I 

116TH CONGRESS 

2D SESSION H. R. 5663 

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 

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. 

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 Section 801(a) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 381(a)) is amended— 


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1 (1) in the fourth sentence insert ‘‘or counterfeit 

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

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

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

5 through ‘‘liable for costs pursuant to subsection 

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

7 the Treasury shall cause the destruction of any such 

8 article refused admission unless such article is ex9 ported, under regulations prescribed by the Sec10 retary of the Treasury, within ninety days of the 

11 date of notice of such refusal or within such addi12 tional time as may be permitted pursuant to such 

13 regulations, except that the Secretary of Health and 

14 Human Services may destroy, without the oppor15 tunity for export, any drug or device refused admis16 sion under this section, if such drug or device is val17 ued at an amount that is $2,500 or less (or such 

18 higher amount as the Secretary of the Treasury may 

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

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

21 was not brought into compliance as described under 

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

23 Services shall issue regulations providing for notice 

24 and an opportunity to appear before the Secretary 

25 of Health and Human Services and introduce testiVerDate Sep 11 2014 21:23 Jan 21, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5663.IH H5663

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1 mony, as described in the first sentence of this sub2 section, on destruction of a drug or device under the 

3 seventh sentence of this subsection. The regulations 

4 shall provide that prior to destruction, appropriate 

5 due process is available to the owner or consignee 

6 seeking to challenge the decision to destroy the drug 

7 or device. Where the Secretary of Health and 

8 Human Services provides notice and an opportunity 

9 to appear and introduce testimony on the destruc10 tion of a drug or device, the Secretary of Health and 

11 Human Services shall store and, as applicable, dis12 pose of the drug or device after the issuance of the 

13 notice, except that the owner and consignee shall re14 main liable for costs pursuant to subsection (c).’’. 

Æ 


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