I 
116TH CONGRESS 
2D SESSION 
H. R. 5663 
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 
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. 
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. 
Section 801(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381(a)) is amended— 
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(1) in the fourth sentence insert ‘‘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 ninety days of the 
date of notice of such refusal or within such addi-
tional time as may be permitted pursuant to such 
regulations, 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 
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-
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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).’’. 
Æ 
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