[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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