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 Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

improve the safety of drugs, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Drug Safety Enhance5 ment Act of 2011’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 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 inspections. 

Sec. 106. Notification, nondistribution, and recall of adulterated or misbranded 

drug products. 

Sec. 107. Notification. 

TITLE II—RESPONSE 

Sec. 201. Administrative detention. 

Sec. 202. Destruction of adulterated, misbranded, or counterfeit drugs offered 

for import. 

Sec. 203. Criminal penalties. 

Sec. 204. Civil penalties. 

Sec. 205. Seizure. 

Sec. 206. Asset forfeiture. 

TITLE III—IMPORTATION AND EXPORTATION 

Sec. 301. Documentation for admissibility of imports. 

Sec. 302. Registration for commercial importers; fee. 

Sec. 303. Registration for customs brokers. 

Sec. 304. Exportation certificate program. 

Sec. 305. Extraterritorial jurisdiction. 

Sec. 306. Dedicated foreign inspectorate. 

TITLE IV—MISCELLANEOUS 

Sec. 401. Unique identification number for establishments, importers, and customs brokers. 

Sec. 402. Country of origin labeling. 

Sec. 403. False or misleading reporting to FDA. 

Sec. 404. Subpoena authority. 

Sec. 405. Whistleblower protections. 

Sec. 406. Rule of construction. 

1 TITLE I—PREVENTION 

2 SEC. 101. REGISTRATION OF PRODUCERS OF DRUGS; AP3 PLICABLE FEE. 

4 (a) FOREIGN REGISTRANTS.— 

5 (1) MISBRANDING.—Section 502(o) of the Fed6 eral, Food, Drug, and Cosmetic Act (21 U.S.C. 

7 352(o)) is amended by inserting ‘‘if it is a drug and 

8 was manufactured, prepared, propagated, com9 pounded, or processed in an establishment not duly 


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1 registered under section 510(i),’’ after ‘‘not duly 

2 registered under section 510,’’. 

3 (2) APPLICATION.—The amendment made by 

4 paragraph (1) applies only with respect to registra5 tion (including failure to register) under section 510 

6 of the Federal Food, Drug, and Cosmetic Act (21 

7 U.S.C. 360) occurring on or after the date of the en8 actment of this Act. 

9 (b) EXCIPIENT MANUFACTURERS.— 

10 (1) IN GENERAL.—Not later than 6 months 

11 after the date of the enactment of this Act, the Sec12 retary of Health and Human Services shall revise 

13 section 207.10 of title 21, Code of Federal Regula14 tions, and such other regulations as may be nec15 essary to require owners and operators of establish16 ments that engage in the manufacture, preparation, 

17 propagation, compounding, or processing of an ex18 cipient of a drug to register such establishments 

19 under section 510 of the Federal Food, Drug, and 

20 Cosmetic Act (21 U.S.C. 360). 

21 (2) APPLICATION.—The revisions to regulations 

22 under paragraph (1) shall apply with respect to the 

23 manufacture, preparation, propagation, 

24 compounding, or processing of an excipient of a drug 


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1 on or after the date that is 18 months after the date 

2 of the enactment of this Act. 

3 (c) DRUG LISTING ELEMENTS AND FREQUENCY.— 

4 (1) IN GENERAL.—Sections 510(j) of the Fed5 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

6 360(j)) is amended— 

7 (A) in paragraph (1), by amending sub8 paragraph (C) to read as follows: 

9 ‘‘(C) in the case of any drug contained in an 

10 applicable list which is described in subparagraph 

11 (A) or (B), a qualitative and quantitative listing of 

12 each of its active and other ingredients, and any 

13 other information that the Secretary finds is nec14 essary to carry out the purposes of this Act; and’’; 

15 and 

16 (B) in paragraph (2), in the matter pre17 ceding subparagraph (A), by inserting ‘‘, unless 

18 otherwise specified by the Secretary’’ after 

19 ‘‘once during the month of December of each 

20 year’’. 

21 (2) APPLICATION.—The amendments made by 

22 paragraph (1) apply with respect to the filing of a 

23 list under section 510(j) of the Federal Food, Drug, 

24 and Cosmetic Act (21 U.S.C. 360(j)) that occurs on 


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1 or after the date that is 6 months after the date of 

2 the enactment of this Act. 

3 (d) SUSPENSION AND CANCELLATION OF REGISTRA4 TION.—Section 510 of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 360j) is amended by adding at the 

6 end the following: 

7 ‘‘(q) SUSPENSION AND CANCELLATION OF REG8 ISTRATION.—With respect to any registration under this 

9 section attributable to the manufacture, preparation, 

10 propagation, compounding, or processing of a drug: 

11 ‘‘(1) SUSPENSION OF REGISTRATION.— 

12 ‘‘(A) IN GENERAL.—Registration under 

13 this section is subject to suspension upon a 

14 finding by the Secretary, after notice and an 

15 opportunity for an informal hearing, of— 

16 ‘‘(i) a violation of this Act; or 

17 ‘‘(ii) the knowing or repeated making 

18 of an inaccurate or incomplete statement 

19 or submission of information relating to 

20 the manufacture, preparation, propagation, 

21 compounding, processing, or importing of a 

22 drug. 

23 ‘‘(B) REQUEST.—Any person or establish24 ment whose registration is suspended under 

25 subparagraph (A) may request that the SecVerDate Mar 15 2010 01:08 Dec 20, 2010 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H6543.IH H6543

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1 retary vacate the suspension when such person 

2 or establishment has corrected the violation 

3 that is the basis for such suspension. 

4 ‘‘(C) VACATING OF SUSPENSION.—If the 

5 Secretary determines that adequate reasons do 

6 not exist to continue the suspension of a reg7 istration under subparagraph (A), the Secretary 

8 shall vacate such suspension. 

9 ‘‘(2) CANCELLATION OF REGISTRATION.— 

10 ‘‘(A) IN GENERAL.—Not earlier than 10 

11 days after providing the notice under subpara12 graph (B), the Secretary may cancel a registra13 tion if the Secretary determines that— 

14 ‘‘(i) such registration was not updated 

15 in accordance with this section or contains 

16 false, incomplete, or inaccurate informa17 tion; or 

18 ‘‘(ii) the fee required under section 

19 736C for such registration has not been 

20 paid within 30 days after the date due. 

21 ‘‘(B) NOTICE OF CANCELLATION.—Before 

22 cancelling the registration of a person or estab23 lishment under this section, the Secretary shall 

24 give notice to the person or establishment of the 


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1 Secretary’s intent to cancel the registration and 

2 the basis for such cancellation. 

3 ‘‘(C) TIMELY UPDATE OR CORRECTION.— 

4 If a registration is adequately updated or cor5 rected no later than 7 days after notice is pro6 vided under subparagraph (B) with respect to 

7 the registration, the Secretary shall not cancel 

8 such registration.’’. 

9 (e) REGISTRATION FEE.— 

10 (1) ESTABLISHMENT.—Part 2 of subchapter C 

11 of chapter VII of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 379g et seq.) is amended by 

13 adding at the end the following: 

14 ‘‘SEC. 736C. REGISTRATION FEE. 

15 ‘‘(a) IN GENERAL.—In the case of any registration 

16 under section 510 that is attributable to the manufacture, 

17 preparation, propagation, compounding, processing, or im18 porting of a drug, the Secretary shall assess and collect 

19 an annual fee for such registration to defray the increase 

20 in the costs of drug safety activities. 

21 ‘‘(b) PAYABLE DATE.—A fee under this section shall 

22 be payable— 

23 ‘‘(1) for a facility that was not registered under 

24 section 510 for the preceding fiscal year, on the date 

25 of registration; and 


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1 ‘‘(2) for any other facility— 

2 ‘‘(A) for fiscal year 2012, not later than 

3 the sooner of 90 days after the date of the en4 actment of this section or December 31, 2011; 

5 and 

6 ‘‘(B) for a subsequent fiscal year, not later 

7 than December 31 of such fiscal year. 

8 ‘‘(c) FEE AMOUNTS.— 

9 ‘‘(1) TOTAL REVENUE AMOUNT.— 

10 ‘‘(A) INITIAL YEAR.—For fiscal year 2012, 

11 fees under subsection (a) shall, except as pro12 vided in subsections (f) and (g), be established 

13 to generate a total revenue amount that is 

14 equal to the increase in the costs of drug safety 

15 activities (as estimated by the Secretary) for 

16 such fiscal year. 

17 ‘‘(B) SUBSEQUENT YEARS.—For each of 

18 fiscal years 2013 through 2016, fees under sub19 section (a) shall, except as provided in sub20 sections (f) and (g), be the total revenue 

21 amount for fiscal year 2012, as adjusted under 

22 subsection (d). 

23 ‘‘(2) ANNUAL FEE SETTING.—For fiscal year 

24 2012 and each subsequent fiscal year, the Secretary 


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1 shall establish registration fees under subsection 

2 (a)— 

3 ‘‘(A) based on the total revenue amount 

4 applicable under paragraph (1); and 

5 ‘‘(B) taking into consideration the dif6 ference in costs of inspections between foreign 

7 and domestic establishments. 

8 ‘‘(3) TRANSMISSION TO CONGRESS.—Not later 

9 than 60 days before the start of fiscal year 2012 

10 and each subsequent fiscal year, the Secretary shall 

11 transmit to the Congress— 

12 ‘‘(A) the total revenue amount for the up13 coming fiscal year, as applicable under para14 graph (1); and 

15 ‘‘(B) the registration fees for such year, as 

16 established under paragraph (2). 

17 ‘‘(d) INFLATION ADJUSTMENT.—For fiscal year 

18 2013 and subsequent fiscal years, the fee amount under 

19 subsection (c) shall be adjusted by the Secretary by notice, 

20 published in the Federal Register, for the respective fiscal 

21 year to reflect the greater of— 

22 ‘‘(1) the total percentage change that occurred 

23 in the Consumer Price Index for all urban con24 sumers (all items; United States city average) for 


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1 the 12-month period ending June 30 preceding the 

2 fiscal year for which fees are being established; 

3 ‘‘(2) the total percentage change for the pre4 vious fiscal year in basic pay under the General 

5 Schedule in accordance with section 5332 of title 5, 

6 United States Code, as adjusted by any locality7 based comparability payment pursuant to section 

8 5304 of such title for Federal employees stationed in 

9 the District of Columbia; or 

10 ‘‘(3) the average annual change in the cost, per 

11 full-time equivalent position of the Food and Drug 

12 Administration, of all personnel compensation and 

13 benefits paid with respect to such positions for the 

14 first 5 years of the preceding 6 fiscal years. 

15 The adjustment made each fiscal year under this sub16 section will be added on a compounded basis to the sum 

17 of all adjustments made each fiscal year after fiscal year 

18 2011 under this subsection. 

19 ‘‘(e) FEE WAIVER OR REDUCTION.—The Secretary 

20 may grant to a person a waiver from, or a reduction of, 

21 one or more fees under this section if the Secretary finds 

22 that— 

23 ‘‘(1) such waiver or reduction is necessary to 

24 protect the public health; or 


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1 ‘‘(2) the assessment of the fee would impose 

2 significant financial hardship because of limited re3 sources available to such person or other cir4 cumstances. 

5 ‘‘(f) LIMITATIONS.— 

6 ‘‘(1) IN GENERAL.—Fees under subsection (a) 

7 shall be refunded for a fiscal year beginning after 

8 fiscal year 2012 unless appropriations for salaries 

9 and expenses of the Food and Drug Administration 

10 for such fiscal year (excluding the amount of fees 

11 appropriated for such fiscal year) are equal to or 

12 greater than the amount of appropriations for the 

13 salaries and expenses of the Food and Drug Admin14 istration for the fiscal year 2012 (excluding the 

15 amount of fees appropriated for such fiscal year) ad16 justed in the same manner that fee amounts are ad17 justed under subsection (d). 

18 ‘‘(2) AUTHORITY.—If the Secretary does not 

19 assess fees under subsection (a) during any portion 

20 of a fiscal year because of paragraph (1) and if at 

21 a later date in such fiscal year the Secretary may as22 sess such fees, the Secretary may assess and collect 

23 such fees, without any modification in the rate, for 

24 registration under section 510 at any time in such 

25 fiscal year. 


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1 ‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 

2 ‘‘(1) IN GENERAL.—Fees authorized under sub3 section (a) shall be collected and available for obliga4 tion only to the extent and in the amount provided 

5 in advance in appropriations Acts. Such fees are au6 thorized to remain available until expended. Such 

7 sums as may be necessary may be transferred from 

8 the Food and Drug Administration salaries and ex9 penses appropriation account without fiscal year lim10 itation to such appropriation account for salaries 

11 and expenses with such fiscal year limitation. 

12 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

13 ACTS.—The fees authorized by this section— 

14 ‘‘(A) shall be retained in each fiscal year in 

15 an amount not to exceed the amount specified 

16 in appropriations Acts, or otherwise made avail17 able for obligation, for such fiscal year; and 

18 ‘‘(B) shall only be collected and available 

19 to defray the costs of drug safety activities. 

20 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

21 For each of the fiscal years 2012 through 2016, 

22 there are authorized to be appropriated for fees 

23 under this section such sums as may be necessary. 

24 ‘‘(h) COLLECTION OF UNPAID FEES.—In any case 

25 in which the Secretary does not receive payment of a fee 


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1 assessed under subsection (a) within 30 days after it is 

2 due, such fee shall be treated as a claim of the United 

3 States Government subject to subchapter II of chapter 37 

4 of title 31, United States Code. 

5 ‘‘(i) CONSTRUCTION.—This section may not be con6 strued to require that the number of full-time equivalent 

7 positions in the Department of Health and Human Serv8 ices, for officers, employers, and advisory committees not 

9 engaged in drug safety activities, be reduced to offset the 

10 number of officers, employees, and advisory committees so 

11 engaged. 

12 ‘‘(j) ANNUAL FISCAL REPORTS.—Beginning with fis13 cal year 2013, not later than 120 days after the end of 

14 each fiscal year for which fees are collected under this sec15 tion, the Secretary shall prepare and submit to the Com16 mittee on Energy and Commerce of the House of Rep17 resentatives and the Committee on Health, Education, 

18 Labor, and Pensions of the Senate a report on the imple19 mentation of the authority for such fees during such fiscal 

20 year and the use, by the Food and Drug Administration, 

21 of the fees collected for such fiscal year. 

22 ‘‘(k) RELATION TO OTHER FEES.—Fees assessed 

23 and collected under this section are in addition to other 

24 fees assessed and collected under this Act with respect to 

25 the same person or establishment. 


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1 ‘‘(l) DEFINITIONS.—In this section: 

2 ‘‘(1) The term ‘costs of drug safety activities’ 

3 means the expenses incurred in connection with drug 

4 safety activities for— 

5 ‘‘(A) officers and employees of the Food 

6 and Drug Administration, contractors of the 

7 Food and Drug Administration, advisory com8 mittees, and costs related to such officers, em9 ployees, and committees and to contracts with 

10 such contractors; 

11 ‘‘(B) laboratory space; 

12 ‘‘(C) management of information, and the 

13 acquisition, maintenance, and repair of infor14 mation technology resources; 

15 ‘‘(D) leasing, maintenance, renovation, and 

16 repair of facilities and acquisition, maintenance, 

17 and repair of fixtures, furniture, scientific 

18 equipment, and other necessary materials and 

19 supplies; and 

20 ‘‘(E) collecting fees under this section and 

21 accounting for resources allocated for drug 

22 safety activities. 

23 ‘‘(2) The term ‘drug safety activities’ means ac24 tivities related to compliance by persons and estab25 lishments registered under section 510 with the reVerDate Mar 15 2010 01:08 Dec 20, 2010 Jkt 099200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H6543.IH H6543

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1 quirements of this Act relating to drugs (including 

2 research related to and the development of stand3 ards (such as performance standards and preventive 

4 controls), risk assessments, hazard analyses, inspec5 tion planning and inspections, third-party inspec6 tions, compliance review and enforcement, import re7 view, information technology support, test develop8 ment, product sampling, risk communication, and 

9 administrative detention).’’. 

10 (2) TRANSITIONAL PROVISIONS.— 

11 (A) FIRST IMPOSITION OF FEES.—The 

12 Secretary of Health and Human Services shall 

13 first impose the fee established under section 

14 736C of the Federal Food, Drug, and Cosmetic 

15 Act, as added by paragraph (1), for fiscal years 

16 beginning with fiscal year 2012. 

17 (B) SUNSET DATE.—Section 736C of the 

18 Federal Food, Drug, and Cosmetic Act, as 

19 added by paragraph (1), does not authorize the 

20 assessment or collection of a fee for registration 

21 under section 510 of such Act (21 U.S.C. 360) 

22 occurring after fiscal year 2016. 

23 (f) MODIFICATION OF REGISTRATION FORM.—Not 

24 later than 180 days after the date of the enactment of 

25 this Act, the Secretary of Health and Human Services 


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1 shall modify the registration forms under section 510 of 

2 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 350d) to comply with the amendments made by this sec4 tion. 

5 SEC. 102. DRUG SUPPLY QUALITY AND SAFETY. 

6 (a) DEFINITIONS.—Section 201(g) of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is 

8 amended by adding at the end the following: 

9 ‘‘(3) In the case of a drug, the term ‘component’ in10 cludes— 

11 ‘‘(A) any active ingredient or bulk drug sub12 stance; 

13 ‘‘(B) any inactive ingredient; 

14 ‘‘(C) any intermediate of an active ingredient, 

15 inactive ingredient, or bulk drug substance, whether 

16 or not it appears in the finished product and wheth17 er or not derived from any chemical, human, animal, 

18 plant, or other material; and 

19 ‘‘(D) any original source material for compo20 nents specified in clauses (A), (B), and (C) whether 

21 or not the original source material— 

22 ‘‘(i) appears in the finished product; and 

23 ‘‘(ii) is derived from any chemical, human, 

24 animal, plant, or other material.’’. 

25 (b) EFFECTIVE QUALITY SYSTEMS.— 


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1 (1) PROHIBITED ACTS.— 

2 (A) RECORDKEEPING.—Section 301(e) of 

3 the Federal Food, Drug, and Cosmetic Act (21 

4 U.S.C. 331(e)) is amended— 

5 (i) by inserting ‘‘503C,’’ after 

6 ‘‘417(g),’’; and 

7 (ii) by inserting ‘‘503C,’’ after 

8 ‘‘417,’’. 

9 (B) ADULTERATION.—Section 501 of the 

10 Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 351) is amended by adding at the end 

12 the following: 

13 ‘‘(j) If it is a drug that was manufactured (as defined 

14 in section 503C) by a manufacturer that is or was at the 

15 time of such manufacture in violation of section 503C be16 cause of the failure to have in effect or implement an effec17 tive quality system in accordance with such section.’’. 

18 (2) SYSTEM REQUIREMENTS.—The Federal 

19 Food, Drug, and Cosmetic Act is amended by insert20 ing after section 503B (21 U.S.C. 353b) the fol21 lowing: 


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1 ‘‘SEC. 503C. EFFECTIVE QUALITY SYSTEM FOR DRUG MANU2 FACTURERS. 

3 ‘‘(a) IN GENERAL.—Each manufacturer of a drug re4 quired to be registered under section 510 shall have in 

5 effect and implement an effective quality system. 

6 ‘‘(b) SYSTEM REQUIREMENTS.—An effective quality 

7 system applicable to a manufacturer of a drug under sub8 section (a) shall require each of the following: 

9 ‘‘(1) MANAGEMENT RESPONSIBILITY.—The 

10 manufacturer shall ensure that— 

11 ‘‘(A) adequate resources are provided to 

12 ensure compliance with current good manufac13 turing practice; 

14 ‘‘(B) procedures are established and main15 tained to ensure timely communication of prod16 uct quality issues to appropriate levels of man17 agement, including executive management; 

18 ‘‘(C) periodic reviews of process perform19 ance, product quality, and other elements of the 

20 quality system are conducted; 

21 ‘‘(D) the periodic reviews under subpara22 graph (C) are evaluated by executive manage23 ment to determine any appropriate action; and 

24 ‘‘(E) the integrity of data, records, and 

25 regulatory submissions, including with respect 


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1 to accuracy, veracity, and validity, is main2 tained. 

3 ‘‘(2) QUALITY RESPONSIBILITY.— 

4 ‘‘(A) INTERNAL, INDEPENDENT UNIT.— 

5 The manufacturer shall establish and maintain 

6 an internal, independent unit with the authority 

7 to ensure that all operations related to manu8 facturing drugs, including those performed by 

9 another person, are appropriately designed, ap10 proved, conducted, monitored, and corrected in 

11 compliance with current good manufacturing 

12 practice. 

13 ‘‘(B) PROCEDURES.—The manufacturer 

14 shall establish and maintain procedures to en15 sure that— 

16 ‘‘(i) any discrepancy related to manu17 facturing a drug (including the 

18 discrepancy’s causes) is promptly identi19 fied, investigated, and corrected, the recur20 rence of the discrepancy is prevented, and 

21 any corrective or preventive action is 

22 verified or validated to ensure that such 

23 action is effective and does not adversely 

24 affect the drug; and 


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1 ‘‘(ii) ongoing reviews of all data re2 lated to manufacturing a drug are con3 ducted to identify trends that might affect 

4 product quality and timely actions are per5 formed to prevent any adverse effect on 

6 product safety, identity, quality, strength, 

7 or purity. 

8 ‘‘(3) RISK MANAGEMENT.—The manufacturer 

9 shall establish and maintain risk management proce10 dures that ensure effective risk assessment, control, 

11 and communication. The risk assessment procedures 

12 shall ensure that all factors throughout the supply 

13 chain that may reasonably be expected to indicate a 

14 risk to the safety, identity, quality, strength, purity, 

15 or security of any drug manufactured by that manu16 facturer are identified, starting with factors relating 

17 to origin of all components including the original 

18 source materials; information relating to all such 

19 factors is continuously gathered, monitored, and 

20 evaluated; and new factors are promptly identified. 

21 ‘‘(4) SUPPLY CHAIN MANAGEMENT.— 

22 ‘‘(A) IN GENERAL.—The manufacturer 

23 shall establish and maintain procedures that en24 sure the safety, identity, quality, strength, pu25 rity, and security of all drugs and other mateVerDate Mar 15 2010 01:08 Dec 20, 2010 Jkt 099200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H6543.IH H6543

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1 rials used by that manufacturer. The supply 

2 chain procedures shall address the entire supply 

3 chain from original source materials used in the 

4 manufacture of the drug to the manufacturer. 

5 The supply chain procedures shall ensure that 

6 there is adequate followup, which shall include 

7 no longer receiving any source materials or 

8 drugs from, or using operations conducted by, 

9 any person who fails to implement timely cor10 rections for supply chain management practices 

11 or other applicable requirements under this Act 

12 or sections 351 or 361 of the Public Health 

13 Service Act. 

14 ‘‘(B) PROCEDURES.—Supply chain man15 agement procedures under subparagraph (A) 

16 shall include— 

17 ‘‘(i) acceptance and rejection criteria 

18 for each component that ensures that such 

19 component is appropriate for its intended 

20 use and that include, unless not feasible 

21 using current technology, a sufficient im22 purity profile for each component, includ23 ing each component that is naturally de24 rived, except that the requirements of this 

25 clause shall not apply to any component of 


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1 a licensed biological product unless re2 quired under the license issued for such 

3 product under section 351 of the Public 

4 Health Service Act or under paragraph 

5 (5); 

6 ‘‘(ii) onsite audits, performed by 

7 qualified individuals, of each person that 

8 supplies a drug or conducts operations re9 lated to manufacturing, before such person 

10 begins initial supply or operation and at an 

11 appropriate frequency to assess the contin12 ued compliance of such person with the 

13 manufacturer’s supply chain practices and 

14 with the applicable requirements under this 

15 Act and sections 351 and 361 of the Pub16 lic Health Service Act; 

17 ‘‘(iii) requirements for a quality 

18 agreement with any person who supplies a 

19 drug or conducts operations related to 

20 manufacturing a drug which addresses all 

21 applicable current good manufacturing 

22 practice requirements; 

23 ‘‘(iv) the sharing of manufacturing in24 formation by any person who supplies a 

25 drug or conducts operations related to 


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1 manufacturing, including timely notifica2 tion concerning any change to, discrepancy 

3 in, or defect in, materials or operations re4 lated to manufacturing, along with ade5 quate information about such change, dis6 crepancy, or defect; 

7 ‘‘(v) when supplying any drug to an8 other manufacturer, provision of a certifi9 cate of analysis for each batch and lot that 

10 includes complete source, manufacturing, 

11 and test information and results; and 

12 ‘‘(vi) methods, which shall include ac13 ceptance and rejection criteria, adequate— 

14 ‘‘(I) to detect, or exclude the pos15 sibility of, the presence of any sub16 stance that may reasonably be ex17 pected to indicate a risk to safety, 

18 identity, quality, strength, purity, or 

19 security; and 

20 ‘‘(II) to detect, or exclude the 

21 possibility of, other risks to safety, 

22 identity, quality, strength, purity, or 

23 security. 

24 ‘‘(5) METHODS.— 


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1 ‘‘(A) IN GENERAL.—Each manufacturer 

2 shall establish and maintain procedures that en3 sure— 

4 ‘‘(i) periodic evaluation and, where 

5 necessary, prompt revision of methods, in6 cluding acceptance and rejection criteria, 

7 to ensure the safety, identity, quality, 

8 strength, purity, and security of each drug 

9 manufactured by such manufacturer, or 

10 component used in the manufacture of 

11 such drug; 

12 ‘‘(ii) when any new risk is identified— 

13 ‘‘(I) adoption of appropriate re14 vised or new methods; and 

15 ‘‘(II) evaluation of every batch 

16 and lot of drug using such revised 

17 methods; and 

18 ‘‘(iii) if required, an application is 

19 submitted for timely approval by the Sec20 retary of the revised or new methods under 

21 section 505, 506A, 512, or 571 of this Act 

22 or section 351 of the Public Health Service 

23 Act. 


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1 ‘‘(B) DETERMINATION OF RISK.—Each 

2 evaluation and revision under subparagraph 

3 (A)(i) shall be based on a determination of risk. 

4 ‘‘(C) NOTIFICATION REGARDING REVISED

5 METHOD.—Each manufacturer of a drug shall 

6 promptly notify the Secretary and the appro7 priate body charged with revision of an official 

8 compendium of any revised method for such 

9 drug and its rationale. Such notification shall 

10 be made in such form and manner as the Sec11 retary shall prescribe by regulation. 

12 ‘‘(D) ORDERS REGARDING REVISED OR

13 NEW METHODS.—If the Secretary determines 

14 that a revised or new method, including accept15 ance and rejection criteria, is appropriate for 

16 the safety, identity, quality, strength, purity, or 

17 security of any drug, the Secretary may by let18 ter order any manufacturer of such drug to 

19 promptly— 

20 ‘‘(i) revise any method, or adopt any 

21 new method, and any related acceptance 

22 and rejection criteria for such drug; and 

23 ‘‘(ii) implement such revised or new 

24 method and any related acceptance and re25 jection criteria. 


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1 ‘‘(6) RECORDS.— 

2 ‘‘(A) IN GENERAL.—Each manufacturer 

3 shall maintain adequate, contemporaneous 

4 records (which may be electronic) to document 

5 conformity with requirements under this sec6 tion. Such records shall be accurate, indelible, 

7 and legible. Each manufacturer shall establish 

8 and maintain a procedure to ensure the identi9 fication, storage, protection, retrieval, retention, 

10 and disposition of such records. 

11 ‘‘(B) MAINTENANCE OF RECORDS; INSPEC12 TION.—Each manufacturer shall maintain 

13 records under subparagraph (A) for at least 2 

14 years from the date of the expiration date of 

15 the drug involved and make such records read16 ily available for inspection by the Secretary. 

17 Such records or copies thereof shall be subject 

18 to photocopying or other means of reproduction 

19 as part of such inspection. Each manufacturer 

20 shall provide to the Secretary these records or 

21 copies thereof in a timely manner, upon verbal 

22 or written request by an officer or employee 

23 duly designated by the Secretary. 

24 ‘‘(7) ADDITIONAL PROVISIONS.—If the Sec25 retary determines that provisions in addition to 


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1 those described in paragraphs (1) through (6) would 

2 be appropriate to provide additional assurance of the 

3 safety, identity, quality, strength, purity, or security 

4 of any drug, the Secretary may promulgate such 

5 provisions by regulation. 

6 ‘‘(c) EXEMPTIONS AND VARIANCES.—Any person 

7 subject to any requirement prescribed pursuant to this 

8 section may petition the Secretary for an exemption or 

9 variance from such requirement. Such a petition shall be 

10 submitted to the Secretary in such form and manner as 

11 the Secretary shall prescribe by regulation. If, when grant12 ing a request for exemption or variance under this sub13 section, the Secretary determines that it is appropriate to 

14 apply the exemption or variance to more than one manu15 facturer, the Secretary shall publish a notice of the exemp16 tion or variance in the Federal Register. 

17 ‘‘(d) DEFINITIONS.—In this section: 

18 ‘‘(1) The term ‘manufacturer’ means any per19 son who manufactures a drug. 

20 ‘‘(2) The terms ‘manufacture’, ‘manufacturing’, 

21 or ‘manufactured’ include preparation, processing, 

22 packing, or holding. 

23 ‘‘(3) The term ‘establish and maintain’ means 

24 adequately— 


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1 ‘‘(A) define, document (by paper or elec2 tronically), implement, and follow; and 

3 ‘‘(B) review and, as needed, revise on an 

4 ongoing basis.’’. 

5 (3) APPLICATION.—The requirements of section 

6 503C of the Federal Food, Drug, and Cosmetic Act, 

7 as added by paragraph (2), apply beginning on the 

8 date that is 2 years after the date of the enactment 

9 of this Act. 

10 (c) DOCUMENTATION OF SUPPLY CHAIN.— 

11 (1) IN GENERAL.—Section 510 of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 

13 amended, is further amended by adding at the end 

14 the following: 

15 ‘‘(r) DOCUMENTATION OF SUPPLY CHAIN.—Each es16 tablishment required to be registered under this section 

17 for the manufacture, preparation, propagation, 

18 compounding, or processing of a drug, shall maintain and 

19 provide to the Secretary, upon request, adequate informa20 tion, in electronic form, establishing— 

21 ‘‘(1) where the drug, including its raw mate22 rials, was produced, including all preceding pro23 ducers, manufacturers, distributors, and shippers; 

24 and 


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1 ‘‘(2) that the drug, its ingredients, and its raw 

2 materials were manufactured, prepared, propagated, 

3 compounded, processed, distributed, shipped, 

4 warehoused, brokered, imported, and conveyed under 

5 conditions that ensure the identity, strength, quality, 

6 and purity of the drug.’’. 

7 (2) APPLICATION.—The amendment made by 

8 paragraph (1) applies beginning on the date that is 

9 2 years after the date of the enactment of this Act. 

10 SEC. 103. INSPECTION OF PRODUCERS OF DRUGS. 

11 (a) INSPECTION.—Subsection (h) of section 510 of 

12 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

13 360) is amended— 

14 (1) by striking ‘‘(h)’’ and inserting ‘‘(h)(1)’’; 

15 and 

16 (2) by adding at the end the following: 

17 ‘‘(2) Notwithstanding paragraph (1), every establish18 ment engaged in the manufacture, propagation, 

19 compounding, or processing of a drug that is a finished 

20 dosage form or an active pharmaceutical ingredient shall 

21 be inspected pursuant to section 704 by one or more offi22 cers or employees duly designated by the Secretary— 

23 ‘‘(A) at least once in the 2-year period begin24 ning with the date of registration of such establishVerDate Mar 15 2010 01:08 Dec 20, 2010 Jkt 099200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\H6543.IH H6543

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1 ment pursuant to this section and at least once in 

2 every successive 2-year period thereafter; or 

3 ‘‘(B) at least once in the 4-year period begin4 ning with the date of registration of such establish5 ment pursuant to this section and at least once in 

6 every successive 4-year period thereafter, if the Sec7 retary determines that sufficient information about 

8 the type of product produced in the establishment, 

9 inspection history, compliance history, and such ad10 ditional factors as the Secretary determines by guid11 ance, exists to assess risk and to establish a risk12 based inspection schedule. 

13 ‘‘(3) The Secretary shall conduct an inspection of a 

14 drug establishment when the establishment begins to man15 ufacture, prepare, propagate, compound, or process a drug 

16 that is a finished dosage form or active pharmaceutical 

17 ingredient before the drug is introduced into interstate 

18 commerce if the active ingredient is new to the drug prod19 uct or the drug has undergone a major change requiring 

20 prior approval by the Secretary of a supplement to an ap21 plication submitted under section 505. Notwithstanding 

22 the preceding sentence, the Secretary may opt against con23 ducting such an inspection if the Secretary determines, 

24 based on the inspection history of the establishment, that 

25 such an inspection is not necessary to verify the data conVerDate Mar 15 2010 01:08 Dec 20, 2010 Jkt 099200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6201 E:\BILLS\H6543.IH H6543

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1 tained in the application (or supplement to the applica2 tion) submitted under section 505, ensure compliance with 

3 current good manufacturing practices, or otherwise ensure 

4 the safety of the drug or ingredient. 

5 ‘‘(4) The Secretary may inspect, pursuant to section 

6 704, every establishment engaged in the manufacture, 

7 propagation, compounding, or processing of an excipient 

8 of a drug to the same extent as the Secretary is authorized 

9 to inspect an establishment engaged in the manufacture, 

10 propagation, compounding, or processing of any other 

11 drug. 

12 ‘‘(5) Nothing in this subsection shall be construed as 

13 limiting the authority of the Secretary to conduct inspec14 tions of establishments under any other provision of the 

15 Act. 

16 ‘‘(6) With respect to fiscal year 2012 and each subse17 quent fiscal year, the Secretary shall submit an annual 

18 report to the Congress on— 

19 ‘‘(A) funding dedicated to inspections under 

20 this subsection of establishments engaged in the 

21 manufacture, propagation, compounding, or proc22 essing of a drug; and 

23 ‘‘(B) the number of such establishments for 

24 which the frequency of such inspections has been 

25 modified pursuant to paragraph (2). 


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1 ‘‘(7) For purposes of determining inspection fre2 quency under paragraph (2), the Secretary shall establish 

3 information systems capacity sufficient to assess risk and 

4 shall develop and maintain a risk-based system for con5 ducting surveillance of current good manufacturing prac6 tices by establishments engaged in the manufacture, prop7 agation, compounding, or processing of a drug that is a 

8 finished dosage form or an active pharmaceutical ingre9 dient. The Secretary shall have such capacity in place and 

10 begin implementation of such risk-based system not later 

11 than 3 years after the date of the enactment of the Drug 

12 Safety Enhancement Act of 2011. Such risk-based system 

13 shall include consideration of the class of the establish14 ment’s products and associated risks, the date the estab15 lishment was last inspected, the establishment’s compli16 ance and safety history, the establishment’s shipping vol17 ume and history, and such other factors as the Secretary 

18 determines relevant to assessing the risk presented by the 

19 establishment.’’. 

20 (b) GAO REPORT.—Not later than 3 years after the 

21 date of the enactment of this Act, the Comptroller General 

22 of the United States shall submit a report to the Congress 

23 on the risk-based process for conducting surveillance of 

24 current good manufacturing practices developed and im25 plemented under section 510(h)(7) of the Federal Food, 


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1 Drug, and Cosmetic Act, as added by subsection (a)(2) 

2 of this section. 

3 (c) APPLICATION.—The amendments made by this 

4 section shall apply to drugs introduced or delivered for in5 troduction into interstate commerce on or after the date 

6 of the enactment of this Act. 

7 SEC. 104. PROHIBITION AGAINST DELAYING, LIMITING, OR 

8 REFUSING INSPECTION. 

9 Section 501 of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 351), as amended, is further amended by 

11 adding at the end the following: 

12 ‘‘(k) If it is a drug and it has been manufactured, 

13 processed, packed, or held in any factory, warehouse, or 

14 establishment and the owner, operator, or agent of such 

15 factory, warehouse, or establishment, or any agent of a 

16 governmental authority in the foreign country within 

17 which such factory, warehouse, or establishment is located, 

18 delays or limits an inspection, or refuses to permit entry 

19 or inspection, under section 510(h) or 704.’’. 

20 SEC. 105. CLARIFICATION OF INSPECTION AUTHORITY RE21 LATED TO BIMO AND IRB INSPECTIONS. 

22 (a) IN GENERAL.—Section 704(a)(1) of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)), is 

24 amended— 


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1 (1) by inserting after the second sentence the 

2 following: ‘‘For purposes of enforcement of this Act, 

3 officers or employees duly designated by the Sec4 retary, upon presenting appropriate credentials and 

5 a written notice to the owner, operator, or agent in 

6 charge, are also authorized to enter, at reasonable 

7 times, any premises of a clinical investigator, spon8 sor, monitor, contract research organization, site 

9 management organization, institutional review 

10 board, or other person that oversees, initiates, or 

11 conducts a clinical investigation subject to section 

12 505(i), or a postmarket study or clinical trial subject 

13 to section 505(k) or 505(o).’’; and 

14 (2) by inserting ‘‘or any establishment associ15 ated with a clinical investigation subject to section 

16 505(i), or a postmarket study or clinical trial subject 

17 to section 505(k) or 505(o) (including the premises 

18 of any clinical investigator, sponsor, monitor, con19 tract research organization, site management organi20 zation, person that oversees or participates in data 

21 acquisition, data generation, data archiving, or data 

22 analysis, institutional review board, or any other 

23 person, other than a subject, that participates in the 

24 conduct of a clinical investigation of a drug),’’ before 

25 ‘‘inspection shall extend to all things therein’’. 


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1 (b) CONFORMING AMENDMENT.—Section 704(a)(2) 

2 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 374(a)(2)) is amended by striking ‘‘third sentence’’ and 

4 inserting ‘‘fourth sentence’’. 

5 SEC. 106. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

6 OF ADULTERATED OR MISBRANDED DRUG 

7 PRODUCTS. 

8 (a) PROHIBITED ACTS.—Section 301 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend10 ed by adding at the end the following: 

11 ‘‘(uu)(1) The failure to notify the Secretary in viola12 tion of section 568(a). 

13 ‘‘(2) The failure to comply with any order issued 

14 under section 568.’’. 

15 (b) NOTIFICATION, NONDISTRIBUTION, AND RECALL

16 OF ADULTERATED OR MISBRANDED DRUGS.—Subchapter 

17 E of chapter V of the Federal Food, Drug, and Cosmetic 

18 Act (21 U.S.C. 360bbb et seq.) is amended by adding at 

19 the end the following: 

20 ‘‘SEC. 568. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

21 OF ADULTERATED OR MISBRANDED DRUGS. 

22 ‘‘(a) NOTIFICATION, NONDISTRIBUTION, AND RE23 CALL OF ADULTERATED OR MISBRANDED DRUGS.— 


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1 ‘‘(1) IN GENERAL.—A person required, with re2 spect to drugs, to register under section 510, 801(r), 

3 or 801(s) that has reason to believe that— 

4 ‘‘(A) a drug when introduced into or while 

5 in interstate commerce, or while held for sale 

6 (regardless of whether the first sale) after ship7 ment in interstate commerce, is adulterated or 

8 misbranded, and 

9 ‘‘(B) as a result, the use or consumption 

10 of, or exposure to, the drug (or an ingredient 

11 or component used in any such drug) may re12 sult in illness or injury to humans or animals, 

13 shall, as soon as practicable, notify the Secretary of 

14 the identity and location of the drug. 

15 ‘‘(2) MANNER OF NOTIFICATION.—Notification 

16 under paragraph (1) shall be made in such manner 

17 and by such means as the Secretary may require by 

18 regulation. 

19 ‘‘(b) VOLUNTARY RECALL.—The Secretary may re20 quest that any person who distributes a drug that the Sec21 retary has reason to believe is adulterated, misbranded, 

22 or otherwise in violation of this Act voluntarily— 

23 ‘‘(1) recall such drug; and 


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1 ‘‘(2) provide for notice, including to individuals 

2 as appropriate, to persons who may be affected by 

3 the recall. 

4 ‘‘(c) ORDER TO CEASE DISTRIBUTION.—If the Sec5 retary has reason to believe that the use or consumption 

6 of, or exposure to, a drug may result in illness or injury 

7 to humans or animals, the Secretary shall have the author8 ity to issue an order requiring any person who distributes 

9 such drug to immediately cease distribution of such drug. 

10 ‘‘(d) ACTION FOLLOWING ORDER.—Any person who 

11 is subject to an order under subsection (c) shall imme12 diately cease distribution of such drug and provide notifi13 cation as required by such order, and may appeal within 

14 24 hours of issuance of such order to the Secretary. Such 

15 appeal may include a request for an informal hearing and 

16 a description of any efforts to recall such drug undertaken 

17 voluntarily by the person, including after a request under 

18 subsection (b). Except as provided in subsection (f), an 

19 informal hearing shall be held as soon as practicable, but 

20 not later than 5 calendar days, or less as determined by 

21 the Secretary, after such an appeal is filed, unless the par22 ties jointly agree to an extension. After affording an op23 portunity for an informal hearing, the Secretary shall de24 termine whether the order should be amended to require 

25 a recall of such drug. If, after providing an opportunity 


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1 for such a hearing, the Secretary determines that inad2 equate grounds exist to support the actions required by 

3 the order, the Secretary shall vacate the order. 

4 ‘‘(e) ORDER TO RECALL.— 

5 ‘‘(1) AMENDMENT.—Except as provided under 

6 subsection (f), if after providing an opportunity for 

7 an informal hearing under subsection (d), the Sec8 retary determines that the order should be amended 

9 to include a recall of the drug with respect to which 

10 the order was issued, the Secretary shall amend the 

11 order to require a recall. 

12 ‘‘(2) CONTENTS.—An amended order under 

13 paragraph (1) shall— 

14 ‘‘(A) specify a timetable in which the recall 

15 will occur; 

16 ‘‘(B) require periodic reports to the Sec17 retary describing the progress of the recall; and 

18 ‘‘(C) provide for notice, including to indi19 viduals as appropriate, to persons who may be 

20 affected by the recall. In providing for such no21 tice, the Secretary may allow for the assistance 

22 of health professionals, State or local officials, 

23 or other individuals designated by the Sec24 retary. 

25 ‘‘(f) EMERGENCY RECALL ORDER.— 


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1 ‘‘(1) IN GENERAL.—If the Secretary has cred2 ible evidence or information that a drug subject to 

3 an order under subsection (c) presents an imminent 

4 threat of serious adverse health consequences or 

5 death to humans or animals, the Secretary may 

6 issue an order requiring any person who distributes 

7 such drug— 

8 ‘‘(A) to immediately recall such drug; and 

9 ‘‘(B) to provide for notice, including to in10 dividuals as appropriate, to persons who may be 

11 affected by the recall. 

12 ‘‘(2) ACTION FOLLOWING ORDER.—Any person 

13 who is subject to an emergency recall order under 

14 this subsection shall immediately recall such drug 

15 and provide notification as required by such order, 

16 and may appeal within 24 hours after issuance such 

17 order to the Secretary. The person subject to an 

18 emergency recall order shall conduct the recall not19 withstanding the pendency of any such appeal. An 

20 informal hearing shall be held as soon as practicable 

21 but not later than 5 calendar days, or less as deter22 mined by the Secretary, after such an appeal is filed, 

23 unless the parties jointly agree to an extension. 

24 After affording an opportunity for an informal hear25 ing, the Secretary shall determine whether the order 


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1 should be amended pursuant to subsection (e)(1). If, 

2 after providing an opportunity for such a hearing, 

3 the Secretary determines that inadequate grounds 

4 exist to support the actions required by the order, 

5 the Secretary shall vacate the order. 

6 ‘‘(g) NOTICE TO CONSUMERS AND HEALTH OFFI7 CIALS.—The Secretary shall, as the Secretary determines 

8 to be necessary, provide notice of a recall order under this 

9 section to consumers to whom the drug was, or may have 

10 been, distributed and to appropriate State and local health 

11 officials. 

12 ‘‘(h) SAVINGS CLAUSE.—Nothing contained in this 

13 section shall be construed as limiting— 

14 ‘‘(1) the authority of the Secretary to issue an 

15 order to cease distribution of, or to recall, a drug 

16 under any other provision of this Act or the Public 

17 Health Service Act; or 

18 ‘‘(2) the ability of the Secretary to request any 

19 person to perform a voluntary activity related to any 

20 drug subject to this Act or the Public Health Service 

21 Act.’’. 

22 (c) ARTICLES SUBJECT TO REFUSAL.—The third 

23 sentence of subsection (a) of section 801 of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amend25 ed by inserting ‘‘or (4) in the case of a drug, such article 


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1 is subject to an order under section 568 to cease distribu2 tion of or recall the article,’’ before ‘‘then such article shall 

3 be refused admission’’. 

4 (d) APPLICATION.—Sections 301(uu) and 568 of the 

5 Federal Food, Drug, and Cosmetic Act, as added by sub6 sections (a) and (b), shall apply with respect to a drug 

7 as of such date, not later than 1 year after the date of 

8 the enactment of this Act, as the Secretary of Health and 

9 Human Services shall specify. 

10 SEC. 107. NOTIFICATION. 

11 (a) IN GENERAL.— 

12 (1) PROHIBITED ACTS.—Section 301 of the 

13 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

14 331), as amended, is further amended by adding at 

15 the end the following: 

16 ‘‘(vv) The failure to notify the Secretary in violation 

17 of section 569.’’. 

18 (2) NOTIFICATION.—Subchapter E of chapter 

19 V of the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 360bbb et seq.), as amended, is further 

21 amended by adding at the end the following: 

22 ‘‘SEC. 569. NOTIFICATION. 

23 ‘‘(a) NOTIFICATION TO SECRETARY.—With respect 

24 to a drug, the Secretary may require notification to the 

25 Secretary by a regulated person of— 


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1 ‘‘(1) the use of, or exposure to, such drug which 

2 may result in illness or injury to humans or animals; 

3 ‘‘(2) a significant loss or known theft of such 

4 drug; 

5 ‘‘(3) a reasonable probability that such drug 

6 has been or is being counterfeited; 

7 ‘‘(4) repeated failures by a manufacturer of a 

8 component or other material used in the manufac9 ture of such drug to ensure compliance with applica10 ble quality systems requirements under section 

11 501(a)(2)(B) or 503C of this Act or section 351 or 

12 361 of the Public Health Service Act; 

13 ‘‘(5) any incident causing such drug to be mis14 taken for, or its labeling applied to, another drug; 

15 ‘‘(6) any contamination or any significant 

16 chemical, physical, or other change or deterioration 

17 in such drug after distribution, or any failure of a 

18 distributed lot or batch of such drug to meet an es19 tablished specification; and 

20 ‘‘(7) any other type of information regarding 

21 such drug that the Secretary deems necessary for 

22 protection of the public health. 

23 ‘‘(b) MANNER OF NOTIFICATION.—Notification 

24 under this section shall be made in such manner and by 


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1 such means as the Secretary may require by regulation 

2 or guidance. 

3 ‘‘(c) DEFINITION.—In this section, the term ‘regu4 lated person’ means a person who is required to register 

5 under section 510, 801(r), or 801(s); a wholesale dis6 tributor of a drug product; and any other person that dis7 tributes drugs except exclusively for retail sale.’’. 

8 (b) EXCHANGE OF INFORMATION.— 

9 (1) PROHIBITED ACTS.— 

10 (A) IN GENERAL.—The first sentence of 

11 section 301(j) of the Federal Food, Drug, and 

12 Cosmetic Act (21 U.S.C. 331(j)) is amended— 

13 (i) by striking ‘‘or’’ before ‘‘to the 

14 courts when relevant’’; and 

15 (ii) by inserting ‘‘, or as specified in 

16 section 708,’’ before ‘‘any information ac17 quired’’. 

18 (B) TECHNICAL CORRECTIONS.—The first 

19 sentence of such section 301(j) is further 

20 amended— 

21 (i) by striking ‘‘573.’’ and inserting 

22 ‘‘573’’; and 

23 (ii) by striking the second of the two 

24 consecutive periods at the end. 


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1 (2) AMENDMENT.—Section 708 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 379) is 

3 amended— 

4 (A) by striking ‘‘The Secretary’’ and in5 serting ‘‘(a) The Secretary’’; and 

6 (B) by adding at the end the following: 

7 ‘‘(b)(1)(A) The Secretary may provide to any Federal 

8 agency acting within the scope of its jurisdiction any infor9 mation respecting a drug that is exempt from disclosure 

10 pursuant to subsection (a) of section 552 of title 5, United 

11 States Code, by reason of subsection (b)(4) of such sec12 tion. 

13 ‘‘(B) Any such information provided to another Fed14 eral agency shall not be disclosed by such agency except 

15 in any investigation within the receiving agency’s jurisdic16 tion or in an action or proceeding under the laws of the 

17 United States in which the receiving agency or the United 

18 States is a party. 

19 ‘‘(2)(A) In carrying out this Act, the Secretary may 

20 provide to a State or local government agency any infor21 mation respecting a drug that is exempt from disclosure 

22 pursuant to section 552(a) of title 5, United States Code, 

23 by reason of subsection (b)(4) of such section. 


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1 ‘‘(B) Any such information provided to a State or 

2 local government agency shall not be disclosed by such 

3 agency. 

4 ‘‘(3) Except as provided by section 301(j), in carrying 

5 out this Act, the Secretary may provide to any person any 

6 information respecting a drug that is exempt from disclo7 sure pursuant to section 552(a) of title 5, United States 

8 Code, by reason of subsection (b)(4) of such section, if 

9 the Secretary determines that providing the information 

10 to the person is appropriate under the circumstances and 

11 the recipient provides adequate assurances to the Sec12 retary that the recipient will preserve the confidentiality 

13 of the information. 

14 ‘‘(4) In carrying out this Act, the Secretary may pro15 vide any information respecting a drug that is exempt 

16 from disclosure pursuant to section 552(a) of title 5, 

17 United States Code, by reason of subsection (b)(4) of such 

18 section— 

19 ‘‘(A) to any foreign government agency; or 

20 ‘‘(B) any international organization established 

21 by law, treaty, or other governmental action and 

22 having responsibility— 

23 ‘‘(i) to facilitate global or regional harmo24 nization of standards and requirements in an 


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1 area of responsibility of the Food and Drug Ad2 ministration; or 

3 ‘‘(ii) to promote and coordinate public 

4 health efforts, if the agency or organization pro5 vides adequate assurances to the Secretary that 

6 the agency or organization will preserve the 

7 confidentiality of the information. 

8 ‘‘(c) Except as provided by section 301(j), the Sec9 retary may disclose to the public any information respect10 ing a drug that is exempt from disclosure pursuant to sec11 tion 552(a) of title 5, United States Code, by reason of 

12 subsection (b)(4) of such section, if the Secretary deter13 mines that such disclosure is necessary to protect the pub14 lic health. 

15 ‘‘(d) Except as provided in subsection (e), the Sec16 retary shall not be required to disclose under section 552 

17 of title 5, United States Code, or any other provision of 

18 law any information respecting a drug obtained from a 

19 Federal, State, or local government agency, or from a for20 eign government agency, or from an international organi21 zation described in subsection (b)(4), if the agency or or22 ganization has requested that the information be kept con23 fidential, or has precluded such disclosure under other use 

24 limitations, as a condition of providing the information. 


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1 ‘‘(e) Nothing in subsection (d) authorizes the Sec2 retary to withhold information from the Congress or pre3 vents the Secretary from complying with an order of a 

4 court of the United States. 

5 ‘‘(f) This section shall not affect the authority of the 

6 Secretary to provide or disclose information under any 

7 other provision of law.’’. 

8 TITLE II—RESPONSE 

9 SEC. 201. ADMINISTRATIVE DETENTION. 

10 (a) ADMINISTRATIVE DETENTION OF DRUGS.—Sec11 tion 304 of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 334) is amended by adding at the end the fol13 lowing: 

14 ‘‘(i) ADMINISTRATIVE DETENTION OF DRUGS.— 

15 ‘‘(1) DETENTION AUTHORITY.— 

16 ‘‘(A) IN GENERAL.—If during any lawful 

17 activity conducted by an officer or employee, a 

18 drug which such officer or employee has reason 

19 to believe is in violation of any provision of this 

20 Act is found, such officer or employee may 

21 order the drug detained (in accordance with 

22 regulations prescribed by the Secretary) for a 

23 reasonable period which may not exceed 20 

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1 quired to institute an action under subsection 

2 (a) or section 302, in which case the Secretary 

3 may authorize a detention period of not to ex4 ceed 60 days. 

5 ‘‘(B) SECRETARY’S APPROVAL.—Regula6 tions of the Secretary prescribed under this 

7 paragraph shall require that, before a drug may 

8 be ordered detained under this paragraph, the 

9 Secretary or an officer or employee designated 

10 by the Secretary approve such order. 

11 ‘‘(C) SECURITY OF DETAINED DRUG.—A 

12 detention order under this paragraph may re13 quire— 

14 ‘‘(i) the labeling or marking of a drug 

15 during the period of its detention for the 

16 purpose of identifying the drug as de17 tained; and 

18 ‘‘(ii) that the drug be removed to a se19 cure facility, as appropriate. 

20 ‘‘(D) APPEAL OF DETENTION ORDER.— 

21 ‘‘(i) RIGHT TO APPEAL.—Any person 

22 who would be entitled to claim a drug if it 

23 were seized under subsection (a) may ap24 peal to the Secretary a detention of such 

25 drug under this paragraph. 


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1 ‘‘(ii) HEARING AND RESPONSE.— 

2 Within 15 days of the date an appeal of a 

3 detention is filed with the Secretary, the 

4 Secretary shall after affording opportunity 

5 for an informal hearing by order confirm 

6 the detention or revoke it. 

7 ‘‘(2) LIMITATION ON MOVEMENT OF DETAINED

8 DRUGS.— 

9 ‘‘(A) IN GENERAL.—Except as authorized 

10 by subparagraph (B), a drug subject to a deten11 tion order issued under paragraph (1) shall not 

12 be moved by any person from the place at 

13 which it is ordered detained until— 

14 ‘‘(i) released by the Secretary; or 

15 ‘‘(ii) the expiration of the detention 

16 period applicable to such order, 

17 whichever occurs first. 

18 ‘‘(B) EXCEPTION.—A drug subject to a de19 tention order under paragraph (1) may be 

20 moved— 

21 ‘‘(i) in accordance with regulations 

22 prescribed by the Secretary; and 

23 ‘‘(ii) if not in final form for shipment, 

24 at the discretion of the manufacturer of 


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1 the device for the purpose of completing 

2 the work required to put it in such form.’’. 

3 (b) REGULATIONS.—The Secretary shall issue regula4 tions or guidance to implement the amendments made by 

5 this section. 

6 (c) PROHIBITED ACTS.—Section 301(r) of the Fed7 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331), is 

8 amended— 

9 (1) by inserting ‘‘, drug,’’ after ‘‘device’’, each 

10 place it appears; and 

11 (2) by inserting ‘‘or section 304(i)’’ after ‘‘sec12 tion 304(g)’’. 

13 (d) EFFECTIVE DATE.—The amendments made by 

14 this section shall apply beginning on the day that is 180 

15 days after the date of enactment of this Act. 

16 SEC. 202. DESTRUCTION OF ADULTERATED, MISBRANDED, 

17 OR COUNTERFEIT DRUGS OFFERED FOR IM18 PORT. 

19 (a) IN GENERAL.—Section 801 of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 381) is amended by 

21 adding at the end the following: 

22 ‘‘(q)(1) Subject to paragraph (2), the Secretary of the 

23 Treasury shall cause the destruction, upon referral from 

24 the Secretary of Health and Human Services, of any drug 

25 that— 


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1 ‘‘(A) poses a reasonable probability of causing 

2 a significant adverse health effect, as determined by 

3 the Secretary of Health and Human Services; or 

4 ‘‘(B) is valued at an amount that is $2,000 or 

5 less (or such higher amount as the Secretary of the 

6 Treasury may set by regulation pursuant to section 

7 498 of the Tariff Act of 1930). 

8 ‘‘(2) The Secretary of Health and Human Services 

9 shall issue regulations providing for notice and an oppor10 tunity for an informal hearing for destruction of drugs 

11 under paragraph (1). The regulations under this para12 graph shall allow the Secretary of Health and Human 

13 Services to provide the notice and opportunity for an infor14 mal hearing to the owner or consignee after the destruc15 tion has occurred. 

16 ‘‘(3) For a drug not described in paragraph (1), the 

17 Secretary of Health and Human Services shall provide for 

18 notice and an opportunity for an informal hearing to the 

19 owner or consignee before the destruction of the drug 

20 under the fifth sentence of subsection (a).’’. 

21 (b) CONFORMING AMENDMENT.—The fifth sentence 

22 of subsection (a) of section 801 of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 381) is amended by 

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1 ing ‘‘Except as provided in subsection (q), the Secretary 

2 of the Treasury shall’’. 

3 (c) APPLICATION.—The amendments made by sub4 sections (a) and (b) shall apply beginning on the day that 

5 is 90 days after the date of the enactment of this Act. 

6 SEC. 203. CRIMINAL PENALTIES. 

7 Section 303 of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 333) is amended— 

9 (1) in subsection (a)— 

10 (A) in paragraph (1), by striking ‘‘Any’’ 

11 and inserting ‘‘Except as provided in paragraph 

12 (2) or (3), any’’; and 

13 (B) by adding at the end the following: 

14 ‘‘(3) Notwithstanding paragraph (1), any person who, 

15 with respect to a drug, knowingly violates paragraph (a), 

16 (b), (c), (d), (f), (g), (i), (k), or (jj)(3) of section 301 shall 

17 be imprisoned for not more than 10 years or fined in ac18 cordance with title 18, United States Code, or both.’’; and 

19 (2) in subsection (b)(1), by striking ‘‘fined not 

20 more than $250,000’’ and inserting ‘‘fined in ac21 cordance with title 18, United States Code’’. 

22 SEC. 204. CIVIL PENALTIES. 

23 (a) IN GENERAL.—Section 303(f) of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 331(f)) is 


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1 amended by striking paragraph (4) and inserting the fol2 lowing: 

3 ‘‘(4)(A) Except as provided in paragraph (3) 

4 and subsection (g), any person who violates a re5 quirement of this Act that relates to drugs shall be 

6 subject to a civil penalty in an amount not to ex7 ceed— 

8 ‘‘(i) $500,000 for each such violation; and 

9 ‘‘(ii) for all such violations adjudicated in 

10 a single proceeding, $10,000,000. 

11 ‘‘(B) Each violation described in subparagraph 

12 (A) and each day during which the violation con13 tinues shall be considered to be a separate offense.’’. 

14 (b) CONFORMING AMENDMENTS.— 

15 (1) Section 303(f)(3) of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 331(f)(3)) is 

17 amended— 

18 (A) in subparagraph (A), by striking ‘‘Any 

19 person who’’ and inserting ‘‘Notwithstanding 

20 paragraph (4), any person who’’; and 

21 (B) in subparagraph (B), by striking ‘‘If a 

22 violation of’’ and inserting ‘‘Notwithstanding 

23 paragraph (4), if a violation of’’. 

24 (2) Section 303(g)(1) of the Federal Food, 

25 Drug, and Cosmetic Act (21 U.S.C. 331(g)(1)) is 


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1 amended by striking ‘‘With respect to a person who’’ 

2 and inserting ‘‘Notwithstanding subsection (f)(4), 

3 with respect to a person who’’. 

4 SEC. 205. SEIZURE. 

5 Section 304(b) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 334(b)) is amended— 

7 (1) by striking ‘‘(b)’’ and inserting ‘‘(b)(1)’’; 

8 and 

9 (2) by adding at the end the following: 

10 ‘‘(2) PROCEDURE WITH RESPECT TO DRUGS; MUL11 TIPLICITY OF PENDING PROCEEDINGS.—In the case of a 

12 violation relating to a drug, the article, equipment, or 

13 other thing proceeded against shall be liable to seizure by 

14 process pursuant to the libel, and the procedure in cases 

15 under this section shall conform, as nearly as may be, to 

16 the procedure in admiralty rather than the procedure used 

17 for civil asset forfeiture proceedings set forth in section 

18 983 of title 18, United States Code. On demand of either 

19 party, any issue of fact joined in any such case brought 

20 under this section shall be tried by jury. Any such seizure 

21 brought under this section is not governed by Rule G of 

22 the Supplemental Rules of Admiralty or Maritime Claims 

23 and Asset Forfeiture Actions. In addition, exigent cir24 cumstances shall be deemed to exist for all such seizures 

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1 mons and arrest warrant shall be issued by the clerk of 

2 the court without court review. When libel for condemna3 tion proceedings relating to a drug under this section, in4 volving the same claimant and the same issues of adultera5 tion or misbranding, are pending in two or more jurisdic6 tions, such pending proceedings, upon application of the 

7 claimant reasonably made to the court of one such juris8 diction, shall be consolidated for trial by order of such 

9 court, and tried in (1) any district selected by the claimant 

10 where one of such proceedings is pending; or (2) a district 

11 agreed upon by stipulation between the parties. If no order 

12 for consolidation is so made within a reasonable time, the 

13 claimant may apply to the court of one such jurisdiction, 

14 and such court (after giving the United States attorney 

15 for such district reasonable notice and opportunity to be 

16 heard) shall by order, unless good cause to the contrary 

17 is shown, specify a district of reasonable proximity to the 

18 claimant’s principal place of business, in which all such 

19 pending proceedings shall be consolidated for trial and 

20 tried. Such order of consolidation shall not apply so as 

21 to require the removal of any case the date for trial of 

22 which has been fixed. The court granting such order shall 

23 give prompt notification thereof to the other courts having 

24 jurisdiction of the cases covered thereby.’’. 


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1 SEC. 206. ASSET FORFEITURE. 

2 (a) IN GENERAL.—Section 303 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 

4 adding at the end the following: 

5 ‘‘(h) FORFEITURE RELATED TO VIOLATIONS WITH

6 RESPECT TO DRUGS.— 

7 ‘‘(1) CRIMINAL FORFEITURE.—Any person con8 victed of a violation of section 301 with respect to 

9 drugs, or a conspiracy to commit such violation, 

10 shall forfeit to the United States any property, real 

11 or personal, constituting or traceable to the gross 

12 proceeds obtained, directly or indirectly, as a result 

13 of such violation. Pursuant to section 2461(c) of 

14 title 28, United States Code, the provisions of sec15 tion 413 of the Controlled Substances Act, except 

16 subsections (a), (d), and (q) of such section 413, 

17 shall apply to criminal forfeitures under this para18 graph. 

19 ‘‘(2) CIVIL FORFEITURE.—Any property, real 

20 or personal, constituting or traceable to the gross 

21 proceeds obtained, directly or indirectly, as a result 

22 of a violation of section 301 with respect to drugs, 

23 or a conspiracy to commit such violation, is subject 

24 to forfeiture to the United States in accordance with 

25 the provisions of chapter 46 of title 18, United 

26 States Code, except that such duties as are imposed 


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1 upon the customs officer or any other person with 

2 respect to the seizure and forfeiture of property 

3 under the customs laws as described in section 

4 981(d) of title 18, United States Code, shall be per5 formed with respect to seizures and forfeitures of 

6 property under this section by such officers, agents, 

7 or other persons as may be authorized or designated 

8 for that purpose by the Secretary.’’. 

9 (b) CIVIL FORFEITURE STATUTE DEFINITION.— 

10 Subparagraph (C) of section 983(i)(2) of title 18, United 

11 States Code, is amended to read as follows: 

12 ‘‘(C) section 304 of the Federal Food, 

13 Drug, and Cosmetic Act;’’. 

14 TITLE III—IMPORTATION AND 

15 EXPORTATION 

16 SEC. 301. DOCUMENTATION FOR ADMISSIBILITY OF IM17 PORTS. 

18 (a) PROHIBITION.—Section 301 of the Federal, 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 331), as 

20 amended, is further amended by adding at the end the 

21 following: 

22 ‘‘(ww) The submission (with respect to drugs) of in23 formation that is required pursuant to section 801 that 

24 is inaccurate or incomplete. 


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1 ‘‘(xx) The failure (with respect to drugs) to submit 

2 information that is required pursuant to section 801.’’. 

3 (b) DOCUMENTATION FOR IMPORTS.—Section 801 of 

4 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

5 381), as amended, is further amended by adding at the 

6 end the following: 

7 ‘‘(r) DOCUMENTATION.— 

8 ‘‘(1) SUBMISSION.—The Secretary may require 

9 by regulation the submission of documentation or 

10 other information for a drug that is imported or of11 fered for import into the United States. When devel12 oping any regulation in accordance with this para13 graph, to the extent that the collection of docu14 mentation or other information involves Customs 

15 and Border Protection efforts or resources, the Sec16 retary shall consult with Customs and Border Pro17 tection. 

18 ‘‘(2) FORMAT.—A regulation under paragraph 

19 (1) may specify the format for submission of the 

20 documentation or other information. 

21 ‘‘(3) REFUSAL OF ADMISSION.—A drug im22 ported or offered for import into the United States 

23 shall be refused admission unless all documentation 

24 and information the Secretary requires under this 


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1 Act or the Public Health Service Act for such article 

2 is submitted.’’. 

3 SEC. 302. REGISTRATION FOR COMMERCIAL IMPORTERS; 

4 FEE. 

5 (a) REGISTRATION.— 

6 (1) PROHIBITIONS.—Section 301 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 331), as 

8 amended, is further amended by adding at the end 

9 the following: 

10 ‘‘(yy) The failure to register in accordance with sec11 tion 801(s).’’. 

12 (2) MISBRANDING.—Section 502(o) of the Fed13 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

14 352(o)), as amended, is further amended by insert15 ing ‘‘if it is imported or offered for import by an im16 porter not duly registered under section 801(s),’’ be17 fore ‘‘or if it does not bear’’. 

18 (3) REGISTRATION.—Section 801 of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 381) 

20 is amended by adding at the end the following: 

21 ‘‘(s) REGISTRATION OF IMPORTERS.— 

22 ‘‘(1) REGISTRATION.—The Secretary shall re23 quire an importer of drugs— 


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1 ‘‘(A) to be registered with the Secretary in 

2 a form and manner specified by the Secretary; 

3 and 

4 ‘‘(B) consistent with section 1012, to sub5 mit appropriate unique identifiers as a condi6 tion of registration. 

7 ‘‘(2) GOOD IMPORTER PRACTICES.—The main8 tenance of registration under this subsection is con9 ditioned on compliance with good importer practices 

10 in accordance with the following: 

11 ‘‘(A) The Secretary, in consultation with 

12 Customs and Border Protection, shall promul13 gate regulations to establish good importer 

14 practices that specify the measures an importer 

15 shall take to ensure imported drugs are in com16 pliance with the requirements of this Act and 

17 the Public Health Service Act. 

18 ‘‘(B) The measures under subparagraph 

19 (A) shall ensure that the importer— 

20 ‘‘(i) has adequate information about 

21 the article, its hazards, and the require22 ments of this Act and the Public Health 

23 Service Act applicable to such article; 

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1 ticle and each person that produced, manu2 factured, processed, packed, transported, 

3 or held the article, including components of 

4 the article, are in compliance with the re5 quirements of this Act and the Public 

6 Health Service Act; and 

7 ‘‘(iii) has adequate procedures in 

8 place to take corrective action, such as the 

9 ability to appropriately trace, withhold, 

10 and recall articles, if an article imported by 

11 the importer is not in compliance with the 

12 requirements of this Act or the Public 

13 Health Service Act. 

14 ‘‘(C) In promulgating good importer prac15 tice regulations under this subsection, the Sec16 retary may, as appropriate, take into account 

17 differences among importers and the types of 

18 imports, including based on the level of risk 

19 posed by the imported drug. 

20 ‘‘(3) SUSPENSION OF REGISTRATION.— 

21 ‘‘(A) IN GENERAL.—Registration under 

22 this subsection is subject to suspension upon a 

23 finding by the Secretary, after notice and an 

24 opportunity for an informal hearing, of— 

25 ‘‘(i) a violation of this Act; or 


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1 ‘‘(ii) the knowing or repeated making 

2 of an inaccurate or incomplete statement 

3 or submission of information relating to 

4 the importation of a drug. 

5 ‘‘(B) REQUEST.—The importer whose reg6 istration is suspended may request that the 

7 Secretary vacate the suspension of registration 

8 when such importer has corrected the violation 

9 that is the basis for such suspension. 

10 ‘‘(C) VACATING OF SUSPENSION.—If the 

11 Secretary determines that adequate reasons do 

12 not exist to continue the suspension of a reg13 istration, the Secretary shall vacate such sus14 pension. 

15 ‘‘(4) CANCELLATION OF REGISTRATION.— 

16 ‘‘(A) IN GENERAL.—Not earlier than 10 

17 days after providing the notice under subpara18 graph (B), the Secretary may cancel a registra19 tion if the Secretary determines that— 

20 ‘‘(i) such registration was not updated 

21 in accordance with this section or other22 wise contains false, incomplete, or inac23 curate information; or 

24 ‘‘(ii) the registration fee required 

25 under section 743 for such registration has 


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1 not been paid within 30 days after the date 

2 due. 

3 ‘‘(B) NOTICE OF CANCELLATION.—Can4 cellation shall be preceded by notice to the im5 porter of the intent to cancel the registration 

6 and the basis for such cancellation. 

7 ‘‘(C) TIMELY UPDATE OR CORRECTION.— 

8 If the registration for the importer is updated 

9 or corrected no later than 7 days after notice 

10 is provided under subparagraph (B), the Sec11 retary shall not cancel such registration. 

12 ‘‘(5) EXEMPTIONS.—The Secretary, by notice 

13 in the Federal Register— 

14 ‘‘(A) shall establish an exemption from the 

15 requirements of this subsection for importations 

16 for personal use; and 

17 ‘‘(B) may establish other exemptions from 

18 the requirements of this subsection.’’. 

19 (4) REGULATIONS.—Not later than 36 months 

20 after the date of the enactment of this Act, the Sec21 retary of Health and Human Services in consulta22 tion with the Commissioner responsible for Customs 

23 and Border Protection shall promulgate the regula24 tions required to carry out section 801(s) of the 

25 Federal Food, Drug, and Cosmetic Act, as added by 


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1 paragraph (3). In establishing the effective date of 

2 a regulation promulgated under section 801(s), the 

3 Secretary shall, in consultation with the Commis4 sioner responsible for Customs and Border Protec5 tion, as appropriate, provide a reasonable period of 

6 time for an importer of a drug to comply with good 

7 importer practices, taking into account differences 

8 among importers and the types of imports, including 

9 based on the level of risk posed by the imported 

10 product. 

11 (5) EFFECTIVE DATE.—The amendments made 

12 by this subsection shall take effect on the date that 

13 is 24 months after the date of enactment of this Act. 

14 (b) FEE.—Subchapter C of chapter VII of the Fed15 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379f et 

16 seq.) is amended by adding at the end the following: 

17 ‘‘PART 6—IMPORTERS OF DRUGS 

18 ‘‘SEC. 743. IMPORTERS OF DRUGS. 

19 ‘‘(a) IMPORTERS.—The Secretary shall assess and 

20 collect an annual fee for the registration of an importer 

21 under section 801(s). 

22 ‘‘(b) AMOUNT OF FEE.— 

23 ‘‘(1) BASE AMOUNTS.—The registration fee 

24 under subsection (a) shall be— 

25 ‘‘(A) for fiscal year 2012, $500; and 


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1 ‘‘(B) for fiscal year 2013 and each subse2 quent fiscal year, the fee for fiscal year 2012 as 

3 adjusted under paragraph (2). 

4 ‘‘(2) ADJUSTMENT.—For fiscal year 2013 and 

5 subsequent fiscal years, the fees established pursu6 ant to paragraph (1) shall be adjusted by the Sec7 retary by notice, published in the Federal Register, 

8 for a fiscal year to reflect the greater of— 

9 ‘‘(A) the total percentage change that oc10 curred in the Consumer Price Index for all 

11 urban consumers (all items; United States city 

12 average) for the 12-month period ending June 

13 30 preceding the fiscal year for which fees are 

14 being established; 

15 ‘‘(B) the total percentage change for the 

16 previous fiscal year in basic pay under the Gen17 eral Schedule in accordance with section 5332 

18 of title 5, United States Code, as adjusted by 

19 any locality-based comparability payment pur20 suant to section 5304 of such title for Federal 

21 employees stationed in the District of Columbia; 

22 or 

23 ‘‘(C) the average annual change in the 

24 cost, per full-time equivalent position of the 

25 Food and Drug Administration, of all personnel 


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1 compensation and benefits paid with respect to 

2 such positions for the first 5 years of the pre3 ceding 6 fiscal years. 

4 ‘‘(3) COMPOUNDED BASIS.—The adjustment 

5 made each fiscal year pursuant to this subsection 

6 shall be added on a compounded basis to the sum 

7 of all adjustments made each fiscal year after fiscal 

8 year 2012 under this subsection. 

9 ‘‘(4) WAIVER FOR IMPORTERS REQUIRED TO

10 PAY REGISTRATION FEE.—The Secretary shall waive 

11 the fee applicable to a person under this section if 

12 such person is required to pay both— 

13 ‘‘(A) a fee under section 736C for registra14 tion of one or more establishments under sec15 tion 510, for drugs; and 

16 ‘‘(B) a fee under this section for registra17 tion as an importer under section 801(s). 

18 ‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 

19 ‘‘(1) IN GENERAL.—Fees authorized under sub20 section (a) shall be collected and available for obliga21 tion only to the extent and in the amount provided 

22 in advance in appropriations Acts. Such fees are au23 thorized to remain available until expended. Such 

24 sums as may be necessary may be transferred from 

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1 penses appropriation account without fiscal year lim2 itation to such appropriation account for salaries 

3 and expenses with such fiscal year limitation. 

4 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

5 ACTS.—The fees authorized by this section— 

6 ‘‘(A) shall be retained in each fiscal year in 

7 an amount not to exceed the amount specified 

8 in appropriations Acts, or otherwise made avail9 able for obligation, for such fiscal year; and 

10 ‘‘(B) shall only be collected and available 

11 to cover the costs associated with registering 

12 importers under sections 801(s) and with en13 suring compliance with good importer practices. 

14 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

15 For each of fiscal years 2012 through 2016, there 

16 are authorized to be appropriated for fees under this 

17 section such sums as may be necessary.’’. 

18 (c) INSPECTION.—Section 704 of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 374) is amended by 

20 adding at the end the following: 

21 ‘‘(h) IMPORTERS.—Every person engaged in the im22 porting of any drug shall, upon request of an officer or 

23 employee designated by the Secretary, permit such officer 

24 or employee at all reasonable times to inspect the facilities 


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1 of such person and have access to, and to copy and verify, 

2 any related records.’’. 

3 SEC. 303. REGISTRATION FOR CUSTOMS BROKERS. 

4 (a) REGISTRATION.— 

5 (1) PROHIBITIONS.—Section 301(yy) of the 

6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 331), as added by section 302(a)(1), is amended by 

8 inserting ‘‘or 801(t)’’ after ‘‘801(s)’’. 

9 (2) MISBRANDING.—Section 502(o) (21 U.S.C. 

10 352(o)), as amended by section 302(a)(2), is amend11 ed— 

12 (A) by inserting ‘‘or a customs broker’’ 

13 after ‘‘by an importer’’; and 

14 (B) by inserting ‘‘or 801(t)’’ after 

15 ‘‘801(s)’’. 

16 (3) REGISTRATION.—Section 801 of the Fed17 eral Food, Drug, and Cosmetic Act (21 U.S.C. 381), 

18 as amended, is further amended by adding at the 

19 end the following: 

20 ‘‘(t) REGISTRATION OF CUSTOMS BROKER.— 

21 ‘‘(1) REGISTRATION.—The Secretary shall re22 quire a customs broker, with respect to the importa23 tion of drugs— 


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1 ‘‘(A) to be registered with the Secretary in 

2 a form and manner specified by the Secretary; 

3 and 

4 ‘‘(B) consistent with section 1012, to sub5 mit appropriate unique identifiers as a condi6 tion of registration. 

7 ‘‘(2) CANCELLATION OF REGISTRATION.— 

8 ‘‘(A) IN GENERAL.—Not earlier than 10 

9 days after providing the notice under subpara10 graph (B), the Secretary may cancel a registra11 tion that the Secretary determines was not up12 dated in accordance with this section or other 

13 wise contains false, incomplete, or inaccurate 

14 information. 

15 ‘‘(B) NOTICE OF CANCELLATION.—Can16 cellation shall be preceded by notice to the cus17 toms broker of the intent to cancel the registra18 tion and the basis for such cancellation. 

19 ‘‘(C) TIMELY UPDATE OR CORRECTION.— 

20 If the registration for the customs broker is up21 dated or corrected no later than 7 days after 

22 notice is provided under subparagraph (B), the 

23 Secretary shall not cancel such registration. 

24 ‘‘(3) NOTIFICATION.—The Secretary shall no25 tify the Commissioner responsible for Customs and 


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1 Border Protection whenever the Secretary cancels a 

2 registration under this subsection. 

3 ‘‘(4) EXEMPTIONS.—In consultation with the 

4 Commissioner responsible for Customs and Border 

5 Protection, the Secretary, by notice published in the 

6 Federal Register— 

7 ‘‘(A) shall establish an exemption from the 

8 requirements of this subsection for importations 

9 for personal use; and 

10 ‘‘(B) may establish other exemptions from 

11 the requirements of this subsection. 

12 ‘‘(5) CIVIL PENALTIES.—Notwithstanding any 

13 other provision in this Act, a customs broker who 

14 violates section 301 because of a violation of sub15 section (ww), (xx), or (yy) of such section shall not 

16 be subject to a civil penalty under section 

17 303(f)(1)(C) of this Act.’’. 

18 (4) REGULATIONS.—Not later than 24 months 

19 after the date of the enactment of this Act, the Sec20 retary of Health and Human Services, in consulta21 tion with the Commissioner responsible for Customs 

22 and Border Protection, shall promulgate the regula23 tions required to carry out section 801(t) of the 

24 Federal Food, Drug, and Cosmetic Act, as added by 

25 paragraph (3). 


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1 (5) EFFECTIVE DATE.—The amendments made 

2 by this subsection shall take effect on the date that 

3 is 24 months after the date of enactment of this Act. 

4 (b) INSPECTION.—Section 704 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 374), as amended, 

6 is further amended by adding at the end the following: 

7 ‘‘(i) BROKERS.—Every customs broker required to be 

8 registered with the Secretary shall, upon request of an of9 ficer or employee designated by the Secretary, permit such 

10 officer or employee at all reasonable times to inspect the 

11 facilities of such person and have access to, and to copy 

12 and verify, any related records.’’. 

13 SEC. 304. EXPORTATION CERTIFICATE PROGRAM. 

14 Section 801(e)(4) of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 381(e)(4)) is amended— 

16 (1) in subparagraph (B), by striking ‘‘If the 

17 Secretary’’ and inserting ‘‘With respect to a device, 

18 if the Secretary’’; and 

19 (2) by adding at the end the following: 

20 ‘‘(C) With respect to a drug: 

21 ‘‘(i) A certification by the Secretary under 

22 subparagraph (A) need not be in writing. 

23 ‘‘(ii) Subparagraph (A) applies only with 

24 respect to exportation from the United States. 


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1 ‘‘(iii) Any person who exports from a coun2 try other than the United States a drug ap3 proved in the United States may request that 

4 the Secretary certify that the exported drug 

5 meets the applicable requirements of this Act. 

6 The Secretary shall issue such a certification 

7 within 20 days of the receipt of a request for 

8 such certification if the request demonstrates 

9 that the drug meets the applicable requirements 

10 of this Act. 

11 ‘‘(iv) For purposes of this subparagraph, a 

12 certification by the Secretary shall be made on 

13 such basis and in such form (such as a publicly 

14 available listing) as the Secretary determines 

15 appropriate. 

16 ‘‘(v) If the Secretary, with respect to a 

17 drug, issues an export certification within the 

18 20 days prescribed by subparagraph (A) or 

19 clause (iii) of this subparagraph, a fee for such 

20 certification may be charged but such fee shall 

21 not exceed such amount as the Secretary deter22 mines is reasonably related to the cost of 

23 issuing such certificates. The Secretary may ad24 just this fee annually to account for inflation 

25 and other cost adjustments. Fees collected for 


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1 a fiscal year pursuant to this subparagraph 

2 shall be credited to the appropriation account 

3 for salaries and expenses of the Food and Drug 

4 Administration and shall be available in accord5 ance with appropriations Acts until expended, 

6 without fiscal year limitation. Such fees shall be 

7 collected in each fiscal year in an amount equal 

8 to the amount specified in appropriations Acts 

9 for such fiscal year and shall only be collected 

10 and available for the costs of the Food and 

11 Drug Administration to cover the cost of 

12 issuing such certifications. Such sums as nec13 essary may be transferred from such appropria14 tion account for salaries and expenses of the 

15 Food and Drug Administration without fiscal 

16 year limitation to such appropriation account 

17 for salaries and expenses with fiscal year limita18 tion.’’. 

19 SEC. 305. EXTRATERRITORIAL JURISDICTION. 

20 (a) IN GENERAL.—Chapter III of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amend22 ed by adding at the end the following: 

23 ‘‘SEC. 311. EXTRATERRITORIAL JURISDICTION. 

24 ‘‘There is extraterritorial jurisdiction over any viola25 tion of this Act relating to any drug if such drug was inVerDate Mar 15 2010 01:08 Dec 20, 2010 Jkt 099200 PO 00000 Frm 00073 Fmt 6652 Sfmt 6201 E:\BILLS\H6543.IH H6543

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1 tended for import into the United States or if any act in 

2 furtherance of the violation was committed in the United 

3 States.’’. 

4 (b) PROHIBITION.—Section 301 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 331), as amended, 

6 is further amended by adding at the end the following: 

7 ‘‘(zz) The production, manufacture, processing, prep8 aration, packing, holding, or distribution of an adulterated 

9 or misbranded drug with the knowledge or intent that 

10 such drug will be imported into the United States, or the 

11 production, manufacture, processing, preparation, pack12 ing, holding, or distribution of a drug with the knowledge 

13 or intent that the drug will be imported into the United 

14 States in violation of section 505.’’. 

15 SEC. 306. DEDICATED FOREIGN INSPECTORATE. 

16 Section 704 of the Federal Food, Drug, and Cosmetic 

17 Act (21 U.S.C. 374), as amended, is further amended by 

18 adding at the end the following: 

19 ‘‘(j) The Secretary shall establish and maintain a 

20 corps of inspectors dedicated to inspections of foreign drug 

21 facilities and establishments. This corps shall be staffed 

22 and funded by the Secretary at a level sufficient to allow 

23 it to conduct inspections of foreign drug facilities and es24 tablishments at a frequency at least equivalent to the inVerDate Mar 15 2010 01:08 Dec 20, 2010 Jkt 099200 PO 00000 Frm 00074 Fmt 6652 Sfmt 6201 E:\BILLS\H6543.IH H6543

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1 spection rate of domestic drug facilities and establish2 ments.’’. 

3 TITLE IV—MISCELLANEOUS 

4 SEC. 401. UNIQUE IDENTIFICATION NUMBER FOR ESTAB5 LISHMENTS, IMPORTERS, AND CUSTOMS BRO6 KERS. 

7 Chapter X of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 391 et seq.) is amended by adding at the 

9 end the following: 

10 ‘‘SEC. 1012. UNIQUE IDENTIFIER. 

11 ‘‘(a) REGISTRATION OF ESTABLISHMENTS.—A per12 son required to register a drug establishment pursuant to 

13 section 510 shall submit, at the time of registration, a 

14 unique identifier for the establishment. 

15 ‘‘(b) REGISTRATION OF IMPORTERS AND CUSTOMS

16 BROKERS.—A person required to register pursuant to sec17 tion 801(s) or 801(t) shall submit, at the time of registra18 tion, a unique identifier for the principal place of business 

19 for which such person is required to register under section 

20 801(s) or 801(t). 

21 ‘‘(c) GUIDANCE.—The Secretary may, by guidance, 

22 and, with respect to importers and customs brokers, in 

23 consultation with the Commissioner responsible for Cus24 toms and Border Protection, specify the unique numerical 

25 identifier system to be used to meet the requirements of 


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1 subsections (a) and (b) and the form, manner, and timing 

2 of a submission under such subsections. Development of 

3 such guidance shall take into account the utilization of ex4 isting unique identification schemes and compatibility with 

5 customs automated systems. 

6 ‘‘(d) IMPORTATION.—A drug imported or offered for 

7 import shall be refused admission unless the appropriate 

8 unique identifiers, as specified by the Secretary, are pro9 vided for such article.’’. 

10 SEC. 402. COUNTRY OF ORIGIN LABELING. 

11 (a) MISBRANDING.—Section 502 of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend13 ed by adding at the end the following: 

14 ‘‘(aa) If it is a finished dosage form drug and the 

15 Web site of the manufacturer of such drug does not list— 

16 ‘‘(1) the country of origin for each active phar17 maceutical ingredient; and 

18 ‘‘(2) the place of manufacture of the finished 

19 dosage form of such drug.’’. 

20 (b) REGULATIONS.—Not later than 3 years after the 

21 date of the enactment of this Act, the Secretary shall pro22 mulgate final regulations to carry out section 502(aa) of 

23 the Federal Food, Drug, and Cosmetic Act, as added by 

24 subsection (a). 


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1 (c) EFFECTIVE DATE.—The requirement of section 

2 502(aa) of the Federal Food, Drug, and Cosmetic Act, 

3 as added by subsection (a), takes effect 4 years after the 

4 date of the enactment of this Act. 

5 SEC. 403. FALSE OR MISLEADING REPORTING TO FDA. 

6 (a) IN GENERAL.—Section 301(q)(2) of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)(2)) is 

8 amended by inserting ‘‘, drug,’’ after ‘‘device’’. 

9 (b) EFFECTIVE DATE.—The amendment made by 

10 subsection (a) shall apply to submissions made on or after 

11 the date of the enactment of this Act. 

12 SEC. 404. SUBPOENA AUTHORITY. 

13 (a) PROHIBITED ACT.—Section 301(f) of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 331(f)) is 

15 amended by inserting before the period ‘‘or the failure or 

16 refusal to obey a subpoena issued pursuant to section 

17 312’’. 

18 (b) EXERCISE OF SUBPOENA AUTHORITY.—Chapter 

19 III of the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 331 et seq.), as amended, is further amended by 

21 adding at the end the following new section: 

22 ‘‘SEC. 312. EXERCISE OF SUBPOENA AUTHORITY. 

23 ‘‘(a) IN GENERAL.—For the purpose of— 

24 ‘‘(1) any hearing, investigation, or other pro25 ceeding respecting a violation of a provision of this 


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1 Act, the Public Health Service Act, or the Federal 

2 Anti-Tampering Act, relating to a drug; or 

3 ‘‘(2) any hearing, investigation, or other pro4 ceeding to determine if a person is in violation of a 

5 specific provision of this Act, the Public Health 

6 Service Act, or the Federal Anti-Tampering Act, re7 lating to a drug, 

8 the Commissioner may issue subpoenas requiring the at9 tendance and testimony of witnesses and the production 

10 of records and other things. 

11 ‘‘(b) TIMING OF COMPLIANCE.—When the Commis12 sioner deems that immediate compliance with a subpoena 

13 issued under this section is necessary to address a threat 

14 of serious adverse health consequences or death, the sub15 poena may require immediate production. 

16 ‘‘(c) SERVICE OF SUBPOENA.—Under this section: 

17 ‘‘(1) IN GENERAL.—Subpoenas of the Commis18 sioner shall be served by a person authorized by the 

19 Commissioner by delivering a copy thereof to the 

20 person named therein or by certified mail addressed 

21 to such person at such person’s last known dwelling 

22 place or principal place of business. 

23 ‘‘(2) CORPORATIONS AND OTHER ENTITIES.— 

24 Service on a domestic or foreign corporation, part25 nership, unincorporated association, or other entity 


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1 that is subject to suit under a common name may 

2 be made by delivering the subpoena to an officer, a 

3 managing or general agent, or any other agent au4 thorized by appointment or by law to receive service 

5 of process. 

6 ‘‘(3) PERSON OUTSIDE U.S. JURISDICTION.— 

7 Service on any person not found within the terri8 torial jurisdiction of any court of the United States 

9 may be made in any manner as the Federal Rules 

10 of Civil Procedure prescribe for service in a foreign 

11 nation. 

12 ‘‘(4) PROOF OF SERVICE.—A verified return by 

13 the person so serving the subpoena setting forth the 

14 manner of service, or, in the case of service by cer15 tified mail, the return post office receipt therefore 

16 signed by the person so served, shall be proof of 

17 service. 

18 ‘‘(d) PAYMENT OF WITNESSES.—Witnesses subpoe19 naed under subsection (a) shall be paid the same fees and 

20 mileage as are paid witnesses in the district courts of the 

21 United States. 

22 ‘‘(e) ENFORCEMENT.—In the case of a refusal to 

23 obey a subpoena duly served upon any person under sub24 section (a), any district court of the United States for the 

25 judicial district in which such person charged with refusal 


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1 to obey is found, resides, or transacts business, upon ap2 plication by the Commissioner, shall have jurisdiction to 

3 issue an order compelling compliance with the subpoena 

4 and requiring such person to appear and give testimony 

5 or to appear and produce records and other things, or 

6 both. The failure to obey such order of the court may be 

7 punished by the court as contempt thereof. If the person 

8 charged with failure or refusal to obey is not found within 

9 the territorial jurisdiction of the United States, the United 

10 States District Court for the District of Columbia shall 

11 have the same jurisdiction, consistent with due process, 

12 to take any action respecting compliance with the sub13 poena by such person that such district court would have 

14 if such person were personally within the jurisdiction of 

15 such district court. 

16 ‘‘(f) NONDISCLOSURE.—A United States district 

17 court for the district in which the subpoena is or will be 

18 served, upon application of the Commissioner, may issue 

19 an ex parte order that no person or entity disclose to any 

20 other person or entity (other than to an attorney to obtain 

21 legal advice) the existence of such subpoena for a period 

22 of up to 90 days. Such order may be issued on a showing 

23 that the records or things being sought may be relevant 

24 to the hearing, investigation, proceeding, or other matter 


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1 and that there is reason to believe that such disclosure 

2 may result in— 

3 ‘‘(1) furtherance of a potential violation under 

4 investigation; 

5 ‘‘(2) endangerment to the life or physical safety 

6 of any person; 

7 ‘‘(3) flight or other action to avoid prosecution 

8 or other enforcement remedies; 

9 ‘‘(4) destruction of or tampering with evidence; 

10 or 

11 ‘‘(5) intimidation of potential witnesses. 

12 An order under this subsection may be renewed for addi13 tional periods of up to 90 days upon a showing that any 

14 of the circumstances described in paragraphs (1) through 

15 (5) continue to exist. 

16 ‘‘(g) RELATION TO OTHER PROVISIONS.—The sub17 poena authority vested in the Commissioner and the dis18 trict courts of the United States by this section is in addi19 tion to any such authority vested in the Commissioner or 

20 such courts by other provisions of law, or as is otherwise 

21 authorized by law. 

22 ‘‘(h) NONDELEGATION.—The authority to issue a 

23 subpoena under this section is limited to the Commis24 sioner or an official designated by the Commissioner. An 

25 official may not be so designated unless the official is the 


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1 director of the district under this Act in which the drug 

2 is located, or is an official senior to such director.’’. 

3 (c) FAILURE TO OBEY SUBPOENA.—Section 801 of 

4 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

5 381), as amended, is further amended by adding at the 

6 end the following new subsection: 

7 ‘‘(u)(1) A drug shall be refused admission if any per8 son who manufactures, processes, packs, holds, or ships 

9 such drug before it is imported or offered for import into 

10 the United States fails or refuses to obey a subpoena 

11 issued pursuant to section 312 and such subpoena was 

12 issued, in whole or in part, for the purpose of determining 

13 whether such drug is adulterated, misbranded, or an unap14 proved new drug. 

15 ‘‘(2) No drug shall be refused admission under this 

16 section based on the failure or refusal to obey a subpoena 

17 that has been withdrawn by the Commissioner or quashed 

18 by a United States district court.’’. 

19 SEC. 405. WHISTLEBLOWER PROTECTIONS. 

20 Chapter X of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 391 et seq.), as amended, is further 

22 amended by adding at the end the following: 


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1 ‘‘SEC. 1013. PROTECTIONS FOR EMPLOYEES WHO REFUSE 

2 TO VIOLATE, OR WHO DISCLOSE VIOLATIONS 

3 OF, THIS ACT. 

4 ‘‘(a) IN GENERAL.—No person who submits or is re5 quired under this Act or the Public Health Service Act 

6 to submit any information related to a drug, or any offi7 cer, employee, contractor, subcontractor, or agent of such 

8 person, may discharge, demote, suspend, threaten, harass, 

9 or in any other manner discriminate against an employee 

10 in the terms and conditions of employment because of any 

11 lawful act done by the employee (including any lawful act 

12 that is within the ordinary course of the job duties of such 

13 employee)— 

14 ‘‘(1) to provide information, cause information 

15 to be provided, or otherwise assist in any investiga16 tion regarding any conduct which the employee rea17 sonably believes constitutes a violation of this Act 

18 that is related to a drug, or any other provision of 

19 Federal law relating to the safety of a drug, if the 

20 information or assistance is provided to, or an inves21 tigation stemming from the provided information is 

22 conducted by— 

23 ‘‘(A) a Federal regulatory or law enforce24 ment agency; 

25 ‘‘(B) any Member of Congress or any com26 mittee of Congress; or 


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1 ‘‘(C) a person with supervisory authority 

2 over the employee (or such other person work3 ing for the employer who has the authority to 

4 investigate, discover, or terminate the mis5 conduct); 

6 ‘‘(2) to file, cause to be filed, testify, participate 

7 in, or otherwise assist in a proceeding filed, or about 

8 to be filed (with any knowledge of the employer), in 

9 any court or administrative forum relating to any 

10 such alleged violation; or 

11 ‘‘(3) to refuse to commit or assist in any such 

12 violation. 

13 ‘‘(b) ENFORCEMENT ACTION.— 

14 ‘‘(1) IN GENERAL.—An employee who alleges 

15 discharge or other discrimination in violation of sub16 section (a) may seek relief in accordance with the 

17 provisions of subsection (c) by— 

18 ‘‘(A) filing a complaint with the Secretary 

19 of Labor; or 

20 ‘‘(B) if the Secretary of Labor has not 

21 issued a final decision within 210 days of the 

22 filing of the complaint and there is no showing 

23 that such delay is due to the bad faith of the 

24 claimant, or within 90 days after receiving a 

25 final decision or order from the Secretary, 


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1 bringing an action at law or equity for de novo 

2 review in the appropriate district court of the 

3 United States, which court shall have jurisdic4 tion over such action without regard to the 

5 amount in controversy, and which action shall, 

6 at the request of either party to such action, be 

7 tried by the court with a jury. 

8 ‘‘(2) PROCEDURE.— 

9 ‘‘(A) IN GENERAL.—Any action under 

10 paragraph (1) shall be governed under the rules 

11 and procedures set forth in section 42121(b) of 

12 title 49, United States Code. 

13 ‘‘(B) EXCEPTION.—Notification in an ac14 tion under paragraph (1) shall be made in ac15 cordance with section 42121(b)(1) of title 49, 

16 United States Code, except that such notifica17 tion shall be made to the person named in the 

18 complaint, the employer, and the Commissioner 

19 of Food and Drugs. 

20 ‘‘(C) BURDENS OF PROOF.—An action 

21 brought under paragraph (1)(A) or (1)(B) shall 

22 be governed by the legal burdens of proof set 

23 forth in section 42121(b) of title 49, United 

24 States Code. 


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1 ‘‘(D) STATUTE OF LIMITATIONS.—An ac2 tion under paragraph (1)(A) shall be com3 menced not later than 180 days after the date 

4 on which the violation occurs. 

5 ‘‘(c) REMEDIES.— 

6 ‘‘(1) IN GENERAL.—An employee prevailing in 

7 any action under subsection (b)(1) shall be entitled 

8 to all relief necessary to make the employee whole. 

9 ‘‘(2) ISSUANCE OF ORDER.—If, in response to 

10 a complaint filed under subsection (b)(1), the Sec11 retary of Labor or the district court, as applicable, 

12 determines that a violation of subsection (a) has oc13 curred, the Secretary or the court shall order the 

14 person who committed such violation— 

15 ‘‘(A) to take affirmative action to abate 

16 the violation; 

17 ‘‘(B) to— 

18 ‘‘(i) reinstate the complainant to his 

19 or her former position together with com20 pensation (including backpay); and 

21 ‘‘(ii) restore the terms, conditions, 

22 and privileges associated with his or her 

23 employment; and 

24 ‘‘(C) to provide compensatory damages to 

25 the complainant. 


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1 If such an order is issued under this paragraph, the 

2 Secretary or the court, at the request of the com3 plainant, shall assess against the person against 

4 whom the order is issued a sum equal to the aggre5 gate amount of all costs and expenses (including at6 torney and expert witness fees) reasonably incurred, 

7 as determined by the Secretary, by the complainant 

8 for, or in connection with, the bringing of the com9 plaint upon which the order was issued. 

10 ‘‘(d) RIGHTS RETAINED BY EMPLOYEE.—Nothing in 

11 this section shall be deemed to diminish the rights, privi12 leges, or remedies of any employee under any Federal or 

13 State law or under any collective bargaining agreement. 

14 The rights and remedies in this section may not be waived 

15 by any agreement, policy, form, or condition of employ16 ment.’’. 

17 SEC. 406. RULE OF CONSTRUCTION. 

18 Nothing in this Act or any amendment made by this 

19 Act shall be construed as affecting any authority or re20 quirement relating to devices (as defined in section 201 

21 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

22 321)). 

Æ 


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