II 

110TH CONGRESS 

2D SESSION S. 3409 

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

and quality of medical products and enhance the authorities of the 

Food and Drug Administration, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JULY 31, 2008 

Mr. REID (for Mr. KENNEDY (for himself and Mr. GRASSLEY)) introduced the 

following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL 

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

ensure the safety and quality of medical products and 

enhance the authorities of the Food and Drug Administration, 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 and Device Ac5 countability Act of 2008’’. 

6 SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT. 

7 (a) TABLE OF CONTENTS.—The table of contents for 

8 this Act is as follows: 


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Sec. 1. Short title. 

Sec. 2. Table of contents; references in Act. 

TITLE I—ENSURING THE SAFETY AND QUALITY OF MEDICAL 

PRODUCTS AND THEIR COMPONENTS 

Subtitle A—Enhanced Registration and Inspection of Drug and Device 

Establishments 

Sec. 101. Registration of drug and device establishments. 

Sec. 102. Registration and licensing of drug importers. 

Sec. 103. Inspection of drug and device establishments. 

Sec. 104. Listing of drugs and devices; enhanced information technology system 

for registration and listing. 

Sec. 105. Registration and inspection fees for drug and device establishments. 

Sec. 106. Technical and conforming amendments. 

Sec. 107. Effective date. 

Subtitle B—Ensuring Identity and Sourcing of Drug Ingredients 

Sec. 111. Testing of drug purity and identity. 

Sec. 112. Manufacturer responsibility for source and quality of drug ingredients. 

Sec. 113. Current manufacturing science. 

Sec. 114. Electronic pedigree for drug ingredients. 

Sec. 115. Country of origin labeling. 

Sec. 116. Effective date. 

Subtitle C—Ensuring Standards for Imported Drugs 

Sec. 121. Good distribution and import practices. 

Sec. 122. Standards for admission of imported drugs and drug ingredients. 

Sec. 123. Prohibition on use of drugs and drug ingredients not declared as 

drugs on importation. 

Sec. 124. Destruction of unsafe products refused admission. 

Sec. 125. Effective date. 

Subtitle D—Enhanced Response to Unsafe Drugs 

Sec. 131. Administrative detention of drugs. 

Sec. 132. Mandatory recall authority for drugs. 

Sec. 133. Records and reports of drug defects and destruction of defective 

drugs that cannot be reconditioned. 

Sec. 134. Civil money penalties. 

Subtitle E—Additional Provisions Related to Medical Products 

Sec. 141. Certification of information. 

Sec. 142. Whistleblower protections. 

TITLE II—GENERAL AUTHORITIES TO ENHANCE FOOD AND 

DRUG ADMINISTRATION OVERSIGHT OF PRODUCTS FROM A 

GLOBAL MARKET 

Sec. 201. Dedicated foreign inspectorate. 

Sec. 202. Authority to exchange confidential information with foreign government officials. 


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Sec. 203. Subpoena authority. 

Sec. 204. Information reporting. 

1 (b) REFERENCES IN ACT.—Except as otherwise spec2 ified, amendments made by this Act to a section or other 

3 provision of law are amendments to such section or other 

4 provision of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 301 et seq.). 

6 TITLE I—ENSURING THE SAFETY 

7 AND QUALITY OF MEDICAL 

8 PRODUCTS AND THEIR COM9 PONENTS 

10 Subtitle A—Enhanced Registration 

11 and Inspection of Drug and De12 vice Establishments 

13 SEC. 101. REGISTRATION OF DRUG AND DEVICE ESTAB14 LISHMENTS. 

15 (a) ENFORCEMENT OF REGISTRATION OF FOREIGN

16 ESTABLISHMENTS.—Section 502(o) (21 U.S.C. 352(o)) is 

17 amended by striking ‘‘in any State’’. 

18 (b) REGISTRATION OF ESTABLISHMENTS FOR DRUG

19 PRECURSOR AND INACTIVE INGREDIENTS.— 

20 (1) REGISTRATION.—Section 510(a) (21 U.S.C. 

21 360(a)) is amended— 

22 (A) in the matter preceding paragraph (1), 

23 by striking ‘‘As used’’ and inserting ‘‘DEFINI24 TIONS.—As used’’; 


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1 (B) by redesignating paragraphs (1) and 

2 (2) as paragraphs (2) and (3), respectively; and 

3 (C) by inserting after ‘‘this section—’’ the 

4 following: 

5 ‘‘(1) DRUG.—The term ‘drug’ includes a pre6 cursor ingredient.’’. 

7 (2) PRECURSOR INGREDIENT.—Section 201 (21 

8 U.S.C. 321) is amended by adding at the end the 

9 following: 

10 ‘‘(rr) The term ‘precursor ingredient’, with respect to 

11 a component of a drug, means an article that is a mate12 rial— 

13 ‘‘(1) of animal origin from which such compo14 nent is derived; or 

15 ‘‘(2) used in the final stage of synthesis or puri16 fication of such component.’’. 

17 (3) TERMINATION OF EFFECT OF REGULA18 TION.—On the date that is 180 days after the date 

19 of enactment of this Act, the exemption from reg20 istration in subsection (e) of section 207.10 of title 

21 21, Code of Federal Regulations, shall cease to have 

22 force or effect. 

23 (c) REGISTRATION OF DOMESTIC ESTABLISH24 MENTS.—Section 510 (21 U.S.C. 360) is amended— 


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1 (1) by striking subsection (b) and inserting the 

2 following: 

3 ‘‘(b) REGISTRATION OF DOMESTIC ESTABLISH4 MENTS.—Any person who owns or operates any establish5 ment in any State engaged in the manufacture, prepara6 tion, propagation, compounding, or processing of a drug 

7 or device shall— 

8 ‘‘(1) upon first engaging in any such activity, 

9 immediately submit a registration to the Secretary 

10 that includes the name of such person, places of 

11 business of such person, all such establishments, the 

12 D-U-N-S number of each such establishment, an e13 mail address for use in an emergency, and payment 

14 of any registration and inspection fee for each such 

15 establishment required under section 741; 

16 ‘‘(2) thereafter immediately submit a registra17 tion that includes the information and fee described 

18 in paragraph (1) for any additional establishment 

19 owned or operated by such person in any State in 

20 which such person begins the manufacture, prepara21 tion, propagation, compounding, or processing of a 

22 drug or device; and 

23 ‘‘(3) thereafter— 

24 ‘‘(A) with respect to such drugs, submit a 

25 registration described in paragraph (1) to the 


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1 Secretary on or before December 31 of each 

2 year; and 

3 ‘‘(B) with respect to such devices, submit 

4 a registration described in paragraph (1) to the 

5 Secretary during the period beginning on Octo6 ber 1 and ending on December 31 of each 

7 year.’’; and 

8 (2) by striking subsections (c) and (d). 

9 (d) REGISTRATION OF FOREIGN ESTABLISH10 MENTS.—Section 510 (U.S.C. 360) is amended— 

11 (1) by transferring subsection (i) so as to ap12 pear after subsection (b) (as amended by subsection 

13 (c)); and 

14 (2) in subsection (i) (as so transferred)— 

15 (A) by striking ‘‘(i) (1)’’ and all that fol16 lows through ‘‘of each year.’’ and inserting the 

17 following: 

18 ‘‘(c) REGISTRATION OF FOREIGN ESTABLISH19 MENTS.— 

20 ‘‘(1) IN GENERAL.—Any person who owns or 

21 operates any establishment within any foreign coun22 try engaged in the manufacture, preparation, propa23 gation, compounding, or processing of a drug or de24 vice that is imported or offered for import into the 

25 United States shall— 


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1 ‘‘(A) upon first engaging in any such activ2 ity, immediately submit a registration to the 

3 Secretary that includes the name and place of 

4 business of such person, all such establish5 ments, the D-U-N-S number of each such es6 tablishment, an e-mail address for use in an 

7 emergency, payment of any registration and in8 spection fee for each such establishment re9 quired under section 741, the name of the 

10 United States agent of each such establishment, 

11 the name of each importer of such drug or de12 vice in the United States that is known to each 

13 such establishment, and the name of each per14 son who imports or offers for import such drug 

15 or device to the United States for purposes of 

16 importation; 

17 ‘‘(B) thereafter immediately submit a reg18 istration that includes the information and fee 

19 described in paragraph (1) for any additional 

20 establishment owned or operated by such per21 son within any foreign country in which such 

22 person begins the manufacture, preparation, 

23 propagation, compounding, or processing of 

24 such a drug or device; and 

25 ‘‘(C) thereafter— 


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1 ‘‘(i) with respect to drugs, submit a 

2 registration described in subparagraph (A) 

3 to the Secretary on or before December 31 

4 of each year; and 

5 ‘‘(ii) with respect to devices, submit a 

6 registration described in subparagraph (A) 

7 to the Secretary during the period begin8 ning on October 1 and ending on Decem9 ber 31 of each year.’’; 

10 (B) by striking paragraph (2); 

11 (C) in paragraph (3), by striking ‘‘(3) 

12 The’’ and inserting ‘‘(2) COOPERATIVE AR13 RANGEMENTS.—’’; and 

14 (D) by moving the indentation of para15 graph (2), as amended, 2 ems to the right. 

16 SEC. 102. REGISTRATION AND LICENSING OF DRUG IM17 PORTERS. 

18 Section 510 (21 U.S.C. 360), as amended by section 

19 101, is further amended by inserting after subsection (c) 

20 the following: 

21 ‘‘(d) REGISTRATION AND LICENSING OF DRUG IM22 PORTERS.— 

23 ‘‘(1) IN GENERAL.—Any person who owns or 

24 operates any establishment engaged in the importaVerDate Aug 31 2005 04:19 Aug 05, 2008 Jkt 069200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3409.IS S3409

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1 tion, filing for importation, or brokering for importa2 tion of drugs into the United States shall— 

3 ‘‘(A) upon first engaging in any such activ4 ity, immediately submit a registration to the 

5 Secretary that includes the name of such per6 son, places of business of such person, all such 

7 establishments, the D-U-N-S number of each 

8 such establishment, and an e-mail address for 

9 use in an emergency; 

10 ‘‘(B) thereafter immediately submit a reg11 istration that includes the information described 

12 in subparagraph (A) for any additional estab13 lishment owned or operated by such person in 

14 which such person begins any such activity; and 

15 ‘‘(C) thereafter submit a registration de16 scribed in subparagraph (A) to the Secretary 

17 during the period beginning on October 1 and 

18 ending on December 31 of each year. 

19 ‘‘(2) LICENSING.— 

20 ‘‘(A) IN GENERAL.—The Secretary may re21 quire any person engaged in the importation, 

22 filing for importation, or brokering for importa23 tion of a drug into the United States, before en24 gaging in those activities, to obtain a license to 

25 be issued by the Secretary. 


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1 ‘‘(B) BOND.—The Secretary may require 

2 as a condition of a license for a person under 

3 subparagraph (A) that the person post a bond 

4 subject to forfeiture if the person has, in con5 nection with the importation, filing for importa6 tion, or brokering for importation of a drug into 

7 the United States— 

8 ‘‘(i) violated, or caused the violation, 

9 of this Act; or 

10 ‘‘(ii) made, or caused to be made, a 

11 false or misleading statement. 

12 ‘‘(C) AMOUNT OF BOND.—The Secretary 

13 shall ensure that the amount of any bond re14 quired under subparagraph (B) for a person is 

15 sufficient to deter such person from, in connec16 tion with the importation, filing for importa17 tion, or brokering for importation of a drug into 

18 the United States— 

19 ‘‘(i) violating, or causing the violation 

20 of, this Act; or 

21 ‘‘(ii) making, or causing to be made, 

22 a false or misleading statement. 

23 ‘‘(D) REVOCATION.—The Secretary may 

24 revoke the license for a person under subpara25 graph (A) if the Secretary finds that, in connecVerDate Aug 31 2005 04:19 Aug 05, 2008 Jkt 069200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3409.IS S3409

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1 tion with the importation, filing for importa2 tion, or brokering for importation of a drug into 

3 the United States, such person has— 

4 ‘‘(i) violated, or caused the violation 

5 of, this Act; or 

6 ‘‘(ii) made, or caused to be made, a 

7 false or misleading statement.’’. 

8 SEC. 103. INSPECTION OF DRUG AND DEVICE ESTABLISH9 MENTS. 

10 (a) REQUIRING EQUAL TREATMENT OF DOMESTIC

11 AND FOREIGN ESTABLISHMENTS.—Section 510(h) (21 

12 U.S.C. 360(h)) is amended by— 

13 (1) striking ‘‘Every’’ and inserting: ‘‘INSPEC14 TIONS.— 

15 ‘‘(1) IN GENERAL.—Every’’; 

16 (2) striking ‘‘in any State’’; 

17 (3) striking ‘‘section shall’’ and inserting: ‘‘sec18 tion— 

19 ‘‘(A) shall’’; 

20 (4) striking ‘‘704 and every such’’ and inserting 

21 ‘‘704; 

22 ‘‘(B) except as provided in paragraph (2), 

23 and for establishments that manufacture, pre24 pare, propagate, compound, or process only in25 active ingredients, every’’; and 


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1 (5) striking ‘‘thereafter.’’ and inserting ‘‘there2 after; and 

3 ‘‘(C) shall not be considered duly reg4 istered under this section if an inspection of 

5 such establishment by the Secretary is refused, 

6 delayed, or limited by— 

7 ‘‘(i) the person who owns or operates 

8 such establishment, or any agent or em9 ployee of such person; or 

10 ‘‘(ii) any agent of a governmental au11 thority in the foreign country within which 

12 such establishment is located.’’. 

13 (b) PROVIDING FOR RISK-BASED INSPECTIONS OF

14 ESTABLISHMENTS.—Section 510(h) (21 U.S.C. 360(h)), 

15 as amended by subsection (a), is further amended by add16 ing at the end the following: 

17 ‘‘(2) RISK-BASED INSPECTION SCHEDULE.— 

18 ‘‘(A) IN GENERAL.—The Secretary may by 

19 regulation provide for an inspection schedule 

20 for establishments described in paragraph (1) 

21 (including those establishments that manufac22 ture, prepare, propagate, compound, or process 

23 only inactive ingredients) different from that re24 quired by such paragraph. 


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1 ‘‘(B) INSPECTION FREQUENCY AND RISK2 BASED FACTORS.—In providing for an inspec3 tion schedule under subparagraph (A), the Sec4 retary— 

5 ‘‘(i) may require inspections of an es6 tablishment more frequently than once in 

7 every successive 2-year period; 

8 ‘‘(ii) shall require inspections of an es9 tablishment at least once in every succes10 sive 5-year period; and 

11 ‘‘(iii) shall consider— 

12 ‘‘(I) the risks of the drug or 

13 drugs, or the device or devices, manu14 factured, prepared, propagated, com15 pounded, or processed by an establish16 ment (including whether the drug is a 

17 finished dosage form, an active ingre18 dient, a precursor ingredient, or an 

19 inactive ingredient; the route of ad20 ministration of the drug; whether the 

21 device is intended to be implanted, 

22 permanently implantable, life sus23 taining, or life supporting; and the 

24 use or uses for which the drug or de25 vice is approved or cleared under this 


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1 Act or licensed under section 351 of 

2 the Public Health Service Act); 

3 ‘‘(II) whether or not an establish4 ment is within a foreign country with 

5 a governmental authority responsible 

6 for drugs or devices, as applicable, 

7 deemed adequate by the Secretary; 

8 ‘‘(III) whether or not, and the 

9 frequency with which, an establish10 ment is subject to inspection by a gov11 ernmental authority responsible for 

12 drugs or devices, as applicable, 

13 deemed adequate by the Secretary; 

14 and 

15 ‘‘(IV) such other factors as the 

16 Secretary determines are relevant to 

17 determining an inspection schedule for 

18 establishments. 

19 ‘‘(C) RISK-BASED FACTORS FOR MODI20 FYING FREQUENCY OF INSPECTIONS OF AN ES21 TABLISHMENT.—The Secretary may inspect an 

22 establishment at a frequency different than that 

23 required by the inspection schedule under sub24 paragraph (A) by considering— 


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1 ‘‘(i) the history of any safety problems 

2 with drugs or devices manufactured, pre3 pared, propagated, compounded, or proc4 essed by the establishment; 

5 ‘‘(ii) the record of inspections by the 

6 Secretary of the establishment; 

7 ‘‘(iii) with respect to a drug that is 

8 not a finished dosage form, the record of 

9 inspections by a governmental authority re10 sponsible for drugs deemed adequate by 

11 the Secretary; 

12 ‘‘(iv) with respect to a drug that is an 

13 inactive ingredient, a quality certification 

14 by a private entity, if the Secretary has 

15 agreed to accept such a certification; and 

16 ‘‘(v) such other factors as the Sec17 retary determines are relevant to assessing 

18 the risk presented by the establishment.’’. 

19 (c) ANNUAL REPORT ON INSPECTIONS OF ESTAB20 LISHMENTS.—Section 510(h) (21 U.S.C. 360(h)), as 

21 amended by subsection (b), is further amended by adding 

22 at the end the following: 

23 ‘‘(3) ANNUAL REPORT ON INSPECTIONS OF ES24 TABLISHMENTS.—Not later than February 1 of each 


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1 year, the Secretary shall submit a report to the Con2 gress about— 

3 ‘‘(A) the appropriations used to inspect es4 tablishments registered pursuant to this section 

5 in the previous fiscal year; 

6 ‘‘(B)(i) the number and identities of do7 mestic and foreign establishments registered 

8 pursuant to this section that the Secretary in9 spected in the previous fiscal year; and 

10 ‘‘(ii) if the Secretary has provided for a 

11 schedule under paragraph (2)(A) with different 

12 frequencies of inspection for different classes of 

13 establishments, the numbers and identities for 

14 each such class; 

15 ‘‘(C)(i) the number of domestic and foreign 

16 establishments registered pursuant to this sec17 tion that the Secretary did not inspect in the 

18 previous fiscal year; and 

19 ‘‘(ii) if the Secretary has provided for a 

20 schedule under paragraph (2)(A) with expected 

21 frequencies of inspection for different classes of 

22 establishments, the numbers for each such 

23 class; 

24 ‘‘(D) information on the performance in 

25 the previous fiscal year of the foreign 


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1 inspectorate established under section 704(h) 

2 including— 

3 ‘‘(i) the number of inspections con4 ducted with and without personnel who are 

5 fluent in the language used in the estab6 lishment under inspection; 

7 ‘‘(ii) the number of personnel in such 

8 inspectorate; 

9 ‘‘(iii) the countries in which such per10 sonnel conduct inspections; 

11 ‘‘(iv) the offices in foreign countries 

12 where such personnel are permanently sta13 tioned; 

14 ‘‘(v) the number of personnel con15 ducting inspections in each country who 

16 are fluent in the language or languages 

17 used in the establishments of that country; 

18 and 

19 ‘‘(vi) the number of personnel who are 

20 permanently stationed in each in-country 

21 office who are fluent in the language or 

22 languages used in the establishments of 

23 that country; 

24 ‘‘(E) the number of domestic and foreign 

25 establishments registered with the Secretary 


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1 under this section during the previous calendar 

2 year; and 

3 ‘‘(F) other information deemed relevant by 

4 the Secretary. 

5 ‘‘(4) PUBLIC AVAILABILITY OF ANNUAL RE6 PORTS.—The Secretary shall make the report re7 quired under paragraph (3) available to the public 

8 on the Internet Web site of the Food and Drug Ad9 ministration.’’. 

10 SEC. 104. LISTING OF DRUGS AND DEVICES; ENHANCED IN11 FORMATION TECHNOLOGY SYSTEM FOR REG12 ISTRATION AND LISTING. 

13 (a) IN GENERAL.—Section 510 (21 U.S.C. 360) is 

14 amended— 

15 (1) in subsection (j)— 

16 (A) by striking ‘‘(j)(1) Every person who 

17 registers with the Secretary under subsection 

18 (b), (c), (d), or (i)’’ and inserting the following: 

19 ‘‘(i) SUBMISSION OF LIST OF DRUGS AND DE20 VICES.— 

21 ‘‘(1) IN GENERAL.—Every person who registers 

22 with the Secretary under subsection (b) or (c)’’; 

23 (B) in paragraph (1)— 


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1 (i) by moving the indentation of sub2 paragraphs (A) through (D) 2 ems to the 

3 right; and 

4 (ii) in subparagraph (B), by moving 

5 the indentation of clauses (i) and (ii) 2 

6 ems to the right; 

7 (C) in paragraph (2)— 

8 (i) by striking ‘‘(2) Each person who 

9 registers with the Secretary under this sec10 tion’’ and inserting the following: 

11 ‘‘(2) REPORT TO SECRETARY.—Every person 

12 who registers with the Secretary under subsection 

13 (b) or (c)’’; and 

14 (ii) by moving the indentation of sub15 paragraphs (A) through (D) 2 ems to the 

16 right; 

17 (D) in paragraph (3), by striking ‘‘(3) The 

18 Secretary’’ and inserting the following: 

19 ‘‘(3) ADDITIONAL LIST.—The Secretary’’; and 

20 (E) by adding at the end the following: 

21 ‘‘(4) SUBMISSION FOR FINISHED DOSAGE

22 FORM.—Every person who files a list under para23 graph (1) or reports a list under paragraph (2) shall 

24 submit with such list, for any drug that is a finished 

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1 gaged in the manufacture, preparation, propagation, 

2 compounding, or processing of— 

3 ‘‘(A) the finished dosage form; 

4 ‘‘(B) any active ingredient of the drug; 

5 ‘‘(C) any inactive ingredient of the drug; 

6 or 

7 ‘‘(D) any precursor ingredient of any such 

8 active or inactive ingredient. 

9 ‘‘(5) ELECTRONIC SUBMISSION AND MAINTE10 NANCE OF INFORMATION.—The Secretary shall es11 tablish and maintain— 

12 ‘‘(A) an Internet-based portal through 

13 which information to register establishments 

14 under subsection (b), (c), and (d) and to list 

15 drugs and devices under this subsection shall be 

16 submitted to the Secretary; and 

17 ‘‘(B) an electronic database (which shall 

18 not be subject to inspection under subsection 

19 (f)) populated with the information submitted 

20 under subparagraph (A) that— 

21 ‘‘(i) includes appropriate links be22 tween registered establishments and be23 tween such establishments and listed drugs 

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1 ments and articles involved in the manu2 facture, preparation, propagation, 

3 compounding, or processing of each drug 

4 that is a finished dosage form or an active 

5 ingredient and each device; 

6 ‘‘(ii) includes the date of each inspec7 tion by the Secretary (with the Secretary’s 

8 report on and assessment of the inspec9 tion) for each such establishment and such 

10 other information on the inspectional 

11 record and compliance history of the estab12 lishment as the Secretary deems necessary 

13 and appropriate to assess the compliance 

14 history of the establishment and, if appli15 cable, apply the inspection schedule under 

16 subsection (h)(2) to such establishment; 

17 and 

18 ‘‘(iii) is interoperable and commu19 nicates with other relevant databases with20 in the Food and Drug Administration.’’. 

21 SEC. 105. REGISTRATION AND INSPECTION FEES FOR DRUG 

22 AND DEVICE ESTABLISHMENTS. 

23 (a) REDESIGNATION.—Chapter VII (21 U.S.C. 371 

24 et seq.) is amended by redesignating sections 741, 742, 

25 and 746 as sections 746, 747, and 749, respectively. 


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1 (b) FEES RELATED TO ESTABLISHMENT INSPEC2 TIONS.—Subchapter C of chapter VII (21 U.S.C. 379f et 

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

4 ‘‘PART 5—FEES RELATED TO ESTABLISHMENT 

5 INSPECTIONS 

6 ‘‘SEC. 741. AUTHORITY TO ASSESS AND USE FEES. 

7 ‘‘(a) TYPES OF FEES.— 

8 ‘‘(1) DRUG REGISTRATION AND INSPECTION

9 FEES.—Beginning in fiscal year 2009, the Secretary 

10 shall collect drug registration and inspection fees in 

11 accordance with this section as follows: 

12 ‘‘(A) IN GENERAL.—Except as provided 

13 under subparagraphs (B), (C), and (D), each 

14 person that during a fiscal year registers a drug 

15 establishment under subsection (b) or (c) of 

16 section 510 shall be subject to a drug registra17 tion and inspection fee established under sub18 section (b)(1). 

19 ‘‘(B) REDUCTION FOR POSITRON EMISSION

20 TOMOGRAPHY DRUGS.—The drug registration 

21 and inspection fee for a drug establishment en22 gaged solely in the manufacture, preparation, 

23 propagation, compounding, or processing of 1 

24 or more drugs to which section 736(a)(2)(C)(i) 

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1 tion and inspection fee otherwise applicable to 

2 such establishment under subsection (b)(1). 

3 ‘‘(C) EXEMPTION FOR CERTAIN POSITRON

4 EMISSION TOMOGRAPHY DRUGS AND CERTAIN

5 ORPHAN DRUGS.—A drug establishment en6 gaged solely in the manufacture, preparation, 

7 propagation, compounding, or processing of 1 

8 or more drugs to which section 736(a)(2)(C)(ii) 

9 or section 736(k) applies shall not be assessed 

10 a drug registration and inspection fee. 

11 ‘‘(D) WAIVER OR REDUCTION.—The Sec12 retary shall grant a waiver from or reduction of 

13 the drug registration and inspection fee as pro14 vided for under section 736(d). 

15 ‘‘(2) DEVICE REGISTRATION AND INSPECTION

16 FEES.—Beginning in fiscal year 2009, the Secretary 

17 shall collect device registration and inspection fees in 

18 accordance with this section as follows: 

19 ‘‘(A) IN GENERAL.—Except as provided 

20 under subparagraphs (B) and (C), each person 

21 that during a fiscal year registers a device es22 tablishment under subsection (b) or (c) of sec23 tion 510 shall pay a device registration and in24 spection fee established under subsection (b)(2). 


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1 ‘‘(B) REDUCTION FOR SMALL BUSI2 NESSES.—The device registration and inspec3 tion fee for a device establishment owned or op4 erated by an entity that qualifies as a small 

5 business under section 738(d)(2) shall be one6 fourth of the device registration and inspection 

7 fee otherwise applicable to such establishment 

8 under subsection (b)(2). 

9 ‘‘(C) EXEMPTION FOR CERTAIN STATE OR

10 FEDERAL GOVERNMENT ESTABLISHMENTS.—A 

11 device establishment operated by a State or 

12 Federal government entity shall not be assessed 

13 a device registration and inspection fee unless a 

14 device classified in class II or class III manu15 factured by the establishment is to be distrib16 uted commercially. 

17 ‘‘(b) FEE AMOUNTS.— 

18 ‘‘(1) DRUG REGISTRATION AND INSPECTION

19 FEE AMOUNTS.— 

20 ‘‘(A) IN GENERAL.—Beginning with fiscal 

21 year 2009, the Secretary shall, not later than 

22 30 days after the amount has been appro23 priated for a fiscal year in an appropriations 

24 Act as described in subsection (d), establish for 

25 such fiscal year, and publish in the Federal 


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1 Register, drug registration and inspection fees, 

2 based on the amount provided for in advance in 

3 appropriations Acts for such fees as described 

4 in subsection (d), considering— 

5 ‘‘(i)(I) the registration and inspection 

6 fee for a drug establishment that under the 

7 inspection schedule provided for under sec8 tion 510(h)(2)(A) is to be inspected more 

9 frequently than once in every 2-year period 

10 shall be more than the registration and in11 spection fee for a drug establishment that 

12 under such schedule is to be inspected once 

13 in every 2-year period, in proportion to the 

14 factor by which such drug establishment to 

15 be is inspected more frequently than once 

16 in every 2-year period; and 

17 ‘‘(II) the registration and inspection 

18 fee for a drug establishment that under the 

19 inspection schedule provided for under sec20 tion 510(h)(2)(A) is to be inspected less 

21 frequently than once in every 2-year period 

22 shall be less than the registration and in23 spection fee for a drug establishment that 

24 under such schedule is to be inspected once 

25 in every 2-year period, in proportion to the 


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•S 3409 IS

1 factor by which such establishment is to be 

2 inspected less frequently than once in every 

3 2-year period; 

4 ‘‘(ii) the reductions required under 

5 subparagraphs (B) and (D) of subsection 

6 (a)(1); and 

7 ‘‘(iii) the number of drug establish8 ments subject to such a fee, considering 

9 subparagraphs (C) and (D) of subsection 

10 (a)(1). 

11 ‘‘(B) FOREIGN DRUG ESTABLISHMENT.— 

12 For a foreign drug establishment, the drug reg13 istration and inspection fee shall be— 

14 ‘‘(i) the applicable drug registration 

15 and inspection fee under subparagraph 

16 (A), plus 

17 ‘‘(ii) the pro rata costs, if any, of— 

18 ‘‘(I) travel to and within, and 

19 lodging in, the country in which the 

20 establishment is located for the indi21 vidual or individuals who conduct the 

22 inspection of the establishment; and 

23 ‘‘(II) a translator for the inspec24 tion of the establishment. 


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1 ‘‘(2) DEVICE REGISTRATION AND INSPECTION

2 FEE AMOUNTS.— 

3 ‘‘(A) IN GENERAL.—Beginning with fiscal 

4 year 2009, the Secretary shall, not later than 

5 30 days after the amount has been appro6 priated for a fiscal year in an appropriations 

7 Act as described in subsection (d) establish for 

8 such fiscal year, and publish in the Federal 

9 Register device registration and inspection fees, 

10 based on the amount provided for in advance in 

11 appropriations Acts for such fees and consid12 ering— 

13 ‘‘(i)(I) the registration and inspection 

14 fee for a device establishment that under 

15 the inspection schedule provided for under 

16 section 510(h)(2)(A) is to be inspected 

17 more frequently than once in every 2-year 

18 period shall be more than the registration 

19 and inspection fee for a device establish20 ment that under such schedule is to be in21 spected once in every 2-year period, in pro22 portion to the factor by which such device 

23 establishment is to be inspected more fre24 quently than once in every 2-year period; 

25 and 


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1 ‘‘(II) the registration and inspection 

2 fee for a device establishment that under 

3 the inspection schedule provided for under 

4 section 510(h)(2)(A) is to be inspected less 

5 frequently than once in every 2-year period 

6 shall be less than the registration and in7 spection fee for a device establishment that 

8 under such schedule is to be inspected once 

9 in every 2-year period, in proportion to the 

10 factor by which such establishment is to be 

11 inspected less frequently than once in every 

12 2-year period; 

13 ‘‘(ii) the reduction required under 

14 subsection (a)(2)(B); and 

15 ‘‘(iii) the number of device establish16 ments subject to such a fee, considering 

17 subsection (a)(2)(C). 

18 ‘‘(B) FOREIGN DEVICE ESTABLISHMENT.— 

19 For a foreign device establishment, the device 

20 registration and inspection fee shall be— 

21 ‘‘(i) the applicable device registration 

22 and inspection fee under subparagraph 

23 (A), plus 

24 ‘‘(ii) the pro rata costs, if any, of— 


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1 ‘‘(I) travel to and within, and 

2 lodging in, the country in which the 

3 establishment is located for the indi4 vidual or individuals who conduct the 

5 inspection of the establishment; and 

6 ‘‘(II) a translator for the inspec7 tion of the establishment. 

8 ‘‘(c) EFFECT OF FAILURE TO PAY FEES.— 

9 ‘‘(1) DRUG REGISTRATION AND INSPECTION

10 FEE.—An establishment subject to a drug registra11 tion and inspection fee under subsection (a) shall be 

12 considered not to be registered under section 510 

13 until all registration and inspection fees under this 

14 section owed by the person required to register such 

15 establishment have been paid. 

16 ‘‘(2) DEVICE REGISTRATION AND INSPECTION

17 FEE.—An establishment subject to a device registra18 tion and inspection fee under subsection (a) shall be 

19 considered not to be registered under section 510 

20 until all registration and inspection fees under this 

21 section owed by the person required to register such 

22 establishment have been paid. 

23 ‘‘(d) CREDITING AND AVAILABILITY OF FEES.— 

24 ‘‘(1) DRUG REGISTRATION AND INSPECTION

25 FEES.—Drug registration and inspection fees auVerDate Aug 31 2005 04:19 Aug 05, 2008 Jkt 069200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\S3409.IS S3409

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1 thorized under subsection (a) shall be collected and 

2 available for obligation only to the extent and in the 

3 amount provided in advance in appropriations Acts. 

4 Such fees are authorized to remain available until 

5 expended. Such sums as may be necessary may be 

6 transferred from the Food and Drug Administration 

7 salaries and expenses appropriation account without 

8 fiscal year limitation to such appropriation account 

9 for salaries and expenses with such fiscal year limi10 tation. The sums transferred shall be available solely 

11 for drug registration and inspection activities. 

12 ‘‘(2) DEVICE REGISTRATION AND INSPECTION

13 FEES.—Device registration and inspection fees au14 thorized under subsection (a) shall be collected and 

15 available for obligation only to the extent and in the 

16 amount provided in advance in appropriations Acts. 

17 Such fees are authorized to remain available until 

18 expended. Such sums as may be necessary may be 

19 transferred from the Food and Drug Administration 

20 salaries and expenses appropriation account without 

21 fiscal year limitation to such appropriation account 

22 for salaries and expenses with such fiscal year limi23 tation. The sums transferred shall be available solely 

24 for device registration and inspection activities. 

25 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 


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1 ‘‘(A) DRUG REGISTRATION AND INSPEC2 TION FEES.—Beginning in fiscal year 2009, 

3 there is authorized to be appropriated for each 

4 fiscal year for drug registration and inspection 

5 fees under this section such sums as may be 

6 necessary to carry out drug registration and in7 spection activities for such fiscal year, except 

8 that such sums may be no greater than the 

9 lesser of— 

10 ‘‘(i) the amount appropriated (exclud11 ing fees) for such activities for such fiscal 

12 year; or 

13 ‘‘(ii) one-half of the amount necessary 

14 to carry out such activities for such fiscal 

15 year. 

16 ‘‘(B) DEVICE REGISTRATION AND INSPEC17 TION FEES.—Beginning in fiscal year 2009, 

18 there is authorized to be appropriated for each 

19 fiscal year for device registration and inspection 

20 fees under this section such sums as may be 

21 necessary to carry out device registration and 

22 inspection activities for such fiscal year, except 

23 that such sums may be no greater than the 

24 lesser of— 


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1 ‘‘(i) the amount appropriated (exclud2 ing fees) for such activities for such fiscal 

3 year; or 

4 ‘‘(ii) one-half of the amount necessary 

5 to carry out such activities for such fiscal 

6 year. 

7 ‘‘(e) AUTHORITY.—If the Secretary does not assess 

8 fees under subsection (a) during any portion of a fiscal 

9 year and if at a later date in such fiscal year the Secretary 

10 may assess such fees, the Secretary may assess and collect 

11 such fees, without any modification in the rate, at any 

12 time in such fiscal year notwithstanding the provisions of 

13 subsections (b) and (c) of section 510 relating to the date 

14 fees are to be paid. 

15 ‘‘(f) COLLECTION OF UNPAID FEES.—In any case 

16 where the Secretary does not receive payment of a reg17 istration and inspection fee required to be paid under sub18 section (a) within 30 days after it is due, such fee shall 

19 be treated as a claim of the United States Government 

20 subject to subchapter II of chapter 37 of title 31, United 

21 States Code. 

22 ‘‘(g) REPORTS.— 

23 ‘‘(1) PERFORMANCE REPORT.—Beginning for 

24 fiscal year 2009, not later than 120 days after the 

25 end of each fiscal year for which drug registration 


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1 and inspection fees and device registration and in2 spection fees are collected under this section, the 

3 Secretary shall prepare and submit to the Com4 mittee on Health, Education, Labor, and Pensions 

5 and the Committee on Appropriations of the Senate 

6 and the Committee on Energy and Commerce and 

7 the Committee on Appropriations of the House of 

8 Representatives a report concerning the performance 

9 of the Food and Drug Administration with respect 

10 to— 

11 ‘‘(A) drug registration and inspection ac12 tivities during such fiscal year; and 

13 ‘‘(B) device registration and inspection ac14 tivities during such fiscal year. 

15 ‘‘(2) FISCAL REPORT.—Beginning for fiscal 

16 year 2009, not later than 120 days after the end of 

17 each fiscal year for which drug registration and in18 spection fees and device registration and inspection 

19 fees are collected under this section, the Secretary 

20 shall prepare and submit to the Committee on 

21 Health, Education, Labor, and Pensions and the 

22 Committee on Appropriations of the Senate and the 

23 Committee on Energy and Commerce and the Com24 mittee on Appropriations of the House of Represent25 atives a report on the implementation of the authorVerDate Aug 31 2005 04:19 Aug 05, 2008 Jkt 069200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6201 E:\BILLS\S3409.IS S3409

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•S 3409 IS

1 ity for such fees during such fiscal year and the use, 

2 by the Food and Drug Administration, of the fees 

3 collected for such fiscal year. 

4 ‘‘(3) PUBLIC AVAILABILITY.—The Secretary 

5 shall make the reports required under paragraphs 

6 (1) and (2) available to the public on the Internet 

7 Web site of the Food and Drug Administration. 

8 ‘‘(h) DEFINITIONS.—In this section: 

9 ‘‘(1) AFFILIATE.—The term ‘affiliate’ means a 

10 business entity that has a relationship with a second 

11 business entity if, directly or indirectly— 

12 ‘‘(A) one business entity controls, or has 

13 the power to control, the other business entity; 

14 or 

15 ‘‘(B) a third business entity controls, or 

16 has the power to control, both of the business 

17 entities. 

18 ‘‘(2) DEVICE ESTABLISHMENT.—The term ‘de19 vice establishment’ means— 

20 ‘‘(A) an establishment in any State that is 

21 engaged in the manufacture, preparation, prop22 agation, compounding, or processing of a device 

23 classified in class II or class III; or 

24 ‘‘(B) an establishment within any foreign 

25 country that is engaged in the manufacture, 


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•S 3409 IS

1 preparation, propagation, compounding, or 

2 processing of a device classified in class II or 

3 class III that is imported or offered for import 

4 into the United States. 

5 ‘‘(3) DEVICE REGISTRATION AND INSPECTION

6 ACTIVITIES.—The term ‘device registration and in7 spection activities’ means the following activities of 

8 the Secretary: 

9 ‘‘(A) The registration of device establish10 ments under subsections (b) and (c) of section 

11 510. 

12 ‘‘(B) The listing of devices under section 

13 510(i), including the activities for devices de14 scribed in section 510(i)(5). 

15 ‘‘(C) The inspection of device establish16 ments under section 510(h)(1)(B) or, if applica17 ble, section 510(h)(2). 

18 ‘‘(D) The review of inspection reports from 

19 such inspections. 

20 ‘‘(E) Any action under this Act pursuant 

21 to such registration, listing, inspections, and re22 views. 

23 ‘‘(4) DRUG ESTABLISHMENT.—The term ‘drug 

24 establishment’ means— 


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•S 3409 IS

1 ‘‘(A) an establishment in any State that 

2 is— 

3 ‘‘(i) engaged in the manufacture, 

4 preparation, propagation, compounding, or 

5 processing of a drug; and 

6 ‘‘(ii) subject to inspection under sub7 section (h)(1)(B) or (h)(2) of section 510, 

8 as applicable; or 

9 ‘‘(B) an establishment within any foreign 

10 country that is— 

11 ‘‘(i) engaged in the manufacture, 

12 preparation, propagation, compounding, or 

13 processing of a drug; and 

14 ‘‘(ii) subject to inspection under sub15 section (h)(1)(B) or (h)(2) of section 510, 

16 as applicable. 

17 ‘‘(5) DRUG REGISTRATION AND INSPECTION AC18 TIVITIES.—The term ‘drug registration and inspec19 tion activities’ means the following activities of the 

20 Secretary: 

21 ‘‘(A) The registration of drug establish22 ments under subsections (b) and (c) of section 

23 510. 


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•S 3409 IS

1 ‘‘(B) The listing of drugs under section 

2 510(i), including the activities for drugs de3 scribed in section 510(i)(5). 

4 ‘‘(C) The inspection of drug establishments 

5 under section 510(h)(1)(B) or, if applicable, 

6 section 510(h)(2). 

7 ‘‘(D) The review of inspection reports from 

8 such inspections. 

9 ‘‘(E) Any action under this Act pursuant 

10 to such registration, listing, inspections, and re11 views. 

12 ‘‘(6) PERSON.—The term ‘person’ includes an 

13 affiliate thereof.’’. 

14 SEC. 106. TECHNICAL AND CONFORMING AMENDMENTS. 

15 (a) SECTION 510.— 

16 (1) LISTING NUMBERS.—Section 510(e) (21 

17 U.S.C. 360(e)) is amended— 

18 (A) by striking ‘‘(e) The Secretary’’ and all 

19 that follows through ‘‘Any number’’ and insert20 ing the following: 

21 ‘‘(e) LISTING NUMBER.—The Secretary may assign 

22 a listing number to each drug or class of drugs listed 

23 under subsection (i). Any number’’; and 

24 (B) by striking ‘‘subsection (j)’’ and insert25 ing ‘‘subsection (i)’’. 


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1 (2) INSPECTION BY PUBLIC OF REGISTRA2 TION.—Section 510(f) (21 U.S.C. 360(f)) is amend3 ed— 

4 (A) by striking ‘‘(f) The Secretary’’ and in5 serting the following: 

6 ‘‘(f) INSPECTION BY PUBLIC OF REGISTRATION.—’’; 

7 and 

8 (B) by striking ‘‘subsection (j)’’ and insert9 ing ‘‘subsection (i)’’. 

10 (3) EXEMPTIONS.—Section 510(g) (21 U.S.C. 

11 360(g)) is amended— 

12 (A) by striking ‘‘(g) The foregoing’’ and 

13 inserting the following: 

14 ‘‘(g) EXEMPTIONS.—The foregoing’’; and 

15 (B) by moving the indentation of para16 graphs (1) through (5) 2 ems to the right. 

17 (4) ELECTRONIC SUBMISSION.—Section 510 

18 (21 U.S.C. 360) is amended by inserting after sub19 section (i) (as redesignated by section 104) the fol20 lowing: 

21 ‘‘(j) ELECTRONIC SUBMISSION.—Registrations and 

22 listings under this section (including the submission of up23 dated information) shall be submitted to the Secretary by 

24 electronic means unless the Secretary grants a request for 

25 waiver of such requirement because use of electronic 


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•S 3409 IS

1 means is not reasonable for the person requesting such 

2 waiver.’’. 

3 (5) DEVICE REPORTS.—Section 510(k) (21 

4 U.S.C. 360(k)) is amended— 

5 (A) by striking ‘‘(k) Each person’’ and in6 serting the following: 

7 ‘‘(k) DEVICE REPORTS.—Each person’’; and 

8 (B) by moving the indentation of para9 graphs (1) and (2) 2 ems to the right. 

10 (6) NO REPORT REQUIRED.—Section 510(l) (21 

11 U.S.C. 360(l)) is amended by striking ‘‘(l) A report’’ 

12 and inserting the following: 

13 ‘‘(l) NO REPORT REQUIRED.—A report’’. 

14 (7) EXEMPTIONS FOR CLASS II DEVICES.—Sec15 tion 510(m) (21 U.S.C. 360(m)) is amended— 

16 (A) by striking ‘‘(m)(1) Not later than’’ 

17 and inserting the following: 

18 ‘‘(m) EXEMPTIONS FOR CLASS II DEVICES.— 

19 ‘‘(1) LIST OF EXEMPTED DEVICES.—Not later 

20 than’’; and 

21 (B) by striking ‘‘(2) Beginning’’ and in22 serting the following: 

23 ‘‘(2) OTHER EXEMPTED DEVICES.—Begin24 ning’’. 


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1 (8) REVIEW OF REPORT.—Section 510(n) (21 

2 U.S.C. 360(n)) is amended by striking ‘‘(n) The 

3 Secretary’’ and inserting the following: 

4 ‘‘(n) REVIEW OF REPORT.—The Secretary’’. 

5 (9) REPROCESSED SINGLE-USE DEVICES.—Sec6 tion 510(o) (21 U.S.C. 360(o)) is amended— 

7 (A) by striking ‘‘(o)(1) With respect to’’ 

8 and inserting the following: 

9 ‘‘(o) REPROCESSED SINGLE-USE DEVICES.— 

10 ‘‘(1) REPROCESSED SINGLE-USE DEVICES FOR

11 WHICH REPORTS ARE REQUIRED.—With respect to’’; 

12 (B) in paragraph (1), by moving the inden13 tation of subparagraphs (A) through (D) 2 ems 

14 to the right; 

15 (C) by striking ‘‘(2) With respect to’’ and 

16 inserting the following: 

17 ‘‘(2) CRITICAL AND SEMICRITICAL REPROC18 ESSED SINGLE-USE DEVICES.—With respect to’’; and 

19 (D) in paragraph (2), by moving the in20 dentation of subparagraphs (A) through (E) 2 

21 ems to the right. 

22 (10) ELECTRONIC SUBMISSION.—Section 510 

23 (21 U.S.C. 360) is amended by striking subsection 

24 (p). 


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1 (b) OTHER PROVISIONS.—The Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 301 et seq.) is amended— 

3 (1) by striking ‘‘510(i)’’ each place it appears 

4 and inserting ‘‘510(c)’’; 

5 (2) in section 301— 

6 (A) in subsection (p)— 

7 (i) by striking ‘‘510(j),’’ and inserting 

8 ‘‘510(i),’’; and 

9 (ii) by striking ‘‘510(j)(2)’’ and in10 serting ‘‘510(i)(2)’’; and 

11 (B) in subsection (o), by striking ‘‘510(j)’’ 

12 and inserting ‘‘510(i)’’; and 

13 (3) in section 801(a), by striking ‘‘subsection 

14 (i) of section 510’’ and inserting ‘‘subsection (c) of 

15 section 510’’. 

16 SEC. 107. EFFECTIVE DATE. 

17 This subtitle, and the amendments made by this sub18 title, shall take effect on October 1, 2008. 

19 Subtitle B—Ensuring Identity and 

20 Sourcing of Drug Ingredients 

21 SEC. 111. TESTING OF DRUG PURITY AND IDENTITY. 

22 (a) IN GENERAL.—Section 501 (21 U.S.C. 351) is 

23 amended by adding at the end the following: 

24 ‘‘(j) If it is a drug— 


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1 ‘‘(1) and it bears or contains an article, unless 

2 the manufacturer of such drug verifies the purity 

3 and identity of such article using scientifically sound 

4 and appropriate methods of sufficient analytical pre5 cision and specificity to detect and quantify the arti6 cle separate from— 

7 ‘‘(A) impurities; and 

8 ‘‘(B) contaminants and adulterants reason9 ably likely to be present in or on such article; 

10 ‘‘(2) unless the manufacturer of such drug peri11 odically evaluates the impurity profile of each active 

12 ingredient of such drug to verify that such profile is 

13 substantially similar to the profile of the lot or lots 

14 of such ingredient used in the clinical investigations 

15 or toxicological evaluations of such drug submitted 

16 to the Secretary under section 505 or section 351 of 

17 the Public Health Service Act; and 

18 ‘‘(3) unless the manufacturer of such drug re19 ports to the Secretary— 

20 ‘‘(A) any deviation from purity and iden21 tity identified under paragraph (1) or (2); and 

22 ‘‘(B) any necessary actions in response to 

23 such a deviation to assure the safety and effec24 tiveness of the drug.’’. 


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1 (b) COMPENDIAL MODERNIZATION.—Section 501(b) 

2 (21 U.S.C. 351(b)) is amended by— 

3 (1) inserting ‘‘or of the appropriate body 

4 charged with the revision of such compendium’’ after 

5 ‘‘in the judgment of the Secretary’’; 

6 (2) inserting ‘‘(1)’’ after ‘‘insufficient for the 

7 making of such determination,’’; 

8 (3) striking ‘‘attention of the appropriate body 

9 charged with the revision of such compendium’’ and 

10 inserting ‘‘attention of such body’’; and 

11 (4) inserting ‘‘, or (2) such body shall bring 

12 such fact to the attention of the Secretary, and the 

13 Secretary shall work with such body to develop ap14 proaches that will allow such body to establish suffi15 cient standards’’ after ‘‘purity shall be made’’. 

16 (c) RULEMAKING.—Section 701(e)(1) (21 U.S.C. 

17 371(e)(1)) is amended in the first sentence by deleting 

18 ‘‘501(b),’’. 

19 (d) ASSESSMENT.—The Secretary of Health and 

20 Human Services, in consultation with the United States 

21 Pharmacopeia, other drug regulatory agencies, academic 

22 experts, and industry, shall periodically assess the tests 

23 and methods of assay for drugs found in official com24 pendia to determine whether, considering current scientific 

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1 ically sound and appropriate and of sufficient analytical 

2 precision and specificity for their purpose. 

3 SEC. 112. MANUFACTURER RESPONSIBILITY FOR SOURCE 

4 AND QUALITY OF DRUG INGREDIENTS. 

5 Section 501 (21 U.S.C. 351), as amended by section 

6 111, is further amended by adding at the end the fol7 lowing: 

8 ‘‘(k) If it is a drug and the manufacturer or importer 

9 fails to establish and maintain for a period of time deter10 mined by the Secretary documentation adequate to— 

11 ‘‘(1) identify each establishment that manufac12 tured, processed, packed, or held each article that is 

13 a component of the drug or a precursor ingredient 

14 of such a component; and 

15 ‘‘(2) establish, including through appropriate 

16 and periodic audits of the establishments described 

17 in paragraph (1), that the drug and each such arti18 cle is not adulterated under this section or mis19 branded under section 502.’’. 

20 SEC. 113. CURRENT MANUFACTURING SCIENCE. 

21 Section 501(a) (21 U.S.C. 351(a)) is amended by 

22 striking ‘‘; or (3)’’ and inserting the following: ‘‘or (D) 

23 if it is manufactured in a manner that is inconsistent with 

24 current manufacturing technologies, including quality 

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1 tion of quality standards to clinical performance of the 

2 drug or device, as determined by the Secretary; or (3)’’. 

3 SEC. 114. ELECTRONIC PEDIGREE FOR DRUG INGREDI4 ENTS. 

5 Section 502 (21 U.S.C. 352) is amended by inserting 

6 after subsection (c) the following: 

7 ‘‘(d) If it is a drug and any article that is a compo8 nent of the drug or a precursor ingredient of such a com9 ponent was distributed by a person, unless such person 

10 distributed with the article an electronic statement (in 

11 such form and containing such information as the Sec12 retary may require by guidance or regulation) identifying 

13 each prior sale, purchase, or trade of the article (including 

14 the date of the transaction and the names and addresses 

15 of all parties to the transaction).’’. 

16 SEC. 115. COUNTRY OF ORIGIN LABELING. 

17 Section 502 (21 U.S.C. 352) is amended by inserting 

18 at the end the following: 

19 ‘‘(aa) If it is a drug in final dosage form or device 

20 for use on or by patients unless its label bears, and the 

21 Internet Web site of the manufacturer of the drug or de22 vice lists, the identity of— 

23 ‘‘(1) the country of manufacture of the drug or 

24 device; and 


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1 ‘‘(2) if it is a drug, the country of manufacture 

2 of each active ingredient in the drug.’’. 

3 SEC. 116. EFFECTIVE DATE. 

4 This subtitle, and the amendments made by this sub5 title, shall take effect on the date that is 180 days after 

6 the date of enactment of this Act. 

7 Subtitle C—Ensuring Standards for 

8 Imported Drugs 

9 SEC. 121. GOOD DISTRIBUTION AND IMPORT PRACTICES. 

10 (a) GOOD DISTRIBUTION AND IMPORT PRACTICES.— 

11 Section 501(a) (21 U.S.C. 351(a)), as amended by section 

12 113, is further amended by striking ‘‘; or (3)’’ and insert13 ing ‘‘or (E) if it is a drug and it is not distributed, 

14 shipped, warehoused, brokered, imported, or conveyed in 

15 conformity with current good distribution and import 

16 practices to assure the identity, strength, quality, and pu17 rity of the drug; or (3)’’. 

18 (b) INSPECTION OF IMPORTERS AND DISTRIBUTORS

19 OF DRUGS.—Section 704 (21 U.S.C. 374) is amended— 

20 (1) in subsection (a)— 

21 (A) in paragraph (1)(A), by inserting 

22 ‘‘(and in the case of drugs, distributed, shipped, 

23 warehoused, or conveyed)’’ after ‘‘or held,’’; and 

24 (B) in the third sentence— 


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1 (i) by inserting ‘‘(and in the case of 

2 drugs, distributed, shipped, warehoused, or 

3 conveyed)’’ after ‘‘packed, or held,’’; and 

4 (ii) by inserting ‘‘, (and in the case of 

5 drugs, distributed, shipped, warehoused, or 

6 conveyed)’’ after ‘‘transported, or held’’; 

7 and 

8 (2) in subsection (e), by striking ‘‘519 or’’ and 

9 inserting ‘‘502(a)(2)(E), 519, or’’. 

10 SEC. 122. STANDARDS FOR ADMISSION OF IMPORTED 

11 DRUGS AND DRUG INGREDIENTS. 

12 Section 801 (21 U.S.C. 381) is amended— 

13 (1) in subsection (o), by striking ‘‘drug or’’; 

14 and 

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

16 ‘‘(p) Except as provided in subsection (g), a drug, 

17 or an article that appears to be a drug, in finished dosage 

18 form, an article that is intended to be a component of a 

19 drug, or an article that is intended to be a precursor ingre20 dient of such a component that is being imported or of21 fered for import into the United States shall be refused 

22 admission unless the person importing or offering for im23 port such drug or article provides to the Secretary, at the 

24 time of being imported or offered for import— 


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1 ‘‘(1) all information submitted to U.S. Customs 

2 and Border Protection in the entry declaration for 

3 such drug or such article; 

4 ‘‘(2) for a drug, or an article that appears to 

5 be a drug, in finished dosage form— 

6 ‘‘(A) the listing number under section 

7 510(e) of such drug; 

8 ‘‘(B) the D-U-N-S number of each estab9 lishment in which such drug was manufactured, 

10 prepared, propagated, compounded, or proc11 essed; 

12 ‘‘(C) the new drug application number, the 

13 abbreviated new drug application number, or 

14 the drug monograph number, as applicable; 

15 ‘‘(D) the label required by the new drug 

16 application, abbreviated new drug application, 

17 or drug monograph, as applicable; and 

18 ‘‘(E) the record of inspections by the Sec19 retary; 

20 ‘‘(3) for an article that is an active ingredient 

21 of a drug, or an article that is a precursor ingredient 

22 of an active ingredient— 

23 ‘‘(A) the listing number under section 

24 510(e) of such article; 


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•S 3409 IS

1 ‘‘(B) the D-U-N-S number of each estab2 lishment in which such article was manufac3 tured, prepared, propagated, compounded, or 

4 processed; 

5 ‘‘(C) the new drug application number, the 

6 abbreviated new drug application number, or 

7 the drug monograph number, as applicable, of 

8 the finished dosage form for which such article 

9 is intended; 

10 ‘‘(D) the label under a regulatory exemp11 tion from section 502(f)(1); and 

12 ‘‘(E) the record of inspections by the Sec13 retary or by a governmental authority respon14 sible for drugs deemed adequate by the Sec15 retary; and 

16 ‘‘(4) for an article (other than an active ingre17 dient) that is intended to be a component of a drug, 

18 or an article that is a precursor ingredient of any 

19 such component— 

20 ‘‘(A) the listing number under section 

21 510(e) of such article; 

22 ‘‘(B) the D-U-N-S number of each estab23 lishment in which such article was manufac24 tured, prepared, propagated, compounded, or 

25 processed; 


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•S 3409 IS

1 ‘‘(C) the new drug application number, the 

2 abbreviated new drug application number, or 

3 the drug monograph number, as applicable, of 

4 the finished dosage form for which such article 

5 is intended; and 

6 ‘‘(D)(i) the record of inspections by the 

7 Secretary or by a governmental authority re8 sponsible for drugs deemed adequate by the 

9 Secretary; 

10 ‘‘(ii) a quality certification by a private en11 tity, if the Secretary has agreed to accept such 

12 a certification; and 

13 ‘‘(iii) other evidence of quality that the 

14 Secretary has deemed acceptable by regula15 tion.’’. 

16 SEC. 123. PROHIBITION ON USE OF DRUGS AND DRUG IN17 GREDIENTS NOT DECLARED AS DRUGS ON 

18 IMPORTATION. 

19 Section 502 (21 U.S.C. 352), as amended by section 

20 115, is further amended by adding at the end the fol21 lowing: 

22 ‘‘(bb) If it is a drug and it is, bears, or contains an 

23 article that, when imported or offered for import into the 

24 United States is intended to be a drug or a component 

25 of a drug, unless— 


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1 ‘‘(1) the label of such article, when so imported 

2 or offered for import, contains the statement ‘for 

3 drug use’; and 

4 ‘‘(2) the article is declared when so imported or 

5 offered for import as ‘for drug use’.’’. 

6 SEC. 124. DESTRUCTION OF UNSAFE PRODUCTS REFUSED 

7 ADMISSION. 

8 Section 801(a) (21 U.S.C. 381(a)) is amended by 

9 striking the sixth sentence and inserting the following: 

10 ‘‘The Secretary of the Treasury shall cause the destruction 

11 of any such article refused admission (1) if the Secretary 

12 of Health and Human Services informs the Secretary of 

13 the Treasury that such article appears to pose a risk of 

14 injury or death; or (2) if such article is not exported, 

15 under regulations prescribed by the Secretary of the 

16 Treasury, within 90 days of the date of notice of such re17 fusal or within such additional time as may be permitted 

18 pursuant to such regulations. The preceding sentence shall 

19 not apply to drugs to which subsection (g) applies.’’. 

20 SEC. 125. EFFECTIVE DATE. 

21 This subtitle, and the amendments made by this sub22 title, shall take effect on the date that is 30 days after 

23 the date of enactment of this Act. 


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1 Subtitle D—Enhanced Response to 

2 Unsafe Drugs 

3 SEC. 131. ADMINISTRATIVE DETENTION OF DRUGS. 

4 (a) IN GENERAL.—Section 304(g) (21 U.S.C. 

5 334(g)) is amended— 

6 (1) in paragraph (1)— 

7 (A) by inserting ‘‘drug or’’ before ‘‘device’’ 

8 each place it appears; and 

9 (B) by inserting ‘‘, or, in the case of a 

10 drug, which the officer or employee making the 

11 inspection has reason to believe is in violation 

12 of section 505,’’ after ‘‘or misbranded’’; and 

13 (2) in paragraph (2), by inserting ‘‘drug or’’ be14 fore ‘‘device’’ each place it appears. 

15 (b) TECHNICAL AMENDMENTS.—Section 304(g)(1) 

16 (21 U.S.C. 334(g)(1)), as amended by subsection (a), is 

17 further amended by— 

18 (1) striking ‘‘(1) If’’ and inserting ‘‘(1)(A) If’’; 

19 (2) striking ‘‘thirty days. Regulations’’ and in20 serting the following: ‘‘thirty days. 

21 ‘‘(B) Regulations’’; 

22 (3) striking ‘‘such order. A detention’’ and in23 serting the following: ‘‘such order. 

24 ‘‘(C) A detention’’; and 


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1 (4) striking ‘‘as detained. Any person’’ and in2 serting the following: ‘‘as detained. 

3 ‘‘(D) Any person’’. 

4 (c) REGULATIONS.—Until the date that the Secretary 

5 of Health and Human Services issues a final regulation 

6 to implement the amendments to section 304(g) of the 

7 Federal Food, Drug, and Cosmetic Act (as made by sub8 section (a)), the regulations on administrative detention 

9 in section 800.55 of title 21, Code of Federal Regulations, 

10 shall apply to any administrative detention of a drug 

11 under such section 304(g). 

12 SEC. 132. MANDATORY RECALL AUTHORITY FOR DRUGS. 

13 (a) IN GENERAL.—Chapter V (21 U.S.C. 351 et seq.) 

14 is amended by inserting after section 506C the following: 

15 ‘‘SEC. 507. MANDATORY RECALL AUTHORITY FOR DRUGS. 

16 ‘‘(a) ORDER TO CEASE DISTRIBUTION; NOTIFICA17 TION; PROCESS.— 

18 ‘‘(1) ORDER TO CEASE DISTRIBUTION; NOTIFI19 CATION.—If the Secretary finds that there is a rea20 sonable probability that a drug intended for human 

21 use would cause serious, adverse health con22 sequences or death, the Secretary shall issue an 

23 order requiring the appropriate person (including 

24 the manufacturers, importers, distributors, or retail25 ers of the drug)— 


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1 ‘‘(A) to immediately cease distribution of 

2 such drug; and 

3 ‘‘(B) to immediately notify health profes4 sionals and hospitals and other health care fa5 cilities of the order and to instruct such profes6 sionals and facilities to cease use of such drug. 

7 ‘‘(2) PROCESS.—The order under paragraph 

8 (1) shall provide the person subject to the order with 

9 an opportunity for an informal hearing, to be held 

10 not later than 10 days after the date of the issuance 

11 of the order, on the actions required by the order 

12 and on whether the order should be amended to re13 quire a recall of such drug. If, after providing an op14 portunity for such a hearing, the Secretary deter15 mines that inadequate grounds exist to support the 

16 actions required by the order, the Secretary shall va17 cate the order. 

18 ‘‘(b) ORDER TO RECALL.— 

19 ‘‘(1) IN GENERAL.—If, after providing an op20 portunity for an informal hearing under subsection 

21 (a), the Secretary determines that the order should 

22 be amended to include a recall of the drug with re23 spect to which the order was issued, the Secretary 

24 shall, except as provided in paragraph (2), amend 

25 the order to require a recall. The Secretary shall 


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•S 3409 IS

1 specify a timetable in which the drug recall will 

2 occur and shall require periodic reports to the Sec3 retary describing the progress of the recall. 

4 ‘‘(2) AMENDED ORDER.—An amended order 

5 under paragraph (1)— 

6 ‘‘(A) shall— 

7 ‘‘(i) not include recall of a drug from 

8 individuals; and 

9 ‘‘(ii) not include recall of a drug from 

10 hospitals and other health care facilities if 

11 the Secretary determines that the risk of 

12 recalling such drug from the facilities pre13 sents a greater health risk than the health 

14 risk of not recalling the drug from use; 

15 and 

16 ‘‘(B) shall provide for notice to individuals 

17 subject to the risks associated with the use of 

18 such drug. 

19 ‘‘(3) ASSISTANCE.—In providing the notice re20 quired by paragraph (2), the Secretary may use the 

21 assistance of health professionals who prescribed or 

22 used such a drug for individuals. If a significant 

23 number of such individuals cannot be identified, the 

24 Secretary shall notify such individuals pursuant to 

25 section 705(b).’’. 


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1 (b) REGULATIONS.—Until the date that the Sec2 retary of Health and Human Services issues a final regu3 lation to implement section 507 of the Federal Food, 

4 Drug, and Cosmetic Act (as added by subsection (a)), the 

5 regulations on medical device recall authority in part 810 

6 of title 21, Code of Federal Regulations, shall apply to 

7 any recall of a drug under such section 507. 

8 SEC. 133. RECORDS AND REPORTS OF DRUG DEFECTS AND 

9 DESTRUCTION OF DEFECTIVE DRUGS THAT 

10 CANNOT BE RECONDITIONED. 

11 (a) IN GENERAL.—Section 503 (21 U.S.C. 353) is 

12 amended by adding at the end the following: 

13 ‘‘(h) DRUG DEFECTS.— 

14 ‘‘(1) RECORDS AND REPORTS.—The manufac15 turer of a drug shall make and maintain records, 

16 and promptly submit reports to the Secretary, about 

17 any defect of the drug. 

18 ‘‘(2) INVESTIGATION AND CORRECTIVE AC19 TION.—The manufacturer of a drug shall— 

20 ‘‘(A) investigate the cause of any defect of 

21 the drug; and 

22 ‘‘(B) take appropriate corrective action. 

23 ‘‘(3) DESTRUCTION.—If a drug may cause in24 jury or death because of a defect, the manufacturer 

25 shall, after the investigation of the defect required 


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•S 3409 IS

1 under paragraph (2), destroy the drug and shall not 

2 recondition the drug. 

3 ‘‘(4) DEFECT.—For purposes of this sub4 section, a drug shall be considered to have a defect 

5 if the manufacturer rejects the drug for manufac6 turing or distribution because of— 

7 ‘‘(A) microbiological or other contamina8 tion; 

9 ‘‘(B) significant chemical, physical, or 

10 other change or deterioration; or 

11 ‘‘(C) any failure of 1 or more batches of 

12 the drug to meet a specification established for 

13 it.’’. 

14 (b) PROHIBITED ACTS.—Section 301 (21 U.S.C. 

15 331) is amended— 

16 (1) in subsection (d), by striking ‘‘505’’ and in17 serting ‘‘503(h), 505’’; and 

18 (2) in subsection (e), by striking ‘‘504’’ and in19 serting ‘‘503(h), 504’’. 

20 (c) EFFECTIVE DATE.—The amendments made by 

21 this section shall take effect on the date that is 180 days 

22 after the date of enactment of this Act. 

23 SEC. 134. CIVIL MONEY PENALTIES. 

24 (a) IN GENERAL.—Section 303(f) (21 U.S.C. 333) 

25 is amended— 


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•S 3409 IS

1 (1) by redesignating paragraphs (5), (6), and 

2 (7) as paragraphs (6), (7), and (8), respectively; 

3 (2) in paragraph (4), by striking ‘‘or 505–1’’ 

4 each place it appears and inserting ‘‘505–1, 505A, 

5 or 523A’’; 

6 (3) by inserting after paragraph (4) the fol7 lowing: 

8 ‘‘(5)(A)(i) Any manufacturer, distributor, im9 porter, broker, or filer that violates a requirement of 

10 this Act that relates to drugs for human use (except 

11 a requirement referred to in paragraph (4) or sub12 section (g)) shall be liable to the United States for 

13 a civil penalty not to exceed $100,000 per violation. 

14 ‘‘(ii) Each day during which a violation con15 tinues shall be considered a separate violation under 

16 clause (i). 

17 ‘‘(B)(i) Any manufacturer, distributor, im18 porter, broker, or filer that knowingly reports or en19 ters false or misleading data on documents related 

20 to the importation of a drug shall be liable to the 

21 United States for a civil penalty not to exceed 

22 $150,000. 

23 ‘‘(ii) Each act of reporting or entering false 

24 data shall be considered a separate violation under 

25 clause (i).’’; 


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1 (4) in paragraph (6), as so redesignated, by 

2 striking ‘‘, or (4)’’ each place it appears and insert3 ing ‘‘(4), or (5)’’; 

4 (5) in paragraph (7), as so redesignated, by 

5 striking ‘‘(5)(A)’’ and inserting ‘‘(6)(A)’’; and 

6 (6) in paragraph (8), as so redesignated, by 

7 striking ‘‘paragraph (6)’’ each place it appears and 

8 inserting ‘‘paragraph (7)’’. 

9 (b) APPLICABILITY.—Section 303(f)(5) (as amended 

10 by subsection (a)), shall apply to violations described in 

11 such section that occur after the date of enactment of this 

12 Act. 

13 Subtitle E—Additional Provisions 

14 Related to Medical Products 

15 SEC. 141. CERTIFICATION OF INFORMATION. 

16 (a) DRUGS.—Chapter V (21 U.S.C. 351 et seq.) is 

17 amended by inserting after section 505D the following: 

18 ‘‘SEC. 505E. CERTIFICATION OF DRUG INFORMATION. 

19 ‘‘(a) CERTIFICATION.— 

20 ‘‘(1) IN GENERAL.—A new drug application 

21 under section 505(b), an abbreviated new drug ap22 plication under section 505(j), a biologics license ap23 plication under section 351 of the Public Health 

24 Service Act, an application for an investigational 

25 new drug exemption under section 505(i), a new aniVerDate Aug 31 2005 04:19 Aug 05, 2008 Jkt 069200 PO 00000 Frm 00059 Fmt 6652 Sfmt 6201 E:\BILLS\S3409.IS S3409

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1 mal drug application under section 512(b), an abbre2 viated new animal drug application under section 

3 512(b), an application under section 571, a request 

4 under section 572, an amendment, supplement, or 

5 other information submitted to the Secretary with 

6 respect to any such application or request, or a 

7 record or report related to the safety or effectiveness 

8 of a drug subject to section 505 or such section 351, 

9 to an adverse event under section 505(k) or 760, or 

10 to a postapproval study or postapproval clinical trial 

11 under section 505(o), when submitted to the Sec12 retary, shall include a certification, in writing and 

13 under penalty of perjury, by the responsible person 

14 that— 

15 ‘‘(A) such person has actual knowledge of 

16 the requirements under this Act and, if applica17 ble, such section 351, with respect to the drug 

18 that is the subject of such submission; 

19 ‘‘(B) such person has actual knowledge of 

20 the information related to such drug; 

21 ‘‘(C) such person has actual knowledge of 

22 the information in such submission; 

23 ‘‘(D) the information in such submission 

24 complies with such requirements; 


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1 ‘‘(E) the information in such submission is 

2 not false or misleading; and 

3 ‘‘(F) full reports of all clinical trials and 

4 postmarket studies (whether conducted within 

5 or outside the United States) related to the 

6 safety or effectiveness of the drug under review 

7 that were funded by the sponsor of such sub8 mission, or the full reports of which the sponsor 

9 of such submission had access, have been sub10 mitted to the Food and Drug Administration. 

11 ‘‘(2) RESPONSIBLE PERSON.—A responsible 

12 person under this section is, with respect to a sub13 mission described under paragraph (1), a senior offi14 cer or director of the sponsor of such submission 

15 with knowledge of, and management responsibility 

16 for, such submission. 

17 ‘‘(b) INSPECTIONS.— 

18 ‘‘(1) IN GENERAL.—If the Secretary deter19 mines, after notice and opportunity for an informal 

20 hearing, that a sponsor described in paragraph 

21 (2)(A) knew or should have known that the informa22 tion in a submission described in subsection (a)(1) 

23 did not comply with the requirements of this Act or 

24 was false or misleading, the Secretary may provide 

25 that any factory, warehouse, establishment, or conVerDate Aug 31 2005 04:19 Aug 05, 2008 Jkt 069200 PO 00000 Frm 00061 Fmt 6652 Sfmt 6201 E:\BILLS\S3409.IS S3409

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1 sulting laboratory related to such noncompliance or 

2 such false or misleading information shall be in3 spected periodically by officers or employees duly 

4 designated by the Secretary for a period of time de5 termined by the Secretary, not to exceed 5 years. 

6 ‘‘(2) COSTS.—The Secretary shall assess the 

7 costs of such inspections to such sponsor.’’. 

8 (b) DEVICES.—Chapter V (21 U.S.C. 351 et seq.) is 

9 amended by inserting after section 523 the following: 

10 ‘‘SEC. 523A. CERTIFICATION OF DEVICE INFORMATION. 

11 ‘‘(a) CERTIFICATION.— 

12 ‘‘(1) CERTIFICATION BY SPONSOR.—An applica13 tion or report for premarket approval under section 

14 515, an application for an investigational device ex15 emption under section 520(g), a report under section 

16 510(k), an application for a humanitarian device ex17 emption under section 520(m), an amendment, sup18 plement, or other information submitted to the Sec19 retary with respect to any such application or report, 

20 or a record or report related to an adverse event, a 

21 report, or postmarket surveillance under section 519 

22 or 522, when submitted to the Secretary, shall in23 clude a certification, in writing and under penalty of 

24 perjury, by the responsible person that— 


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1 ‘‘(A) such person has actual knowledge of 

2 the requirements under this Act with respect to 

3 the device that is the subject of such submis4 sion; 

5 ‘‘(B) such person has actual knowledge of 

6 the information related to such device; 

7 ‘‘(C) such person has actual knowledge of 

8 the information in such submission; 

9 ‘‘(D) the information in such submission 

10 complies with such requirements; 

11 ‘‘(E) the information in such submission is 

12 not false or misleading; and 

13 ‘‘(F) full reports of all clinical trials and 

14 postmarket studies (whether conducted within 

15 or outside the United States) related to the 

16 safety or effectiveness of the device under re17 view that were funded by the sponsor of such 

18 submission, or the full reports of which the 

19 sponsor of such submission had access, have 

20 been submitted to the Food and Drug Adminis21 tration. 

22 ‘‘(2) RESPONSIBLE PERSON.—A responsible 

23 person under this section is, with respect to a sub24 mission described under paragraph (1), a senior offi25 cer or director of the sponsor of such submission 


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•S 3409 IS

1 with knowledge of, and management responsibility 

2 for, such submission. 

3 ‘‘(b) INSPECTIONS.— 

4 ‘‘(1) IN GENERAL.—If the Secretary deter5 mines, after notice and opportunity for an informal 

6 hearing, that a sponsor described in paragraph 

7 (a)(2) knew or should have known that the informa8 tion in a submission described in subsection (a)(1) 

9 did not comply with the requirements of this Act or 

10 was false or misleading, the Secretary may provide 

11 that any factory, warehouse, establishment, or con12 sulting laboratory related to such noncompliance or 

13 such false or misleading information shall be in14 spected periodically by officers or employees duly 

15 designated by the Secretary for a period of time de16 termined by the Secretary, not to exceed 5 years. 

17 ‘‘(2) COSTS.—The Secretary shall assess the 

18 costs of such inspections to such sponsor.’’. 

19 (c) CRIMINAL PENALTIES.—Chapter 47 of title 18, 

20 United States Code, is amended by adding at the end the 

21 following: 

22 ‘‘§ 1041. Certifications related to drug and device in23 formation 

24 ‘‘(a) If a responsible person— 


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1 ‘‘(1) certifies any submission as set forth in sec2 tion 505E or 523A of the Federal Food, Drug, and 

3 Cosmetic Act knowing that a component of such cer4 tification is false or misleading, then— 

5 ‘‘(A) the sponsor of such submission shall 

6 be fined not more than $1,000,000; and 

7 ‘‘(B) such responsible person shall be fined 

8 not more than $1,000,000, imprisoned for not 

9 more than 10 years, or both; or 

10 ‘‘(2) willfully certifies any submission as set 

11 forth in section 505E or 523A of the Federal Food, 

12 Drug, and Cosmetic Act knowing that a component 

13 of such certification is false or misleading, then— 

14 ‘‘(A) the sponsor of such submission shall 

15 be fined not more than $5,000,000; and 

16 ‘‘(B) such responsible person shall be fined 

17 not more than $5,000,000, imprisoned not more 

18 than 20 years, or both. 

19 ‘‘(b) In this section: 

20 ‘‘(1) The term ‘responsible person’— 

21 ‘‘(A) with respect to a submission related 

22 to a drug, has the meaning given that term in 

23 section 505E(a)(2) of the Federal Food, Drug, 

24 and Cosmetic Act; and 


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1 ‘‘(B) with respect to a submission related 

2 to device, has the meaning given that term in 

3 section 523A(a)(2) of such Act. 

4 ‘‘(2) The term ‘submission’ means— 

5 ‘‘(A) with respect to a drug— 

6 ‘‘(i) a new drug application under sec7 tion 505(b) of the Federal Food, Drug, 

8 and Cosmetic Act; 

9 ‘‘(ii) an abbreviated new drug applica10 tion under section 505(j) of such Act; 

11 ‘‘(iii) a biologics license application 

12 under section 351 of the Public Health 

13 Service Act; 

14 ‘‘(iv) an application for an investiga15 tional new drug exemption under section 

16 505(i) of the Federal Food, Drug, and 

17 Cosmetic Act; 

18 ‘‘(v) a new animal drug application 

19 under section 512(b) of the Federal Food, 

20 Drug, and Cosmetic Act; 

21 ‘‘(vi) an abbreviated new animal drug 

22 application under section 512(b) of such 

23 Act; 

24 ‘‘(vii) an application under section 

25 571 of such Act; 


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1 ‘‘(viii) a request under section 572 of 

2 such Act; 

3 ‘‘(ix) an amendment, supplement, or 

4 other information submitted to the Sec5 retary with respect to any application or 

6 request described in clauses (i) through 

7 (viii); or 

8 ‘‘(x) a record or report related to the 

9 safety or effectiveness of a drug subject to 

10 section 505 of such Act or section 351 of 

11 the Public Health Service Act, to an ad12 verse event under section 505(k) or 760 of 

13 the Federal Food, Drug, and Cosmetic 

14 Act, or to a postapproval study or post15 approval clinical trial under section 505(o) 

16 of such Act; and 

17 ‘‘(B) with respect to a device— 

18 ‘‘(i) an application or report for pre19 market approval under section 515 of the 

20 Federal Food, Drug, and Cosmetic Act; 

21 ‘‘(ii) an application for an investiga22 tional device exemption under section 

23 520(g) of such Act; 

24 ‘‘(iii) a report under section 510(k) of 

25 such Act; 


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1 ‘‘(iv) an application for a humani2 tarian device exemption under section 

3 520(m) of such Act; 

4 ‘‘(v) an amendment, supplement, or 

5 other information submitted to the Sec6 retary with respect to any application or 

7 report described in clauses (i) through (iv); 

8 or 

9 ‘‘(vi) a record or report related to an 

10 adverse event, a report, or postmarket sur11 veillance under section 519 or 522 of such 

12 Act.’’. 

13 (d) CONFORMING AMENDMENT.—The table of sec14 tions for chapter 47 of title 18, United States Code, is 

15 amended by inserting after the item relating to section 

16 1040 the following: 

‘‘1041. Certification of drug and device information.’’. 

17 SEC. 142. WHISTLEBLOWER PROTECTIONS. 

18 Chapter IX (21 U.S.C. 391 et seq.) is amended by 

19 adding at the end the following: 

20 ‘‘SEC. 911. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO 

21 VIOLATE, OR WHO DISCLOSE VIOLATIONS OF, 

22 THIS ACT OR SECTION 351 OF THE PUBLIC 

23 HEALTH SERVICE ACT. 

24 ‘‘(a) IN GENERAL.—No person that submits or is re25 quired to submit to the Secretary, a new drug application 


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•S 3409 IS

1 under section 505(b), an abbreviated new drug application 

2 under section 505(j), a biologics license application under 

3 section 351 of the Public Health Service Act, an applica4 tion for an investigational new drug exemption under sec5 tion 505(i), a new animal drug application under section 

6 512(b), an abbreviated new animal drug application under 

7 section 512(b), an application under section 571, a request 

8 under section 572, an application or report for premarket 

9 approval under section 515, an application for an inves10 tigational device exemption under section 520(g), a report 

11 under section 510(k), an application for a humanitarian 

12 device exemption under section 520(m), an amendment, 

13 supplement, or other submission with respect to any such 

14 application or report, or a record or report related to an 

15 adverse event, a postapproval study, a postapproval clin16 ical trial, a report, or postmarket surveillance under sec17 tion 505(k), 505(o), 519, 522, or 760, or any officer, em18 ployee, contractor, subcontractor, or agent of such a per19 son, may discharge, demote, suspend, threaten, harass, or 

20 in any other manner discriminate against an employee in 

21 the terms and conditions of employment because of any 

22 lawful act done by the employee, including within the ordi23 nary course of the job duties of such employee— 

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

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1 tion regarding any conduct which the employee rea2 sonably believes constitutes a violation of any such 

3 section of this Act or such section 351 of the Public 

4 Health Service Act, any other provision of Federal 

5 law relating to the safety or effectiveness of a drug, 

6 biological product, or device, or any provision of 

7 Federal law prohibiting fraud against the Food and 

8 Drug Administration, if the information or assist9 ance is provided to, or an investigation stemming 

10 from the provided information is conducted by— 

11 ‘‘(A) a Federal regulatory or law enforce12 ment agency; 

13 ‘‘(B) any Member of Congress or any com14 mittee of Congress; or 

15 ‘‘(C) a person with supervisory authority 

16 over the employee (or such other person work17 ing for the employer who has the authority to 

18 investigate, discover, or terminate the mis19 conduct); 

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

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

22 to be filed (with any knowledge of the employer) re23 lating to an alleged violation of any such section of 

24 this Act or such section 351 of the Public Health 

25 Service Act, any other provision of Federal law reVerDate Aug 31 2005 04:19 Aug 05, 2008 Jkt 069200 PO 00000 Frm 00070 Fmt 6652 Sfmt 6201 E:\BILLS\S3409.IS S3409

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1 lating to the safety or effectiveness of a drug, bio2 logical product, or device, or any provision of Fed3 eral law prohibiting fraud against the Food and 

4 Drug Administration; or 

5 ‘‘(3) to refuse to violate or assist in the viola6 tion of any such section of this Act or such section 

7 351 of the Public Health Service Act, any other pro8 vision of Federal law relating to the safety or effec9 tiveness of a drug, biological product, or device, or 

10 any provision of Federal law prohibiting fraud 

11 against the Food and Drug Administration. 

12 ‘‘(b) ENFORCEMENT ACTION.— 

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

14 discharge, or other discrimination in violation of 

15 subsection (a), may seek relief in accordance with 

16 the provisions of subsection (c), by— 

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

18 of Labor; or 

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

20 issued a final decision within 210 days of the 

21 filing of the complaint and there is no showing 

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

23 claimant, bringing an action at law or equity 

24 for de novo review in the appropriate district 

25 court of the United States, which shall have juVerDate Aug 31 2005 04:19 Aug 05, 2008 Jkt 069200 PO 00000 Frm 00071 Fmt 6652 Sfmt 6201 E:\BILLS\S3409.IS S3409

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1 risdiction over such an action without regard to 

2 the amount in controversy. 

3 ‘‘(2) PROCEDURE.— 

4 ‘‘(A) IN GENERAL.—Any action under 

5 paragraph (1) shall be governed under the rules 

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

7 title 49, United States Code. 

8 ‘‘(B) EXCEPTION.—Notification in an ac9 tion under paragraph (1) shall be made in ac10 cordance with section 42121(b)(1) of title 49, 

11 United States Code, except that such notifica12 tion shall be made to the person named in the 

13 complaint and to the employer. 

14 ‘‘(C) BURDENS OF PROOF.—An action 

15 brought under paragraph (1)(B) shall be gov16 erned by the legal burdens of proof set forth in 

17 section 42121(b) of title 49, United States 

18 Code. 

19 ‘‘(D) STATUTE OF LIMITATIONS.—An ac20 tion under paragraph (1) shall be commenced 

21 not later than 180 days after the date on which 

22 the violation occurs. 

23 ‘‘(c) REMEDIES.— 


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1 ‘‘(1) IN GENERAL.—An employee prevailing in 

2 any action under subsection (b)(1) shall be entitled 

3 to all relief necessary to make the employee whole. 

4 ‘‘(2) COMPENSATORY DAMAGES.—Relief in an 

5 action under subsection (b) shall include— 

6 ‘‘(A) reinstatement with the same seniority 

7 status that the employee would have had, but 

8 for the discrimination; 

9 ‘‘(B) the amount of backpay owed to the 

10 employee, with interest; and 

11 ‘‘(C) compensation for any special damages 

12 sustained as a result of the discrimination, in13 cluding litigation costs, expert witness fees, and 

14 reasonable attorney fees. 

15 ‘‘(d) RIGHTS RETAINED BY EMPLOYEE.—Nothing in 

16 this section shall be deemed to diminish the rights, privi17 leges, or remedies of any employee under any Federal or 

18 State law or under any collective bargaining agreement. 

19 The rights and remedies in this section may not be waived 

20 by any agreement, policy, form, or condition of employ21 ment.’’. 


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1 TITLE II—GENERAL AUTHORI2 TIES TO ENHANCE FOOD AND 

3 DRUG ADMINISTRATION 

4 OVERSIGHT OF PRODUCTS 

5 FROM A GLOBAL MARKET 

6 SEC. 201. DEDICATED FOREIGN INSPECTORATE. 

7 Section 704 (21 U.S.C. 374) is amended by adding 

8 at the end the following: 

9 ‘‘(h) FOREIGN INSPECTORATE.— 

10 ‘‘(1) IN GENERAL.—The Secretary shall estab11 lish and maintain a corps of inspectors dedicated to 

12 inspections of foreign establishments registered 

13 under section 510 and foreign facilities registered 

14 under section 415. Such corps shall include per15 sonnel, in numbers sufficient to act as inspectors or 

16 translators for inspectors on each inspection by such 

17 corps, who are able to understand and speak the 

18 language used in the establishment or facility under 

19 inspection. 

20 ‘‘(2) ORGANIZATION.—The corps established 

21 under paragraph (1) shall be organized into the fol22 lowing 4 units: 

23 ‘‘(A) A unit with expertise in inspections of 

24 food facilities. 


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1 ‘‘(B) A unit with expertise in inspections 

2 of human drug establishments. 

3 ‘‘(C) A unit with expertise in inspections of 

4 animal drug establishments. 

5 ‘‘(D) A unit with expertise in inspections 

6 of medical device establishments. 

7 ‘‘(3) STAFFING AND FUNDING.—Each unit 

8 shall be staffed and funded by the Secretary at a 

9 level sufficient to allow the unit to conduct inspec10 tions, as applicable— 

11 ‘‘(A) of foreign establishments registered 

12 under section 510 at a frequency, considering 

13 risk, that is comparable to the inspection rate 

14 of domestic establishments registered under sec15 tion 510; or 

16 ‘‘(B) of foreign facilities registered under 

17 section 415 at a frequency, considering risk, 

18 that is comparable to the inspection rate of do19 mestic facilities registered under section 415. 

20 ‘‘(4) DISTRIBUTION.—The Secretary shall dis21 tribute the staff of each unit described in paragraph 

22 (2) in countries, and may modify such distribution 

23 over time, considering— 

24 ‘‘(A) the volume of product exported from 

25 such country to the United States; 


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1 ‘‘(B) an assessment of the effectiveness of 

2 the regulatory oversight provided by such coun3 try for such products; 

4 ‘‘(C) an assessment of the risk posed by 

5 such products; and 

6 ‘‘(D) such other factors as the Secretary 

7 determines are relevant to such distribution.’’. 

8 SEC. 202. AUTHORITY TO EXCHANGE CONFIDENTIAL IN9 FORMATION WITH FOREIGN GOVERNMENT 

10 OFFICIALS. 

11 (a) AUTHORITY TO EXCHANGE CONFIDENTIAL IN12 FORMATION WITH FOREIGN GOVERNMENT OFFICIALS.— 

13 Section 803 (21 U.S.C. 383) is amended by adding the 

14 following: 

15 ‘‘(d) EXCHANGE OF CONFIDENTIAL INFORMATION.— 

16 ‘‘(1) DISCLOSURE BY SECRETARY.—The Sec17 retary may disclose information about food, drugs, 

18 devices, and cosmetics to officials of a foreign gov19 ernment if— 

20 ‘‘(A) such government is able, and agrees, 

21 to guard the confidentiality and guarantee non22 disclosure of such information; and 

23 ‘‘(B) the Secretary determines that such 

24 disclosure is necessary to promote a regulatory, 

25 enforcement, or other public health function. 


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1 ‘‘(2) DISCLOSURE TO SECRETARY.—The Sec2 retary may receive information from officials of for3 eign governments under conditions of confidentiality. 

4 Such information shall be exempt from disclosure 

5 under section 552 of title 5, United States Code.’’. 

6 (b) CONFORMING AMENDMENT.—Section 301(j) (21 

7 U.S.C. 331(j)) is amended by inserting ‘‘or pursuant to 

8 section 803(d),’’ after ‘‘judicial proceeding under this 

9 Act,’’. 

10 SEC. 203. SUBPOENA AUTHORITY. 

11 Section 702 (21 U.S.C. 372) is amended by adding 

12 at the end the following: 

13 ‘‘(f)(1) The Secretary may conduct investigations as 

14 the Secretary deems necessary— 

15 ‘‘(A) to carry out the authority of the Secretary 

16 under this Act or section 351 of the Public Health 

17 Service Act; or 

18 ‘‘(B) to determine whether any person has en19 gaged or is about to engage in any act that con20 stitutes or will constitute a violation of this Act or 

21 such section 351. 

22 ‘‘(2) For the purpose of any investigation conducted 

23 under paragraph (1), the Secretary may administer oaths 

24 and affirmations, subpoena witnesses, compel the attend25 ance of such witnesses, take evidence, and require the proVerDate Aug 31 2005 04:19 Aug 05, 2008 Jkt 069200 PO 00000 Frm 00077 Fmt 6652 Sfmt 6201 E:\BILLS\S3409.IS S3409

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1 duction of any books, papers, documents, or other mate2 rials that are relevant to the investigation. 

3 ‘‘(3)(A) In case of contumacy or refusal to obey a 

4 subpoena issued under paragraph (2), the district court 

5 of the United States for the judicial district in which such 

6 investigation or proceeding is conducted, or in which the 

7 subpoenaed person resides or conducts business, may issue 

8 an order requiring such person to appear before the Sec9 retary, testify, or produce books, papers, documents, or 

10 other materials that are relevant to the investigation. All 

11 process in any such case may be served in the judicial dis12 trict in which such person resides or may be found. 

13 ‘‘(B) Any failure to obey an order issued under sub14 paragraph (A) may be punished by the court as contempt 

15 of court.’’. 

16 SEC. 204. INFORMATION REPORTING. 

17 Subchapter G of chapter VII (21 U.S.C. 379v et seq.) 

18 is amended by adding at the end the following: 

19 ‘‘SEC. 757. INFORMATION REPORTING. 

20 ‘‘(a) NOTIFICATION OF SETTLEMENTS OR JUDG21 MENTS.—If a particular product regulated by the Sec22 retary under this Act or section 351 of the Public Health 

23 Service Act is the subject of at least 3 civil actions that 

24 have been filed in Federal or State court alleging death, 

25 serious injury, or serious illness caused in whole or in part 


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1 by such product which, in any 24-month period, result in 

2 either a final settlement involving the manufacturer or a 

3 court judgment in favor of the plaintiff, the manufacturer 

4 of such product shall, in accordance with subsection (b), 

5 report to the Secretary each such civil action not later 

6 than 30 days after the final settlement or court judgment 

7 in the third of such civil actions, and report to the Sec8 retary any other such action not later than 30 days after 

9 any subsequent such settlement or judgment that— 

10 ‘‘(1) occurs within 24 months of any other 2 

11 such settlements or judgments; and 

12 ‘‘(2) has not been previously reported to the 

13 Secretary under this section. 

14 ‘‘(b) INFORMATION TO BE REPORTED.— 

15 ‘‘(1) REQUIRED INFORMATION.—The informa16 tion required by subsection (a) to be reported to the 

17 Secretary, with respect to each civil action described 

18 in such subsection, shall include and, in addition to 

19 any voluntary information provided under paragraph 

20 (2), shall be limited to the following: 

21 ‘‘(A) The name and address of the manu22 facturer. 

23 ‘‘(B) The name or model of the product 

24 subject to the civil action. 


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1 ‘‘(C) A statement as to whether the civil 

2 action alleged death, injury, or illness and in 

3 the case of an allegation of injury, a statement 

4 of the category of such injury. 

5 ‘‘(D) A statement as to whether the civil 

6 action resulted in a final settlement or a judg7 ment in favor of the plaintiff. 

8 ‘‘(E) In the case of a judgment in favor of 

9 the plaintiff, the name of the civil action, the 

10 number assigned the civil action, and the court 

11 in which the civil action was filed. 

12 ‘‘(2) VOLUNTARY INFORMATION.—A manufac13 turer furnishing the report required by paragraph 

14 (1) may include— 

15 ‘‘(A) a statement as to whether any judg16 ment in favor of the plaintiff is under appeal or 

17 is expected to be appealed; or 

18 ‘‘(B) any other information which the 

19 manufacturer chooses to provide. 

20 ‘‘(c) SAFETY REPORT.—A report of a civil action de21 scribed in subsection (a) shall be considered a safety re22 port under section 756 and may be accompanied by a 

23 statement, which shall be part of any report released for 

24 public disclosure, that denies that the report constitutes 


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1 an admission that the product involved caused or contrib2 uted to a death, serious injury, or serious illness. 

3 ‘‘(d) ADMISSION.—A report of a civil action described 

4 in subsection (a) shall not be considered an admission that 

5 the product involved is adulterated or caused or contrib6 uted to a death, serious injury, or serious illness. 

7 ‘‘(e) DEFINITIONS.—The terms ‘serious illness’ and 

8 ‘serious injury’ mean illness or injury, respectively, that— 

9 ‘‘(1) is life threatening, 

10 ‘‘(2) results in permanent impairment of a body 

11 function or permanent damage to a body structure, 

12 or 

13 ‘‘(3) necessitates medical or surgical interven14 tion to preclude permanent impairment of a body 

15 function or permanent damage to a body struc16 ture.’’. 

Æ 


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