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 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 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 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 manufacturer, 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.’’. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.