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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5663 Enrolled Bill (ENR)]

        H.R.5663

                     One Hundred Sixteenth Congress

                                 of the

                        United States of America

                          AT THE SECOND SESSION

           Begun and held at the City of Washington on Friday,
            the third day of January, two thousand and twenty

                                 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 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.''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
```