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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Recall Unsafe Drugs 
Act of 2020’’. 
SEC. 2. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED DRUGS. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
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‘‘(fff) The failure to comply with— 
‘‘(1) the notification requirement under section 
569D(a); 
‘‘(2) an order issued under paragraph (1) of 
section 569D(c), following a hearing, if requested, 
under paragraph (2)(C) of such section; 
‘‘(3) an order amended under paragraph (2) or 
paragraph (3) of section 569D(c); or 
‘‘(4) an emergency order issued under section 
569D(d). 
‘‘(ggg) The failure to have in effect a recall plan 
under section 569(g).’’. 
(b) NONDISTRIBUTION AND RECALL OF ADULTER-
ATED OR MISBRANDED DRUGS.—Subchapter E of chapter 
V of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 569E. NOTIFICATION, NONDISTRIBUTION, AND RE-
CALL OF CERTAIN ADULTERATED OR MIS-
BRANDED DRUGS. 
‘‘(a) NOTIFICATION REGARDING CERTAIN ADULTER-
ATED OR MISBRANDED DRUGS.— 
‘‘(1) IN GENERAL.—Any person required to reg-
ister under section 510 shall, as soon as practicable, 
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notify the Secretary of the identity and location of 
a drug, if such person has reason to believe— 
‘‘(A) that such drug, when introduced into 
or while in interstate commerce, or while held 
for sale (regardless of whether the first sale) 
after shipment in interstate commerce, is adul-
terated or misbranded; and 
‘‘(B) there is a reasonable probability that 
the use or consumption of, or exposure to, the 
drug (or an ingredient or component used in 
any such drug) will cause a threat of serious 
adverse health consequences or death to hu-
mans or animals. 
‘‘(2) MANNER OF NOTIFICATION.—Notification 
under paragraph (1) shall be made in such manner 
and by such means as the Secretary may require by 
regulation or guidance. 
‘‘(b) VOLUNTARY RECALL.—The Secretary may re-
quest that any person who distributes a drug that the Sec-
retary has reason to believe is adulterated, misbranded, 
or otherwise in violation of this Act voluntarily— 
‘‘(1) recall such drug; and 
‘‘(2) provide for notice, including to individuals 
as appropriate, to persons who may be affected by 
the recall. 
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‘‘(c) ORDER TO CEASE DISTRIBUTION AND RECALL 
DRUG AND RELATED PROCEDURES.— 
‘‘(1) ISSUANCE OF ORDER.—If the Secretary 
has reason to believe that the use or consumption of, 
or exposure to, a drug (or an ingredient or compo-
nent used in any such drug) may cause serious ad-
verse health consequences or death to humans or 
animals, the Secretary shall have the authority to 
issue an order requiring any person who distributes 
such drug— 
‘‘(A) to immediately cease distribution of 
such drug; and 
‘‘(B) to provide for notice, including to in-
dividuals as appropriate, to persons who may be 
affected by such cessation of distribution. 
‘‘(2) ACTION FOLLOWING ORDER.— 
‘‘(A) CEASE DISTRIBUTION AND NOTIFICA-
TION.—Any person who is subject to an order 
under paragraph (1) shall immediately cease 
distribution of such drug and provide notifica-
tion as required by such order. 
‘‘(B) APPEAL.—Any person who is subject 
to an order under paragraph (1) may appeal 
within 24 hours of issuance such order to the 
Secretary. Such appeal may include a request 
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for an informal hearing and a description of 
any efforts to recall such drug undertaken vol-
untarily by the person, including after a request 
under subsection (b). 
‘‘(C) INFORMAL HEARING.—Except as pro-
vided in subsection (d), if an appeal made 
under subparagraph (B) contains a request for 
an informal hearing, such hearing shall be held 
as soon as practicable, but not later than 5 cal-
endar days, or less as determined by the Sec-
retary, after such an appeal is filed, unless the 
parties jointly agree to an extension. 
‘‘(D) DETERMINATION.—After affording 
an opportunity for an informal hearing, the 
Secretary shall determine— 
‘‘(i) whether— 
‘‘(I) the order under paragraph 
(1) should be amended to require a 
recall of such drug; or 
‘‘(II) inadequate grounds exist to 
support the actions required by the 
order; or 
‘‘(ii) that the order under paragraph 
(1) was appropriate as issued. 
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‘‘(E) 
AMENDMENT
OR
VACATION
OF 
ORDER.— 
‘‘(i) AMENDMENT.—In the case of a 
determination made under subparagraph 
(D)(i)(I), the Secretary shall amend the 
order made under paragraph (1) accord-
ingly. 
‘‘(ii) VACATION.—In the case of a de-
termination made under subparagraph 
(D)(i)(II), the Secretary shall vacate the 
order made under paragraph (1). 
‘‘(3) ORDER TO RECALL.— 
‘‘(A) AMENDMENT.—Except as provided 
under subsection (d), if after providing an op-
portunity for an informal hearing under para-
graph (2)(C), the Secretary determines that the 
order should be amended to include a recall of 
the drug with respect to which the order was 
issued, the Secretary shall amend the order to 
require a recall. 
‘‘(B) 
CONTENTS.—An 
amended 
order 
under subparagraph (A) shall— 
‘‘(i) specify a timetable in which the 
recall will occur; 
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‘‘(ii) require periodic reports to the 
Secretary describing the progress of the re-
call; and 
‘‘(iii) provide for notice, including to 
individuals as appropriate, to persons who 
may be affected by the recall. 
In providing for such notice, the Secretary may 
allow for the assistance of health professionals, 
State or local officials, or other individuals des-
ignated by the Secretary. 
‘‘(C) 
NONDELEGATION.—An 
amended 
order under this paragraph shall be ordered by 
the Secretary or an official designated by the 
Secretary. An official may not be so designated 
unless the official is the director of the district 
under this Act in which the drug involved is lo-
cated, or is an official senior to such director. 
‘‘(d) EMERGENCY RECALL ORDER.— 
‘‘(1) IN GENERAL.—If the Secretary has cred-
ible evidence or information that a drug subject to 
an order under subsection (c)(1) presents an immi-
nent threat of serious adverse health consequences 
or death to humans or animals, the Secretary may 
issue an order requiring any person who distributes 
such drug— 
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‘‘(A) to immediately recall such drug; and 
‘‘(B) to provide for notice, including to in-
dividuals as appropriate, to persons who may be 
affected by the recall. 
‘‘(2) ACTION FOLLOWING ORDER.— 
‘‘(A) RECALL
AND
NOTIFICATION.—Any 
person who is subject to an emergency recall 
order under this subsection shall immediately 
recall such drug and provide notification as re-
quired by such order. 
‘‘(B) APPEAL.— 
‘‘(i) TIMING.—Any person who is sub-
ject to an emergency recall order under 
this subsection may appeal within 24 hours 
after issuance such order to the Secretary. 
‘‘(ii) CONTINUATION
OF
RECALL.— 
The person subject to an emergency recall 
order shall conduct the recall notwith-
standing the pendency of any appeal of 
such order. 
‘‘(C) INFORMAL
HEARING.—An informal 
hearing shall be held as soon as practicable but 
not later than 5 calendar days, or less as deter-
mined by the Secretary, after an appeal under 
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subparagraph (B) is filed, unless the parties 
jointly agree to an extension. 
‘‘(D) DETERMINATION.—After affording 
an opportunity for an informal hearing, the 
Secretary shall determine— 
‘‘(i) whether— 
‘‘(I) the order under paragraph 
(1) should be amended to require a 
recall of such drug; or 
‘‘(II) inadequate grounds exist to 
support the actions required by the 
order; or 
‘‘(ii) that the order under paragraph 
(1) was appropriate as issued. 
‘‘(E) 
AMENDMENT
OR
VACATION
OF 
ORDER.— 
‘‘(i) AMENDMENT.—In the case of a 
determination made under subparagraph 
(D)(i)(I), the Secretary shall amend the 
order made under paragraph (1) accord-
ingly. 
‘‘(ii) VACATION.—In the case of a de-
termination made under subparagraph 
(D)(i)(II), the Secretary shall vacate the 
order made under paragraph (1). 
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‘‘(3) NONDELEGATION.—An order under this 
subsection shall be issued by the Commissioner of 
Food and Drugs, the Principal Deputy Commis-
sioner, or the Associate Commissioner for Regu-
latory Affairs of the Food and Drug Administration. 
‘‘(e) NOTICE TO CONSUMERS AND HEALTH OFFI-
CIALS.—The Secretary shall, as the Secretary determines 
to be necessary, provide notice of a recall order under this 
section to consumers to whom the drug was, or may have 
been, distributed and to appropriate State and local health 
officials. 
‘‘(f) SAVINGS CLAUSE.—Nothing contained in this 
section shall be construed as limiting— 
‘‘(1) the authority of the Secretary to issue an 
order to cease distribution of, or to recall, a drug 
under any other provision of this Act or the Public 
Health Service Act; or 
‘‘(2) the ability of the Secretary to request any 
person to perform a voluntary activity related to any 
drug subject to this Act or the Public Health Service 
Act. 
‘‘(g) RECALL PLAN.—Any person required to register 
under section 510 shall have in effect a recall plan con-
sistent with the requirements of this section.’’. 
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(c) DELAYED
APPLICABILITY.—The amendments 
made by this section apply beginning on the date that is 
one year after the date of the enactment of this Act. 
Æ 
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