    [United States Statutes at Large, Volume 134, 116th Congress, 2nd Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    Public Law 116-304
    116th Congress

    An Act

    To amend the Federal Food, Drug, and Cosmetic Act to give authority to
    the Secretary of Health and Human Services, acting through the
    Commissioner of Food and Drugs, to destroy counterfeit
    devices. <>

    Be it enacted by the Senate and House of Representatives of the
    United States of America in Congress assembled, <>
    SECTION 1. <>  SHORT TITLE.

    This Act may be cited as the ``Safeguarding Therapeutics Act''.
    SEC. 2. AUTHORITY TO DESTROY COUNTERFEIT DEVICES.

    (a) In General.--Section 801(a) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 381(a)) is amended--
    (1) in the fourth sentence, by inserting ``or counterfeit
    device'' after ``counterfeit drug''; and
    (2) <>  by striking ``The Secretary of the
    Treasury shall cause the destruction of'' and all that follows
    through ``liable for costs pursuant to subsection (c).'' and
    inserting the following:
    ``The <> Secretary of the Treasury
    shall cause the destruction of any such article refused
    admission unless such article is exported, under regulations
    prescribed by the Secretary of the Treasury, within 90 days of
    the date of notice of such refusal or within such additional
    time as may be permitted pursuant to such regulations, except
    that the Secretary of Health and Human Services may destroy,
    without the opportunity for export, any drug or device refused
    admission under this section, if such drug or device is valued
    at an amount that is $2,500 or less (or such higher amount as
    the Secretary of the Treasury may set by regulation pursuant to
    section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C.
    1498(a)(1))) and was not brought into compliance as described
    under subsection (b). <> The Secretary of
    Health and Human Services shall issue regulations providing for
    notice and an opportunity to appear before the Secretary of
    Health and Human Services and introduce testimony, as described
    in the first sentence of this subsection, on destruction of a
    drug or device under the seventh sentence of this subsection.
    The regulations shall provide that prior to destruction,
    appropriate due process is available to the owner or consignee
    seeking to challenge the decision to destroy the drug or device.
    Where the Secretary of Health and Human Services provides notice
    and an opportunity to appear and introduce testimony on the
    destruction of a drug or device, the Secretary of Health and
    Human Services shall store and, as applicable, dispose of the
    drug or device after the issuance

    [[Page 4916]]

    of the notice, except that the owner and consignee shall remain
    liable for costs pursuant to subsection (c).''.

    (b) Definition.--Section 201(h) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 321(h)) is amended--
    (1) by redesignating subparagraphs (1), (2), and (3) as
    clauses (A), (B), and (C), respectively; and
    (2) after making such redesignations--
    (A) by striking ``(h) The term'' and inserting
    ``(h)(1) The term''; and
    (B) by adding at the end the following:

    ``(2) The term `counterfeit device' means a device which, or the
    container, packaging, or labeling of which, without authorization, bears
    a trademark, trade name, or other identifying mark or imprint, or any
    likeness thereof, or is manufactured using a design, of a device
    manufacturer, processor, packer, or distributor other than the person or
    persons who in fact manufactured, processed, packed, or distributed such
    device and which thereby falsely purports or is represented to be the
    product of, or to have been packed or distributed by, such other device
    manufacturer, processor, packer, or distributor.''.

    Approved January 5, 2021.

    LEGISLATIVE HISTORY--H.R. 5663:
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    HOUSE REPORTS: No. 116-512 (Comm. on Energy and Commerce).
    CONGRESSIONAL RECORD, Vol. 166 (2020):
    Sept. 21, considered and passed House.
    Dec. 8, considered and passed Senate, amended.
    Dec. 10, House concurred in Senate amendment.