Safeguarding Therapeutics Act
PL 116-304 (H.R.5663), enacted 01/05/2021

[116th Congress Public Law 304]
[From the U.S. Government Publishing Office]



[[Page 134 STAT. 4915]]

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. <<NOTE: Jan. 5, 2021 -  [H.R. 5663]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Safeguarding 
Therapeutics Act.>> 
SECTION 1. <<NOTE: 21 USC 301 note.>>  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) <<NOTE: Notices.>>  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 <<NOTE: Regulations. Deadline.>> 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). <<NOTE: Regulations.>> 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 134 STAT. 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.

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