IIB 

116TH CONGRESS 

2D SESSION H. R. 5663 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 22, 2020 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Safeguarding Thera3 peutics Act’’. 

4 SEC. 2. AUTHORITY TO DESTROY COUNTERFEIT DEVICES. 

5 (a) IN GENERAL.—Section 801(a) of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is 

7 amended— 

8 (1) in the fourth sentence, by inserting ‘‘or 

9 counterfeit device’’ after ‘‘counterfeit drug’’; and 

10 (2) by striking ‘‘The Secretary of the Treasury 

11 shall cause the destruction of’’ and all that follows 

12 through ‘‘liable for costs pursuant to subsection 

13 (c).’’ and inserting the following: ‘‘The Secretary of 

14 the Treasury shall cause the destruction of any such 

15 article refused admission unless such article is ex16 ported, under regulations prescribed by the Sec17 retary of the Treasury, within 90 days of the date 

18 of notice of such refusal or within such additional 

19 time as may be permitted pursuant to such regula20 tions, except that the Secretary of Health and 

21 Human Services may destroy, without the oppor22 tunity for export, any drug or device refused admis23 sion under this section, if such drug or device is val24 ued at an amount that is $2,500 or less (or such 

25 higher amount as the Secretary of the Treasury may 

26 set by regulation pursuant to section 498(a)(1) of 


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1 the Tariff Act of 1930 (19 U.S.C. 1498(a)(1))) and 

2 was not brought into compliance as described under 

3 subsection (b). The Secretary of Health and Human 

4 Services shall issue regulations providing for notice 

5 and an opportunity to appear before the Secretary 

6 of Health and Human Services and introduce testi7 mony, as described in the first sentence of this sub8 section, on destruction of a drug or device under the 

9 seventh sentence of this subsection. The regulations 

10 shall provide that prior to destruction, appropriate 

11 due process is available to the owner or consignee 

12 seeking to challenge the decision to destroy the drug 

13 or device. Where the Secretary of Health and 

14 Human Services provides notice and an opportunity 

15 to appear and introduce testimony on the destruc16 tion of a drug or device, the Secretary of Health and 

17 Human Services shall store and, as applicable, dis18 pose of the drug or device after the issuance of the 

19 notice, except that the owner and consignee shall re20 main liable for costs pursuant to subsection (c).’’. 

21 (b) DEFINITION.—Section 201(h) of the Federal 

22 Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) is 

23 amended— 


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1 (1) by redesignating subparagraphs (1), (2), 

2 and (3) as clauses (A), (B), and (C), respectively; 

3 and 

4 (2) after making such redesignations— 

5 (A) by striking ‘‘(h) The term’’ and insert6 ing ‘‘(h)(1) The term’’; and 

7 (B) by adding at the end the following: 

8 ‘‘(2) The term ‘counterfeit device’ means a de9 vice which, or the container, packaging, or labeling 

10 of which, without authorization, bears a trademark, 

11 trade name, or other identifying mark, imprint, or 

12 symbol, or any likeness thereof, or is manufactured 

13 using a design, of a device manufacturer, packer, or 

14 distributor other than the person or persons who in 

15 fact manufactured, packed, or distributed such de16 vice and which thereby falsely purports or is rep17 resented to be the product of, or to have been 

18 packed or distributed by, such other device manufac19 turer, packer, or distributor. 

20 ‘‘(3) For purposes of subparagraph (2)— 

21 ‘‘(A) the term ‘manufactured’ refers to any 

22 of the following activities: manufacture, prepa23 ration, propagation, compounding, assembly, or 

24 processing; and 


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1 ‘‘(B) the term ‘manufacturer’ means a per2 son who is engaged in any of the activities list3 ed in clause (A).’’. 

4 SEC. 3. DETERMINATION OF BUDGETARY EFFECTS. 

5 The budgetary effects of this Act, for the purpose of 

6 complying with the Statutory Pay-As-You-Go Act of 2010, 

7 shall be determined by reference to the latest statement 

8 titled ‘‘Budgetary Effects of PAYGO Legislation’’ for this 

9 Act, submitted for printing in the Congressional Record 

10 by the Chairman of the House Budget Committee, pro11 vided that such statement has been submitted prior to the 

12 vote on passage. 

Passed the House of Representatives September 21, 

2020. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


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