‘‘(ii) shall only be collected and avail-
able to defray increases in the costs of in-
specting establishments registered under 
subsection (b), (c), (d), or (i) of section 
510 to ensure compliance by such estab-
lishments with the requirements of this Act 
relating to drugs and devices (including in-
creases in such costs for an additional 
number of full-time equivalent positions in 
the Department of Health and Human 
Services to be engaged in such inspections) 
over such costs, excluding costs paid from 
fees collected under this section, for fiscal 
year 2009 multiplied by the adjustment 
factor. 
‘‘(B) COMPLIANCE.—The Secretary shall 
be considered to have met the requirements of 
subparagraph (A)(ii) in any fiscal year if the 
costs funded by appropriations and allocated for 
inspections described in subsection (a)— 
‘‘(i) are not more than 3 percent 
below the level specified in subparagraph 
(A)(ii); or 
‘‘(ii)(I) are more than 3 percent below 
the level specified in subparagraph (A)(ii), 
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and fees assessed for the fiscal year fol-
lowing the subsequent fiscal year are de-
creased by the amount in excess of 3 per-
cent by which such costs fell below the 
level specified in such subparagraph; and 
‘‘(II) such costs are not more than 5 
percent below the level specified in such 
subparagraph. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of the fiscal years 2010 through 2014, 
there is authorized to be appropriated for fees under 
this section an amount equal to the total revenue 
amount determined under subsection (c)(1) for the 
fiscal year, as adjusted or otherwise affected under 
subsection (d) and paragraph (4) of this subsection. 
‘‘(4) OFFSET.—If the sum of the cumulative 
amount of fees collected under this section for the 
fiscal years 2010 through 2013 and the amount of 
fees estimated to be collected under this section for 
fiscal year 2014 exceeds the cumulative amount ap-
propriated under paragraph (3) for the fiscal years 
2010 through 2014, the excess shall be credited to 
the appropriation account of the Food and Drug Ad-
ministration as provided in paragraph (1), and shall 
be subtracted from the amount of fees that would 
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otherwise be authorized to be collected under this 
section for fiscal year 2014. 
‘‘(h) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed 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. 
‘‘(i) WRITTEN REQUESTS
FOR WAIVERS, REDUC-
TIONS, AND REFUNDS.—To qualify for consideration for 
a waiver or reduction under subsection (e), or for a refund 
of any fee collected in accordance with subsection (a), a 
person shall submit to the Secretary a written request for 
such waiver, reduction, or refund not later than 180 days 
after such fee is due. 
‘‘(j) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, for officers, employers, and advisory committees not 
engaged in inspections described in subsection (a), be re-
duced to offset the number of officers, employees, and ad-
visory committees so engaged. 
‘‘(k) ANNUAL FISCAL REPORTS.—Beginning with fis-
cal year 2011, not later than 120 days after the end of 
each fiscal year for which fees are collected under this sec-
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tion, the Secretary shall prepare and submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on the imple-
mentation 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. 
‘‘(l) DEFINITION.—The term ‘costs of inspecting es-
tablishments registered under subsection (b), (c), (d), or 
(i) of section 510 to ensure compliance by such establish-
ments with the requirements of this Act relating to drugs 
and devices’ means the expenses incurred, in connection 
with inspecting establishments registered under subsection 
(b), (c), (d), or (i) of section 510 to ensure compliance 
by such establishments with the requirements of this Act 
relating to drugs and devices, for— 
‘‘(1) officers and employees of the Food and 
Drug Administration, contractors of the Food and 
Drug Administration, and costs related to such offi-
cers and employees and to contracts with such con-
tractors; 
‘‘(2) management of information, and the ac-
quisition, maintenance, and repair of information 
technology resources; 
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‘‘(3) leasing, maintenance, renovation, and re-
pair of facilities and acquisition, maintenance, and 
repair of fixtures, furniture, scientific equipment, 
and other necessary materials and supplies; and 
‘‘(4) collecting fees under this section and ac-
counting for resources allocated for such inspec-
tions.’’. 
(3) 
EFFECTIVE
DATE.—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 para-
graph (2), for fiscal years beginning with fiscal year 
2010. 
(4) SUNSET DATE.—Section 736C of the Fed-
eral Food, Drug, and Cosmetic Act, as added by 
paragraph (2), 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 2014. 
SEC. 202. INSPECTION OF PRODUCERS OF DRUGS AND AC-
TIVE PHARMACEUTICAL INGREDIENTS. 
(a) INSPECTION.—Subsection (h) of section 510 (21 
U.S.C. 351) is amended— 
(1) by striking ‘‘(h)’’ and inserting ‘‘(h)(1)’’; 
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(2) by striking ‘‘Every establishment in any 
State registered with the Secretary pursuant to this 
section’’ and inserting ‘‘Every establishment reg-
istered with the Secretary pursuant to subsection 
(b), (c), (d), or (i)’’; 
(3) by striking ‘‘704(g), at least once’’ and all 
that follows and inserting the following: ‘‘704(g)— 
‘‘(A) at least once in the 2-year period begin-
ning with the date of registration of such establish-
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 
guidance, exists to assess risk and to establish a 
risk-based inspection schedule.’’; and 
(4) by adding at the end the following: 
‘‘(2)(A) The Secretary shall conduct an inspection of 
a drug establishment when the establishment begins to 
manufacture, prepare, propagate, compound, or process a 
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drug or active pharmaceutical ingredient of a drug before 
its introduction into interstate commerce if the drug or 
ingredient is new or has undergone a major change requir-
ing prior approval by the Secretary of a supplement to 
an application submitted under section 505. Notwith-
standing the preceding sentence, the Secretary may opt 
against conducting such an inspection if the Secretary de-
termines, based on the inspection history of the establish-
ment, 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 com-
pliance with current good manufacturing practice, or oth-
erwise ensure the safety of the drug or ingredient. 
‘‘(B) The Secretary shall annually submit a report 
to the Congress on each instance during the preceding 
year in which the Secretary determined under subpara-
graph (A) that an inspection was not necessary. 
‘‘(3) The Secretary may, by regulation, provide for 
a risk-based inspection schedule for establishments en-
gaged in the manufacture, propagation, compounding, or 
processing of an excipient of a drug at a frequency dif-
ferent than the inspection schedule for an establishment 
under paragraph (1). 
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‘‘(4) Nothing in this subsection shall be construed as 
limiting the authority of the Secretary to conduct inspec-
tions under any other provision of the Act. 
‘‘(5) With respect to fiscal year 2010 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; and 
‘‘(B) the number of establishments for which 
the frequency of such inspections has been modified 
pursuant to paragraph (1)(B). 
‘‘(6) For purposes of determining inspection fre-
quency under subparagraphs (A) and (B) of paragraph 
(1), the Secretary shall establish information systems ca-
pacity sufficient to assess risk and shall develop and main-
tain a risk-based system for conducting surveillance of 
current good manufacturing practices by establishments 
registered with the Secretary pursuant to subsection (b), 
(c), (d), or (i). 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 Food and Drug Administration Globalization Act of 
2009. 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 
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establishment’s compliance and safety history, the estab-
lishment’s shipping volume 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)(6) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a)(4) 
of this section. 
(c) EFFECTIVE DATE.—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. 
SEC. 203. DOCUMENTATION FOR ADMISSIBILITY OF DRUG 
IMPORTS. 
Section 801 (21 U.S.C. 381), as amended by section 
123, is further amended by adding at the end the fol-
lowing: 
‘‘(q) Beginning 3 years after the date of the enact-
ment of this subsection, a drug shall not enter the United 
States unless the party offering the drug for import pro-
vides the Secretary, at the time of offering the drug for 
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import, information demonstrating compliance with appli-
cable requirements pertaining to identity, strength, qual-
ity, purity, approval, listing, labeling, registration, and 
such additional categories as the Secretary, by guidance, 
determines are necessary for protection of the public 
health. The Secretary may allow that such compliance be 
demonstrated through verification by an accredited third 
party or through such other means as determined, by 
guidance, by the Secretary.’’. 
SEC. 204. DRUG SUPPLY QUALITY AND SAFETY. 
(a) ADULTERATION.—Section 501 (21 U.S.C. 351) 
is amended by adding at the end the following: 
‘‘(j) If it is drug that was manufactured, prepared, 
propagated, compounded, or processed by an establish-
ment that is or was at the time of such manufacture, prep-
aration, propagation, compounding, or processing in viola-
tion of section 505–2 because of— 
‘‘(1) the failure to have in effect and implement 
a quality risk management plan in accordance with 
section 505–2; or 
‘‘(2) the failure to transmit information in elec-
tronic form as requested by the Secretary under sec-
tion 505–2(f).’’. 
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(b) QUALITY RISK MANAGEMENT PLANS.—Chapter 
V (21 U.S.C. 351 et seq.) is amended by inserting after 
section 505–1 the following: 
‘‘SEC. 505–2. DRUG SUPPLY QUALITY AND SAFETY. 
‘‘(a) IMPLEMENTATION OF QUALITY RISK MANAGE-
MENT PLAN.—An establishment required to be registered 
with the Secretary pursuant to subsection (b), (c), (d), or 
(i) of section 510 for the manufacture, preparation, propa-
gation, compounding, or processing of a drug shall have 
in effect and implement an adequate quality risk manage-
ment plan that ensures the safety and quality of each such 
drug, including any ingredients produced, manufactured, 
processed, packed, or held by another person. 
‘‘(b) PLAN PROVISIONS.—A quality risk management 
plan required by subsection (a) shall address risk assess-
ment, risk control, risk communication, and risk review 
and shall— 
‘‘(1) provide for an assessment, prior to con-
tracting with a person to supply raw materials or in-
gredients or to undertake any aspect of the manu-
facturing of the drug, of the suitability and com-
petence of such person to carry out such activity, 
using audits, material evaluations, or qualification, 
as appropriate; 
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‘‘(2) define responsibilities and communication 
processes for manufacturing, quality control, and 
quality assurance activities of any person referred to 
in paragraph (1); 
‘‘(3) provide for the monitoring and review 
through periodic on-site audits of the facility condi-
tions, controls, and practices of any person referred 
to in paragraph (1) and ensure the implementation 
of appropriate measures to improve such conditions, 
controls, and practices; 
‘‘(4) provide for the monitoring of incoming 
materials to ensure they are from a person that 
meets the requirements in paragraphs (1) through 
(3); 
‘‘(5) provide for implementation of effective sys-
tems, including appropriate specifications and test 
methods and verification of the drug ingredients’ 
identity, quality, strength, and purity, to detect any 
hazard that has been, or is reasonably likely to be, 
present in or on the drug during production, manu-
facturing, processing, packing, holding, or trans-
porting; and 
‘‘(6) be periodically reviewed and, as needed, 
updated. 
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‘‘(c) ADDITIONAL PROVISIONS.—If the Secretary de-
termines that provisions in addition to those described in 
subsections (a) and (b) would be appropriate to include 
in a quality risk management plan for protection of the 
public health, including provisions for the prevention of 
intentional adulteration of a drug or class of drugs, the 
Secretary may by regulation require the inclusion of such 
provisions in a quality risk management plan. 
‘‘(d) APPLICATION
OF SPECIFICATIONS
OR TEST 
METHODS BY ORDER OF THE SECRETARY.—Upon a find-
ing that there is a significant threat to public health, the 
Secretary may order an establishment— 
‘‘(1) to promptly revise its quality risk manage-
ment plan to include new or modified specifications 
or test methods for a drug; and 
‘‘(2) to promptly implement such specifications 
or test methods. 
‘‘(e) INSPECTION OF QUALITY RISK MANAGEMENT 
PLAN.—The Secretary shall, in the course of an inspection 
of an establishment subject to this section or upon request 
by the Secretary, conduct a review of the establishment’s 
quality risk management plan. 
‘‘(f) DOCUMENTATION OF SUPPLY CHAIN.— 
‘‘(1) IN
GENERAL.—Each establishment re-
quired to be registered with the Secretary pursuant 
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to subsection (b), (c), (d), or (i) of Section 510 for 
the 
manufacture, 
preparation, 
propagation, 
compounding, or processing of a drug, shall provide 
to the Secretary, upon request, adequate information 
transmitted in electronic form, establishing— 
‘‘(A) where the drug, including its raw ma-
terials, were produced, including all preceding 
producers, manufacturers, distributors, and 
shippers; and 
‘‘(B) that the drug, its ingredients and raw 
materials were manufactured, prepared, propa-
gated, 
compounded, 
processed, 
distributed, 
shipped, warehoused, brokered, imported, and 
conveyed under conditions that ensure the iden-
tity, strength, quality, and purity of the drug. 
‘‘(2) REPACKAGERS.—For those establishments 
that are repackagers, paragraph (1)(A) requires only 
information regarding the immediately preceding es-
tablishment.’’. 
(c) EFFECTIVE DATE.— 
(1) IN GENERAL.—The requirements of sections 
501(j) and 505–2 of the Federal Food, Drug, and 
Cosmetic Act, as added by subsections (a) and (b), 
take effect 2 years after the date of the enactment 
of this Act. 
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(2) EXCEPTION.—Notwithstanding the effective 
date specified in paragraph (1)— 
(A) the authority of the Secretary to order 
an establishment to promptly implement new or 
modified specifications or test methods for a 
drug, as described in section 505–2(d)(2) of the 
Federal Food, Drug, and Cosmetic Act, as 
amended by subsection (b), shall take effect on 
the date of the enactment of this Act; 
(B) such authority shall apply irrespective 
of whether the establishment has in effect a 
quality risk management plan; and 
(C) a civil penalty under section 303(f)(5) 
of the Federal Food, Drug, and Cosmetic Act, 
as added by section 211 of this Act, shall apply 
to a violation of an order under this paragraph 
to the same extent and in the same manner as 
such a penalty applies to a violation of an order 
under such section 505–2(d)(2). 
SEC. 205. DELAY, LIMITATION, OR DENIAL OF INSPECTION. 
(a) REQUIREMENT.—Subsection (h) of section 510 
(21 U.S.C. 351), as amended by section 202(a), is further 
amended by adding at the end the following: 
‘‘(7) The person who owns or operates an establish-
ment registered with the Secretary pursuant to subsection 
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100 
(b), (c), (d), or (i), any agent or employee of such person, 
and any agent of a governmental authority in the foreign 
country within which such establishment is located shall 
not delay or limit an inspection, or refuse to permit entry 
or inspection, authorized by this subsection.’’. 
(b) REFERENCE TO PROHIBITED ACT.—For provi-
sion making delay, limiting, or denying an inspection 
under section 510(h) of the Federal Food, Drug, and Cos-
metic Act a prohibited act under section 301(f) of such 
Act, see the amendment made by section 403. 
(c) DRUGS OFFERED FOR IMPORT.—The third sen-
tence of subsection (a) of section 801 (21 U.S.C. 381), 
as amended by section 105(b), is amended by inserting 
‘‘or (5) such article has been manufactured, prepared, 
propagated, compounded, or processed by an establish-
ment required to be registered with the Secretary pursu-
ant to subsection (b), (c), (d), or (i) of section 510 and 
such establishment is in violation of section 510(h)(7) 
(prohibiting the delay, limitation, or denial of an inspec-
tion under section 510(h)),’’ before ‘‘then such article 
shall be refused admission’’. 
SEC. 206. COUNTRY OF ORIGIN LABELING. 
(a) MISBRANDING.—Section 502 (21 U.S.C. 352) is 
amended by adding at the end the following: 
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107 
termined by the Secretary. Upon the production of satis-
factory proof that the destruction of the article was not 
within the authority of the Secretary as provided in this 
section, the Secretary shall order the value of the article 
restored to the applicant.’’. 
(d) SAMPLES OF DESTROYED ARTICLES.—Section 
801 (21 U.S.C. 381), as amended by sections 123 and 
203 and subsection (c) of this section, is amended by add-
ing at the end the following: 
‘‘(s) Where an article is caused to be destroyed under 
subsection (a) the Secretary shall, upon request, provide 
a sample of the article to the owner of the article, the 
owner’s attorney or agent, or if applicable any person 
named on the label of the article, except that the Secretary 
is authorized, by regulations, to make such reasonable ex-
ceptions from, and impose such reasonable terms and con-
ditions relating to, the operation of this subsection as the 
Secretary finds necessary for the proper administration of 
the provisions of this Act.’’. 
(e) EFFECTIVE DATE.—The amendments made by 
subsections (a), (b), (c), and (d) shall take effect 90 days 
after the date of the enactment of this Act. 
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