline="yes-display-inline">With respect to fiscal year 2012 and each
subsequent fiscal year, the Secretary shall submit an annual report to the
Congress on—</text>
<subparagraph id="H061BB213BB634E69A03140C7AB813677"><enum>(A)</enum><text>funding dedicated to inspections under
this subsection of establishments engaged in the manufacture, propagation,
compounding, or processing of a drug; and</text>
</subparagraph><subparagraph id="H5335E227D06D4EFE9438A7FB7ADD79B1"><enum>(B)</enum><text display-inline="yes-display-inline">the number of such establishments for which
the frequency of such inspections has been modified pursuant to paragraph
(2).</text>
</subparagraph></paragraph><paragraph id="H76B6989EC52D4FB99D7AFAD6D61FB9A5" indent="up1"><enum>(7)</enum><text display-inline="yes-display-inline">For purposes of determining inspection
frequency under paragraph (2), the Secretary shall establish information
systems capacity sufficient to assess risk and shall develop and maintain a
risk-based system for conducting surveillance of current good manufacturing
practices by establishments engaged in the manufacture, propagation,
compounding, or processing of a drug that is a finished dosage form or an
active pharmaceutical ingredient. The Secretary shall have such capacity in
place and begin implementation of such risk-based system not later than 3 years
after the date of the enactment of the <short-title>Drug
Safety Enhancement Act of 2011</short-title>. Such risk-based system shall
include consideration of the class of the establishment’s products and
associated risks, the date the establishment was last inspected, the
establishment’s compliance and safety history, the establishment’s shipping
volume and history, and such other factors as the Secretary determines relevant
to assessing the risk presented by the
establishment.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" id="H334A066F368B4B4586E27367C1CCDA1A"><enum>(b)</enum><header>GAO
report</header><text>Not later than 3 years after the date of the enactment of
this Act, the Comptroller General of the United States shall submit a report to
the Congress on the risk-based process for conducting surveillance of current
good manufacturing practices developed and implemented under section 510(h)(7)
of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)(2) of
this section.</text>
</subsection><subsection commented="no" id="H8D7500115F434FD1B076D644D4BCCFAC"><enum>(c)</enum><header>Application</header><text>The
amendments made by this section shall apply to drugs introduced or delivered
for introduction into interstate commerce on or after the date of the enactment
of this Act.</text>
</subsection></section><section id="H30017591B12042779A830F01FEEA1B12"><enum>104.</enum><header>Prohibition
against delaying, limiting, or refusing inspection</header><text display-inline="no-display-inline">Section
501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351), as amended, is
further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H03DDD955375B4E9389A6272D33203C80" style="OLC">
<subsection id="HD01D1A556D5342A68593CFE42689E4A6"><enum>(k)</enum><text display-inline="yes-display-inline">If it is a drug and it has been
manufactured, processed, packed, or held in any factory, warehouse, or
establishment and the owner, operator, or agent of such factory, warehouse, or
establishment, or any agent of a governmental authority in the foreign country
within which such factory, warehouse, or establishment is located, delays or
limits an inspection, or refuses to permit entry or inspection, under section
510(h) or
704.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="H5C278E2A88B94D2DAEE22A51006AAC34"><enum>105.</enum><header>Clarification
of inspection authority related to BIMO and IRB inspections</header>
<subsection commented="no" id="HECEEF92BDC654AB9A710D3DE5B1ED034"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 704(a)(1) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)), is
amended—</text>
<paragraph commented="no" id="HBA5DA8B621CF45FCB56911942F90EAC9"><enum>(1)</enum><text>by inserting after
the second sentence the following: <quote>For purposes of enforcement of this
Act, officers or employees duly designated by the Secretary, upon presenting
appropriate credentials and a written notice to the owner, operator, or agent
in charge, are also authorized to enter, at reasonable times, any premises of a
clinical investigator, sponsor, monitor, contract research organization, site
management organization, institutional review board, or other person that
oversees, initiates, or conducts a clinical investigation subject to section
505(i), or a postmarket study or clinical trial subject to section 505(k) or
505(o).</quote>; and</text>
</paragraph><paragraph commented="no" id="HD24A101C947E485EA1A44C30BA7A6000"><enum>(2)</enum><text>by inserting
<quote>or any establishment associated with a clinical investigation subject to
section 505(i), or a postmarket study or clinical trial subject to section
505(k) or 505(o) (including the premises of any clinical investigator, sponsor,
monitor, contract research organization, site management organization, person
that oversees or participates in data acquisition, data generation, data
archiving, or data analysis, institutional review board, or any other person,
other than a subject, that participates in the conduct of a clinical
investigation of a drug),</quote> before <quote>inspection shall extend to all
things therein</quote>.</text>
</paragraph></subsection><subsection commented="no" id="H98CAA1943A4D462ABD5B6922E9B093E4"><enum>(b)</enum><header>Conforming
amendment</header><text display-inline="yes-display-inline">Section 704(a)(2)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(2)) is amended by
striking <quote>third sentence</quote> and inserting <quote>fourth
sentence</quote>.</text>
</subsection></section><section id="H47803CBEECC44B3F9695FF415662DB3C"><enum>106.</enum><header>Notification,
nondistribution, and recall of adulterated or misbranded drug products</header>
<subsection id="H29CBFB18FC3E421FB9BD0F450938E576"><enum>(a)</enum><header>Prohibited
acts</header><text display-inline="yes-display-inline">Section 301 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H868CD4C08D6A46948FF3DA35ACBCF3E6" style="OLC">
<subsection id="H3CA3D4A0CC9E44B3B8777F5EF972AA62"><enum>(uu)</enum><paragraph commented="no" display-inline="yes-display-inline" id="HB9F7485E38484657BBB703DCE6FF9E58"><enum>(1)</enum><text>The failure to notify
the Secretary in violation of section 568(a).</text>
</paragraph><paragraph id="H916034D0715E44F685C59FDD99A48613" indent="up1"><enum>(2)</enum><text>The failure to comply with any order
issued under section
568.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H4E90C7A1FDF84FF7913189B05A913655"><enum>(b)</enum><header>Notification,
nondistribution, and recall of adulterated or misbranded
drugs</header><text>Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HC0E23F00241F45DDAD2144D7E9453011" style="OLC">
<section id="H5FC2B532AAA144B29E520BE404C3A4B0"><enum>568.</enum><header>Notification,
Nondistribution, And Recall Of Adulterated Or Misbranded Drugs</header>
<subsection id="H40511616D8BC4A99B1230D425FF25108"><enum>(a)</enum><header>Notification,
nondistribution, and recall of adulterated or misbranded drugs</header>
<paragraph id="H26FD83D6C0AE4DEC816863457781C4D4"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">A person required,
with respect to drugs, to register under section 510, 801(r), or 801(s) that
has reason to believe that—</text>
<subparagraph id="H3D19EE8EBA3A4CA7AB11AD85B1F5A762"><enum>(A)</enum><text>a drug when
introduced into or while in interstate commerce, or while held for sale
(regardless of whether the first sale) after shipment in interstate commerce,
is adulterated or misbranded, and</text>
</subparagraph><subparagraph id="H1885B979F6D5481BA876A22270A351DE"><enum>(B)</enum><text>as a result, the
use or consumption of, or exposure to, the drug (or an ingredient or component
used in any such drug) may result in illness or injury to humans or
animals,</text>
</subparagraph><continuation-text continuation-text-level="paragraph">shall, as
soon as practicable, notify the Secretary of the identity and location of the
drug.</continuation-text></paragraph><paragraph id="HD0491DAF4CAE4A7C86ED8DC0914A3FCD"><enum>(2)</enum><header>Manner of
notification</header><text>Notification under paragraph (1) shall be made in
such manner and by such means as the Secretary may require by regulation.</text>
</paragraph></subsection><subsection id="HE0B6E3FF77044690B3EACC765ADFDB7E"><enum>(b)</enum><header>Voluntary
recall</header><text>The Secretary may request that any person who distributes
a drug that the Secretary has reason to believe is adulterated, misbranded, or
otherwise in violation of this Act voluntarily—</text>
<paragraph id="H31E2735EBA724592B27AC14C7A9C5435"><enum>(1)</enum><text>recall such drug;
and</text>
</paragraph><paragraph id="H10F81C3E75214210945DB615A9A806BC"><enum>(2)</enum><text>provide for
notice, including to individuals as appropriate, to persons who may be affected
by the recall.</text>
</paragraph></subsection><subsection id="H434D313804764E30A489A69410936B3F"><enum>(c)</enum><header>Order To cease
distribution</header><text>If the Secretary has reason to believe that the use
or consumption of, or exposure to, a drug may result in illness or injury to
humans or animals, the Secretary shall have the authority to issue an order
requiring any person who distributes such drug to immediately cease
distribution of such drug.</text>
</subsection><subsection id="HC77B211FC4F94EF4AA2F4A59A004016F"><enum>(d)</enum><header>Action following
order</header><text>Any person who is subject to an order under subsection (c)
shall immediately cease distribution of such drug and provide notification as
required by such order, and may appeal within 24 hours of issuance of such
order to the Secretary. Such appeal may include a request for an informal
hearing and a description of any efforts to recall such drug undertaken
voluntarily by the person, including after a request under subsection (b).
Except as provided in subsection (f), an informal hearing shall be held as soon
as practicable, but not later than 5 calendar days, or less as determined by
the Secretary, after such an appeal is filed, unless the parties jointly agree
to an extension. After affording an opportunity for an informal hearing, the
Secretary shall determine whether the order should be amended to require a
recall of such drug. If, after providing an opportunity for such a hearing, the
Secretary determines that inadequate grounds exist to support the actions
required by the order, the Secretary shall vacate the order.</text>
</subsection><subsection id="HD3F4BC0B5F944DCCA6DE5B7792CB6367"><enum>(e)</enum><header>Order To
recall</header>
<paragraph id="H40133B4EAF8C40BBB61E13DC41A03507"><enum>(1)</enum><header>Amendment</header><text>Except
as provided under subsection (f), if after providing an opportunity for an
informal hearing under subsection (d), the Secretary determines that the order
should be amended to include a recall of the drug with respect to which the
order was issued, the Secretary shall amend the order to require a recall.</text>
</paragraph><paragraph id="HB0FA4F7DF115419CB78F41A913F93DA1"><enum>(2)</enum><header>Contents</header><text>An
amended order under paragraph (1) shall—</text>
<subparagraph id="H67386F2F0EA44A289D1B022EAB4CEFBC"><enum>(A)</enum><text>specify a
timetable in which the recall will occur;</text>
</subparagraph><subparagraph id="H7FCB07738DD54DA0BB677D8538C81F33"><enum>(B)</enum><text>require periodic
reports to the Secretary describing the progress of the recall; and</text>
</subparagraph><subparagraph id="H340AA07A6F8E421F8A5A814CAE9B076E"><enum>(C)</enum><text>provide for
notice, including to individuals as appropriate, to persons who may be affected
by the recall. In providing for such notice, the Secretary may allow for the
assistance of health professionals, State or local officials, or other
individuals designated by the Secretary.</text>
</subparagraph></paragraph></subsection><subsection id="H3119E59765E34F8CA823A2E8C8DA36F5"><enum>(f)</enum><header>Emergency recall
order</header>
<paragraph id="H6D997893A0804867AD15D16D9D5D8F48"><enum>(1)</enum><header>In
general</header><text>If the Secretary has credible evidence or information
that a drug subject to an order under subsection (c) presents an imminent
threat of serious adverse health consequences or death to humans or animals,
the Secretary may issue an order requiring any person who distributes such
drug—</text>
<subparagraph id="H89F36E4E900941EE8EC7C8DB7C035721"><enum>(A)</enum><text>to immediately
recall such drug; and</text>
</subparagraph><subparagraph id="HCAF8AF57481A47CB81FD5596BC638D1D"><enum>(B)</enum><text>to provide for
notice, including to individuals as appropriate, to persons who may be affected
by the recall.</text>
</subparagraph></paragraph><paragraph id="H18EF58201E9247939BC7A0E0A2931BEF"><enum>(2)</enum><header>Action following
order</header><text>Any person who is subject to an emergency recall order
under this subsection shall immediately recall such drug and provide
notification as required by such order, and may appeal within 24 hours after
issuance such order to the Secretary. The person subject to an emergency recall
order shall conduct the recall notwithstanding the pendency of any such appeal.
An informal hearing shall be held as soon as practicable but not later than 5
calendar days, or less as determined by the Secretary, after such an appeal is
filed, unless the parties jointly agree to an extension. After affording an
opportunity for an informal hearing, the Secretary shall determine whether the
order should be amended pursuant to subsection (e)(1). If, after providing an
opportunity for such a hearing, the Secretary determines that inadequate
grounds exist to support the actions required by the order, the Secretary shall
vacate the order.</text>
</paragraph></subsection><subsection id="H0B17E4B6746842868C10CF8A7203EC1C"><enum>(g)</enum><header>Notice to
consumers and health officials</header><text>The Secretary shall, as the
Secretary determines to be necessary, provide notice of a recall order under
this section to consumers to whom the drug was, or may have been, distributed
and to appropriate State and local health officials.</text>
</subsection><subsection id="H80D034A3426E4FDCB512159C00B8E413"><enum>(h)</enum><header>Savings
clause</header><text>Nothing contained in this section shall be construed as
limiting—</text>
<paragraph id="H2F8DC61C6AFA4234B83F604B5A2491F5"><enum>(1)</enum><text>the authority of
the Secretary to issue an order to cease distribution of, or to recall, a drug
under any other provision of this Act or the Public Health Service Act; or</text>
</paragraph><paragraph id="H823BAA2C839247B8BFCD75035A832D1D"><enum>(2)</enum><text>the ability of the
Secretary to request any person to perform a voluntary activity related to any
drug subject to this Act or the Public Health Service Act.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H3BC16B789E084C4899137FB4BC84654B"><enum>(c)</enum><header>Articles subject
to refusal</header><text display-inline="yes-display-inline">The third sentence
of subsection (a) of section 801 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381) is amended by inserting <quote>or (4) in the case of a drug,
such article is subject to an order under section 568 to cease distribution of
or recall the article,</quote> before <quote>then such article shall be refused
admission</quote>.</text>
</subsection><subsection id="H2EA036E4F69D48D086F4F9DC124DCF39"><enum>(d)</enum><header>Application</header><text>Sections
301(uu) and 568 of the Federal Food, Drug, and Cosmetic Act, as added by
subsections (a) and (b), shall apply with respect to a drug as of such date,
not later than 1 year after the date of the enactment of this Act, as the
Secretary of Health and Human Services shall specify.</text>
</subsection></section><section id="H008486C9538843E68EA1DCCB69ADAF54"><enum>107.</enum><header>Notification</header>
<subsection id="H190BF0E3D5AA46CD86710577F76DD2B0"><enum>(a)</enum><header>In
general</header>
<paragraph id="HA89458B528194757B505546605ED5242"><enum>(1)</enum><header>Prohibited
acts</header><text display-inline="yes-display-inline">Section 301 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended, is further
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H65EA02BB3CA44A18B9BD721CBFF6E50E" style="OLC">
<subsection id="H420891190BFB47009FCF799A02833681"><enum>(vv)</enum><text display-inline="yes-display-inline">The failure to notify the Secretary in
violation of section
569.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H84F6ADB377C74EFAAE83219CF5F23D48"><enum>(2)</enum><header>Notification</header><text display-inline="yes-display-inline">Subchapter E of chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.), as amended, is further
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H53E58259CA23483DBF6877E3CA80FF38" style="OLC">
<section id="H3E84535C21404C64B3BF324814D96573"><enum>569.</enum><header>Notification</header>
<subsection id="HAAED192471CB4FCDA8DBDEE0B76CA158"><enum>(a)</enum><header>Notification to
Secretary</header><text>With respect to a drug, the Secretary may require
notification to the Secretary by a regulated person of—</text>
<paragraph id="H57592BA4D07543C9B303444D1FB2E102"><enum>(1)</enum><text>the use of, or
exposure to, such drug which may result in illness or injury to humans or
animals;</text>
</paragraph><paragraph id="H1ADB71DC27A84C6BBF9BE13CBBAD3D08"><enum>(2)</enum><text>a significant loss
or known theft of such drug;</text>
</paragraph><paragraph id="H71629E1068724DEF96E333DA7C90CF5D"><enum>(3)</enum><text>a reasonable
probability that such drug has been or is being counterfeited;</text>
</paragraph><paragraph id="H1A07AB15847A4FAE9245E3BED3D0AD14"><enum>(4)</enum><text>repeated failures
by a manufacturer of a component or other material used in the manufacture of
such drug to ensure compliance with applicable quality systems requirements
under section 501(a)(2)(B) or 503C of this Act or section 351 or 361 of the
Public Health Service Act;</text>
</paragraph><paragraph id="H6FB6F6E2B28D488AB393793B014AABB9"><enum>(5)</enum><text>any incident
causing such drug to be mistaken for, or its labeling applied to, another drug;</text>
</paragraph><paragraph id="H5AA4E9E3296C474A8005AA47DE81C66E"><enum>(6)</enum><text>any contamination
or any significant chemical, physical, or other change or deterioration in such
drug after distribution, or any failure of a distributed lot or batch of such
drug to meet an established specification; and</text>
</paragraph><paragraph id="H88A91C0F3232426888F094CC466065DC"><enum>(7)</enum><text>any other type of
information regarding such drug that the Secretary deems necessary for
protection of the public health.</text>
</paragraph></subsection><subsection id="H665C1505CC3C44B6B061152E31471832"><enum>(b)</enum><header>Manner of
notification</header><text>Notification under this section shall be made in
such manner and by such means as the Secretary may require by regulation or
guidance.</text>
</subsection><subsection id="H470ADBC0289A4399A0A60A4A681AF6CD"><enum>(c)</enum><header>Definition</header><text>In
this section, the term <term>regulated person</term> means a person who is
required to register under section 510, 801(r), or 801(s); a wholesale
distributor of a drug product; and any other person that distributes drugs
except exclusively for retail sale.</text>
</subsection></section><after-quoted-block>.
</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" id="HE339516539A64C90966EC7331654E269"><enum>(b)</enum><header>Exchange of
Information</header>
<paragraph commented="no" id="H5C7028194E9F4B1694BB8E2A8F9CDDCC"><enum>(1)</enum><header>Prohibited
acts</header>
<subparagraph id="H9491413DAA744B93A80CEEF4A4A5B6ED"><enum>(A)</enum><header>In
general</header><text>The first sentence of section 301(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(j)) is amended—</text>
<clause id="H72443A8DB5EF4CDE80090E07C200806D"><enum>(i)</enum><text>by
striking <quote>or</quote> before <quote>to the courts when relevant</quote>;
and</text>
</clause><clause id="HD819469E52764EFFBDBEC031B49BE26E"><enum>(ii)</enum><text>by
inserting <quote>, or as specified in section 708,</quote> before <quote>any
information acquired</quote>.</text>
</clause></subparagraph><subparagraph id="H84FB18FA940E4056A879FBA351F361FF"><enum>(B)</enum><header>Technical
corrections</header><text display-inline="yes-display-inline">The first
sentence of such section 301(j) is further amended—</text>
<clause id="H57D08A4094214EA08BEB81A7908F4DF3"><enum>(i)</enum><text>by
striking <quote>573.</quote> and inserting <quote>573</quote>; and</text>
</clause><clause id="H343F753477D14F9B9B26D7CFE5EFF48E"><enum>(ii)</enum><text>by
striking the second of the two consecutive periods at the end.</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="HB8F53D13DC984FA1BD54233A20E4078C"><enum>(2)</enum><header>Amendment</header><text>Section
708 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379) is
amended—</text>
<subparagraph commented="no" id="H6BD6015CB361499D8EC5BF7884FF29FB"><enum>(A)</enum><text>by striking
<quote>The Secretary</quote> and inserting <quote>(a) The Secretary</quote>;
and</text>
</subparagraph><subparagraph commented="no" id="HDB5E10CE09484208A92CDC47474BAFB1"><enum>(B)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="H3607870C0F414E769CE97029A338C5E2" style="OLC">
<subsection commented="no" id="HB444E716A28648A58BAE7AE8C25C2188"><enum>(b)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H688F91786B3F452E905D41BEC52F9DEA"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H7793C03F65874AEA91D45D7205312E5A"><enum>(A)</enum><text>The Secretary may
provide to any Federal agency acting within the scope of its jurisdiction any
information respecting a drug that is exempt from disclosure pursuant to
subsection (a) of section 552 of title 5, United States Code, by reason of
subsection (b)(4) of such section.</text>
</subparagraph><subparagraph commented="no" id="H66FC476EDE0D4CFF893ABA4DBF0C53BC" indent="up2"><enum>(B)</enum><text>Any such information provided to
another Federal agency shall not be disclosed by such agency except in any
investigation within the receiving agency’s jurisdiction or in an action or
proceeding under the laws of the United States in which the receiving agency or
the United States is a party.</text>
</subparagraph></paragraph><paragraph commented="no" id="HB66ED817CE3F488499D1C4666E242C75" indent="up1"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H3877A5A8B18740F8B5B5767371F308C6"><enum>(A)</enum><text>In carrying out this
Act, the Secretary may provide to a State or local government agency any
information respecting a drug that is exempt from disclosure pursuant to
section 552(a) of title 5, United States Code, by reason of subsection (b)(4)
of such section.</text>
</subparagraph><subparagraph commented="no" id="HC2CA78587D3641328F73BC02D1234642" indent="up1"><enum>(B)</enum><text>Any such information provided to a
State or local government agency shall not be disclosed by such agency.</text>
</subparagraph></paragraph><paragraph commented="no" id="H679AB26F15194F5ABC3E4CAE2C1949F3" indent="up1"><enum>(3)</enum><text>Except as provided by section 301(j),
in carrying out this Act, the Secretary may provide to any person any
information respecting a drug that is exempt from disclosure pursuant to
section 552(a) of title 5, United States Code, by reason of subsection (b)(4)
of such section, if the Secretary determines that providing the information to
the person is appropriate under the circumstances and the recipient provides
adequate assurances to the Secretary that the recipient will preserve the
confidentiality of the information.</text>
</paragraph><paragraph commented="no" id="H98DC77E08054487A81DFB0F80E9FD900" indent="up1"><enum>(4)</enum><text>In carrying out this Act, the
Secretary may provide any information respecting a drug that is exempt from
disclosure pursuant to section 552(a) of title 5, United States Code, by reason
of subsection (b)(4) of such section—</text>
<subparagraph commented="no" id="HF6230CFC568541D38AC8CE0CAB019DE7"><enum>(A)</enum><text>to any foreign government agency; or</text>
</subparagraph><subparagraph commented="no" id="HD544493457D54329AA8171CDF6328F1E"><enum>(B)</enum><text>any international organization
established by law, treaty, or other governmental action and having
responsibility—</text>
<clause commented="no" id="HC5398C434C564F2F93FD75F1CBED50D0"><enum>(i)</enum><text>to facilitate global or regional
harmonization of standards and requirements in an area of responsibility of the
Food and Drug Administration; or</text>
</clause><clause commented="no" id="HDAE8AE5D73634220B02EEC3F44095818"><enum>(ii)</enum><text>to promote and coordinate public
health efforts, if the agency or organization provides adequate assurances to
the Secretary that the agency or organization will preserve the confidentiality
of the information.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" id="H3FE9DE3187634433A73C919851463671"><enum>(c)</enum><text>Except as provided
by section 301(j), the Secretary may disclose to the public any information
respecting a drug that is exempt from disclosure pursuant to section 552(a) of
title 5, United States Code, by reason of subsection (b)(4) of such section, if
the Secretary determines that such disclosure is necessary to protect the
public health.</text>
</subsection><subsection commented="no" id="H936B376A84E04DB285D2529D270756EB"><enum>(d)</enum><text>Except as provided
in subsection (e), the Secretary shall not be required to disclose under
section 552 of title 5, United States Code, or any other provision of law any
information respecting a drug obtained from a Federal, State, or local
government agency, or from a foreign government agency, or from an
international organization described in subsection (b)(4), if the agency or
organization has requested that the information be kept confidential, or has
precluded such disclosure under other use limitations, as a condition of
providing the information.</text>
</subsection><subsection commented="no" id="H51434DC2583F4528A160F5FF746A690B"><enum>(e)</enum><text>Nothing in
subsection (d) authorizes the Secretary to withhold information from the
Congress or prevents the Secretary from complying with an order of a court of
the United States.</text>
</subsection><subsection commented="no" id="H8C09A3DC69F54FBBABD31B801A447F7F"><enum>(f)</enum><text>This section shall
not affect the authority of the Secretary to provide or disclose information
under any other provision of law.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection></section><enum>II</enum><header>Response</header>
<section commented="no" id="H2D4857291BBC44568C1FDC0A6DBA0CE1"><enum>201.</enum><header>Administrative
detention</header>
<subsection id="H85EE6BCDD91F4402AD3C70978BA9F135"><enum>(a)</enum><header>Administrative
detention of drugs</header><text display-inline="yes-display-inline">Section
304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H79F86F7E8B8A4C7CB0A5BAFD69C50D97" style="OLC">
<subsection commented="no" id="HA9C5E0B1F71940CC826BA4EB20A1F186"><enum>(i)</enum><header>Administrative
detention of drugs</header>
<paragraph id="H2B530CC7D0B6413DA6F3B14C23A664C3"><enum>(1)</enum><header>Detention
authority</header>
<subparagraph id="H65E42EF7AD254590B5A1976926A36212"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">If during any lawful
activity conducted by an officer or employee, a drug which such officer or
employee has reason to believe is in violation of any provision of this Act is
found, such officer or employee may order the drug detained (in accordance with
regulations prescribed by the Secretary) for a reasonable period which may not
exceed 20 days unless the Secretary determines that a period of detention
greater than 20 days is required to institute an action under subsection (a) or
section 302, in which case the Secretary may authorize a detention period of
not to exceed 60 days.</text>
</subparagraph><subparagraph id="H29C0A0A07C14436ABFA1A7C82E9B325C"><enum>(B)</enum><header>Secretary’s
approval</header><text>Regulations of the Secretary prescribed under this
paragraph shall require that, before a drug may be ordered detained under this
paragraph, the Secretary or an officer or employee designated by the Secretary
approve such order.</text>
</subparagraph><subparagraph id="H380873022BD543C6ABC69E605C91841F"><enum>(C)</enum><header>Security of
detained drug</header><text>A detention order under this paragraph may
require—</text>
<clause id="H0E5EF32278754F509E5B27D4F9B6FD5D"><enum>(i)</enum><text>the labeling or
marking of a drug during the period of its detention for the purpose of
identifying the drug as detained; and</text>
</clause><clause id="HBC66069AC6A34B6B83E7C15A90D0297D"><enum>(ii)</enum><text display-inline="yes-display-inline">that the drug be removed to a secure
facility, as appropriate.</text>
</clause></subparagraph><subparagraph id="H563549AB8F414C7A8C824BF5F79F2F6E"><enum>(D)</enum><header>Appeal of
detention order</header>
<clause id="H5DBF619338F04309B524E36F891FC644"><enum>(i)</enum><header>Right to
appeal</header><text>Any person who would be entitled to claim a drug if it
were seized under subsection (a) may appeal to the Secretary a detention of
such drug under this paragraph.</text>
</clause><clause id="H5BA48726AECD40699DC71103A3515F1E"><enum>(ii)</enum><header>Hearing and
response</header><text>Within 15 days of the date an appeal of a detention is
filed with the Secretary, the Secretary shall after affording opportunity for
an informal hearing by order confirm the detention or revoke it.</text>
</clause></subparagraph></paragraph><paragraph id="H0AB152B5A5594ECC83A0DC12CFA76EC2"><enum>(2)</enum><header>Limitation on
movement of detained drugs</header>
<subparagraph id="H32323E7294274962998AD6BEC51FB920"><enum>(A)</enum><header>In
general</header><text>Except as authorized by subparagraph (B), a drug subject
to a detention order issued under paragraph (1) shall not be moved by any
person from the place at which it is ordered detained until—</text>
<clause id="HB614DF32C279430EAC97361664DA35EF"><enum>(i)</enum><text>released by the
Secretary; or</text>
</clause><clause id="HC385FC90BB904866A0C915A951CC6DF2"><enum>(ii)</enum><text>the expiration of
the detention period applicable to such order,</text>
</clause><continuation-text continuation-text-level="subparagraph">whichever occurs first.</continuation-text></subparagraph><subparagraph id="H0E0E0B7E3E524D559BA10AE3A8A61C92"><enum>(B)</enum><header>Exception</header><text display-inline="yes-display-inline">A drug subject to a detention order under
paragraph (1) may be moved—</text>
<clause id="H39DA70E70635412AB615D01538946E9B"><enum>(i)</enum><text>in
accordance with regulations prescribed by the Secretary; and</text>
</clause><clause id="H03FB29D1DBAB4DA2A2698768A49CE37F"><enum>(ii)</enum><text>if not in final
form for shipment, at the discretion of the manufacturer of the device for the
purpose of completing the work required to put it in such form.</text>
</clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H515E89A2CAC748C7B482230253BE97BE"><enum>(b)</enum><header>Regulations</header><text>The
Secretary shall issue regulations or guidance to implement the amendments made
by this section.</text>
</subsection><subsection commented="no" id="H34DB6232A715419D838A61A1DEACCCF5"><enum>(c)</enum><header>Prohibited
Acts</header><text display-inline="yes-display-inline">Section 301(r) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), is amended—</text>
<paragraph id="H74CA943AB05741D6A76586A6F0A0CA15"><enum>(1)</enum><text>by inserting
<quote>, drug,</quote> after <quote>device</quote>, each place it appears;
and</text>
</paragraph><paragraph id="H13A696DBCF7E4CF6A7EE26AFBB34120D"><enum>(2)</enum><text>by inserting
<quote>or section 304(i)</quote> after <quote>section 304(g)</quote>.</text>
</paragraph></subsection><subsection commented="no" id="H420D8FE066274163A241E75466F4401E"><enum>(d)</enum><header>Effective
date</header><text>The amendments made by this section shall apply beginning on
the day that is 180 days after the date of enactment of this Act.</text>
</subsection></section><section commented="no" id="H7A5D90600B5C483F9CD5CCB5CFBA40AF"><enum>202.</enum><header>Destruction of
adulterated, misbranded, or counterfeit drugs offered for import</header>
<subsection commented="no" id="HAF30F134B60640AE967CB160FBA0EC19"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 801 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H506387547D8648E39EDBE63FC5C922B1" style="traditional">
<subsection commented="no" id="H5A2419F68F244092BC02AD37F34FCC56"><enum>(q)</enum><paragraph commented="no" display-inline="yes-display-inline" id="HECE092C57CE847C4B2BC0BCA9AA9944E"><enum>(1)</enum><text display-inline="yes-display-inline">Subject to paragraph (2), the Secretary of
the Treasury shall cause the destruction, upon referral from the Secretary of
Health and Human Services, of any drug that—</text>
<subparagraph commented="no" id="HA4B4960CFD39458FAB337848105FC792" indent="up1"><enum>(A)</enum><text>poses a reasonable probability of
causing a significant adverse health effect, as determined by the Secretary of
Health and Human Services; or</text>
</subparagraph><subparagraph commented="no" id="HED171EB013C04729B9AD3227D7999C0A" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">is
valued at an amount that is $2,000 or less (or such higher amount as the
Secretary of the Treasury may set by regulation pursuant to section 498 of the
Tariff Act of 1930).</text>
</subparagraph></paragraph><paragraph commented="no" id="H3E12C9DCF36B4A1E8E02CD191176BE80" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">The Secretary of Health and Human Services
shall issue regulations providing for notice and an opportunity for an informal
hearing for destruction of drugs under paragraph (1). The regulations under
this paragraph shall allow the Secretary of Health and Human Services to
provide the notice and opportunity for an informal hearing to the owner or
consignee after the destruction has occurred.</text>
</paragraph><paragraph commented="no" id="H1021A2B8F2EB44A38263BC144690B128" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">For a drug not described in paragraph (1),
the Secretary of Health and Human Services shall provide for notice and an
opportunity for an informal hearing to the owner or consignee before the
destruction of the drug under the fifth sentence of subsection
(a).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H9E48835ED8944E329F67F882DCCDD1F0"><enum>(b)</enum><header>Conforming
amendment</header><text>The fifth sentence of subsection (a) of section 801 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by striking
<quote>The Secretary of the Treasury shall</quote> and inserting <quote>Except
as provided in subsection (q), the Secretary of the Treasury shall</quote>.</text>
</subsection><subsection commented="no" id="H46ACEE9D4FAE45FA98C15806F4DB5DC2"><enum>(c)</enum><header>Application</header><text>The
amendments made by subsections (a) and (b) shall apply beginning on the day
that is 90 days after the date of the enactment of this Act.</text>
</subsection></section><section id="H07D7B2F079964795B7A30E116C22A69A"><enum>203.</enum><header>Criminal
penalties</header><text display-inline="no-display-inline">Section 303 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended—</text>
<paragraph id="HC5908E028D6643009DE2C08957288DE1"><enum>(1)</enum><text>in subsection
(a)—</text>
<subparagraph id="H1EC165E2A0AE42DB897CA2F8B2CE89AE"><enum>(A)</enum><text>in paragraph (1),
by striking <quote>Any</quote> and inserting <quote>Except as provided in
paragraph (2) or (3), any</quote>; and</text>
</subparagraph><subparagraph id="H3599FB9728E94E02AEF3CC9072B86BEF"><enum>(B)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HEC25B33F076F4EBF80EEA27079D58026" style="OLC">
<paragraph id="H8CBD3977B2B748358F3F6E794A514F16" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">Notwithstanding paragraph (1), any person
who, with respect to a drug, knowingly violates paragraph (a), (b), (c), (d),
(f), (g), (i), (k), or (jj)(3) of section 301 shall be imprisoned for not more
than 10 years or fined in accordance with title 18, United States Code, or
both.</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" id="HF9D87265DFD84BD195E7AAB4900271A3"><enum>(2)</enum><text>in subsection
(b)(1), by striking <quote>fined not more than $250,000</quote> and inserting
<quote>fined in accordance with title 18, United States Code</quote>.</text>
</paragraph></section><section id="H37A35887BB19474688BFF593E2AF9C6F"><enum>204.</enum><header>Civil
penalties</header>
<subsection id="H3F8949FAF0D44C989483DAEF09F552AB"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 303(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(f)) is amended by striking
paragraph (4) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H8755420295ED4B62BB815E413224D109" style="OLC">
<paragraph id="HD9FB680A55154C778FC1A799FE9480AE"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HF32DFEB4B55B4E218982ACAE5EF18859"><enum>(A)</enum><text>Except as provided in
paragraph (3) and subsection (g), any person who violates a requirement of this
Act that relates to drugs shall be subject to a civil penalty in an amount not
to exceed—</text>
<clause id="H6760FDC68EFC496582F0ED00F1FF6D59" indent="up1"><enum>(i)</enum><text>$500,000 for each such violation;
and</text>
</clause><clause id="HCBE24D6366EC410B93ABD7E4F2834D8D" indent="up1"><enum>(ii)</enum><text>for all such violations
adjudicated in a single proceeding, $10,000,000.</text>
</clause></subparagraph><subparagraph id="HADED9464F7184E1F8284DF2083B0F479" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">Each violation described in
<internal-xref idref="HF32DFEB4B55B4E218982ACAE5EF18859" legis-path="(4)(A)">subparagraph (A)</internal-xref> and each day during which
the violation continues shall be considered to be a separate
offense.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HD56956E2E590482A9DB145BD9B05D09E"><enum>(b)</enum><header>Conforming
amendments</header>
<paragraph id="H2E70C9F51159438C9AA2BD4A51A15E00"><enum>(1)</enum><text display-inline="yes-display-inline">Section 303(f)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(f)(3)) is amended—</text>
<subparagraph id="H3218BE177E3E4B4483738692D282C1EF"><enum>(A)</enum><text>in subparagraph
(A), by striking <quote>Any person who</quote> and inserting
<quote>Notwithstanding paragraph (4), any person who</quote>; and</text>
</subparagraph><subparagraph id="HE2A9C548A24F413F96CCC180A1089897"><enum>(B)</enum><text>in subparagraph
(B), by striking <quote>If a violation of</quote> and inserting
<quote>Notwithstanding paragraph (4), if a violation of</quote>.</text>
</subparagraph></paragraph><paragraph id="H410C3BA4454E431C81FF6338EE96F3D7"><enum>(2)</enum><text>Section 303(g)(1)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(g)(1)) is amended by
striking <quote>With respect to a person who</quote> and inserting
<quote>Notwithstanding subsection (f)(4), with respect to a person
who</quote>.</text>
</paragraph></subsection></section><section id="H71FB902922B74C3CBA5FF51700D39D88"><enum>205.</enum><header>Seizure</header><text display-inline="no-display-inline">Section 304(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 334(b)) is amended—</text>
<paragraph id="HE55E2B07B6C34AACAEDD68AD81980805"><enum>(1)</enum><text>by striking
<quote>(b)</quote> and inserting <quote>(b)(1)</quote>; and</text>
</paragraph><paragraph id="H6194175A863C4C73B1815E665967C116"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="H219619CF12AE42F1AC777023219C90DA" style="OLC">
<paragraph id="H064D161FA33C4CA2B3B5D97A99B8FE09" indent="up1"><enum>(2)</enum><header>Procedure with respect to drugs;
multiplicity of pending proceedings</header><text display-inline="yes-display-inline">In the case of a violation relating to a
drug, the article, equipment, or other thing proceeded against shall be liable
to seizure by process pursuant to the libel, and the procedure in cases under
this section shall conform, as nearly as may be, to the procedure in admiralty
rather than the procedure used for civil asset forfeiture proceedings set forth
in section 983 of title 18, United States Code. On demand of either party, any
issue of fact joined in any such case brought under this section shall be tried
by jury. Any such seizure brought under this section is not governed by Rule G
of the Supplemental Rules of Admiralty or Maritime Claims and Asset Forfeiture
Actions. In addition, exigent circumstances shall be deemed to exist for all
such seizures brought under this section, and in such cases, the summons and
arrest warrant shall be issued by the clerk of the court without court review.
When libel for condemnation proceedings relating to a drug under this section,
involving the same claimant and the same issues of adulteration or misbranding,
are pending in two or more jurisdictions, such pending proceedings, upon
application of the claimant reasonably made to the court of one such
jurisdiction, shall be consolidated for trial by order of such court, and tried
in (1) any district selected by the claimant where one of such proceedings is
pending; or (2) a district agreed upon by stipulation between the parties. If
no order for consolidation is so made within a reasonable time, the claimant
may apply to the court of one such jurisdiction, and such court (after giving
the United States attorney for such district reasonable notice and opportunity
to be heard) shall by order, unless good cause to the contrary is shown,
specify a district of reasonable proximity to the claimant's principal place of
business, in which all such pending proceedings shall be consolidated for trial
and tried. Such order of consolidation shall not apply so as to require the
removal of any case the date for trial of which has been fixed. The court
granting such order shall give prompt notification thereof to the other courts
having jurisdiction of the cases covered
thereby.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="HF1B26A8F5F19441C97FF4E001DCD9AF1"><enum>206.</enum><header>Asset
forfeiture</header>
<subsection id="H0180FE8429754AC69BBDDAC6DA1527D9"><enum>(a)</enum><header>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="H68DF8B51576940EBA3F572699FD19B1A" style="OLC">
<subsection id="HCD4C051FD825431181902B45B380DD10"><enum>(h)</enum><header>Forfeiture
related to violations with respect to drugs</header>
<paragraph id="H56C4453C2AEA444F960DB97C9F3CA957"><enum>(1)</enum><header>Criminal
forfeiture</header><text display-inline="yes-display-inline">Any person
convicted of a violation of section 301 with respect to drugs, or a conspiracy
to commit such violation, shall forfeit to the United States any property, real
or personal, constituting or traceable to the gross proceeds obtained, directly
or indirectly, as a result of such violation. Pursuant to section 2461(c) of
title 28, United States Code, the provisions of section 413 of the Controlled
Substances Act, except subsections (a), (d), and (q) of such section 413, shall
apply to criminal forfeitures under this paragraph.</text>
</paragraph><paragraph id="HC2B9CD03B040403384744311BC76723F"><enum>(2)</enum><header>Civil
forfeiture</header><text display-inline="yes-display-inline">Any property, real
or personal, constituting or traceable to the gross proceeds obtained, directly
or indirectly, as a result of a violation of section 301 with respect to drugs,
or a conspiracy to commit such violation, is subject to forfeiture to the
United States in accordance with the provisions of chapter 46 of title 18,
United States Code, except that such duties as are imposed upon the customs
officer or any other person with respect to the seizure and forfeiture of
property under the customs laws as described in section 981(d) of title 18,
United States Code, shall be performed with respect to seizures and forfeitures
of property under this section by such officers, agents, or other persons as
may be authorized or designated for that purpose by the
Secretary.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H5F86115086224C9FB932BEC1C8DB61A5"><enum>(b)</enum><header>Civil forfeiture
statute definition</header><text>Subparagraph (C) of section 983(i)(2) of title
18, United States Code, is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H648C8DEA67E34BAA88B3030A7348850B" style="OLC">
<subparagraph commented="no" id="H2D28A0CE11174638A28187B6FD858DD1"><enum>(C)</enum><text display-inline="yes-display-inline">section 304 of the Federal Food, Drug, and
Cosmetic
Act;</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><enum>III</enum><header>Importation and
Exportation</header>
<section id="H1A7576639E5840499E18D3F14EE5CD38"><enum>301.</enum><header>Documentation
for admissibility of imports</header>
<subsection id="H43D63F5C88754E26965C082554A7EED0"><enum>(a)</enum><header>Prohibition</header><text>Section
301 of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended,
is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HEED86A361ACB46E9BC5B0032056D3396" style="OLC">
<subsection id="H6E02C8ABE2C0443D964D9A2AB8D1C93C"><enum>(ww)</enum><text display-inline="yes-display-inline">The submission (with respect to drugs) of
information that is required pursuant to section 801 that is inaccurate or
incomplete.</text>
</subsection><subsection id="HF5C2149522EE487E851802FD970242A0"><enum>(xx)</enum><text>The failure (with
respect to drugs) to submit information that is required pursuant to section
801.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H8500005BB6284657A474081625E70C54"><enum>(b)</enum><header>Documentation
for imports</header><text>Section 801 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 381), as amended, is further amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H26DD318DC57A441581126E81637F407D" style="OLC">
<subsection id="H1A16D58A47C14631B37A6D41D5F9FDB1"><enum>(r)</enum><header>Documentation</header>
<paragraph id="HEFC1E997A0E34D60A4BE8D47A660B412"><enum>(1)</enum><header>Submission</header><text>The
Secretary may require by regulation the submission of documentation or other
information for a drug that is imported or offered for import into the United
States. When developing any regulation in accordance with this paragraph, to
the extent that the collection of documentation or other information involves
Customs and Border Protection efforts or resources, the Secretary shall consult
with Customs and Border Protection.</text>
</paragraph><paragraph id="HC8837D8A949A4EE8B82B8D124014615A"><enum>(2)</enum><header>Format</header><text>A
regulation under paragraph (1) may specify the format for submission of the
documentation or other information.</text>
</paragraph><paragraph id="H5C4E570E2D5746AD9AF21AD0AECEEF45"><enum>(3)</enum><header>Refusal of
admission</header><text>A drug imported or offered for import into the United
States shall be refused admission unless all documentation and information the
Secretary requires under this Act or the Public Health Service Act for such
article is
submitted.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="H538D592582B649049931BF514B538B0A"><enum>302.</enum><header>Registration
for commercial importers; fee</header>
<subsection id="H8CD3598BD89F4557AA4363A5E6D5F751"><enum>(a)</enum><header>Registration</header>
<paragraph id="HEF707BF111A54538A5EF299C3B3B2998"><enum>(1)</enum><header>Prohibitions</header><text display-inline="yes-display-inline">Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended, is further amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="H744094AF7F0945C3AE2E0F0B010E38D9" style="OLC">
<subsection id="HCFF6C2B0298C4F70A256D4F9D7607C46"><enum>(yy)</enum><text display-inline="yes-display-inline">The failure to register in accordance with
section
801(s).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H643A73A1AE3249C6BEC41321E3D93FF8"><enum>(2)</enum><header>Misbranding</header><text display-inline="yes-display-inline">Section 502(o) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352(o)), as amended, is further amended by
inserting <quote>if it is imported or offered for import by an importer not
duly registered under section 801(s),</quote> before <quote>or if it does not
bear</quote>.</text>
</paragraph><paragraph id="HA83A368829D04598B75003FA8ACB6DDF"><enum>(3)</enum><header>Registration</header><text display-inline="yes-display-inline">Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HE899AB944D7A4953A00FC6182FB0B52A" style="OLC">
<subsection id="HE4AE7315E74D4115BB38595DFBAD24C1"><enum>(s)</enum><header>Registration of
importers</header>
<paragraph id="H4045144409C34BD585F9AED93590A11B"><enum>(1)</enum><header>Registration</header><text>The
Secretary shall require an importer of drugs—</text>
<subparagraph id="H327041C50091417D8D9A68C731C39204"><enum>(A)</enum><text>to be registered
with the Secretary in a form and manner specified by the Secretary; and</text>
</subparagraph><subparagraph id="HF975FDF9304444919313BFA39F8E8EB1"><enum>(B)</enum><text>consistent with
section 1012, to submit appropriate unique identifiers as a condition of
registration.</text>
</subparagraph></paragraph><paragraph id="HDD45B4298B224013A1545A58A4A74B02"><enum>(2)</enum><header>Good importer
practices</header><text>The maintenance of registration under this subsection
is conditioned on compliance with good importer practices in accordance with
the following:</text>
<subparagraph id="H5A6F8A493AA34545B1C2E99F5B262CC3"><enum>(A)</enum><text>The Secretary, in
consultation with Customs and Border Protection, shall promulgate regulations
to establish good importer practices that specify the measures an importer
shall take to ensure imported drugs are in compliance with the requirements of
this Act and the Public Health Service Act.</text>
</subparagraph><subparagraph id="H20E60CCBECE3498EB84DE32A21310B33"><enum>(B)</enum><text>The measures under
subparagraph (A) shall ensure that the importer—</text>
<clause id="H3E465443AEEF4424A25A5D9E5FD30510"><enum>(i)</enum><text>has adequate
information about the article, its hazards, and the requirements of this Act
and the Public Health Service Act applicable to such article;</text>
</clause><clause id="H0E279A442DB04651BBBA8628822CE637"><enum>(ii)</enum><text>has adequate
information or procedures in place to verify that both the article and each
person that produced, manufactured, processed, packed, transported, or held the
article, including components of the article, are in compliance with the
requirements of this Act and the Public Health Service Act; and</text>
</clause><clause id="HC89FA77DA8094C93B137CF743DA375FA"><enum>(iii)</enum><text>has adequate
procedures in place to take corrective action, such as the ability to
appropriately trace, withhold, and recall articles, if an article imported by
the importer is not in compliance with the requirements of this Act or the
Public Health Service Act.</text>
</clause></subparagraph><subparagraph id="H30C8F5DA252349F19F5C25826FD91692"><enum>(C)</enum><text>In promulgating
good importer practice regulations under this subsection, the Secretary may, as
appropriate, take into account differences among importers and the types of
imports, including based on the level of risk posed by the imported
drug.</text>
</subparagraph></paragraph><paragraph id="HFD65261A7E99455EA8C5165700B7403C"><enum>(3)</enum><header>Suspension of
registration</header>
<subparagraph id="H78873818B84E4B8A8F34C6FF767C20FA"><enum>(A)</enum><header>In
general</header><text>Registration under this subsection is subject to
suspension upon a finding by the Secretary, after notice and an opportunity for
an informal hearing, of—</text>
<clause id="H7112ED44EDFA49DEB6CDC4BEA2226028"><enum>(i)</enum><text>a
violation of this Act; or</text>
</clause><clause id="H165385A9FC9C4B91902741D457772E01"><enum>(ii)</enum><text>the knowing or
repeated making of an inaccurate or incomplete statement or submission of
information relating to the importation of a drug.</text>
</clause></subparagraph><subparagraph id="H80AE8E93963947B3A773D41A6485EBFC"><enum>(B)</enum><header>Request</header><text>The
importer whose registration is suspended may request that the Secretary vacate
the suspension of registration when such importer has corrected the violation
that is the basis for such suspension.</text>
</subparagraph><subparagraph id="H2E574F84A34943328B915197B9B130D5"><enum>(C)</enum><header>Vacating of
suspension</header><text>If the Secretary determines that adequate reasons do
not exist to continue the suspension of a registration, the Secretary shall
vacate such suspension.</text>
</subparagraph></paragraph><paragraph id="H76D997913A3E400BBEE2B008241849EB"><enum>(4)</enum><header>Cancellation of
registration</header>
<subparagraph id="H0FE794950F03480C88F1F89C8B501159"><enum>(A)</enum><header>In
general</header><text>Not earlier than 10 days after providing the notice under
subparagraph (B), the Secretary may cancel a registration if the Secretary
determines that—</text>
<clause id="H3349EA87C487488FB6E3BF70B57F9C0D"><enum>(i)</enum><text>such registration
was not updated in accordance with this section or otherwise contains false,
incomplete, or inaccurate information; or</text>
</clause><clause id="H28AE2E5FE6EE424188B521A74E601D38"><enum>(ii)</enum><text>the registration
fee required under section 743 for such registration has not been paid within
30 days after the date due.</text>
</clause></subparagraph><subparagraph id="H9620203E66014483B88B8B17FFC69DD7"><enum>(B)</enum><header>Notice of
cancellation</header><text>Cancellation shall be preceded by notice to the
importer of the intent to cancel the registration and the basis for such
cancellation.</text>
</subparagraph><subparagraph id="H04D8D2C4C561415CAF395D9BC18CECF9"><enum>(C)</enum><header>Timely update or
correction</header><text>If the registration for the importer is updated or
corrected no later than 7 days after notice is provided under subparagraph (B),
the Secretary shall not cancel such registration.</text>
</subparagraph></paragraph><paragraph id="HA28A0A97AB644308B458E59DC7481017"><enum>(5)</enum><header>Exemptions</header><text>The
Secretary, by notice in the Federal Register—</text>
<subparagraph id="H87F5C0C39E5B4D1991C6B6B2F8A732D9"><enum>(A)</enum><text>shall establish an
exemption from the requirements of this subsection for importations for
personal use; and</text>
</subparagraph><subparagraph id="H0C3F5DB82D8B4A9E9FD292FECEE88774"><enum>(B)</enum><text>may establish
other exemptions from the requirements of this subsection.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="HA4D7E3209E484DFC9B7E7A73123C4574"><enum>(4)</enum><header>Regulations</header><text>Not
later than 36 months after the date of the enactment of this Act, the Secretary
of Health and Human Services in consultation with the Commissioner responsible
for Customs and Border Protection shall promulgate the regulations required to
carry out section 801(s) of the Federal Food, Drug, and Cosmetic Act, as added
by paragraph (3). In establishing the effective date of a regulation
promulgated under section 801(s), the Secretary shall, in consultation with the
Commissioner responsible for Customs and Border Protection, as appropriate,
provide a reasonable period of time for an importer of a drug to comply with
good importer practices, taking into account differences among importers and
the types of imports, including based on the level of risk posed by the
imported product.</text>
</paragraph><paragraph id="HFEE757EBC973404BAB036511298CB906"><enum>(5)</enum><header>Effective
date</header><text>The amendments made by this subsection shall take effect on
the date that is 24 months after the date of enactment of this Act.</text>
</paragraph></subsection><subsection id="HA50AD3FCB9A84D53B318589974D16885"><enum>(b)</enum><header>Fee</header><text>Subchapter
C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et
seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HBA00893DB0144F4292D2E76F16F21C39" style="OLC">
<part id="H03179157ED4A426F975D6C34AFD5FBFA"><enum>6</enum><header>Importers of
Drugs</header>
<section id="H6F33A312C0924F539D614DB98A1280F3"><enum>743.</enum><header>Importers of
drugs</header>
<subsection id="H19AF4423340B4F20A8956194FC4B762B"><enum>(a)</enum><header>Importers</header><text>The
Secretary shall assess and collect an annual fee for the registration of an
importer under section 801(s).</text>
</subsection><subsection id="HA125280331A84F58AF6745D312574A18"><enum>(b)</enum><header>Amount of
fee</header>
<paragraph id="HCA6928729CFC45DBA668F94D31B574ED"><enum>(1)</enum><header>Base
amounts</header><text>The registration fee under subsection (a) shall
be—</text>
<subparagraph id="HEB49FA3F969A4FB0A6CB2A443BEB565D"><enum>(A)</enum><text>for fiscal year
2012, $500; and</text>
</subparagraph><subparagraph id="H598432D840CF4CD59E5BF09CAD91A4DD"><enum>(B)</enum><text>for fiscal year
2013 and each subsequent fiscal year, the fee for fiscal year 2012 as adjusted
under paragraph (2).</text>
</subparagraph></paragraph><paragraph id="HF0FA082C2EF84F6092E997D1401686B0"><enum>(2)</enum><header>Adjustment</header><text>For
fiscal year 2013 and subsequent fiscal years, the fees established pursuant to
paragraph (1) shall be adjusted by the Secretary by notice, published in the
Federal Register, for a fiscal year to reflect the greater of—</text>
<subparagraph id="H9C0A0F1E700D41BEB2AC2BAA074A090D"><enum>(A)</enum><text>the total
percentage change that occurred in the Consumer Price Index for all urban
consumers (all items; United States city average) for the 12-month period
ending June 30 preceding the fiscal year for which fees are being established;</text>
</subparagraph><subparagraph id="H9A7CD4029EDB47479EF1698AB4AD6851"><enum>(B)</enum><text>the total
percentage change for the previous fiscal year in basic pay under the General
Schedule in accordance with section 5332 of title 5, United States Code, as
adjusted by any locality-based comparability payment pursuant to section 5304
of such title for Federal employees stationed in the District of Columbia; or</text>
</subparagraph><subparagraph id="H0FDB869987D14D24BAF2561FDE9B3CFD"><enum>(C)</enum><text>the average annual
change in the cost, per full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits paid with respect to
such positions for the first 5 years of the preceding 6 fiscal years.</text>
</subparagraph></paragraph><paragraph id="HFD54102D06384B9E9838AAB8DA740F9F"><enum>(3)</enum><header>Compounded
basis</header><text>The adjustment made each fiscal year pursuant to this
subsection shall be added on a compounded basis to the sum of all adjustments
made each fiscal year after fiscal year 2012 under this subsection.</text>
</paragraph><paragraph id="H3CEE9A5ED220488C86BDF8B643161D5F"><enum>(4)</enum><header>Waiver for
importers required to pay registration fee</header><text>The Secretary shall
waive the fee applicable to a person under this section if such person is
required to pay both—</text>
<subparagraph id="HF0EEAEA2A4CA4214B56FDA3C9C29C89F"><enum>(A)</enum><text>a fee under
section 736C for registration of one or more establishments under section 510,
for drugs; and</text>
</subparagraph><subparagraph id="H6B07730AE28C4D83B49FC40623986001"><enum>(B)</enum><text>a fee under this
section for registration as an importer under section 801(s).</text>
</subparagraph></paragraph></subsection><subsection id="HB83CDDF0EA33447CB035E01E97816549"><enum>(c)</enum><header>Crediting and
availability of fees</header>
<paragraph id="H1E28D3CFC8644BC994880C5CBCDE935D"><enum>(1)</enum><header>In
general</header><text>Fees authorized under subsection (a) shall be collected
and available for obligation only to the extent and in the amount provided in
advance in appropriations Acts. Such fees are authorized to remain available
until expended. Such sums as may be necessary may be transferred from the Food
and Drug Administration salaries and expenses appropriation account without
fiscal year limitation to such appropriation account for salaries and expenses
with such fiscal year limitation.</text>
</paragraph><paragraph id="H2A95D070621844DAAF243663477A1A83"><enum>(2)</enum><header>Collections and
appropriations acts</header><text>The fees authorized by this section—</text>
<subparagraph id="HB4D893E9B1D24248ABC0AD309B22753E"><enum>(A)</enum><text>shall be retained
in each fiscal year in an amount not to exceed the amount specified in
appropriations Acts, or otherwise made available for obligation, for such
fiscal year; and</text>
</subparagraph><subparagraph id="H459B82AE57EE4C3EACF4489BC971D403"><enum>(B)</enum><text>shall only be
collected and available to cover the costs associated with registering
importers under sections 801(s) and with ensuring compliance with good importer
practices.</text>
</subparagraph></paragraph><paragraph id="HA521F46B8AB844199F4A06127EBE01FC"><enum>(3)</enum><header>Authorization of
appropriations</header><text>For each of fiscal years 2012 through 2016, there
are authorized to be appropriated for fees under this section such sums as may
be necessary.</text>
</paragraph></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H3D66203DD27348B1A36360570EEB5E9B"><enum>(c)</enum><header>Inspection</header><text display-inline="yes-display-inline">Section 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H2F4464446B78449F8697E4D8D56D4A46" style="OLC">
<subsection id="HDFBB4CA891C04D7C8AF9F0290551A719"><enum>(h)</enum><header>Importers</header><text display-inline="yes-display-inline">Every person engaged in the importing of
any drug shall, upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable times to inspect
the facilities of such person and have access to, and to copy and verify, any
related
records.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="HDC75C27D929E4E63B9528C8708667C62"><enum>303.</enum><header>Registration
for customs brokers</header>
<subsection id="H5E9AAAE0C1BA4D71B0BF35EDAE8769F8"><enum>(a)</enum><header>Registration</header>
<paragraph id="HB4354F4F738547D689066DCA71711B24"><enum>(1)</enum><header>Prohibitions</header><text display-inline="yes-display-inline">Section 301(yy) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331), as added by section 302(a)(1), is amended by
inserting <quote>or 801(t)</quote> after <quote>801(s)</quote>.</text>
</paragraph><paragraph id="H5B17649E2E6B4343B7851BB8D4F0D53F"><enum>(2)</enum><header>Misbranding</header><text display-inline="yes-display-inline">Section 502(o) (21 U.S.C. 352(o)), as
amended by section 302(a)(2), is amended—</text>
<subparagraph id="H7159D65D716A4E9CA39A066E59B279E4"><enum>(A)</enum><text display-inline="yes-display-inline">by inserting <quote>or a customs
broker</quote> after <quote>by an importer</quote>; and</text>
</subparagraph><subparagraph id="H27E484A49781444CA317E88FB459ED58"><enum>(B)</enum><text>by inserting
<quote>or 801(t)</quote> after <quote>801(s)</quote>.</text>
</subparagraph></paragraph><paragraph id="H0022A9E215B64454AEF2789CDE8C989E"><enum>(3)</enum><header>Registration</header><text display-inline="yes-display-inline">Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381), as amended, is further amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HB2C5BE3A010140EAAEB1F732F1B1663D" style="OLC">
<subsection id="H9A414695F66F4EC5BAE50743FCA7123E"><enum>(t)</enum><header>Registration of
customs broker</header>
<paragraph id="H0C51E28ED33543B5BEF964A5AA80EF1A"><enum>(1)</enum><header>Registration</header><text>The
Secretary shall require a customs broker, with respect to the importation of
drugs—</text>
<subparagraph id="HCA8B7FBB0F904060BE8AB551B73B95F6"><enum>(A)</enum><text>to be registered
with the Secretary in a form and manner specified by the Secretary; and</text>
</subparagraph><subparagraph id="HA8BDC6FAF78645A8B89F4D31D952A964"><enum>(B)</enum><text>consistent with
section 1012, to submit appropriate unique identifiers as a condition of
registration.</text>
</subparagraph></paragraph><paragraph id="HE36A5B684EFC4A57AED7A093D252B6C0"><enum>(2)</enum><header>Cancellation of
registration</header>
<subparagraph id="H393544EB14B1487DA437DEF256CE5F15"><enum>(A)</enum><header>In
general</header><text>Not earlier than 10 days after providing the notice under
subparagraph (B), the Secretary may cancel a registration that the Secretary
determines was not updated in accordance with this section or other wise
contains false, incomplete, or inaccurate information.</text>
</subparagraph><subparagraph id="HA2C635FC71134BC2BF7904322728696C"><enum>(B)</enum><header>Notice of
cancellation</header><text>Cancellation shall be preceded by notice to the
customs broker of the intent to cancel the registration and the basis for such
cancellation.</text>
</subparagraph><subparagraph id="HF38B7A56990C4B5C92BE60671183A778"><enum>(C)</enum><header>Timely update or
correction</header><text>If the registration for the customs broker is updated
or corrected no later than 7 days after notice is provided under subparagraph
(B), the Secretary shall not cancel such registration.</text>
</subparagraph></paragraph><paragraph id="H637B300BF310494F800CA49E8328C757"><enum>(3)</enum><header>Notification</header><text>The
Secretary shall notify the Commissioner responsible for Customs and Border
Protection whenever the Secretary cancels a registration under this subsection.</text>
</paragraph><paragraph id="HE0C126F901704640AC357CEFCF9465C5"><enum>(4)</enum><header>Exemptions</header><text>In
consultation with the Commissioner responsible for Customs and Border
Protection, the Secretary, by notice published in the Federal Register—</text>
<subparagraph id="HF45AF1652A4D4B86A7B1AE58F5F6E61D"><enum>(A)</enum><text>shall establish an
exemption from the requirements of this subsection for importations for
personal use; and</text>
</subparagraph><subparagraph id="HFE413E7D858549958E968CA1A45D6842"><enum>(B)</enum><text>may establish
other exemptions from the requirements of this subsection.</text>
</subparagraph></paragraph><paragraph commented="no" id="HEC6FC7BF54A548C0A5DD2C715C637882"><enum>(5)</enum><header>Civil
penalties</header><text>Notwithstanding any other provision in this Act, a
customs broker who violates section 301 because of a violation of subsection
(ww), (xx), or (yy) of such section shall not be subject to a civil penalty
under section 303(f)(1)(C) of this Act.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="HFE5F8D2084A1470EA977382C9CEB303B"><enum>(4)</enum><header>Regulations</header><text>Not
later than 24 months after the date of the enactment of this Act, the Secretary
of Health and Human Services, in consultation with the Commissioner responsible
for Customs and Border Protection, shall promulgate the regulations required to
carry out section 801(t) of the Federal Food, Drug, and Cosmetic Act, as added
by paragraph (3).</text>
</paragraph><paragraph id="H84A0916629AD4794AAD63C243F62443B"><enum>(5)</enum><header>Effective
date</header><text>The amendments made by this subsection shall take effect on
the date that is 24 months after the date of enactment of this Act.</text>
</paragraph></subsection><subsection id="H12F4927114554169B99ADFFE2B3C7485"><enum>(b)</enum><header>Inspection</header><text display-inline="yes-display-inline">Section 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374), as amended, is further amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="H66FB7236BB1A40839E04A46267753147" style="OLC">
<subsection id="H140B15C6862A461DB73568513F60F6FF"><enum>(i)</enum><header>Brokers</header><text display-inline="yes-display-inline">Every customs broker required to be
registered with the Secretary shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee at all reasonable
times to inspect the facilities of such person and have access to, and to copy
and verify, any related
records.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="H963C23100E5F4A0EA3E7CB026CFF5998"><enum>304.</enum><header>Exportation
certificate program</header><text display-inline="no-display-inline">Section
801(e)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)) is
amended—</text>
<paragraph id="H977CA5E37A1A47C8802AD8A1833617D4"><enum>(1)</enum><text>in subparagraph
(B), by striking <quote>If the Secretary</quote> and inserting <quote>With
respect to a device, if the Secretary</quote>; and</text>
</paragraph><paragraph id="HB2FF6A8279034856AF3379E73F940C3C"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="H6E0C9E7CDD0C4E148912C41EEB213432" style="OLC">
<subparagraph id="HE917832E6A4345038D8CFF6895D25E87" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">With respect to a drug:</text>
<clause id="H06708D8213BD4ACF97CBF116F32DC865"><enum>(i)</enum><text display-inline="yes-display-inline">A certification by the Secretary under
subparagraph (A) need not be in writing.</text>
</clause><clause id="H63D76AC36F5B4852B35DFF239B272D6B"><enum>(ii)</enum><text>Subparagraph (A) applies only with
respect to exportation from the United States.</text>
</clause><clause id="H8B9DBE8C9DF1418EA61CCF8EA90B128E"><enum>(iii)</enum><text>Any person who exports from a
country other than the United States a drug approved in the United States may
request that the Secretary certify that the exported drug meets the applicable
requirements of this Act. The Secretary shall issue such a certification within
20 days of the receipt of a request for such certification if the request
demonstrates that the drug meets the applicable requirements of this
Act.</text>
</clause><clause id="H395B2D6AC4A44334AC1F1BEA238817FC"><enum>(iv)</enum><text display-inline="yes-display-inline">For purposes of this subparagraph, a
certification by the Secretary shall be made on such basis and in such form
(such as a publicly available listing) as the Secretary determines
appropriate.</text>
</clause><clause id="H0D74310AA1BE41ACA55D4520006D8269"><enum>(v)</enum><text display-inline="yes-display-inline">If the Secretary, with respect to a drug,
issues an export certification within the 20 days prescribed by subparagraph
(A) or clause (iii) of this subparagraph, a fee for such certification may be
charged but such fee shall not exceed such amount as the Secretary determines
is reasonably related to the cost of issuing such certificates. The Secretary
may adjust this fee annually to account for inflation and other cost
adjustments. Fees collected for a fiscal year pursuant to this subparagraph
shall be credited to the appropriation account for salaries and expenses of the
Food and Drug Administration and shall be available in accordance with
appropriations Acts until expended, without fiscal year limitation. Such fees
shall be collected in each fiscal year in an amount equal to the amount
specified in appropriations Acts for such fiscal year and shall only be
collected and available for the costs of the Food and Drug Administration to
cover the cost of issuing such certifications. Such sums as necessary may be
transferred from such appropriation account for salaries and expenses of the
Food and Drug Administration without fiscal year limitation to such
appropriation account for salaries and expenses with fiscal year
limitation.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" id="H3FE63F611E154845965F49EBD863E532"><enum>305.</enum><header>Extraterritorial
jurisdiction</header>
<subsection commented="no" id="H99997CCA258640F7860C8053D7E546B7"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Chapter III of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HD21A07AFBFE949AEA138D21BF76732CE" style="OLC">
<section commented="no" id="H651BBCA63FD64FE2BB46A7A555B8B6C2"><enum>311.</enum><header>Extraterritorial
jurisdiction</header><text display-inline="no-display-inline">There is
extraterritorial jurisdiction over any violation of this Act relating to any
drug if such drug was intended for import into the United States or if any act
in furtherance of the violation was committed in the United
States.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H56775F1AE8854D8283FC18E55943042F"><enum>(b)</enum><header>Prohibition</header><text display-inline="yes-display-inline">Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended, is further amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HD5F9B19A6EF44C0A948C3B8566D729DA" style="OLC">
<subsection commented="no" id="HE45A04A71EEE475BB1B5BCAE347866B9"><enum>(zz)</enum><text display-inline="yes-display-inline">The production, manufacture, processing,
preparation, packing, holding, or distribution of an adulterated or misbranded
drug with the knowledge or intent that such drug will be imported into the
United States, or the production, manufacture, processing, preparation,
packing, holding, or distribution of a drug with the knowledge or intent that
the drug will be imported into the United States in violation of section 505.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="HBF8B34700AA84D149B909207C547D928"><enum>306.</enum><header>Dedicated
foreign inspectorate</header><text display-inline="no-display-inline">Section
704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as amended, is
further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HF6ECC756840A4AA2A35CF7CCDC765713" style="OLC">
<subsection id="H1909EF832C7344BDAEE790FBF5E560FE"><enum>(j)</enum><text display-inline="yes-display-inline">The Secretary shall establish and maintain
a corps of inspectors dedicated to inspections of foreign drug facilities and
establishments. This corps shall be staffed and funded by the Secretary at a
level sufficient to allow it to conduct inspections of foreign drug facilities
and establishments at a frequency at least equivalent to the inspection rate of
domestic drug facilities and
establishments.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>IV</enum><header>Miscellaneous</header>
<section id="H26C18A0FE1804BD98C1250E5051186DD"><enum>401.</enum><header>Unique
identification number for establishments, importers, and customs
brokers</header><text display-inline="no-display-inline">Chapter X of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H90B84FFFEE2C490594C0C867DC3525B9" style="OLC">
<section id="H5B3A7EB105A04ED6B9ABB8769DED543B"><enum>1012.</enum><header>Unique
identifier</header>
<subsection id="HB235334BAA134BC586DA1A5027FDABB1"><enum>(a)</enum><header>Registration of
establishments</header><text>A person required to register a drug establishment
pursuant to section 510 shall submit, at the time of registration, a unique
identifier for the establishment.</text>
</subsection><subsection id="H667F5BEB97474CEBB44918B483A7840F"><enum>(b)</enum><header>Registration of
importers and customs brokers</header><text>A person required to register
pursuant to section 801(s) or 801(t) shall submit, at the time of registration,
a unique identifier for the principal place of business for which such person
is required to register under section 801(s) or 801(t).</text>
</subsection><subsection id="H6D4743CD82A348E480DE20072E4832AB"><enum>(c)</enum><header>Guidance</header><text>The
Secretary may, by guidance, and, with respect to importers and customs brokers,
in consultation with the Commissioner responsible for Customs and Border
Protection, specify the unique numerical identifier system to be used to meet
the requirements of subsections (a) and (b) and the form, manner, and timing of
a submission under such subsections. Development of such guidance shall take
into account the utilization of existing unique identification schemes and
compatibility with customs automated systems.</text>
</subsection><subsection id="HECE377C62A134F5AB4F7AF547F463CB2"><enum>(d)</enum><header>Importation</header><text>A
drug imported or offered for import shall be refused admission unless the
appropriate unique identifiers, as specified by the Secretary, are provided for
such article.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H7C994CCCA24545F79CF904CEE9B232C4"><enum>402.</enum><header>Country of
origin labeling</header>
<subsection id="H7E2BD975A8584BA79935550DE12211D3"><enum>(a)</enum><header>Misbranding</header><text>Section
502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by
adding at the end the following:</text>
<quoted-block id="H7AFDC974FE5040AF8A55504D271E576E" style="OLC">
<subsection id="HD0D4B5C6A38C416C93D0FF3733EB60F3"><enum>(aa)</enum><text>If it is a
finished dosage form drug and the Web site of the manufacturer of such drug
does not list—</text>
<paragraph id="HF8D9397F3F584D599206288D5D880B5A"><enum>(1)</enum><text>the country of
origin for each active pharmaceutical ingredient; and</text>
</paragraph><paragraph id="H50EF17C0B7E246E298D030E1E1C7CD2D"><enum>(2)</enum><text>the place of
manufacture of the finished dosage form of such
drug.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H825248888D304F5AA9010DB7FCA66CA8"><enum>(b)</enum><header>Regulations</header><text>Not
later than 3 years after the date of the enactment of this Act, the Secretary
shall promulgate final regulations to carry out section 502(aa) of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a).</text>
</subsection><subsection id="HB063030F17744A5D9AA4558C8717F5F4"><enum>(c)</enum><header>Effective
date</header><text>The requirement of section 502(aa) of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a), takes effect 4 years after
the date of the enactment of this Act.</text>
</subsection></section><section id="H078D2B7F5EF54BDDAF38B4996DFE49B3"><enum>403.</enum><header>False or
misleading reporting to FDA</header>
<subsection id="HE519B80D3E5741D680BDF8D850093903"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 301(q)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)(2)) is amended by
inserting <quote>, drug,</quote> after <quote>device</quote>.</text>
</subsection><subsection id="H065BB53346A141EA96099FCBA58FDE07"><enum>(b)</enum><header>Effective
date</header><text>The amendment made by subsection (a) shall apply to
submissions made on or after the date of the enactment of this Act.</text>
</subsection></section><section id="HC6EFF926EC8F48E5BFC0BEF172F7DACB"><enum>404.</enum><header>Subpoena
authority</header>
<subsection id="HF938F47620384D99A0BC77968BF6BC82"><enum>(a)</enum><header>Prohibited
Act</header><text display-inline="yes-display-inline">Section 301(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(f)) is amended by inserting
before the period <quote>or the failure or refusal to obey a subpoena issued
pursuant to section 312</quote>.</text>
</subsection><subsection id="H8BFCA357F10743539855D546E9E7EC79"><enum>(b)</enum><header>Exercise of
subpoena authority</header><text display-inline="yes-display-inline">Chapter
III of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.), as
amended, is further amended by adding at the end the following new
section:</text>
<quoted-block display-inline="no-display-inline" id="H9129D3EFAD344170AE012E513EC1BAD0" style="OLC">
<section id="H12C9DDBE033A499A8503180D9DD3B184"><enum>312.</enum><header>Exercise of
subpoena authority</header>
<subsection id="HA50A152664654F8ABDF5142F89B86213"><enum>(a)</enum><header>In
general</header><text>For the purpose of—</text>
<paragraph id="HE11294EB63CE496DA47A5A4B4E23AC29"><enum>(1)</enum><text>any hearing,
investigation, or other proceeding respecting a violation of a provision of
this Act, the Public Health Service Act, or the Federal Anti-Tampering Act,
relating to a drug; or</text>
</paragraph><paragraph id="H43A1B30D5A1F45EF97AC8F53EEFB8477"><enum>(2)</enum><text>any hearing,
investigation, or other proceeding to determine if a person is in violation of
a specific provision of this Act, the Public Health Service Act, or the Federal
Anti-Tampering Act, relating to a drug,</text>
</paragraph><continuation-text continuation-text-level="subsection">the
Commissioner may issue subpoenas requiring the attendance and testimony of
witnesses and the production of records and other things.</continuation-text></subsection><subsection id="H530B7128E1E5409C834084E2DEE134D4"><enum>(b)</enum><header>Timing of
compliance</header><text>When the Commissioner deems that immediate compliance
with a subpoena issued under this section is necessary to address a threat of
serious adverse health consequences or death, the subpoena may require
immediate production.</text>
</subsection><subsection id="H616A7D946AF447149C3E09E14A456854"><enum>(c)</enum><header>Service of
subpoena</header><text>Under this section:</text>
<paragraph id="H0AE1E046571649FAB100FB55B81D887C"><enum>(1)</enum><header>In
general</header><text>Subpoenas of the Commissioner shall be served by a person
authorized by the Commissioner by delivering a copy thereof to the person named
therein or by certified mail addressed to such person at such person’s last
known dwelling place or principal place of business.</text>
</paragraph><paragraph id="HAD8B92F741E54E3A971E9A4F4E2B4AE6"><enum>(2)</enum><header>Corporations and
other entities</header><text>Service on a domestic or foreign corporation,
partnership, unincorporated association, or other entity that is subject to
suit under a common name may be made by delivering the subpoena to an officer,
a managing or general agent, or any other agent authorized by appointment or by
law to receive service of process.</text>
</paragraph><paragraph id="HB7FF5C692F7645AB81D8FC2C5628DEC8"><enum>(3)</enum><header>Person outside
U.S. jurisdiction</header><text>Service on any person not found within the
territorial jurisdiction of any court of the United States may be made in any
manner as the Federal Rules of Civil Procedure prescribe for service in a
foreign nation.</text>
</paragraph><paragraph id="HD218551ABC6B497A926A19BBBD9625B1"><enum>(4)</enum><header>Proof of
service</header><text>A verified return by the person so serving the subpoena
setting forth the manner of service, or, in the case of service by certified
mail, the return post office receipt therefore signed by the person so served,
shall be proof of service.</text>
</paragraph></subsection><subsection id="H5294CAA5BAAA4067B2220552CC5D6006"><enum>(d)</enum><header>Payment of
witnesses</header><text>Witnesses subpoenaed under subsection (a) shall be paid
the same fees and mileage as are paid witnesses in the district courts of the
United States.</text>
</subsection><subsection id="H5E0D6C2BAE4E4081821E736933E273C0"><enum>(e)</enum><header>Enforcement</header><text>In
the case of a refusal to obey a subpoena duly served upon any person under
subsection (a), any district court of the United States for the judicial
district in which such person charged with refusal to obey is found, resides,
or transacts business, upon application by the Commissioner, shall have
jurisdiction to issue an order compelling compliance with the subpoena and
requiring such person to appear and give testimony or to appear and produce
records and other things, or both. The failure to obey such order of the court
may be punished by the court as contempt thereof. If the person charged with
failure or refusal to obey is not found within the territorial jurisdiction of
the United States, the United States District Court for the District of
Columbia shall have the same jurisdiction, consistent with due process, to take
any action respecting compliance with the subpoena by such person that such
district court would have if such person were personally within the
jurisdiction of such district court.</text>
</subsection><subsection id="H2874B7650737423B9DB227A736012BEF"><enum>(f)</enum><header>Nondisclosure</header><text>A
United States district court for the district in which the subpoena is or will
be served, upon application of the Commissioner, may issue an ex parte order
that no person or entity disclose to any other person or entity (other than to
an attorney to obtain legal advice) the existence of such subpoena for a period
of up to 90 days. Such order may be issued on a showing that the records or
things being sought may be relevant to the hearing, investigation, proceeding,
or other matter and that there is reason to believe that such disclosure may
result in—</text>
<paragraph id="H89A05284DD1846009CCE88FA3C2A9F07"><enum>(1)</enum><text>furtherance of a
potential violation under investigation;</text>
</paragraph><paragraph id="HFEA783E526434D2A9DBC2062FBDFF198"><enum>(2)</enum><text>endangerment to
the life or physical safety of any person;</text>
</paragraph><paragraph id="H1E6CB2ACF5554003850751262D0E11A2"><enum>(3)</enum><text>flight or other
action to avoid prosecution or other enforcement remedies;</text>
</paragraph><paragraph id="HF26964A8596E43F6871B7E0DC1B4B3C3"><enum>(4)</enum><text>destruction of or
tampering with evidence; or</text>
</paragraph><paragraph id="HF1084FC246B54E04ABF49DED00F935CB"><enum>(5)</enum><text>intimidation of
potential witnesses.</text>
</paragraph><continuation-text continuation-text-level="subsection">An order
under this subsection may be renewed for additional periods of up to 90 days
upon a showing that any of the circumstances described in paragraphs (1)
through (5) continue to exist.</continuation-text></subsection><subsection id="HC34F49AEF2664684A668C13E646CCDC5"><enum>(g)</enum><header>Relation to
other provisions</header><text>The subpoena authority vested in the
Commissioner and the district courts of the United States by this section is in
addition to any such authority vested in the Commissioner or such courts by
other provisions of law, or as is otherwise authorized by law.</text>
</subsection><subsection commented="no" id="H353117CEE31F45EFAE64E159C133454B"><enum>(h)</enum><header>Nondelegation</header><text>The
authority to issue a subpoena under this section is limited to the Commissioner
or an official designated by the Commissioner. An official may not be so
designated unless the official is the director of the district under this Act
in which the drug is located, or is an official senior to such
director.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H949E3AFA8CAD43E9AECDAC0832FFE5A1"><enum>(c)</enum><header>Failure To obey
subpoena</header><text>Section 801 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381), as amended, is further amended by adding at the end the
following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="H7B6768963CE945C68E87BA1DA7C4E02F" style="OLC">
<subsection id="HE1A5426C088B49D196967FB722702EE6"><enum>(u)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H26834F5940914DB4820E9B1FE0166F57"><enum>(1)</enum><text>A drug shall be refused
admission if any person who manufactures, processes, packs, holds, or ships
such drug before it is imported or offered for import into the United States
fails or refuses to obey a subpoena issued pursuant to section 312 and such
subpoena was issued, in whole or in part, for the purpose of determining
whether such drug is adulterated, misbranded, or an unapproved new drug.</text>
</paragraph><paragraph id="HAEB956A435384EDCA11C67D27C0E27E5" indent="up1"><enum>(2)</enum><text>No drug shall be refused admission
under this section based on the failure or refusal to obey a subpoena that has
been withdrawn by the Commissioner or quashed by a United States district
court.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="H14A701F41B8B4D82A49B4CBB1D0C7D7D"><enum>405.</enum><header>Whistleblower
protections</header><text display-inline="no-display-inline">Chapter X of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.), as amended, is
further amended by adding at the end the following:</text>
<quoted-block id="HE6428D01FE094FC1962265CBCA0D3A9A" style="OLC">
<section id="H6EAA7E5A8A3B41999CFD20725AE47E54"><enum>1013.</enum><header>Protections
for employees who refuse to violate, or who disclose violations of, this
Act</header>
<subsection id="HC7C6A16C88BE4B6190C6F7579264F401"><enum>(a)</enum><header>In
general</header><text>No person who submits or is required under this Act or
the Public Health Service Act to submit any information related to a drug, or
any officer, employee, contractor, subcontractor, or agent of such person, may
discharge, demote, suspend, threaten, harass, or in any other manner
discriminate against an employee in the terms and conditions of employment
because of any lawful act done by the employee (including any lawful act that
is within the ordinary course of the job duties of such employee)—</text>
<paragraph id="HB2C6C7B754214757BA2F9635C5609819"><enum>(1)</enum><text>to provide
information, cause information to be provided, or otherwise assist in any
investigation regarding any conduct which the employee reasonably believes
constitutes a violation of this Act that is related to a drug, or any other
provision of Federal law relating to the safety of a drug, if the information
or assistance is provided to, or an investigation stemming from the provided
information is conducted by—</text>
<subparagraph id="HFCA4AFE976CD4D6A839EC1B3008BD720"><enum>(A)</enum><text>a Federal
regulatory or law enforcement agency;</text>
</subparagraph><subparagraph id="H4E0F0C695C184FA9848905219E667C1E"><enum>(B)</enum><text>any Member of
Congress or any committee of Congress; or</text>
</subparagraph><subparagraph id="H83112A188F5944D0A1CA6CF6AB6DB851"><enum>(C)</enum><text>a person with
supervisory authority over the employee (or such other person working for the
employer who has the authority to investigate, discover, or terminate the
misconduct);</text>
</subparagraph></paragraph><paragraph id="HE8672EB8CD1346F58167A5D8F47E010A"><enum>(2)</enum><text>to file, cause to
be filed, testify, participate in, or otherwise assist in a proceeding filed,
or about to be filed (with any knowledge of the employer), in any court or
administrative forum relating to any such alleged violation; or</text>
</paragraph><paragraph id="H786C09D0F1B545B78AA741EA17954F98"><enum>(3)</enum><text>to refuse to
commit or assist in any such violation.</text>
</paragraph></subsection><subsection id="HD7EF441D4C06485DB7B8988243D77F71"><enum>(b)</enum><header>Enforcement
action</header>
<paragraph id="HBC2B92FDFD2D4267BB3E74430E04C855"><enum>(1)</enum><header>In
general</header><text>An employee who alleges discharge or other discrimination
in violation of subsection (a) may seek relief in accordance with the
provisions of subsection (c) by—</text>
<subparagraph id="H4F4BACFE8493469190E1AA2F7FF94C33"><enum>(A)</enum><text>filing a complaint
with the Secretary of Labor; or</text>
</subparagraph><subparagraph id="H864FDE7E1E0D4F67B1D4119B3FD283F0"><enum>(B)</enum><text>if the Secretary
of Labor has not issued a final decision within 210 days of the filing of the
complaint and there is no showing that such delay is due to the bad faith of
the claimant, or within 90 days after receiving a final decision or order from
the Secretary, bringing an action at law or equity for de novo review in the
appropriate district court of the United States, which court shall have
jurisdiction over such action without regard to the amount in controversy, and
which action shall, at the request of either party to such action, be tried by
the court with a jury.</text>
</subparagraph></paragraph><paragraph id="H179F90D5D0C54E23A6A8242B41044AD9"><enum>(2)</enum><header>Procedure</header>
<subparagraph id="H8826F044597340209AB8155EE1757A55"><enum>(A)</enum><header>In
general</header><text>Any action under paragraph (1) shall be governed under
the rules and procedures set forth in section 42121(b) of title 49, United
States Code.</text>
</subparagraph><subparagraph id="H917DAD3FBA4C477D8048F1F5292EE634"><enum>(B)</enum><header>Exception</header><text>Notification
in an action under paragraph (1) shall be made in accordance with section
42121(b)(1) of title 49, United States Code, except that such notification
shall be made to the person named in the complaint, the employer, and the
Commissioner of Food and Drugs.</text>
</subparagraph><subparagraph id="H9694A81FAD184DAE82F4BF19FAE72266"><enum>(C)</enum><header>Burdens of
proof</header><text>An action brought under paragraph (1)(A) or (1)(B) shall be
governed by the legal burdens of proof set forth in section 42121(b) of title
49, United States Code.</text>
</subparagraph><subparagraph id="H39DFB8C016434970A048AFA4A1AB7A55"><enum>(D)</enum><header>Statute of
limitations</header><text>An action under paragraph (1)(A) shall be commenced
not later than 180 days after the date on which the violation occurs.</text>
</subparagraph></paragraph></subsection><subsection id="H8F4AF488FC2D482C871164102905F392"><enum>(c)</enum><header>Remedies</header>
<paragraph id="HA53E552A9FC64E639FBBDFB50DCBEDF2"><enum>(1)</enum><header>In
general</header><text>An employee prevailing in any action under subsection
(b)(1) shall be entitled to all relief necessary to make the employee
whole.</text>
</paragraph><paragraph id="H255BBD28F96241D39CE1A5D316F6FEA9"><enum>(2)</enum><header>Issuance of
order</header><text>If, in response to a complaint filed under subsection
(b)(1), the Secretary of Labor or the district court, as applicable, determines
that a violation of subsection (a) has occurred, the Secretary or the court
shall order the person who committed such violation—</text>
<subparagraph id="HD7CD1AE995DC4110BDA340F9EF01AFED"><enum>(A)</enum><text>to take
affirmative action to abate the violation;</text>
</subparagraph><subparagraph id="H0865E3CB388243FCA0D2D654BF9312DD"><enum>(B)</enum><text>to—</text>
<clause id="HC19C8EF0F787441680273E2164D287F8"><enum>(i)</enum><text>reinstate the
complainant to his or her former position together with compensation (including
backpay); and</text>
</clause><clause id="H4D6C62021B1D429A874CC1319C540003"><enum>(ii)</enum><text>restore the
terms, conditions, and privileges associated with his or her employment;
and</text>
</clause></subparagraph><subparagraph id="HDE3E25A7237943B79807F7F092AE3C50"><enum>(C)</enum><text>to provide
compensatory damages to the complainant.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">If such an
order is issued under this paragraph, the Secretary or the court, at the
request of the complainant, shall assess against the person against whom the
order is issued a sum equal to the aggregate amount of all costs and expenses
(including attorney and expert witness fees) reasonably incurred, as determined
by the Secretary, by the complainant for, or in connection with, the bringing
of the complaint upon which the order was issued.</continuation-text></paragraph></subsection><subsection id="HCB14F507ADA046628C950D58A0C00117"><enum>(d)</enum><header>Rights retained
by employee</header><text>Nothing in this section shall be deemed to diminish
the rights, privileges, or remedies of any employee under any Federal or State
law or under any collective bargaining agreement. The rights and remedies in
this section may not be waived by any agreement, policy, form, or condition of
employment.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="HAE03331A72154C0B9FFBEFC344CA8BAF"><enum>406.</enum><header>Rule of
construction</header><text display-inline="no-display-inline">Nothing in this
Act or any amendment made by this Act shall be construed as affecting any
authority or requirement relating to devices (as defined in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)).</text>
</section>