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. 
‘‘(c) EXEMPTIONS
AND VARIANCES.—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 grant-
ing a request for exemption or variance under this sub-
section, the Secretary determines that it is appropriate to 
apply the exemption or variance to more than one manu-
facturer, the Secretary shall publish a notice of the exemp-
tion or variance in the Federal Register. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) The term ‘manufacturer’ means any per-
son who manufactures a drug. 
‘‘(2) The terms ‘manufacture’, ‘manufacturing’, 
or ‘manufactured’ include preparation, processing, 
packing, or holding. 
‘‘(3) The term ‘establish and maintain’ means 
adequately— 
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‘‘(A) define, document (by paper or elec-
tronically), implement, and follow; and 
‘‘(B) review and, as needed, revise on an 
ongoing basis.’’. 
(3) APPLICATION.—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. 
(c) DOCUMENTATION OF SUPPLY CHAIN.— 
(1) IN GENERAL.—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: 
‘‘(r) DOCUMENTATION OF SUPPLY CHAIN.—Each es-
tablishment 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 informa-
tion, in electronic form, establishing— 
‘‘(1) where the drug, including its raw mate-
rials, was produced, including all preceding pro-
ducers, manufacturers, distributors, and shippers; 
and 
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‘‘(2) 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.’’. 
(2) APPLICATION.—The amendment made by 
paragraph (1) applies beginning on the date that is 
2 years after the date of the enactment of this Act. 
SEC. 103. INSPECTION OF PRODUCERS OF DRUGS. 
(a) INSPECTION.—Subsection (h) of section 510 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360) is amended— 
(1) by striking ‘‘(h)’’ and inserting ‘‘(h)(1)’’; 
and 
(2) by adding at the end the following: 
‘‘(2) Notwithstanding paragraph (1), every establish-
ment 
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 offi-
cers or employees duly designated by the Secretary— 
‘‘(A) at least once in the 2-year period begin-
ning with the date of registration of such establish-
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ment pursuant to this section and at least once in 
every successive 2-year period thereafter; or 
‘‘(B) at least once in the 4-year period begin-
ning with the date of registration of such establish-
ment pursuant to this section and at least once in 
every successive 4-year period thereafter, if the Sec-
retary determines that sufficient information about 
the type of product produced in the establishment, 
inspection history, compliance history, and such ad-
ditional factors as the Secretary determines by guid-
ance, exists to assess risk and to establish a risk- 
based inspection schedule. 
‘‘(3) The Secretary shall conduct an inspection of a 
drug establishment when the establishment begins to man-
ufacture, 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 prod-
uct or the drug has undergone a major change requiring 
prior approval by the Secretary of a supplement to an ap-
plication submitted under section 505. Notwithstanding 
the preceding sentence, the Secretary may opt against con-
ducting 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 con-
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tained in the application (or supplement to the applica-
tion) submitted under section 505, ensure compliance with 
current good manufacturing practices, or otherwise ensure 
the safety of the drug or ingredient. 
‘‘(4) 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. 
‘‘(5) Nothing in this subsection shall be construed as 
limiting the authority of the Secretary to conduct inspec-
tions of establishments under any other provision of the 
Act. 
‘‘(6) With respect to fiscal year 2012 and each subse-
quent fiscal year, the Secretary shall submit an annual 
report to the Congress on— 
‘‘(A) funding dedicated to inspections under 
this subsection of establishments engaged in the 
manufacture, propagation, compounding, or proc-
essing of a drug; and 
‘‘(B) the number of such establishments for 
which the frequency of such inspections has been 
modified pursuant to paragraph (2). 
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‘‘(7) For purposes of determining inspection fre-
quency under paragraph (2), the Secretary shall establish 
information systems capacity sufficient to assess risk and 
shall develop and maintain a risk-based system for con-
ducting surveillance of current good manufacturing prac-
tices by establishments engaged in the manufacture, prop-
agation, compounding, or processing of a drug that is a 
finished dosage form or an active pharmaceutical ingre-
dient. 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 Drug 
Safety Enhancement Act of 2011. Such risk-based system 
shall include consideration of the class of the establish-
ment’s products and associated risks, the date the estab-
lishment was last inspected, the establishment’s compli-
ance and safety history, the establishment’s shipping vol-
ume and history, and such other factors as the Secretary 
determines relevant to assessing the risk presented by the 
establishment.’’. 
(b) GAO REPORT.—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 im-
plemented under section 510(h)(7) of the Federal Food, 
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Drug, and Cosmetic Act, as added by subsection (a)(2) 
of this section. 
(c) APPLICATION.—The amendments made by this 
section shall apply to drugs introduced or delivered for in-
troduction into interstate commerce on or after the date 
of the enactment of this Act. 
SEC. 104. PROHIBITION AGAINST DELAYING, LIMITING, OR 
REFUSING INSPECTION. 
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: 
‘‘(k) 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.’’. 
SEC. 105. CLARIFICATION OF INSPECTION AUTHORITY RE-
LATED TO BIMO AND IRB INSPECTIONS. 
(a) IN GENERAL.—Section 704(a)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)), is 
amended— 
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(1) by inserting after the second sentence the 
following: ‘‘For purposes of enforcement of this Act, 
officers or employees duly designated by the Sec-
retary, 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, spon-
sor, 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).’’; and 
(2) by inserting ‘‘or any establishment associ-
ated 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, con-
tract research organization, site management organi-
zation, 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),’’ before 
‘‘inspection shall extend to all things therein’’. 
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(b) CONFORMING AMENDMENT.—Section 704(a)(2) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
374(a)(2)) is amended by striking ‘‘third sentence’’ and 
inserting ‘‘fourth sentence’’. 
SEC. 106. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED DRUG 
PRODUCTS. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(aaa)(1) The failure to notify the Secretary in viola-
tion of section 568(a). 
‘‘(2) The failure to comply with any order issued 
under section 568.’’. 
(b) NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED DRUGS.—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: 
‘‘SEC. 568. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED DRUGS. 
‘‘(a) NOTIFICATION, NONDISTRIBUTION, AND RE-
CALL OF ADULTERATED OR MISBRANDED DRUGS.— 
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‘‘(1) IN GENERAL.—A person required, with re-
spect to drugs, to register under section 510, 801(t), 
or 801(u) that has reason to believe that— 
‘‘(A) a drug when introduced into or while 
in interstate commerce, or while held for sale 
(regardless of whether the first sale) after ship-
ment in interstate commerce, is adulterated or 
misbranded, and 
‘‘(B) as a result, the use or consumption 
of, or exposure to, the drug (or an ingredient 
or component used in any such drug) may re-
sult in illness or injury to humans or animals, 
shall, as soon as practicable, notify the Secretary of 
the identity and location of the drug. 
‘‘(2) MANNER OF NOTIFICATION.—Notification 
under paragraph (1) shall be made in such manner 
and by such means as the Secretary may require by 
regulation. 
‘‘(b) VOLUNTARY RECALL.—The Secretary may re-
quest that any person who distributes a drug that the Sec-
retary has reason to believe is adulterated, misbranded, 
or otherwise in violation of this Act voluntarily— 
‘‘(1) recall such drug; and 
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‘‘(2) provide for notice, including to individuals 
as appropriate, to persons who may be affected by 
the recall. 
‘‘(c) ORDER TO CEASE DISTRIBUTION.—If the Sec-
retary 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 author-
ity to issue an order requiring any person who distributes 
such drug to immediately cease distribution of such drug. 
‘‘(d) ACTION FOLLOWING ORDER.—Any person who 
is subject to an order under subsection (c) shall imme-
diately cease distribution of such drug and provide notifi-
cation 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 par-
ties jointly agree to an extension. After affording an op-
portunity for an informal hearing, the Secretary shall de-
termine whether the order should be amended to require 
a recall of such drug. If, after providing an opportunity 
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for such a hearing, the Secretary determines that inad-
equate grounds exist to support the actions required by 
the order, the Secretary shall vacate the order. 
‘‘(e) ORDER TO RECALL.— 
‘‘(1) AMENDMENT.—Except as provided under 
subsection (f), if after providing an opportunity for 
an informal hearing under subsection (d), the Sec-
retary 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. 
‘‘(2) CONTENTS.—An amended order under 
paragraph (1) shall— 
‘‘(A) specify a timetable in which the recall 
will occur; 
‘‘(B) require periodic reports to the Sec-
retary describing the progress of the recall; and 
‘‘(C) provide for notice, including to indi-
viduals as appropriate, to persons who may be 
affected by the recall. In providing for such no-
tice, the Secretary may allow for the assistance 
of health professionals, State or local officials, 
or other individuals designated by the Sec-
retary. 
‘‘(f) EMERGENCY RECALL ORDER.— 
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‘‘(1) IN GENERAL.—If the Secretary has cred-
ible 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— 
‘‘(A) to immediately recall such drug; and 
‘‘(B) to provide for notice, including to in-
dividuals as appropriate, to persons who may be 
affected by the recall. 
‘‘(2) ACTION FOLLOWING ORDER.—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 not-
withstanding 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 deter-
mined by the Secretary, after such an appeal is filed, 
unless the parties jointly agree to an extension. 
After affording an opportunity for an informal hear-
ing, the Secretary shall determine whether the order 
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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. 
‘‘(g) NOTICE TO CONSUMERS AND HEALTH OFFI-
CIALS.—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. 
‘‘(h) SAVINGS CLAUSE.—Nothing contained in this 
section shall be construed as limiting— 
‘‘(1) 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 
‘‘(2) 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.’’. 
(c) ARTICLES SUBJECT
TO REFUSAL.—The third 
sentence of subsection (a) of section 801 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amend-
ed by inserting ‘‘or (5) in the case of a drug, such article 
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is subject to an order under section 568 to cease distribu-
tion of or recall the article,’’ before ‘‘then such article shall 
be refused admission’’. 
(d) APPLICATION.—Sections 301(aaa) and 568 of the 
Federal Food, Drug, and Cosmetic Act, as added by sub-
sections (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. 
SEC. 107. NOTIFICATION. 
(a) IN GENERAL.— 
(1) PROHIBITED
ACTS.—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: 
‘‘(bbb) The failure to notify the Secretary in violation 
of section 569.’’. 
(2) NOTIFICATION.—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: 
‘‘SEC. 569. NOTIFICATION. 
‘‘(a) NOTIFICATION TO SECRETARY.—With respect 
to a drug, the Secretary may require notification to the 
Secretary by a regulated person of— 
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‘‘(1) the use of, or exposure to, such drug which 
may result in illness or injury to humans or animals; 
‘‘(2) a significant loss or known theft of such 
drug; 
‘‘(3) a reasonable probability that such drug 
has been or is being counterfeited; 
‘‘(4) repeated failures by a manufacturer of a 
component or other material used in the manufac-
ture of such drug to ensure compliance with applica-
ble 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; 
‘‘(5) any incident causing such drug to be mis-
taken for, or its labeling applied to, another drug; 
‘‘(6) 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 es-
tablished specification; and 
‘‘(7) any other type of information regarding 
such drug that the Secretary deems necessary for 
protection of the public health. 
‘‘(b) 
MANNER
OF
NOTIFICATION.—Notification 
under this section shall be made in such manner and by 
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such means as the Secretary may require by regulation 
or guidance. 
‘‘(c) DEFINITION.—In this section, the term ‘regu-
lated person’ means a person who is required to register 
under section 510, 801(t), or 801(u); a wholesale dis-
tributor of a drug product; and any other person that dis-
tributes drugs except exclusively for retail sale.’’. 
(b) EXCHANGE OF INFORMATION.— 
(1) PROHIBITED ACTS.— 
(A) IN GENERAL.—The first sentence of 
section 301(j) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(j)) is amended— 
(i) by striking ‘‘or’’ before ‘‘to the 
courts when relevant’’; and 
(ii) by inserting ‘‘, or as specified in 
section 708,’’ before ‘‘any information ac-
quired’’. 
(B) TECHNICAL CORRECTIONS.—The first 
sentence of such section 301(j) is further 
amended— 
(i) by striking ‘‘573.’’ and inserting 
‘‘573’’; and 
(ii) by striking the second of the two 
consecutive periods at the end. 
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(2) AMENDMENT.—Section 708 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379) is 
amended— 
(A) by striking ‘‘The Secretary’’ and in-
serting ‘‘(a) The Secretary’’; and 
(B) by adding at the end the following: 
‘‘(b)(1)(A) The Secretary may provide to any Federal 
agency acting within the scope of its jurisdiction any infor-
mation 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 sec-
tion. 
‘‘(B) Any such information provided to another Fed-
eral agency shall not be disclosed by such agency except 
in any investigation within the receiving agency’s jurisdic-
tion 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. 
‘‘(2)(A) In carrying out this Act, the Secretary may 
provide to a State or local government agency any infor-
mation 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. 
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‘‘(B) Any such information provided to a State or 
local government agency shall not be disclosed by such 
agency. 
‘‘(3) 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 disclo-
sure 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 Sec-
retary that the recipient will preserve the confidentiality 
of the information. 
‘‘(4) In carrying out this Act, the Secretary may pro-
vide 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— 
‘‘(A) to any foreign government agency; or 
‘‘(B) any international organization established 
by law, treaty, or other governmental action and 
having responsibility— 
‘‘(i) to facilitate global or regional harmo-
nization of standards and requirements in an 
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area of responsibility of the Food and Drug Ad-
ministration; or 
‘‘(ii) to promote and coordinate public 
health efforts, if the agency or organization pro-
vides adequate assurances to the Secretary that 
the agency or organization will preserve the 
confidentiality of the information. 
‘‘(c) Except as provided by section 301(j), the Sec-
retary may disclose to the public any information respect-
ing a drug that is exempt from disclosure pursuant to sec-
tion 552(a) of title 5, United States Code, by reason of 
subsection (b)(4) of such section, if the Secretary deter-
mines that such disclosure is necessary to protect the pub-
lic health. 
‘‘(d) Except as provided in subsection (e), the Sec-
retary 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 for-
eign government agency, or from an international organi-
zation described in subsection (b)(4), if the agency or or-
ganization has requested that the information be kept con-
fidential, or has precluded such disclosure under other use 
limitations, as a condition of providing the information. 
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‘‘(e) Nothing in subsection (d) authorizes the Sec-
retary to withhold information from the Congress or pre-
vents the Secretary from complying with an order of a 
court of the United States. 
‘‘(f) This section shall not affect the authority of the 
Secretary to provide or disclose information under any 
other provision of law.’’. 
TITLE II—RESPONSE 
SEC. 201. ADMINISTRATIVE DETENTION. 
(a) ADMINISTRATIVE DETENTION OF DRUGS.—Sec-
tion 304 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 334) is amended by adding at the end the fol-
lowing: 
‘‘(i) ADMINISTRATIVE DETENTION OF DRUGS.— 
‘‘(1) DETENTION AUTHORITY.— 
‘‘(A) IN GENERAL.—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 pe-
riod of detention greater than 20 days is re-
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quired to institute an action under subsection 
(a) or section 302, in which case the Secretary 
may authorize a detention period of not to ex-
ceed 60 days. 
‘‘(B) SECRETARY’S
APPROVAL.—Regula-
tions 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. 
‘‘(C) SECURITY OF DETAINED DRUG.—A 
detention order under this paragraph may re-
quire— 
‘‘(i) the labeling or marking of a drug 
during the period of its detention for the 
purpose of identifying the drug as de-
tained; and 
‘‘(ii) that the drug be removed to a se-
cure facility, as appropriate. 
‘‘(D) APPEAL OF DETENTION ORDER.— 
‘‘(i) RIGHT TO APPEAL.—Any person 
who would be entitled to claim a drug if it 
were seized under subsection (a) may ap-
peal to the Secretary a detention of such 
drug under this paragraph. 
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‘‘(ii) HEARING
AND
RESPONSE.— 
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. 
‘‘(2) LIMITATION ON MOVEMENT OF DETAINED 
DRUGS.— 
‘‘(A) IN GENERAL.—Except as authorized 
by subparagraph (B), a drug subject to a deten-
tion order issued under paragraph (1) shall not 
be moved by any person from the place at 
which it is ordered detained until— 
‘‘(i) released by the Secretary; or 
‘‘(ii) the expiration of the detention 
period applicable to such order, 
whichever occurs first. 
‘‘(B) EXCEPTION.—A drug subject to a de-
tention order under paragraph (1) may be 
moved— 
‘‘(i) in accordance with regulations 
prescribed by the Secretary; and 
‘‘(ii) if not in final form for shipment, 
at the discretion of the manufacturer of 
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the device for the purpose of completing 
the work required to put it in such form.’’. 
(b) REGULATIONS.—The Secretary shall issue regula-
tions or guidance to implement the amendments made by 
this section. 
(c) PROHIBITED ACTS.—Section 301(r) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331), is 
amended— 
(1) by inserting ‘‘, drug,’’ after ‘‘device’’, each 
place it appears; and 
(2) by inserting ‘‘or section 304(i)’’ after ‘‘sec-
tion 304(g)’’. 
(d) EFFECTIVE DATE.—The amendments made by 
this section shall apply beginning on the day that is 180 
days after the date of enactment of this Act. 
SEC. 202. DESTRUCTION OF ADULTERATED, MISBRANDED, 
OR COUNTERFEIT DRUGS OFFERED FOR IM-
PORT. 
(a) IN GENERAL.—Section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381) is amended by 
adding at the end the following: 
‘‘(r)(1) 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— 
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‘‘(A) poses a reasonable probability of causing 
a significant adverse health effect, as determined by 
the Secretary of Health and Human Services; or 
‘‘(B) 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). 
‘‘(2) The Secretary of Health and Human Services 
shall issue regulations providing for notice and an oppor-
tunity for an informal hearing for destruction of drugs 
under paragraph (1). The regulations under this para-
graph shall allow the Secretary of Health and Human 
Services to provide the notice and opportunity for an infor-
mal hearing to the owner or consignee after the destruc-
tion has occurred. 
‘‘(3) 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).’’. 
(b) CONFORMING AMENDMENT.—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 ‘‘The Secretary of the Treasury shall’’ and insert-
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ing ‘‘Except as provided in subsection (r), the Secretary 
of the Treasury shall’’. 
(c) APPLICATION.—The amendments made by sub-
sections (a) and (b) shall apply beginning on the day that 
is 90 days after the date of the enactment of this Act. 
SEC. 203. CRIMINAL PENALTIES. 
Section 303 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 333) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1), by striking ‘‘Any’’ 
and inserting ‘‘Except as provided in paragraph 
(2) or (3), any’’; and 
(B) by adding at the end the following: 
‘‘(3) 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 ac-
cordance with title 18, United States Code, or both.’’; and 
(2) in subsection (b)(1), by striking ‘‘fined not 
more than $250,000’’ and inserting ‘‘fined in ac-
cordance with title 18, United States Code’’. 
SEC. 204. CIVIL PENALTIES. 
(a) IN GENERAL.—Section 303(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331(f)) is 
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amended by striking paragraph (4) and inserting the fol-
lowing: 
‘‘(4)(A) Except as provided in paragraph (3) 
and subsection (g), any person who violates a re-
quirement of this Act that relates to drugs shall be 
subject to a civil penalty in an amount not to ex-
ceed— 
‘‘(i) $500,000 for each such violation; and 
‘‘(ii) for all such violations adjudicated in 
a single proceeding, $10,000,000. 
‘‘(B) Each violation described in subparagraph 
(A) and each day during which the violation con-
tinues shall be considered to be a separate offense.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) Section 303(f)(3) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331(f)(3)) is 
amended— 
(A) in subparagraph (A), by striking ‘‘Any 
person who’’ and inserting ‘‘Notwithstanding 
paragraph (4), any person who’’; and 
(B) in subparagraph (B), by striking ‘‘If a 
violation of’’ and inserting ‘‘Notwithstanding 
paragraph (4), if a violation of’’. 
(2) Section 303(g)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331(g)(1)) is 
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amended by striking ‘‘With respect to a person who’’ 
and inserting ‘‘Notwithstanding subsection (f)(4), 
with respect to a person who’’. 
SEC. 205. SEIZURE. 
Section 304(b) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 334(b)) is amended— 
(1) by striking ‘‘(b)’’ and inserting ‘‘(b)(1)’’; 
and 
(2) by adding at the end the following: 
‘‘(2) PROCEDURE WITH RESPECT TO DRUGS; MUL-
TIPLICITY OF PENDING PROCEEDINGS.—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 cir-
cumstances shall be deemed to exist for all such seizures 
brought under this section, and in such cases, the sum-
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mons and arrest warrant shall be issued by the clerk of 
the court without court review. When libel for condemna-
tion proceedings relating to a drug under this section, in-
volving the same claimant and the same issues of adultera-
tion or misbranding, are pending in two or more jurisdic-
tions, such pending proceedings, upon application of the 
claimant reasonably made to the court of one such juris-
diction, 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.’’. 
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SEC. 206. ASSET FORFEITURE. 
(a) IN GENERAL.—Section 303 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 
adding at the end the following: 
‘‘(h) FORFEITURE RELATED TO VIOLATIONS WITH 
RESPECT TO DRUGS.— 
‘‘(1) CRIMINAL FORFEITURE.—Any person con-
victed 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 sec-
tion 413 of the Controlled Substances Act, except 
subsections (a), (d), and (q) of such section 413, 
shall apply to criminal forfeitures under this para-
graph. 
‘‘(2) CIVIL
FORFEITURE.—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 
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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 per-
formed 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.’’. 
(b) CIVIL FORFEITURE STATUTE DEFINITION.— 
Subparagraph (C) of section 983(i)(2) of title 18, United 
States Code, is amended to read as follows: 
‘‘(C) section 304 of the Federal Food, 
Drug, and Cosmetic Act;’’. 
TITLE III—IMPORTATION AND 
EXPORTATION 
SEC. 301. DOCUMENTATION FOR ADMISSIBILITY OF IM-
PORTS. 
(a) PROHIBITION.—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: 
‘‘(ccc) The submission (with respect to drugs) of in-
formation that is required pursuant to section 801 that 
is inaccurate or incomplete. 
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‘‘(ddd) The failure (with respect to drugs) to submit 
information that is required pursuant to section 801.’’. 
(b) DOCUMENTATION FOR IMPORTS.—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: 
‘‘(s) DOCUMENTATION.— 
‘‘(1) SUBMISSION.—The Secretary may require 
by regulation the submission of documentation or 
other information for a drug that is imported or of-
fered for import into the United States. When devel-
oping any regulation in accordance with this para-
graph, to the extent that the collection of docu-
mentation or other information involves Customs 
and Border Protection efforts or resources, the Sec-
retary shall consult with Customs and Border Pro-
tection. 
‘‘(2) FORMAT.—A regulation under paragraph 
(1) may specify the format for submission of the 
documentation or other information. 
‘‘(3) REFUSAL
OF
ADMISSION.—A drug im-
ported or offered for import into the United States 
shall be refused admission unless all documentation 
and information the Secretary requires under this 
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Act or the Public Health Service Act for such article 
is submitted.’’. 
SEC. 302. REGISTRATION FOR COMMERCIAL IMPORTERS; 
FEE. 
(a) REGISTRATION.— 
(1) PROHIBITIONS.—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: 
‘‘(eee) The failure to register in accordance with sec-
tion 801(t).’’. 
(2) MISBRANDING.—Section 502(o) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
352(o)), as amended, is further amended by insert-
ing ‘‘if it is imported or offered for import by an im-
porter not duly registered under section 801(t),’’ be-
fore ‘‘or if it does not bear’’. 
(3) REGISTRATION.—Section 801 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 381) 
is amended by adding at the end the following: 
‘‘(t) REGISTRATION OF IMPORTERS.— 
‘‘(1) REGISTRATION.—The Secretary shall re-
quire an importer of drugs— 
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‘‘(A) to be registered with the Secretary in 
a form and manner specified by the Secretary; 
and 
‘‘(B) consistent with section 1013, to sub-
mit appropriate unique identifiers as a condi-
tion of registration. 
‘‘(2) GOOD IMPORTER PRACTICES.—The main-
tenance of registration under this subsection is con-
ditioned on compliance with good importer practices 
in accordance with the following: 
‘‘(A) The Secretary, in consultation with 
Customs and Border Protection, shall promul-
gate regulations to establish good importer 
practices that specify the measures an importer 
shall take to ensure imported drugs are in com-
pliance with the requirements of this Act and 
the Public Health Service Act. 
‘‘(B) The measures under subparagraph 
(A) shall ensure that the importer— 
‘‘(i) has adequate information about 
the article, its hazards, and the require-
ments of this Act and the Public Health 
Service Act applicable to such article; 
‘‘(ii) has adequate information or pro-
cedures in place to verify that both the ar-
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ticle and each person that produced, manu-
factured, processed, packed, transported, 
or held the article, including components of 
the article, are in compliance with the re-
quirements of this Act and the Public 
Health Service Act; and 
‘‘(iii) 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. 
‘‘(C) In promulgating good importer prac-
tice regulations under this subsection, the Sec-
retary 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. 
‘‘(3) SUSPENSION OF REGISTRATION.— 
‘‘(A) IN
GENERAL.—Registration under 
this subsection is subject to suspension upon a 
finding by the Secretary, after notice and an 
opportunity for an informal hearing, of— 
‘‘(i) a violation of this Act; or 
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‘‘(ii) the knowing or repeated making 
of an inaccurate or incomplete statement 
or submission of information relating to 
the importation of a drug. 
‘‘(B) REQUEST.—The importer whose reg-
istration 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. 
‘‘(C) VACATING OF SUSPENSION.—If the 
Secretary determines that adequate reasons do 
not exist to continue the suspension of a reg-
istration, the Secretary shall vacate such sus-
pension. 
‘‘(4) CANCELLATION OF REGISTRATION.— 
‘‘(A) IN GENERAL.—Not earlier than 10 
days after providing the notice under subpara-
graph (B), the Secretary may cancel a registra-
tion if the Secretary determines that— 
‘‘(i) such registration was not updated 
in accordance with this section or other-
wise contains false, incomplete, or inac-
curate information; or 
‘‘(ii) the registration fee required 
under section 744 for such registration has 
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not been paid within 30 days after the date 
due. 
‘‘(B) NOTICE
OF
CANCELLATION.—Can-
cellation shall be preceded by notice to the im-
porter of the intent to cancel the registration 
and the basis for such cancellation. 
‘‘(C) TIMELY UPDATE OR CORRECTION.— 
If the registration for the importer is updated 
or corrected no later than 7 days after notice 
is provided under subparagraph (B), the Sec-
retary shall not cancel such registration. 
‘‘(5) EXEMPTIONS.—The Secretary, by notice 
in the Federal Register— 
‘‘(A) shall establish an exemption from the 
requirements of this subsection for importations 
for personal use; and 
‘‘(B) may establish other exemptions from 
the requirements of this subsection.’’. 
(4) REGULATIONS.—Not later than 36 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services in consulta-
tion with the Commissioner responsible for Customs 
and Border Protection shall promulgate the regula-
tions required to carry out section 801(t) of the 
Federal Food, Drug, and Cosmetic Act, as added by 
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paragraph (3). In establishing the effective date of 
a regulation promulgated under section 801(t), the 
Secretary shall, in consultation with the Commis-
sioner responsible for Customs and Border Protec-
tion, 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. 
(5) EFFECTIVE DATE.—The amendments made 
by this subsection shall take effect on the date that 
is 24 months after the date of enactment of this Act. 
(b) FEE.—Subchapter C of chapter VII of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379f et 
seq.) is amended by adding at the end the following: 
‘‘PART 7—IMPORTERS OF DRUGS 
‘‘SEC. 744. IMPORTERS OF DRUGS. 
‘‘(a) IMPORTERS.—The Secretary shall assess and 
collect an annual fee for the registration of an importer 
under section 801(t). 
‘‘(b) AMOUNT OF FEE.— 
‘‘(1) BASE
AMOUNTS.—The registration fee 
under subsection (a) shall be— 
‘‘(A) for fiscal year 2012, $500; and 
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‘‘(B) for fiscal year 2013 and each subse-
quent fiscal year, the fee for fiscal year 2012 as 
adjusted under paragraph (2). 
‘‘(2) ADJUSTMENT.—For fiscal year 2013 and 
subsequent fiscal years, the fees established pursu-
ant to paragraph (1) shall be adjusted by the Sec-
retary by notice, published in the Federal Register, 
for a fiscal year to reflect the greater of— 
‘‘(A) the total percentage change that oc-
curred 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; 
‘‘(B) the total percentage change for the 
previous fiscal year in basic pay under the Gen-
eral Schedule in accordance with section 5332 
of title 5, United States Code, as adjusted by 
any locality-based comparability payment pur-
suant to section 5304 of such title for Federal 
employees stationed in the District of Columbia; 
or 
‘‘(C) the average annual change in the 
cost, per full-time equivalent position of the 
Food and Drug Administration, of all personnel 
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compensation and benefits paid with respect to 
such positions for the first 5 years of the pre-
ceding 6 fiscal years. 
‘‘(3) COMPOUNDED
BASIS.—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. 
‘‘(4) WAIVER
FOR
IMPORTERS
REQUIRED
TO 
PAY REGISTRATION FEE.—The Secretary shall waive 
the fee applicable to a person under this section if 
such person is required to pay both— 
‘‘(A) a fee under section 736C for registra-
tion of one or more establishments under sec-
tion 510, for drugs; and 
‘‘(B) a fee under this section for registra-
tion as an importer under section 801(t). 
‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
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penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATIONS 
ACTS.—The fees authorized by this section— 
‘‘(A) shall be retained in each fiscal year in 
an amount not to exceed the amount specified 
in appropriations Acts, or otherwise made avail-
able for obligation, for such fiscal year; and 
‘‘(B) shall only be collected and available 
to cover the costs associated with registering 
importers under sections 801(t) and with ensur-
ing compliance with good importer practices. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
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.’’. 
(c) INSPECTION.—Section 704 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374) is amended by 
adding at the end the following: 
‘‘(h) IMPORTERS.—Every person engaged in the im-
porting 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 
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‘‘(A) to be registered with the Secretary in 
a form and manner specified by the Secretary; 
and 
‘‘(B) consistent with section 1013, to sub-
mit appropriate unique identifiers as a condi-
tion of registration. 
‘‘(2) CANCELLATION OF REGISTRATION.— 
‘‘(A) IN GENERAL.—Not earlier than 10 
days after providing the notice under subpara-
graph (B), the Secretary may cancel a registra-
tion that the Secretary determines was not up-
dated in accordance with this section or other 
wise contains false, incomplete, or inaccurate 
information. 
‘‘(B) NOTICE
OF
CANCELLATION.—Can-
cellation shall be preceded by notice to the cus-
toms broker of the intent to cancel the registra-
tion and the basis for such cancellation. 
‘‘(C) TIMELY UPDATE OR CORRECTION.— 
If the registration for the customs broker is up-
dated or corrected no later than 7 days after 
notice is provided under subparagraph (B), the 
Secretary shall not cancel such registration. 
‘‘(3) NOTIFICATION.—The Secretary shall no-
tify the Commissioner responsible for Customs and 
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Border Protection whenever the Secretary cancels a 
registration under this subsection. 
‘‘(4) EXEMPTIONS.—In consultation with the 
Commissioner responsible for Customs and Border 
Protection, the Secretary, by notice published in the 
Federal Register— 
‘‘(A) shall establish an exemption from the 
requirements of this subsection for importations 
for personal use; and 
‘‘(B) may establish other exemptions from 
the requirements of this subsection. 
‘‘(5) CIVIL PENALTIES.—Notwithstanding any 
other provision in this Act, a customs broker who 
violates section 301 because of a violation of sub-
section (ccc), (ddd), or (eee) of such section shall not 
be subject to a civil penalty under section 
303(f)(1)(C) of this Act.’’. 
(4) REGULATIONS.—Not later than 24 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services, in consulta-
tion with the Commissioner responsible for Customs 
and Border Protection, shall promulgate the regula-
tions required to carry out section 801(u) of the 
Federal Food, Drug, and Cosmetic Act, as added by 
paragraph (3). 
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(5) EFFECTIVE DATE.—The amendments made 
by this subsection shall take effect on the date that 
is 24 months after the date of enactment of this Act. 
(b) INSPECTION.—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: 
‘‘(i) BROKERS.—Every customs broker required to be 
registered with the Secretary shall, upon request of an of-
ficer 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.’’. 
SEC. 304. EXPORTATION CERTIFICATE PROGRAM. 
Section 801(e)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(e)(4)) is amended— 
(1) in subparagraph (B), by striking ‘‘If the 
Secretary’’ and inserting ‘‘With respect to a device, 
if the Secretary’’; and 
(2) by adding at the end the following: 
‘‘(E) With respect to a drug: 
‘‘(i) A certification by the Secretary under 
subparagraph (A) need not be in writing. 
‘‘(ii) Subparagraph (A) applies only with 
respect to exportation from the United States. 
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‘‘(iii) Any person who exports from a coun-
try other than the United States a drug ap-
proved 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. 
‘‘(iv) 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. 
‘‘(v) 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 deter-
mines is reasonably related to the cost of 
issuing such certificates. The Secretary may ad-
just this fee annually to account for inflation 
and other cost adjustments. Fees collected for 
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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 accord-
ance 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 nec-
essary may be transferred from such appropria-
tion 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 limita-
tion.’’. 
SEC. 305. EXTRATERRITORIAL JURISDICTION. 
(a) IN GENERAL.—Chapter III of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 311. EXTRATERRITORIAL JURISDICTION. 
‘‘There is extraterritorial jurisdiction over any viola-
tion of this Act relating to any drug if such drug was in-
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tended for import into the United States or if any act in 
furtherance of the violation was committed in the United 
States.’’. 
(b) PROHIBITION.—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: 
‘‘(fff) The production, manufacture, processing, prep-
aration, 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, pack-
ing, 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.’’. 
SEC. 306. DEDICATED FOREIGN INSPECTORATE. 
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: 
‘‘(j) 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 es-
tablishments at a frequency at least equivalent to the in-
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spection rate of domestic drug facilities and establish-
ments.’’. 
TITLE IV—MISCELLANEOUS 
SEC. 401. UNIQUE IDENTIFICATION NUMBER FOR ESTAB-
LISHMENTS, IMPORTERS, AND CUSTOMS BRO-
KERS. 
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: 
‘‘SEC. 1013. UNIQUE IDENTIFIER. 
‘‘(a) REGISTRATION OF ESTABLISHMENTS.—A per-
son required to register a drug establishment pursuant to 
section 510 shall submit, at the time of registration, a 
unique identifier for the establishment. 
‘‘(b) REGISTRATION OF IMPORTERS AND CUSTOMS 
BROKERS.—A person required to register pursuant to sec-
tion 801(t) or 801(u) shall submit, at the time of registra-
tion, a unique identifier for the principal place of business 
for which such person is required to register under section 
801(t) or 801(u). 
‘‘(c) GUIDANCE.—The Secretary may, by guidance, 
and, with respect to importers and customs brokers, in 
consultation with the Commissioner responsible for Cus-
toms and Border Protection, specify the unique numerical 
identifier system to be used to meet the requirements of 
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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 ex-
isting unique identification schemes and compatibility with 
customs automated systems. 
‘‘(d) IMPORTATION.—A drug imported or offered for 
import shall be refused admission unless the appropriate 
unique identifiers, as specified by the Secretary, are pro-
vided for such article.’’. 
SEC. 402. COUNTRY OF ORIGIN LABELING. 
(a) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
ed by adding at the end the following: 
‘‘(aa) If it is a finished dosage form drug and the 
Web site of the manufacturer of such drug does not list— 
‘‘(1) the country of origin for each active phar-
maceutical ingredient; and 
‘‘(2) the place of manufacture of the finished 
dosage form of such drug.’’. 
(b) REGULATIONS.—Not later than 3 years after the 
date of the enactment of this Act, the Secretary shall pro-
mulgate final regulations to carry out section 502(aa) of 
the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a). 
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(c) EFFECTIVE DATE.—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. 
SEC. 403. FALSE OR MISLEADING REPORTING TO FDA. 
(a) IN GENERAL.—Section 301(q)(2) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)(2)) is 
amended by inserting ‘‘, drug,’’ after ‘‘device’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to submissions made on or after 
the date of the enactment of this Act. 
SEC. 404. SUBPOENA AUTHORITY. 
(a) PROHIBITED ACT.—Section 301(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331(f)) is 
amended by inserting before the period ‘‘or the failure or 
refusal to obey a subpoena issued pursuant to section 
312’’. 
(b) EXERCISE OF SUBPOENA AUTHORITY.—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: 
‘‘SEC. 312. EXERCISE OF SUBPOENA AUTHORITY. 
‘‘(a) IN GENERAL.—For the purpose of— 
‘‘(1) any hearing, investigation, or other pro-
ceeding respecting a violation of a provision of this 
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Act, the Public Health Service Act, or the Federal 
Anti-Tampering Act, relating to a drug; or 
‘‘(2) any hearing, investigation, or other pro-
ceeding 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, re-
lating to a drug, 
the Commissioner may issue subpoenas requiring the at-
tendance and testimony of witnesses and the production 
of records and other things. 
‘‘(b) TIMING OF COMPLIANCE.—When the Commis-
sioner 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 sub-
poena may require immediate production. 
‘‘(c) SERVICE OF SUBPOENA.—Under this section: 
‘‘(1) IN GENERAL.—Subpoenas of the Commis-
sioner 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. 
‘‘(2) CORPORATIONS AND OTHER ENTITIES.— 
Service on a domestic or foreign corporation, part-
nership, unincorporated association, or other entity 
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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 au-
thorized by appointment or by law to receive service 
of process. 
‘‘(3) PERSON
OUTSIDE
U.S. JURISDICTION.— 
Service on any person not found within the terri-
torial 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. 
‘‘(4) PROOF OF SERVICE.—A verified return by 
the person so serving the subpoena setting forth the 
manner of service, or, in the case of service by cer-
tified mail, the return post office receipt therefore 
signed by the person so served, shall be proof of 
service. 
‘‘(d) PAYMENT OF WITNESSES.—Witnesses subpoe-
naed under subsection (a) shall be paid the same fees and 
mileage as are paid witnesses in the district courts of the 
United States. 
‘‘(e) ENFORCEMENT.—In the case of a refusal to 
obey a subpoena duly served upon any person under sub-
section (a), any district court of the United States for the 
judicial district in which such person charged with refusal 
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to obey is found, resides, or transacts business, upon ap-
plication 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 sub-
poena by such person that such district court would have 
if such person were personally within the jurisdiction of 
such district court. 
‘‘(f) NONDISCLOSURE.—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 
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