IB 
Union Calendar No. 412 
116TH CONGRESS 
2D SESSION 
H. R. 5663 
[Report No. 116–512] 
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. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 21, 2020 
Mr. GUTHRIE (for himself and Mr. ENGEL) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
SEPTEMBER 17, 2020 
Additional sponsor: Mr. BALDERSON 
SEPTEMBER 17, 2020 
Reported with an amendment; committed to the Committee of the Whole 
House on the State of the Union and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on January 21, 2020] 
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A BILL 
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. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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 coun-
terfeit 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 arti-
cle 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 per-
mitted pursuant to such regulations, except that the 
Secretary of Health and Human Services may de-
stroy, 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 
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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 sen-
tence of this subsection, on destruction of a drug or 
device under the seventh sentence of this subsection. 
The regulations shall provide that prior to destruc-
tion, 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 ap-
plicable, dispose of the drug or device after the 
issuance of the notice, except that the owner and con-
signee shall remain liable for costs pursuant to sub-
section (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 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 distrib-
uted 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, prepara-
tion, propagation, compounding, assembly, or 
processing; and 
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Union Calendar No. 412 
116TH CONGRESS 
2D SESSION 
H. R. 5663 
[Report No. 116–512] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic 
Act to give authority to the Secretary of Health 
and Human Services, acting through the Com-
missioner of Food and Drugs, to destroy counter-
feit devices. 
SEPTEMBER 17, 2020 
Reported with an amendment; committed to the Com-
mittee of the Whole House on the State of the Union 
and ordered to be printed 
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