In the Senate of the United States, 
December 8, 2020. 
Resolved, That the bill from the House of Representa-
tives (H.R. 5663) entitled ‘‘An Act to amend the Federal 
Food, Drug, and Cosmetic Act to give authority to the Sec-
retary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, to destroy counterfeit de-
vices.’’, do pass with the following 
AMENDMENT: 
Strike all after the enacting clause and insert the 
following: 
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
† HR 5663 EAS 
(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 
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.
† HR 5663 EAS 
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— 
(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 or imprint, or any likeness thereof, 
or is manufactured using a design, of a device manufac-
† HR 5663 EAS 
turer, 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.’’. 
Attest: 
Secretary.