I 

108TH CONGRESS 

1ST SESSION H. R. 3297

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

authority regarding drugs, to increase criminal penalties for the sale 

or trade of prescription drugs knowingly caused to be adulterated or 

misbranded, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 15, 2003

Mr. ISRAEL introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

A BILL

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

establish recall authority regarding drugs, to increase 

criminal penalties for the sale or trade of prescription 

drugs knowingly caused to be adulterated or misbranded, 

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 ‘‘Counterfeit Drug En5 forcement Act’’. 
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1 SEC. 2. RECALL AUTHORITY REGARDING DRUGS. 

2 Subchapter A of chapter V of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend4 ed by inserting after section 506C the following section: 

5 ‘‘SEC. 506D. RECALL AUTHORITY. 

6 ‘‘(a) ORDER TO CEASE DISTRIBUTION OF DRUG; NO7 TIFICATION OF HEALTH PROFESSIONALS.—

8 ‘‘(1) IN GENERAL.—If the Secretary finds that 

9 there is a reasonable probability that a drug in10 tended for human use would cause serious, adverse 

11 health consequences or death, the Secretary shall 

12 issue an order requiring the appropriate person (in13 cluding the manufacturers, importers, distributors, 

14 or retailers of the drug)—

15 ‘‘(A) to immediately cease distribution of 

16 the drug; and 

17 ‘‘(B) to immediately notify health profes18 sionals of the order and to instruct such profes19 sionals to cease administering or prescribing the 

20 drug. 

21 ‘‘(2) INFORMAL HEARING.—An order under 

22 paragraph (1) shall provide the person subject to the 

23 order with an opportunity for an informal hearing, 

24 to be held not later than 10 days after the date of 

25 the issuance of the order, on the actions required by 

26 the order and on whether the order should be 
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1 amended to require a recall of the drug involved. If, 

2 after providing an opportunity for such a hearing, 

3 the Secretary determines that inadequate grounds 

4 exist to support the actions required by the order, 

5 the Secretary shall vacate the order. 

6 ‘‘(b) ORDER TO RECALL DRUG.—

7 ‘‘(1) IN GENERAL.—If, after providing an op8 portunity for an informal hearing under subsection 

9 (a)(2), the Secretary determines that the order 

10 should be amended to include a recall of the drug 

11 with respect to which the order was issued, the Sec12 retary shall, except as provided in paragraphs (2) 

13 and (3), amend the order to require a recall. The 

14 Secretary shall specify a timetable in which the drug 

15 recall will occur and shall require periodic reports to 

16 the Secretary describing the progress of the recall. 

17 ‘‘(2) CERTAIN ACTIONS.—An amended order 

18 under paragraph (1)—

19 ‘‘(A) shall not include recall of a drug from 

20 individuals; and 

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

22 subject to the risks associated with the use of 

23 the drug. 

24 ‘‘(3) ASSISTANCE OF HEALTH PROFES25 SIONALS.—In providing the notice required by para-
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1 graph (2)(B), the Secretary may use the assistance 

2 of health professionals who administered the drug 

3 involved to individuals or prescribed the drug for in4 dividuals. If a significant number of such individuals 

5 cannot be identified, the Secretary shall notify such 

6 individuals pursuant to section 705(b).’’. 

7 SEC. 3. SALE OR TRADE OF PRESCRIPTION DRUGS KNOW8 INGLY CAUSED TO BE ADULTERATED OR MIS9 BRANDED; KNOWING PURCHASE OR TRADE. 

10 (a) CRIMINAL PENALTY.—Section 303(a) of the Fed11 eral Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)) 

12 is amended by adding at the end the following paragraph: 

13 ‘‘(3) Notwithstanding paragraph (1) or (2), in the 

14 case of a person who violates section 301(a), 301(b), or 

15 301(c) with respect to a drug that is subject to section 

16 503(b)(1)(B), if the person knowingly caused the drug to 

17 be adulterated or misbranded and sells or trades the drug, 

18 or the person purchases or trades for the drug knowing 

19 or having reason to know that the drug was knowingly 

20 caused to be adulterated or misbranded, the person shall 

21 be fined in accordance with title 18, United States Code, 

22 or imprisoned for any term of years or for life, or both.’’. 

23 (b) NOTIFICATION OF FOOD AND DRUG ADMINIS24 TRATION BY MANUFACTURERS.—Section 505(k) of the 
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1 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(k)) 

2 is amended by adding at the end the following paragraph: 

3 ‘‘(3) A manufacturer of a drug that receives or other4 wise becomes aware of information that reasonably sug5 gests that a violation described in section 303(a)(3) may 

6 have occurred with respect to the drug shall report such 

7 information to the Secretary not later than 48 hours after 

8 first receiving or otherwise becoming aware of the infor9 mation.’’. 

10 (c) INCREASED FUNDING FOR INSPECTIONS, EXAMI11 NATIONS, AND INVESTIGATIONS.—For the purpose of in12 creasing the capacity of the Food and Drug Administra13 tion to conduct inspections, examinations, and investiga14 tions under the Federal Food, Drug, and Cosmetic Act 

15 with respect to violations described in section 303(a)(3) 

16 of such Act, there is authorized to be appropriated 

17 $60,000,000 for each of the fiscal years 2004 through 

18 2008, in addition to other authorizations of appropriations 

19 that are available for such purpose. 

20 SEC. 4. OTHER CRIMINAL PENALTIES; CLARIFICATION RE21 GARDING FINES. 

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

23 Act (21 U.S.C. 333) is amended—

24 (1) in subsection (a)—
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1 (A) in paragraph (1), by striking ‘‘shall be 

2 imprisoned’’ and all that follows and inserting 

3 the following: ‘‘shall be fined in accordance with 

4 title 18, United States Code, or imprisoned not 

5 more than one year, or both.’’; and 

6 (B) in paragraph (2), by striking ‘‘shall be 

7 imprisoned’’ and all that follows and inserting 

8 the following: ‘‘shall be fined in accordance with 

9 title 18, United States Code, or imprisoned not 

10 more than three years, or both.’’; and 

11 (2) in subsection (b)(1), in the matter after and 

12 below subparagraph (D), by striking ‘‘shall be im13 prisoned’’ and all that follows an inserting the fol14 lowing: ‘‘shall be fined in accordance with title 18, 

15 United States Code, or imprisoned not more than 10 

16 years, or both.’’.

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