I 

111TH CONGRESS 

2D SESSION H. R. 5740 

To provide for the mandatory recall of adulterated or misbranded drugs. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 14, 2010 

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

on Energy and Commerce 

A BILL 

To provide for the mandatory recall of adulterated or 

misbranded drugs. 

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

3 SECTION 1. NOTIFICATION, NONDISTRIBUTION, AND RE4 CALL OF ADULTERATED OR MISBRANDED 

5 DRUGS. 

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

7 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend8 ed by adding at the end the following: 

9 ‘‘(uu) The failure to comply with— 

10 ‘‘(1) the notification requirement under section 

11 568(a); 


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1 ‘‘(2) an order issued under paragraph (1) of 

2 section 568(c), following a hearing, if requested, 

3 under paragraph (2)(C) of such section; 

4 ‘‘(3) an order amended under paragraph (2) or 

5 paragraph (3) of section 568(c); or 

6 ‘‘(4) an emergency order issued under section 

7 568(d).’’. 

8 (b) NONDISTRIBUTION AND RECALL OF ADULTER9 ATED OR MISBRANDED DRUGS.—Subchapter E of chapter 

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

11 U.S.C. 360bbb et seq.) is amended by adding at the end 

12 the following: 

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

14 OF CERTAIN ADULTERATED OR MISBRANDED 

15 DRUGS. 

16 ‘‘(a) NOTIFICATION REGARDING CERTAIN ADULTER17 ATED OR MISBRANDED DRUGS.— 

18 ‘‘(1) IN GENERAL.—Any person required to reg19 ister under section 510 shall, as soon as practicable, 

20 notify the Secretary of the identity and location of 

21 a drug, if such person has reason to believe— 

22 ‘‘(A) that such drug, when introduced into 

23 or while in interstate commerce, or while held 

24 for sale (regardless of whether the first sale) 


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1 after shipment in interstate commerce, is adul2 terated or misbranded; and 

3 ‘‘(B) there is a reasonable probability that 

4 the use or consumption of, or exposure to, the 

5 drug (or an ingredient or component used in 

6 any such drug) will cause a threat of serious 

7 adverse health consequences or death to hu8 mans or animals. 

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

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

11 and by such means as the Secretary may require by 

12 regulation or guidance. 

13 ‘‘(b) VOLUNTARY RECALL.—The Secretary may re14 quest that any person who distributes a drug that the Sec15 retary has reason to believe is adulterated, misbranded, 

16 or otherwise in violation of this Act voluntarily— 

17 ‘‘(1) recall such drug; and 

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

19 as appropriate, to persons who may be affected by 

20 the recall. 

21 ‘‘(c) ORDER TO CEASE DISTRIBUTION AND RECALL

22 DRUG AND RELATED PROCEDURES.— 

23 ‘‘(1) ISSUANCE OF ORDER.—If the Secretary 

24 has reason to believe that the use or consumption of, 

25 or exposure to, a drug (or an ingredient or compoVerDate Mar 15 2010 03:29 Jul 15, 2010 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5740.IH H5740

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1 nent used in any such drug) may cause serious ad2 verse health consequences or death to humans or 

3 animals, the Secretary shall have the authority to 

4 issue an order requiring any person who distributes 

5 such drug— 

6 ‘‘(A) to immediately cease distribution of 

7 such drug; and 

8 ‘‘(B) to provide for notice, including to in9 dividuals as appropriate, to persons who may be 

10 affected by such cessation of distribution. 

11 ‘‘(2) ACTION FOLLOWING ORDER.— 

12 ‘‘(A) CEASE DISTRIBUTION AND NOTIFICA13 TION.—Any person who is subject to an order 

14 under paragraph (1) shall immediately cease 

15 distribution of such drug and provide notifica16 tion as required by such order. 

17 ‘‘(B) APPEAL.—Any person who is subject 

18 to an order under paragraph (1) may appeal 

19 within 24 hours of issuance such order to the 

20 Secretary. Such appeal may include a request 

21 for an informal hearing and a description of 

22 any efforts to recall such drug undertaken vol23 untarily by the person, including after a request 

24 under subsection (b). 


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1 ‘‘(C) INFORMAL HEARING.—Except as pro2 vided in subsection (d), if an appeal made 

3 under subparagraph (B) contains a request for 

4 an informal hearing, such hearing shall be held 

5 as soon as practicable, but not later than 5 cal6 endar days, or less as determined by the Sec7 retary, after such an appeal is filed, unless the 

8 parties jointly agree to an extension. 

9 ‘‘(D) DETERMINATION.—After affording 

10 an opportunity for an informal hearing, the 

11 Secretary shall determine— 

12 ‘‘(i) whether— 

13 ‘‘(I) the order under paragraph 

14 (1) should be amended to require a 

15 recall of such drug; or 

16 ‘‘(II) inadequate grounds exist to 

17 support the actions required by the 

18 order; or 

19 ‘‘(ii) that the order under paragraph 

20 (1) was appropriate as issued. 

21 ‘‘(E) AMENDMENT OR VACATION OF

22 ORDER.— 

23 ‘‘(i) AMENDMENT.—In the case of a 

24 determination made under subparagraph 

25 (D)(i)(I), the Secretary shall amend the 


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1 order made under paragraph (1) accord2 ingly. 

3 ‘‘(ii) VACATION.—In the case of a de4 termination made under subparagraph 

5 (D)(i)(II), the Secretary shall vacate the 

6 order made under paragraph (1). 

7 ‘‘(3) ORDER TO RECALL.— 

8 ‘‘(A) AMENDMENT.—Except as provided 

9 under subsection (d), if after providing an op10 portunity for an informal hearing under para11 graph (2)(C), the Secretary determines that the 

12 order should be amended to include a recall of 

13 the drug with respect to which the order was 

14 issued, the Secretary shall amend the order to 

15 require a recall. 

16 ‘‘(B) CONTENTS.—An amended order 

17 under subparagraph (A) shall— 

18 ‘‘(i) specify a timetable in which the 

19 recall will occur; 

20 ‘‘(ii) require periodic reports to the 

21 Secretary describing the progress of the re22 call; and 

23 ‘‘(iii) provide for notice, including to 

24 individuals as appropriate, to persons who 

25 may be affected by the recall. 


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1 In providing for such notice, the Secretary may 

2 allow for the assistance of health professionals, 

3 State or local officials, or other individuals des4 ignated by the Secretary. 

5 ‘‘(C) NONDELEGATION.—An amended 

6 order under this paragraph shall be ordered by 

7 the Secretary or an official designated by the 

8 Secretary. An official may not be so designated 

9 unless the official is the director of the district 

10 under this Act in which the drug involved is lo11 cated, or is an official senior to such director. 

12 ‘‘(d) EMERGENCY RECALL ORDER.— 

13 ‘‘(1) IN GENERAL.—If the Secretary has cred14 ible evidence or information that a drug subject to 

15 an order under subsection (c)(1) presents an immi16 nent threat of serious adverse health consequences 

17 or death to humans or animals, the Secretary may 

18 issue an order requiring any person who distributes 

19 such drug— 

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

21 ‘‘(B) to provide for notice, including to in22 dividuals as appropriate, to persons who may be 

23 affected by the recall. 

24 ‘‘(2) ACTION FOLLOWING ORDER.— 


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1 ‘‘(A) RECALL AND NOTIFICATION.—Any 

2 person who is subject to an emergency recall 

3 order under this subsection shall immediately 

4 recall such drug and provide notification as re5 quired by such order. 

6 ‘‘(B) APPEAL.— 

7 ‘‘(i) TIMING.—Any person who is sub8 ject to an emergency recall order under 

9 this subsection may appeal within 24 hours 

10 after issuance such order to the Secretary. 

11 ‘‘(ii) CONTINUATION OF RECALL.— 

12 The person subject to an emergency recall 

13 order shall conduct the recall notwith14 standing the pendency of any appeal of 

15 such order. 

16 ‘‘(C) INFORMAL HEARING.—An informal 

17 hearing shall be held as soon as practicable but 

18 not later than 5 calendar days, or less as deter19 mined by the Secretary, after an appeal under 

20 subparagraph (B) is filed, unless the parties 

21 jointly agree to an extension. 

22 ‘‘(D) DETERMINATION.—After affording 

23 an opportunity for an informal hearing, the 

24 Secretary shall determine— 

25 ‘‘(i) whether— 


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1 ‘‘(I) the order under paragraph 

2 (1) should be amended to require a 

3 recall of such drug; or 

4 ‘‘(II) inadequate grounds exist to 

5 support the actions required by the 

6 order; or 

7 ‘‘(ii) that the order under paragraph 

8 (1) was appropriate as issued. 

9 ‘‘(E) AMENDMENT OR VACATION OF

10 ORDER.— 

11 ‘‘(i) AMENDMENT.—In the case of a 

12 determination made under subparagraph 

13 (D)(i)(I), the Secretary shall amend the 

14 order made under paragraph (1) accord15 ingly. 

16 ‘‘(ii) VACATION.—In the case of a de17 termination made under subparagraph 

18 (D)(i)(II), the Secretary shall vacate the 

19 order made under paragraph (1). 

20 ‘‘(3) NONDELEGATION.—An order under this 

21 subsection shall be issued by the Commissioner of 

22 Food and Drugs, the Principal Deputy Commis23 sioner, or the Associate Commissioner for Regu24 latory Affairs of the Food and Drug Administration. 


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1 ‘‘(e) NOTICE TO CONSUMERS AND HEALTH OFFI2 CIALS.—The Secretary shall, as the Secretary determines 

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

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

5 been, distributed and to appropriate State and local health 

6 officials. 

7 ‘‘(f) SAVINGS CLAUSE.—Nothing contained in this 

8 section shall be construed as limiting— 

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

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

11 under any other provision of this Act or the Public 

12 Health Service Act; or 

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

14 person to perform a voluntary activity related to any 

15 drug subject to this Act or the Public Health Service 

16 Act.’’. 

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

18 this section shall take effect one year period after the date 

19 of the enactment of this Act. 

Æ 


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