IIB 

115TH CONGRESS 

2D SESSION H. R. 5752 

IN THE SENATE OF THE UNITED STATES 

JUNE 14, 2018 

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 with 

respect to the importation of certain drugs, and for other 

purposes. 

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; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Stop Illicit Drug Importation Act of 2018’’. 

4 (b) TABLE OF CONTENTS.—The table of contents of 

5 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Detention, refusal, and destruction of drugs offered for importation. 

Sec. 3. Seizure. 

Sec. 4. Debarring violative individuals or companies. 

6 SEC. 2. DETENTION, REFUSAL, AND DESTRUCTION OF 

7 DRUGS OFFERED FOR IMPORTATION. 

8 (a) ARTICLES TREATED AS DRUGS FOR PURPOSES

9 OF IMPORTATION.—Section 801 of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 381) is amended by 

11 adding at the end the following: 

12 ‘‘(t) ARTICLES TREATED AS DRUGS FOR PURPOSES

13 OF THIS SECTION.— 

14 ‘‘(1) LABELED ARTICLES.—An article shall not 

15 be treated as a drug pursuant to this subsection if— 

16 ‘‘(A) an electronic import entry for such 

17 article is submitted using an authorized elec18 tronic data interchange system; and 

19 ‘‘(B) such article is designated in such sys20 tem as a drug, device, dietary supplement, or 

21 other product that is regulated under this Act. 

22 ‘‘(2) ARTICLES COVERED.—Subject to para23 graph (1), for purposes of this section, an article deVerDate Sep 11 2014 00:28 Jun 15, 2018 Jkt 079200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5752.RFS H5752

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1 scribed in this paragraph may be treated by the Sec2 retary as a drug if it— 

3 ‘‘(A) is or contains an ingredient that is an 

4 active ingredient that is contained within— 

5 ‘‘(i) a drug that has been approved 

6 under section 505 of this Act; or 

7 ‘‘(ii) a biological product that has 

8 been approved under section 351 of the 

9 Public Health Service Act; 

10 ‘‘(B) is or contains an ingredient that is an 

11 active ingredient in a drug or biological product 

12 if— 

13 ‘‘(i) an investigational use exemption 

14 has been authorized for such drug or bio15 logical product under section 505(i) of this 

16 Act or section 351(a) of the Public Health 

17 Service Act; 

18 ‘‘(ii) substantial clinical investigation 

19 has been instituted for such drug or bio20 logical product; and 

21 ‘‘(iii) the existence of such clinical in22 vestigation has been made public; or 

23 ‘‘(C) is or contains a substance that has a 

24 chemical structure that is substantially similar 

25 to the chemical structure of an active ingredient 


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1 in a drug or biological product described in sub2 paragraph (A) or (B). 

3 ‘‘(3) EFFECT.—Except to the extent that an ar4 ticle may be treated as a drug pursuant to para5 graph (2), this subsection shall not be construed as 

6 bearing on or being relevant to the question of 

7 whether any article is a drug as defined in section 

8 201(g).’’. 

9 (b) ARTICLES OF CONCERN.— 

10 (1) DELIVERY BY TREASURY TO HHS.—The 

11 first sentence of section 801(a) of the Federal Food, 

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

13 amended by striking ‘‘and cosmetics’’ and inserting 

14 ‘‘cosmetics, and potential articles of concern (as de15 fined in subsection (u))’’. 

16 (2) REFUSED ADMISSION.—The third sentence 

17 of section 801(a) of the Federal Food, Drug, and 

18 Cosmetic Act (21 U.S.C. 381(a)) is amended by 

19 striking ‘‘then such article shall be refused admis20 sion’’ and inserting ‘‘or (5) such article is an article 

21 of concern (as defined in subsection (u)), or (6) such 

22 article is a drug that is being imported or offered for 

23 import in violation of section 301(cc), then such ar24 ticle shall be refused admission’’. 


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1 (3) DEFINITION OF ARTICLE OF CONCERN.— 

2 Section 801 of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 381), as amended, is further 

4 amended by adding at the end the following: 

5 ‘‘(u) ARTICLE OF CONCERN DEFINED.—For pur6 poses of subsection (a), the term ‘article of concern’ means 

7 an article that is or contains a drug or other substance— 

8 ‘‘(1) for which, during the 24-month period 

9 prior to the article being imported or offered for im10 port, the Secretary of Health and Human Services— 

11 ‘‘(A) has requested that, based on a deter12 mination that the drug or other substance ap13 pears to meet the requirements for temporary 

14 or permanent scheduling pursuant to section 

15 201 of the Controlled Substances Act, the At16 torney General initiate the process to control 

17 the drug or other substance in accordance with 

18 such Act; or 

19 ‘‘(B) has, following the publication by the 

20 Attorney General of a notice in the Federal 

21 Register of the intention to issue an order tem22 porarily scheduling such drug or substance in 

23 schedule I of section 202 of the Controlled Sub24 stances Act pursuant to section 201(h) of such 

25 Act, made a determination that such article 


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1 presents an imminent hazard to public safety; 

2 and 

3 ‘‘(2) with respect to which the Attorney General 

4 has not— 

5 ‘‘(A) scheduled the drug or other substance 

6 under such Act; or 

7 ‘‘(B) notified the Secretary of Health and 

8 Human Services that the Attorney General has 

9 made a determination not to schedule the drug 

10 or other substance under such Act.’’. 

11 SEC. 3. SEIZURE. 

12 Section 304(b) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 334(b)) is amended by striking the 

14 first sentence and inserting the following: ‘‘The article, 

15 equipment, or other thing proceeded against shall be liable 

16 to seizure by process pursuant to the libel, and the proce17 dure in cases under this section shall conform, as nearly 

18 as may be, to the procedure in admiralty rather than the 

19 procedure used for civil asset forfeiture proceedings set 

20 forth in section 983 of title 18, United States Code. On 

21 demand of either party any issue of fact joined in any such 

22 a case brought under this section shall be tried by jury. 

23 A seizure brought under this section is not governed by 

24 Rule G of the Supplemental Rules of Admiralty or Mari25 time Claims and Asset Forfeiture Actions. Exigent cirVerDate Sep 11 2014 00:28 Jun 15, 2018 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5752.RFS H5752

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1 cumstances shall be deemed to exist for all seizures 

2 brought under this section, and in such cases, the sum3 mons and arrest warrant shall be issued by the clerk of 

4 the court without court review.’’. 

5 SEC. 4. DEBARRING VIOLATIVE INDIVIDUALS OR COMPA6 NIES. 

7 (a) PROHIBITED ACT.—Section 301(cc) of the Fed8 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) 

9 is amended— 

10 (1) by inserting after ‘‘an article of food’’ the 

11 following: ‘‘or a drug’’; and 

12 (2) by inserting after ‘‘a person debarred’’ the 

13 following: ‘‘from such activity’’. 

14 (b) DEBARMENT.—Section 306(b) of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is 

16 amended— 

17 (1) in paragraph (1)— 

18 (A) in the matter preceding subparagraph 

19 (A), by striking ‘‘paragraph (2)’’ and inserting 

20 ‘‘paragraph (2) or (3)’’; 

21 (B) in subparagraph (B), by striking ‘‘or’’ 

22 at the end; 

23 (C) in subparagraph (C), by striking the 

24 period at the end and inserting ‘‘, or’’; and 

25 (D) by adding at the end the following: 


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1 ‘‘(D) a person from importing or offering 

2 to import into the United States— 

3 ‘‘(i) a controlled substance as defined 

4 in section 102(6) of the Controlled Sub5 stances Act; or 

6 ‘‘(ii) any drug, if such drug is de7 clared to be valued at an amount that is 

8 $2,500 or less (or such higher amount as 

9 the Secretary of the Treasury may set by 

10 regulation pursuant to section 498(a)(1) of 

11 the Tariff Act of 1930), or if such drug is 

12 entering the United States by mail.’’; and 

13 (2) in paragraph (3)— 

14 (A) in the paragraph heading after 

15 ‘‘FOOD’’ by inserting ‘‘OR DRUG’’; 

16 (B) by redesignating subparagraphs (A) 

17 and (B) as clauses (i) and (ii), respectively, and 

18 moving the indentation of each such clause two 

19 ems to the right; 

20 (C) after making the amendments required 

21 by subparagraph (B), by striking ‘‘A person is 

22 subject’’ and inserting the following: 

23 ‘‘(A) FOOD.—A person is subject’’; and 

24 (D) by adding at the end the following: 


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1 ‘‘(B) IMPORTATION OF DRUGS.—A person 

2 is subject to debarment under paragraph (1)(D) 

3 if— 

4 ‘‘(i) the person has been convicted of 

5 a felony for conduct relating to the impor6 tation into the United States of any drug 

7 or controlled substance (as defined in sec8 tion 102 of the Controlled Substances 

9 Act); or 

10 ‘‘(ii) the person has engaged in a pat11 tern of importing or offering for import ar12 ticles of drug that are— 

13 ‘‘(I)(aa) adulterated, misbranded, 

14 or in violation of section 505; and 

15 ‘‘(bb) present a threat of serious 

16 adverse health consequences or death 

17 to humans or animals; or 

18 ‘‘(II) controlled substances whose 

19 importation is prohibited pursuant to 

20 section 401(m) of the Tariff Act of 

21 1930. 

22 ‘‘(C) DEFINITION.—For purposes of sub23 paragraph (B), the term ‘pattern of importing 

24 or offering for import articles of drug’ means 

25 importing or offering for import articles of drug 


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1 described in subclause (I) or (II) of subpara2 graph (B)(ii) in an amount, frequency, or dos3 age that is inconsistent with personal or house4 hold use by the importer.’’. 

Passed the House of Representatives June 13, 2018. 

Attest: KAREN L. HAAS, 

Clerk. 


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