IB 

Union Calendar No. 412 

116TH CONGRESS 

2D SESSION H. R. 5663 

[Report No. 116–512] 

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 

SEPTEMBER 17, 2020 

Additional sponsor: Mr. BALDERSON

SEPTEMBER 17, 2020 

Reported with an amendment; committed to the Committee of the Whole 

House on the State of the Union and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on January 21, 2020] 


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•HR 5663 RH

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. 


kjohnson on DSK79L0C42PROD with BILLS
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•HR 5663 RH

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Safeguarding Thera5 peutics Act’’. 

6 SEC. 2. AUTHORITY TO DESTROY COUNTERFEIT DEVICES. 

7 (a) IN GENERAL.—Section 801(a) of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended— 

9 (1) in the fourth sentence, by inserting ‘‘or coun10 terfeit device’’ after ‘‘counterfeit drug’’; and 

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

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

13 through ‘‘liable for costs pursuant to subsection (c).’’ 

14 and inserting the following: ‘‘The Secretary of the 

15 Treasury shall cause the destruction of any such arti16 cle refused admission unless such article is exported, 

17 under regulations prescribed by the Secretary of the 

18 Treasury, within 90 days of the date of notice of such 

19 refusal or within such additional time as may be per20 mitted pursuant to such regulations, except that the 

21 Secretary of Health and Human Services may de22 stroy, without the opportunity for export, any drug or 

23 device refused admission under this section, if such 

24 drug or device is valued at an amount that is $2,500 

25 or less (or such higher amount as the Secretary of the 


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•HR 5663 RH

1 Treasury may set by regulation pursuant to section 

2 498(a)(1) of the Tariff Act of 1930 (19 U.S.C. 

3 1498(a)(1))) and was not brought into compliance as 

4 described under subsection (b). The Secretary of 

5 Health and Human Services shall issue regulations 

6 providing for notice and an opportunity to appear 

7 before the Secretary of Health and Human Services 

8 and introduce testimony, as described in the first sen9 tence of this subsection, on destruction of a drug or 

10 device under the seventh sentence of this subsection. 

11 The regulations shall provide that prior to destruc12 tion, appropriate due process is available to the 

13 owner or consignee seeking to challenge the decision to 

14 destroy the drug or device. Where the Secretary of 

15 Health and Human Services provides notice and an 

16 opportunity to appear and introduce testimony on 

17 the destruction of a drug or device, the Secretary of 

18 Health and Human Services shall store and, as ap19 plicable, dispose of the drug or device after the 

20 issuance of the notice, except that the owner and con21 signee shall remain liable for costs pursuant to sub22 section (c).’’. 

23 (b) DEFINITION.—Section 201(h) of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 321(h)) is amended— 


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•HR 5663 RH

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

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

3 (2) after making such redesignations— 

4 (A) by striking ‘‘(h) The term’’ and insert5 ing ‘‘(h)(1) The term’’; and 

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

7 ‘‘(2) The term ‘counterfeit device’ means a device 

8 which, or the container, packaging, or labeling of 

9 which, without authorization, bears a trademark, 

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

11 symbol, or any likeness thereof, or is manufactured 

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

13 distributor other than the person or persons who in 

14 fact manufactured, packed, or distributed such device 

15 and which thereby falsely purports or is represented 

16 to be the product of, or to have been packed or distrib17 uted by, such other device manufacturer, packer, or 

18 distributor. 

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

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

21 of the following activities: manufacture, prepara22 tion, propagation, compounding, assembly, or 

23 processing; and 


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•HR 5663 RH

1 ‘‘(B) the term ‘manufacturer’ means a per2 son who is engaged in any of the activities listed 

3 in clause (A).’’. 


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Union Calendar No. 412 

116TH CONGRESS 

2D SESSION H. R. 5663 

[Report No. 116–512] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

feit devices. missioner of Food and Drugs, to destroy counterand Human Services, acting through the ComAct to give authority to the Secretary of Health 

SEPTEMBER 17, 2020 

Reported with an amendment; committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union 


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