In the Senate of the United States, 

December 8, 2020. 

Resolved, That the bill from the House of Representatives (H.R. 5663) entitled ‘‘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.’’, do pass with the following 

AMENDMENT: 

Strike all after the enacting clause and insert the 

following: 

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 Food, 

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

7 (1) in the fourth sentence, by inserting ‘‘or coun8 terfeit device’’ after ‘‘counterfeit drug’’; and 
2 

† HR 5663 EAS 

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

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

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

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

5 Treasury shall cause the destruction of any such arti6 cle refused admission unless such article is exported, 

7 under regulations prescribed by the Secretary of the 

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

9 refusal or within such additional time as may be per10 mitted pursuant to such regulations, except that the 

11 Secretary of Health and Human Services may de12 stroy, without the opportunity for export, any drug or 

13 device refused admission under this section, if such 

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

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

16 Treasury may set by regulation pursuant to section 

17 498(a)(1) of the Tariff Act of 1930 (19 U.S.C. 

18 1498(a)(1))) and was not brought into compliance as 

19 described under subsection (b). The Secretary of 

20 Health and Human Services shall issue regulations 

21 providing for notice and an opportunity to appear 

22 before the Secretary of Health and Human Services 

23 and introduce testimony, as described in the first sen24 tence of this subsection, on destruction of a drug or 

25 device under the seventh sentence of this subsection. 
3 

† HR 5663 EAS 

1 The regulations shall provide that prior to destruc2 tion, appropriate due process is available to the 

3 owner or consignee seeking to challenge the decision to 

4 destroy the drug or device. Where the Secretary of 

5 Health and Human Services provides notice and an 

6 opportunity to appear and introduce testimony on 

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

8 Health and Human Services shall store and, as ap9 plicable, dispose of the drug or device after the 

10 issuance of the notice, except that the owner and con11 signee shall remain liable for costs pursuant to sub12 section (c).’’. 

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

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

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

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

17 (2) after making such redesignations— 

18 (A) by striking ‘‘(h) The term’’ and insert19 ing ‘‘(h)(1) The term’’; and 

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

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

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

23 without authorization, bears a trademark, trade name, or 

24 other identifying mark or imprint, or any likeness thereof, 

25 or is manufactured using a design, of a device manufac-
4 

† HR 5663 EAS 

1 turer, processor, packer, or distributor other than the person 

2 or persons who in fact manufactured, processed, packed, or 

3 distributed such device and which thereby falsely purports 

4 or is represented to be the product of, or to have been packed 

5 or distributed by, such other device manufacturer, processor, 

6 packer, or distributor.’’. 

Attest: 

Secretary. 

116TH CONGRESS 

2D SESSION H.R. 5663 

AMENDMENT