I 

116TH CONGRESS 

2D SESSION H. R. 5578 

To provide for the mandatory recall of drugs regulated by the Food and 

Drug Administration. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 10, 2020 

Ms. DELAURO introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To provide for the mandatory recall of drugs regulated by 

the Food and Drug Administration. 

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 ‘‘Recall Unsafe Drugs 

5 Act of 2020’’. 

6 SEC. 2. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

7 OF ADULTERATED OR MISBRANDED DRUGS. 

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

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


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1 ‘‘(fff) The failure to comply with— 

2 ‘‘(1) the notification requirement under section 

3 569D(a); 

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

5 section 569D(c), following a hearing, if requested, 

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

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

8 paragraph (3) of section 569D(c); or 

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

10 569D(d). 

11 ‘‘(ggg) The failure to have in effect a recall plan 

12 under section 569(g).’’. 

13 (b) NONDISTRIBUTION AND RECALL OF ADULTER14 ATED OR MISBRANDED DRUGS.—Subchapter E of chapter 

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

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

17 the following: 

18 ‘‘SEC. 569E. NOTIFICATION, NONDISTRIBUTION, AND RE19 CALL OF CERTAIN ADULTERATED OR MIS20 BRANDED DRUGS. 

21 ‘‘(a) NOTIFICATION REGARDING CERTAIN ADULTER22 ATED OR MISBRANDED DRUGS.— 

23 ‘‘(1) IN GENERAL.—Any person required to reg24 ister under section 510 shall, as soon as practicable, 


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1 notify the Secretary of the identity and location of 

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

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

4 or while in interstate commerce, or while held 

5 for sale (regardless of whether the first sale) 

6 after shipment in interstate commerce, is adul7 terated or misbranded; and 

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

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

10 drug (or an ingredient or component used in 

11 any such drug) will cause a threat of serious 

12 adverse health consequences or death to hu13 mans or animals. 

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

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

16 and by such means as the Secretary may require by 

17 regulation or guidance. 

18 ‘‘(b) VOLUNTARY RECALL.—The Secretary may re19 quest that any person who distributes a drug that the Sec20 retary has reason to believe is adulterated, misbranded, 

21 or otherwise in violation of this Act voluntarily— 

22 ‘‘(1) recall such drug; and 

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

24 as appropriate, to persons who may be affected by 

25 the recall. 


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

2 DRUG AND RELATED PROCEDURES.— 

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

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

5 or exposure to, a drug (or an ingredient or compo6 nent used in any such drug) may cause serious ad7 verse health consequences or death to humans or 

8 animals, the Secretary shall have the authority to 

9 issue an order requiring any person who distributes 

10 such drug— 

11 ‘‘(A) to immediately cease distribution of 

12 such drug; and 

13 ‘‘(B) to provide for notice, including to in14 dividuals as appropriate, to persons who may be 

15 affected by such cessation of distribution. 

16 ‘‘(2) ACTION FOLLOWING ORDER.— 

17 ‘‘(A) CEASE DISTRIBUTION AND NOTIFICA18 TION.—Any person who is subject to an order 

19 under paragraph (1) shall immediately cease 

20 distribution of such drug and provide notifica21 tion as required by such order. 

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

23 to an order under paragraph (1) may appeal 

24 within 24 hours of issuance such order to the 

25 Secretary. Such appeal may include a request 


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1 for an informal hearing and a description of 

2 any efforts to recall such drug undertaken vol3 untarily by the person, including after a request 

4 under subsection (b). 

5 ‘‘(C) INFORMAL HEARING.—Except as pro6 vided in subsection (d), if an appeal made 

7 under subparagraph (B) contains a request for 

8 an informal hearing, such hearing shall be held 

9 as soon as practicable, but not later than 5 cal10 endar days, or less as determined by the Sec11 retary, after such an appeal is filed, unless the 

12 parties jointly agree to an extension. 

13 ‘‘(D) DETERMINATION.—After affording 

14 an opportunity for an informal hearing, the 

15 Secretary shall determine— 

16 ‘‘(i) whether— 

17 ‘‘(I) the order under paragraph 

18 (1) should be amended to require a 

19 recall of such drug; or 

20 ‘‘(II) inadequate grounds exist to 

21 support the actions required by the 

22 order; or 

23 ‘‘(ii) that the order under paragraph 

24 (1) was appropriate as issued. 


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1 ‘‘(E) AMENDMENT OR VACATION OF

2 ORDER.— 

3 ‘‘(i) AMENDMENT.—In the case of a 

4 determination made under subparagraph 

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

6 order made under paragraph (1) accord7 ingly. 

8 ‘‘(ii) VACATION.—In the case of a de9 termination made under subparagraph 

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

11 order made under paragraph (1). 

12 ‘‘(3) ORDER TO RECALL.— 

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

14 under subsection (d), if after providing an op15 portunity for an informal hearing under para16 graph (2)(C), the Secretary determines that the 

17 order should be amended to include a recall of 

18 the drug with respect to which the order was 

19 issued, the Secretary shall amend the order to 

20 require a recall. 

21 ‘‘(B) CONTENTS.—An amended order 

22 under subparagraph (A) shall— 

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

24 recall will occur; 


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1 ‘‘(ii) require periodic reports to the 

2 Secretary describing the progress of the re3 call; and 

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

5 individuals as appropriate, to persons who 

6 may be affected by the recall. 

7 In providing for such notice, the Secretary may 

8 allow for the assistance of health professionals, 

9 State or local officials, or other individuals des10 ignated by the Secretary. 

11 ‘‘(C) NONDELEGATION.—An amended 

12 order under this paragraph shall be ordered by 

13 the Secretary or an official designated by the 

14 Secretary. An official may not be so designated 

15 unless the official is the director of the district 

16 under this Act in which the drug involved is lo17 cated, or is an official senior to such director. 

18 ‘‘(d) EMERGENCY RECALL ORDER.— 

19 ‘‘(1) IN GENERAL.—If the Secretary has cred20 ible evidence or information that a drug subject to 

21 an order under subsection (c)(1) presents an immi22 nent threat of serious adverse health consequences 

23 or death to humans or animals, the Secretary may 

24 issue an order requiring any person who distributes 

25 such drug— 


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

2 ‘‘(B) to provide for notice, including to in3 dividuals as appropriate, to persons who may be 

4 affected by the recall. 

5 ‘‘(2) ACTION FOLLOWING ORDER.— 

6 ‘‘(A) RECALL AND NOTIFICATION.—Any 

7 person who is subject to an emergency recall 

8 order under this subsection shall immediately 

9 recall such drug and provide notification as re10 quired by such order. 

11 ‘‘(B) APPEAL.— 

12 ‘‘(i) TIMING.—Any person who is sub13 ject to an emergency recall order under 

14 this subsection may appeal within 24 hours 

15 after issuance such order to the Secretary. 

16 ‘‘(ii) CONTINUATION OF RECALL.— 

17 The person subject to an emergency recall 

18 order shall conduct the recall notwith19 standing the pendency of any appeal of 

20 such order. 

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

22 hearing shall be held as soon as practicable but 

23 not later than 5 calendar days, or less as deter24 mined by the Secretary, after an appeal under 


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1 subparagraph (B) is filed, unless the parties 

2 jointly agree to an extension. 

3 ‘‘(D) DETERMINATION.—After affording 

4 an opportunity for an informal hearing, the 

5 Secretary shall determine— 

6 ‘‘(i) whether— 

7 ‘‘(I) the order under paragraph 

8 (1) should be amended to require a 

9 recall of such drug; or 

10 ‘‘(II) inadequate grounds exist to 

11 support the actions required by the 

12 order; or 

13 ‘‘(ii) that the order under paragraph 

14 (1) was appropriate as issued. 

15 ‘‘(E) AMENDMENT OR VACATION OF

16 ORDER.— 

17 ‘‘(i) AMENDMENT.—In the case of a 

18 determination made under subparagraph 

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

20 order made under paragraph (1) accord21 ingly. 

22 ‘‘(ii) VACATION.—In the case of a de23 termination made under subparagraph 

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

25 order made under paragraph (1). 


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

2 subsection shall be issued by the Commissioner of 

3 Food and Drugs, the Principal Deputy Commis4 sioner, or the Associate Commissioner for Regu5 latory Affairs of the Food and Drug Administration. 

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

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

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

10 been, distributed and to appropriate State and local health 

11 officials. 

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

13 section shall be construed as limiting— 

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

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

16 under any other provision of this Act or the Public 

17 Health Service Act; or 

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

19 person to perform a voluntary activity related to any 

20 drug subject to this Act or the Public Health Service 

21 Act. 

22 ‘‘(g) RECALL PLAN.—Any person required to register 

23 under section 510 shall have in effect a recall plan con24 sistent with the requirements of this section.’’. 


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1 (c) DELAYED APPLICABILITY.—The amendments 

2 made by this section apply beginning on the date that is 

3 one year after the date of the enactment of this Act. 

Æ 


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