H. R. 5663 
One Hundred Sixteenth Congress 
of the 
United States of America 
AT THE SECOND SESSION 
Begun and held at the City of Washington on Friday, 
the third day of January, two thousand and twenty 
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 Sec-
retary 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 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
H. R. 5663—2 
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 authoriza-
tion, bears a trademark, trade name, or other identifying mark 
or imprint, or any likeness thereof, or is manufactured using a 
design, of a device manufacturer, processor, packer, or distributor 
other than the person or persons who in fact manufactured, proc-
essed, 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.’’. 
Speaker of the House of Representatives. 
Vice President of the United States and
President of the Senate.