[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3688 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 3688
To provide for the mandatory recall of drugs regulated by the Food and
Drug Administration.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 25, 2023
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 Representatives of the
United States of America in Congress assembled,
SEC. 1. SHORT TITLE.
This Act may be cited as the ``Recall Unsafe Drugs Act of 2023''.
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 amended by adding at the end the
following:
``(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 Adulterated 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 RECALL OF CERTAIN
ADULTERATED OR MISBRANDED DRUGS.
``(a) Notification Regarding Certain Adulterated or Misbranded
Drugs.--
``(1) In general.--Any person required to register under
section 510 shall, as soon as practicable, 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 adulterated 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 humans 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 request that any person
who distributes a drug that the Secretary 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.
``(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 component used in any such drug) may cause
serious adverse 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
individuals as appropriate, to persons who may be
affected by such cessation of distribution.
``(2) Action following order.--
``(A) Cease distribution and notification.--Any
person who is subject to an order under paragraph (1)
shall immediately cease distribution of such drug and
provide notification 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 for an informal hearing and a
description of any efforts to recall such drug
undertaken voluntarily by the person, including after a
request under subsection (b).
``(C) Informal hearing.--Except as provided 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 calendar days, or less as determined by
the Secretary, 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.
``(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) accordingly.
``(ii) Vacation.--In the case of a
determination 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 opportunity for
an informal hearing under paragraph (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;
``(ii) require periodic reports to the
Secretary describing the progress of the
recall; 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 designated 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 located, or is an official senior to
such director.
``(d) Emergency Recall Order.--
``(1) In general.--If the Secretary has credible evidence
or information that a drug subject to an order under subsection
(c)(1) presents an imminent 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--
``(A) to immediately recall such drug; and
``(B) to provide for notice, including to
individuals 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 required by such order.
``(B) Appeal.--
``(i) Timing.--Any person who is subject 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 notwithstanding 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 determined by the Secretary,
after an appeal under 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) accordingly.
``(ii) Vacation.--In the case of a
determination made under subparagraph
(D)(i)(II), the Secretary shall vacate the
order made under paragraph (1).
``(3) Nondelegation.--An order under this subsection shall
be issued by the Commissioner of Food and Drugs, the Principal
Deputy Commissioner, or the Associate Commissioner for
Regulatory Affairs of the Food and Drug Administration.
``(e) Notice to Consumers and Health Officials.--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 consistent with the requirements
of this section.''.
(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.
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