I 
111TH CONGRESS 
2D SESSION 
H. R. 6543 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
of drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 17, 2010 
Mr. DINGELL (for himself, Mr. WAXMAN, Mr. PALLONE, and Mr. STUPAK) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
improve the safety of drugs, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Drug Safety Enhance-
ment Act of 2011’’. 
SEC. 2. TABLE OF CONTENTS. 
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. 
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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 inspec-
tions. 
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 cus-
toms 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. 
TITLE I—PREVENTION 
SEC. 101. REGISTRATION OF PRODUCERS OF DRUGS; AP-
PLICABLE FEE. 
(a) FOREIGN REGISTRANTS.— 
(1) MISBRANDING.—Section 502(o) of the Fed-
eral, Food, Drug, and Cosmetic Act (21 U.S.C. 
352(o)) is amended by inserting ‘‘if it is a drug and 
was manufactured, prepared, propagated, com-
pounded, or processed in an establishment not duly 
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registered under section 510(i),’’ after ‘‘not duly 
registered under section 510,’’. 
(2) APPLICATION.—The amendment made by 
paragraph (1) applies only with respect to registra-
tion (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 en-
actment of this Act. 
(b) EXCIPIENT MANUFACTURERS.— 
(1) IN
GENERAL.—Not later than 6 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services shall revise 
section 207.10 of title 21, Code of Federal Regula-
tions, and such other regulations as may be nec-
essary to require owners and operators of establish-
ments that engage in the manufacture, preparation, 
propagation, compounding, or processing of an ex-
cipient of a drug to register such establishments 
under section 510 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360). 
(2) APPLICATION.—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 
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on or after the date that is 18 months after the date 
of the enactment of this Act. 
(c) DRUG LISTING ELEMENTS AND FREQUENCY.— 
(1) IN GENERAL.—Sections 510(j) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360(j)) is amended— 
(A) in paragraph (1), by amending sub-
paragraph (C) to read as follows: 
‘‘(C) 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 nec-
essary to carry out the purposes of this Act; and’’; 
and 
(B) in paragraph (2), in the matter pre-
ceding subparagraph (A), by inserting ‘‘, unless 
otherwise specified by the Secretary’’ after 
‘‘once during the month of December of each 
year’’. 
(2) APPLICATION.—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 
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or after the date that is 6 months after the date of 
the enactment of this Act. 
(d) SUSPENSION AND CANCELLATION OF REGISTRA-
TION.—Section 510 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j) is amended by adding at the 
end the following: 
‘‘(q) SUSPENSION
AND CANCELLATION
OF REG-
ISTRATION.—With respect to any registration under this 
section attributable to the manufacture, preparation, 
propagation, compounding, or processing of a drug: 
‘‘(1) SUSPENSION OF REGISTRATION.— 
‘‘(A) IN
GENERAL.—Registration under 
this section 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 
‘‘(ii) 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. 
‘‘(B) REQUEST.—Any person or establish-
ment whose registration is suspended under 
subparagraph (A) may request that the Sec-
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retary vacate the suspension when such person 
or establishment 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 under subparagraph (A), the Secretary 
shall vacate such suspension. 
‘‘(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 if the Secretary determines that— 
‘‘(i) such registration was not updated 
in accordance with this section or contains 
false, incomplete, or inaccurate informa-
tion; or 
‘‘(ii) the fee required under section 
736C for such registration has not been 
paid within 30 days after the date due. 
‘‘(B) NOTICE OF CANCELLATION.—Before 
cancelling the registration of a person or estab-
lishment under this section, the Secretary shall 
give notice to the person or establishment of the 
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Secretary’s intent to cancel the registration and 
the basis for such cancellation. 
‘‘(C) TIMELY UPDATE OR CORRECTION.— 
If a registration is adequately updated or cor-
rected no later than 7 days after notice is pro-
vided under subparagraph (B) with respect to 
the registration, the Secretary shall not cancel 
such registration.’’. 
(e) REGISTRATION FEE.— 
(1) ESTABLISHMENT.—Part 2 of subchapter C 
of chapter VII of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379g et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 736C. REGISTRATION FEE. 
‘‘(a) IN GENERAL.—In the case of any registration 
under section 510 that is attributable to the manufacture, 
preparation, propagation, compounding, processing, or im-
porting 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. 
‘‘(b) PAYABLE DATE.—A fee under this section shall 
be payable— 
‘‘(1) for a facility that was not registered under 
section 510 for the preceding fiscal year, on the date 
of registration; and 
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‘‘(2) for any other facility— 
‘‘(A) for fiscal year 2012, not later than 
the sooner of 90 days after the date of the en-
actment of this section or December 31, 2011; 
and 
‘‘(B) for a subsequent fiscal year, not later 
than December 31 of such fiscal year. 
‘‘(c) FEE AMOUNTS.— 
‘‘(1) TOTAL REVENUE AMOUNT.— 
‘‘(A) INITIAL YEAR.—For fiscal year 2012, 
fees under subsection (a) shall, except as pro-
vided 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. 
‘‘(B) SUBSEQUENT YEARS.—For each of 
fiscal years 2013 through 2016, fees under sub-
section (a) shall, except as provided in sub-
sections (f) and (g), be the total revenue 
amount for fiscal year 2012, as adjusted under 
subsection (d). 
‘‘(2) ANNUAL FEE SETTING.—For fiscal year 
2012 and each subsequent fiscal year, the Secretary 
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shall establish registration fees under subsection 
(a)— 
‘‘(A) based on the total revenue amount 
applicable under paragraph (1); and 
‘‘(B) taking into consideration the dif-
ference in costs of inspections between foreign 
and domestic establishments. 
‘‘(3) TRANSMISSION TO CONGRESS.—Not later 
than 60 days before the start of fiscal year 2012 
and each subsequent fiscal year, the Secretary shall 
transmit to the Congress— 
‘‘(A) the total revenue amount for the up-
coming fiscal year, as applicable under para-
graph (1); and 
‘‘(B) the registration fees for such year, as 
established under paragraph (2). 
‘‘(d) INFLATION
ADJUSTMENT.—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— 
‘‘(1) the total percentage change that occurred 
in the Consumer Price Index for all urban con-
sumers (all items; United States city average) for 
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the 12-month period ending June 30 preceding the 
fiscal year for which fees are being established; 
‘‘(2) the total percentage change for the pre-
vious 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 
‘‘(3) 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. 
The adjustment made each fiscal year under this sub-
section will be added on a compounded basis to the sum 
of all adjustments made each fiscal year after fiscal year 
2011 under this subsection. 
‘‘(e) FEE WAIVER OR REDUCTION.—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— 
‘‘(1) such waiver or reduction is necessary to 
protect the public health; or 
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‘‘(2) the assessment of the fee would impose 
significant financial hardship because of limited re-
sources available to such person or other cir-
cumstances. 
‘‘(f) LIMITATIONS.— 
‘‘(1) IN GENERAL.—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 Admin-
istration for the fiscal year 2012 (excluding the 
amount of fees appropriated for such fiscal year) ad-
justed in the same manner that fee amounts are ad-
justed under subsection (d). 
‘‘(2) AUTHORITY.—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 as-
sess 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. 
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‘‘(g) 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-
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 defray the costs of drug safety activities. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
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. 
‘‘(h) COLLECTION OF UNPAID FEES.—In any case 
in which the Secretary does not receive payment of a fee 
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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. 
‘‘(i) 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 drug safety activities, be reduced to offset the 
number of officers, employees, and advisory committees so 
engaged. 
‘‘(j) ANNUAL FISCAL REPORTS.—Beginning with fis-
cal year 2013, not later than 120 days after the end of 
each fiscal year for which fees are collected under this sec-
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. 
‘‘(k) RELATION TO OTHER FEES.—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. 
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‘‘(l) DEFINITIONS.—In this section: 
‘‘(1) The term ‘costs of drug safety activities’ 
means the expenses incurred in connection with drug 
safety activities for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees, and costs related to such officers, em-
ployees, and committees and to contracts with 
such contractors; 
‘‘(B) laboratory space; 
‘‘(C) management of information, and the 
acquisition, maintenance, and repair of infor-
mation technology resources; 
‘‘(D) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific 
equipment, and other necessary materials and 
supplies; and 
‘‘(E) collecting fees under this section and 
accounting for resources allocated for drug 
safety activities. 
‘‘(2) The term ‘drug safety activities’ means ac-
tivities related to compliance by persons and estab-
lishments registered under section 510 with the re-
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quirements of this Act relating to drugs (including 
research related to and the development of stand-
ards (such as performance standards and preventive 
controls), risk assessments, hazard analyses, inspec-
tion planning and inspections, third-party inspec-
tions, compliance review and enforcement, import re-
view, information technology support, test develop-
ment, product sampling, risk communication, and 
administrative detention).’’. 
(2) TRANSITIONAL PROVISIONS.— 
(A) FIRST
IMPOSITION
OF
FEES.—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. 
(B) SUNSET DATE.—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. 
(f) MODIFICATION OF REGISTRATION FORM.—Not 
later than 180 days after the date of the enactment of 
this Act, the Secretary of Health and Human Services 
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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 sec-
tion. 
SEC. 102. DRUG SUPPLY QUALITY AND SAFETY. 
(a) DEFINITIONS.—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: 
‘‘(3) In the case of a drug, the term ‘component’ in-
cludes— 
‘‘(A) any active ingredient or bulk drug sub-
stance; 
‘‘(B) any inactive ingredient; 
‘‘(C) any intermediate of an active ingredient, 
inactive ingredient, or bulk drug substance, whether 
or not it appears in the finished product and wheth-
er or not derived from any chemical, human, animal, 
plant, or other material; and 
‘‘(D) any original source material for compo-
nents specified in clauses (A), (B), and (C) whether 
or not the original source material— 
‘‘(i) appears in the finished product; and 
‘‘(ii) is derived from any chemical, human, 
animal, plant, or other material.’’. 
(b) EFFECTIVE QUALITY SYSTEMS.— 
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‘‘SEC. 503C. EFFECTIVE QUALITY SYSTEM FOR DRUG MANU-
FACTURERS. 
‘‘(a) IN GENERAL.—Each manufacturer of a drug re-
quired to be registered under section 510 shall have in 
effect and implement an effective quality system. 
‘‘(b) SYSTEM REQUIREMENTS.—An effective quality 
system applicable to a manufacturer of a drug under sub-
section (a) shall require each of the following: 
‘‘(1) 
MANAGEMENT
RESPONSIBILITY.—The 
manufacturer shall ensure that— 
‘‘(A) adequate resources are provided to 
ensure compliance with current good manufac-
turing practice; 
‘‘(B) procedures are established and main-
tained to ensure timely communication of prod-
uct quality issues to appropriate levels of man-
agement, including executive management; 
‘‘(C) periodic reviews of process perform-
ance, product quality, and other elements of the 
quality system are conducted; 
‘‘(D) the periodic reviews under subpara-
graph (C) are evaluated by executive manage-
ment to determine any appropriate action; and 
‘‘(E) the integrity of data, records, and 
regulatory submissions, including with respect 
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to accuracy, veracity, and validity, is main-
tained. 
‘‘(2) QUALITY RESPONSIBILITY.— 
‘‘(A) INTERNAL, INDEPENDENT
UNIT.— 
The manufacturer shall establish and maintain 
an internal, independent unit with the authority 
to ensure that all operations related to manu-
facturing drugs, including those performed by 
another person, are appropriately designed, ap-
proved, conducted, monitored, and corrected in 
compliance with current good manufacturing 
practice. 
‘‘(B) PROCEDURES.—The manufacturer 
shall establish and maintain procedures to en-
sure that— 
‘‘(i) any discrepancy related to manu-
facturing 
a 
drug 
(including 
the 
discrepancy’s causes) is promptly identi-
fied, investigated, and corrected, the recur-
rence 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 
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‘‘(ii) ongoing reviews of all data re-
lated to manufacturing a drug are con-
ducted to identify trends that might affect 
product quality and timely actions are per-
formed to prevent any adverse effect on 
product safety, identity, quality, strength, 
or purity. 
‘‘(3) RISK
MANAGEMENT.—The manufacturer 
shall establish and maintain risk management proce-
dures 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 manu-
facturer 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. 
‘‘(4) SUPPLY CHAIN MANAGEMENT.— 
‘‘(A) IN
GENERAL.—The manufacturer 
shall establish and maintain procedures that en-
sure the safety, identity, quality, strength, pu-
rity, and security of all drugs and other mate-
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rials 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 cor-
rections for supply chain management practices 
or other applicable requirements under this Act 
or sections 351 or 361 of the Public Health 
Service Act. 
‘‘(B) PROCEDURES.—Supply chain man-
agement procedures under subparagraph (A) 
shall include— 
‘‘(i) 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 im-
purity profile for each component, includ-
ing each component that is naturally de-
rived, except that the requirements of this 
clause shall not apply to any component of 
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a licensed biological product unless re-
quired under the license issued for such 
product under section 351 of the Public 
Health Service Act or under paragraph 
(5); 
‘‘(ii) onsite audits, performed by 
qualified individuals, of each person that 
supplies a drug or conducts operations re-
lated to manufacturing, before such person 
begins initial supply or operation and at an 
appropriate frequency to assess the contin-
ued 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 Pub-
lic Health Service Act; 
‘‘(iii) 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; 
‘‘(iv) the sharing of manufacturing in-
formation by any person who supplies a 
drug or conducts operations related to 
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manufacturing, including timely notifica-
tion concerning any change to, discrepancy 
in, or defect in, materials or operations re-
lated to manufacturing, along with ade-
quate information about such change, dis-
crepancy, or defect; 
‘‘(v) when supplying any drug to an-
other manufacturer, provision of a certifi-
cate of analysis for each batch and lot that 
includes complete source, manufacturing, 
and test information and results; and 
‘‘(vi) methods, which shall include ac-
ceptance and rejection criteria, adequate— 
‘‘(I) to detect, or exclude the pos-
sibility of, the presence of any sub-
stance that may reasonably be ex-
pected to indicate a risk to safety, 
identity, quality, strength, purity, or 
security; and 
‘‘(II) to detect, or exclude the 
possibility of, other risks to safety, 
identity, quality, strength, purity, or 
security. 
‘‘(5) METHODS.— 
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‘‘(A) IN
GENERAL.—Each manufacturer 
shall establish and maintain procedures that en-
sure— 
‘‘(i) periodic evaluation and, where 
necessary, prompt revision of methods, in-
cluding 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; 
‘‘(ii) when any new risk is identified— 
‘‘(I) adoption of appropriate re-
vised or new methods; and 
‘‘(II) evaluation of every batch 
and lot of drug using such revised 
methods; and 
‘‘(iii) if required, an application is 
submitted for timely approval by the Sec-
retary 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. 
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‘‘(B) DETERMINATION
OF
RISK.—Each 
evaluation and revision under subparagraph 
(A)(i) shall be based on a determination of risk. 
‘‘(C) NOTIFICATION REGARDING REVISED 
METHOD.—Each manufacturer of a drug shall 
promptly notify the Secretary and the appro-
priate 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 Sec-
retary shall prescribe by regulation. 
‘‘(D) ORDERS
REGARDING
REVISED
OR 
NEW
METHODS.—If the Secretary determines 
that a revised or new method, including accept-
ance and rejection criteria, is appropriate for 
the safety, identity, quality, strength, purity, or 
security of any drug, the Secretary may by let-
ter order any manufacturer of such drug to 
promptly— 
‘‘(i) revise any method, or adopt any 
new method, and any related acceptance 
and rejection criteria for such drug; and 
‘‘(ii) implement such revised or new 
method and any related acceptance and re-
jection criteria. 
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‘‘(6) RECORDS.— 
‘‘(A) IN
GENERAL.—Each manufacturer 
shall 
maintain 
adequate, 
contemporaneous 
records (which may be electronic) to document 
conformity with requirements under this sec-
tion. Such records shall be accurate, indelible, 
and legible. Each manufacturer shall establish 
and maintain a procedure to ensure the identi-
fication, storage, protection, retrieval, retention, 
and disposition of such records. 
‘‘(B) MAINTENANCE OF RECORDS; INSPEC-
TION.—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 read-
ily 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. 
‘‘(7) ADDITIONAL
PROVISIONS.—If the Sec-
retary determines that provisions in addition to 
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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: 
‘‘(uu)(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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