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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5663 Engrossed in House (EH)]

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116th CONGRESS
  2d Session
                                H. R. 5663

_______________________________________________________________________

                                 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, imprint, or symbol, or any likeness thereof, 
        or is manufactured using a design, of a device manufacturer, 
        packer, or distributor other than the person or persons who in 
        fact manufactured, 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, packer, or distributor.
            ``(3) For purposes of subparagraph (2)--
                    ``(A) the term `manufactured' refers to any of the 
                following activities: manufacture, preparation, 
                propagation, compounding, assembly, or processing; and
                    ``(B) the term `manufacturer' means a person who is 
                engaged in any of the activities listed in clause 
                (A).''.

SEC. 3. DETERMINATION OF BUDGETARY EFFECTS.

    The budgetary effects of this Act, for the purpose of complying 
with the Statutory Pay-As-You-Go Act of 2010, shall be determined by 
reference to the latest statement titled ``Budgetary Effects of PAYGO 
Legislation'' for this Act, submitted for printing in the Congressional 
Record by the Chairman of the House Budget Committee, provided that 
such statement has been submitted prior to the vote on passage.

            Passed the House of Representatives September 21, 2020.

            Attest:

                                                                 Clerk.
116th CONGRESS

  2d Session

                               H. R. 5663

_______________________________________________________________________

                                 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.
```