IIB 
116TH CONGRESS 
2D SESSION 
H. R. 5663 
IN THE SENATE OF THE UNITED STATES 
SEPTEMBER 22, 2020 
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
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 Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safeguarding Thera-
peutics 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 ex-
ported, under regulations prescribed by the Sec-
retary 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 regula-
tions, except that the Secretary of Health and 
Human Services may destroy, without the oppor-
tunity for export, any drug or device refused admis-
sion under this section, if such drug or device is val-
ued 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 
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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 testi-
mony, as described in the first sentence of this sub-
section, 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 destruc-
tion of a drug or device, the Secretary of Health and 
Human Services shall store and, as applicable, dis-
pose of the drug or device after the issuance of the 
notice, except that the owner and consignee shall re-
main 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— 
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(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 insert-
ing ‘‘(h)(1) The term’’; and 
(B) by adding at the end the following: 
‘‘(2) The term ‘counterfeit device’ means a de-
vice 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 de-
vice and which thereby falsely purports or is rep-
resented to be the product of, or to have been 
packed or distributed by, such other device manufac-
turer, packer, or distributor. 
‘‘(3) For purposes of subparagraph (2)— 
‘‘(A) the term ‘manufactured’ refers to any 
of the following activities: manufacture, prepa-
ration, propagation, compounding, assembly, or 
processing; and 
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‘‘(B) the term ‘manufacturer’ means a per-
son who is engaged in any of the activities list-
ed 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, pro-
vided that such statement has been submitted prior to the 
vote on passage. 
Passed the House of Representatives September 21, 
2020. 
Attest: 
CHERYL L. JOHNSON, 
Clerk. 
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