I 

115TH CONGRESS 

2D SESSION H. R. 5752 

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

importation of certain drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 10, 2018 

Mrs. BLACKBURN 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 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, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

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

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

7 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. 


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

2 DRUGS OFFERED FOR IMPORTATION. 

3 (a) ARTICLES TREATED AS DRUGS FOR PURPOSES

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

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

6 adding at the end the following: 

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

8 OF THIS SECTION.— 

9 ‘‘(1) IN GENERAL.—For purposes of this sec10 tion, an article described in paragraph (2) may be 

11 treated by the Secretary as a drug. 

12 ‘‘(2) ARTICLES COVERED.—An article is de13 scribed in this section if it— 

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

15 active ingredient that is contained within— 

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

17 under section 505 of this Act; or 

18 ‘‘(ii) a biological product that has 

19 been approved under section 351 of the 

20 Public Health Service Act; 

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

22 active ingredient in a drug or biological product 

23 if— 

24 ‘‘(i) an investigational use exemption 

25 is in effect for such drug or biological 

26 product under section 505(i) of this Act or 


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1 section 351(a) of the Public Health Service 

2 Act; 

3 ‘‘(ii) substantial clinical investigation 

4 has been instituted for such drug or bio5 logical product; and 

6 ‘‘(iii) the existence of such clinical in7 vestigation has been made public; or 

8 ‘‘(C) is or contains a chemical analog of an 

9 active ingredient in a drug or biological product 

10 described in paragraph (A) or (B). 

11 ‘‘(3) EFFECT.—Except to the extent that an ar12 ticle may be treated as a drug pursuant to para13 graph (1), this subsection shall not be construed as 

14 bearing on or being relevant to the question of 

15 whether any article is a drug as defined in section 

16 201(g).’’. 

17 (b) ARTICLES OF CONCERN.— 

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

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

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

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

22 ‘‘cosmetics, and potential articles of concern (as de23 fined in subsection (u))’’. 

24 (2) REFUSED ADMISSION.—The third sentence 

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


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

2 striking ‘‘then such article shall be refused admis3 sion’’ and inserting ‘‘or (5) such article is an article 

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

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

6 import in violation of section 301(cc), then such ar7 ticle may (in the case of drugs) and shall (in the 

8 case of other products) be refused admission’’. 

9 (3) DEFINITION OF ARTICLE OF CONCERN.— 

10 Section 801 of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 381), as amended, is further 

12 amended by adding at the end the following: 

13 ‘‘(u) ARTICLE OF CONCERN DEFINED.—For pur14 poses of subsection (a), the term ‘article of concern’ means 

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

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

17 prior to the article being imported or offered for im18 port, the Secretary of Health and Human Services— 

19 ‘‘(A) has requested that, based on a deter20 mination that the drug or other substance ap21 pears to meet the requirements for temporary 

22 or permanent scheduling pursuant to section 

23 201 of the Controlled Substances Act, the At24 torney General initiate the process to control 


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1 the drug or other substance in accordance with 

2 such Act; or 

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

4 Attorney General of a notice in the Federal 

5 Register of the intention to issue an order tem6 porarily scheduling such drug or substance in 

7 schedule I of section 202 of the Controlled Sub8 stances Act pursuant to section 201(h) of such 

9 Act, made a determination that such article 

10 presents an imminent hazard to public safety; 

11 and 

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

13 has not— 

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

15 under such Act; or 

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

17 Human Services that the Attorney General has 

18 made a determination not to schedule the drug 

19 or other substance under such Act.’’. 

20 SEC. 3. SEIZURE. 

21 Section 304(b) of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 334(b)) is amended by striking the 

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

24 equipment, or other thing proceeded against shall be liable 

25 to seizure by process pursuant to the libel, and the proceVerDate Sep 11 2014 00:30 May 16, 2018 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5752.IH H5752

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1 dure in cases under this section shall conform, as nearly 

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

3 procedure used for civil asset forfeiture proceedings set 

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

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

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

7 A seizure brought under this section is not governed by 

8 Rule G of the Supplemental Rules of Admiralty or Mari9 time Claims and Asset Forfeiture Actions. Exigent cir10 cumstances shall be deemed to exist for all seizures 

11 brought under this section, and in such cases, the sum12 mons and arrest warrant shall be issued by the clerk of 

13 the court without court review.’’. 

14 SEC. 4. DEBARRING VIOLATIVE INDIVIDUALS OR COMPA15 NIES. 

16 (a) PROHIBITED ACT.—Section 301(cc) of the Fed17 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) 

18 is amended— 

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

20 following: ‘‘or a drug’’; and 

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

22 following: ‘‘from such activity’’. 

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

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

25 amended— 


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1 (1) in paragraph (1)— 

2 (A) in the matter preceding subparagraph 

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

4 ‘‘paragraph (2) or (3)’’; 

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

6 at the end; 

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

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

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

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

11 to import into the United States— 

12 ‘‘(i) a controlled substance as defined 

13 in section 102(6) of the Controlled Sub14 stances Act; or 

15 ‘‘(ii) any drug, if such drug is de16 clared to be valued at an amount that is 

17 $2,500 or less (or such higher amount as 

18 the Secretary of the Treasury may set by 

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

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

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

22 (2) in paragraph (3)— 

23 (A) in the paragraph heading after 

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


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1 (B) by redesignating subparagraphs (A) 

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

3 moving the indentation of each such clause 2 

4 ems to the right; 

5 (C) after making the amendments required 

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

7 subject’’ and inserting the following: 

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

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

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

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

12 if— 

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

14 a felony for conduct relating to the impor15 tation into the United States of any drug 

16 or controlled substance (as defined in sec17 tion 102 of the Controlled Substances 

18 Act); or 

19 ‘‘(ii) the person has engaged in a pat20 tern of importing or offering for import ar21 ticles of drug that are— 

22 ‘‘(I) adulterated, misbranded, or 

23 in violation of section 505; or 

24 ‘‘(II) controlled substances whose 

25 importation is prohibited pursuant to 


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1 section 401(m) of the Tariff Act of 

2 1930.’’. 

Æ 


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