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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Stop Illicit Drug Importation Act of 2018’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
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. 
SEC. 2. DETENTION, REFUSAL, AND DESTRUCTION OF 
DRUGS OFFERED FOR IMPORTATION. 
(a) ARTICLES TREATED AS DRUGS FOR PURPOSES 
OF IMPORTATION.—Section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381) is amended by 
adding at the end the following: 
‘‘(t) ARTICLES TREATED AS DRUGS FOR PURPOSES 
OF THIS SECTION.— 
‘‘(1) LABELED ARTICLES.—An article shall not 
be treated as a drug pursuant to this subsection if— 
‘‘(A) an electronic import entry for such 
article is submitted using an authorized elec-
tronic data interchange system; and 
‘‘(B) such article is designated in such sys-
tem as a drug, device, dietary supplement, or 
other product that is regulated under this Act. 
‘‘(2) ARTICLES
COVERED.—Subject to para-
graph (1), for purposes of this section, an article de-
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scribed in this paragraph may be treated by the Sec-
retary as a drug if it— 
‘‘(A) is or contains an ingredient that is an 
active ingredient that is contained within— 
‘‘(i) a drug that has been approved 
under section 505 of this Act; or 
‘‘(ii) a biological product that has 
been approved under section 351 of the 
Public Health Service Act; 
‘‘(B) is or contains an ingredient that is an 
active ingredient in a drug or biological product 
if— 
‘‘(i) an investigational use exemption 
has been authorized for such drug or bio-
logical product under section 505(i) of this 
Act or section 351(a) of the Public Health 
Service Act; 
‘‘(ii) substantial clinical investigation 
has been instituted for such drug or bio-
logical product; and 
‘‘(iii) the existence of such clinical in-
vestigation has been made public; or 
‘‘(C) is or contains a substance that has a 
chemical structure that is substantially similar 
to the chemical structure of an active ingredient 
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in a drug or biological product described in sub-
paragraph (A) or (B). 
‘‘(3) EFFECT.—Except to the extent that an ar-
ticle may be treated as a drug pursuant to para-
graph (2), this subsection shall not be construed as 
bearing on or being relevant to the question of 
whether any article is a drug as defined in section 
201(g).’’. 
(b) ARTICLES OF CONCERN.— 
(1) DELIVERY
BY
TREASURY
TO
HHS.—The 
first sentence of section 801(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(a)) is 
amended by striking ‘‘and cosmetics’’ and inserting 
‘‘cosmetics, and potential articles of concern (as de-
fined in subsection (u))’’. 
(2) REFUSED ADMISSION.—The third sentence 
of section 801(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)) is amended by 
striking ‘‘then such article shall be refused admis-
sion’’ and inserting ‘‘or (5) such article is an article 
of concern (as defined in subsection (u)), or (6) such 
article is a drug that is being imported or offered for 
import in violation of section 301(cc), then such ar-
ticle shall be refused admission’’. 
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(3) DEFINITION OF ARTICLE OF CONCERN.— 
Section 801 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381), as amended, is further 
amended by adding at the end the following: 
‘‘(u) ARTICLE OF CONCERN DEFINED.—For pur-
poses of subsection (a), the term ‘article of concern’ means 
an article that is or contains a drug or other substance— 
‘‘(1) for which, during the 24-month period 
prior to the article being imported or offered for im-
port, the Secretary of Health and Human Services— 
‘‘(A) has requested that, based on a deter-
mination that the drug or other substance ap-
pears to meet the requirements for temporary 
or permanent scheduling pursuant to section 
201 of the Controlled Substances Act, the At-
torney General initiate the process to control 
the drug or other substance in accordance with 
such Act; or 
‘‘(B) has, following the publication by the 
Attorney General of a notice in the Federal 
Register of the intention to issue an order tem-
porarily scheduling such drug or substance in 
schedule I of section 202 of the Controlled Sub-
stances Act pursuant to section 201(h) of such 
Act, made a determination that such article 
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presents an imminent hazard to public safety; 
and 
‘‘(2) with respect to which the Attorney General 
has not— 
‘‘(A) scheduled the drug or other substance 
under such Act; or 
‘‘(B) notified the Secretary of Health and 
Human Services that the Attorney General has 
made a determination not to schedule the drug 
or other substance under such Act.’’. 
SEC. 3. SEIZURE. 
Section 304(b) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 334(b)) is amended by striking the 
first sentence and inserting the following: ‘‘The article, 
equipment, or other thing proceeded against shall be liable 
to seizure by process pursuant to the libel, and the proce-
dure in cases under this section shall conform, as nearly 
as may be, to the procedure in admiralty rather than the 
procedure used for civil asset forfeiture proceedings set 
forth in section 983 of title 18, United States Code. On 
demand of either party any issue of fact joined in any such 
a case brought under this section shall be tried by jury. 
A seizure brought under this section is not governed by 
Rule G of the Supplemental Rules of Admiralty or Mari-
time Claims and Asset Forfeiture Actions. Exigent cir-
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cumstances shall be deemed to exist for all seizures 
brought under this section, and in such cases, the sum-
mons and arrest warrant shall be issued by the clerk of 
the court without court review.’’. 
SEC. 4. DEBARRING VIOLATIVE INDIVIDUALS OR COMPA-
NIES. 
(a) PROHIBITED ACT.—Section 301(cc) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) 
is amended— 
(1) by inserting after ‘‘an article of food’’ the 
following: ‘‘or a drug’’; and 
(2) by inserting after ‘‘a person debarred’’ the 
following: ‘‘from such activity’’. 
(b) DEBARMENT.—Section 306(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is 
amended— 
(1) in paragraph (1)— 
(A) in the matter preceding subparagraph 
(A), by striking ‘‘paragraph (2)’’ and inserting 
‘‘paragraph (2) or (3)’’; 
(B) in subparagraph (B), by striking ‘‘or’’ 
at the end; 
(C) in subparagraph (C), by striking the 
period at the end and inserting ‘‘, or’’; and 
(D) by adding at the end the following: 
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‘‘(D) a person from importing or offering 
to import into the United States— 
‘‘(i) a controlled substance as defined 
in section 102(6) of the Controlled Sub-
stances Act; or 
‘‘(ii) any drug, if such drug is de-
clared to be valued at an amount that is 
$2,500 or less (or such higher amount as 
the Secretary of the Treasury may set by 
regulation pursuant to section 498(a)(1) of 
the Tariff Act of 1930), or if such drug is 
entering the United States by mail.’’; and 
(2) in paragraph (3)— 
(A) in the paragraph heading after 
‘‘FOOD’’ by inserting ‘‘OR DRUG’’; 
(B) by redesignating subparagraphs (A) 
and (B) as clauses (i) and (ii), respectively, and 
moving the indentation of each such clause two 
ems to the right; 
(C) after making the amendments required 
by subparagraph (B), by striking ‘‘A person is 
subject’’ and inserting the following: 
‘‘(A) FOOD.—A person is subject’’; and 
(D) by adding at the end the following: 
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‘‘(B) IMPORTATION OF DRUGS.—A person 
is subject to debarment under paragraph (1)(D) 
if— 
‘‘(i) the person has been convicted of 
a felony for conduct relating to the impor-
tation into the United States of any drug 
or controlled substance (as defined in sec-
tion 102 of the Controlled Substances 
Act); or 
‘‘(ii) the person has engaged in a pat-
tern of importing or offering for import ar-
ticles of drug that are— 
‘‘(I)(aa) adulterated, misbranded, 
or in violation of section 505; and 
‘‘(bb) present a threat of serious 
adverse health consequences or death 
to humans or animals; or 
‘‘(II) controlled substances whose 
importation is prohibited pursuant to 
section 401(m) of the Tariff Act of 
1930. 
‘‘(C) DEFINITION.—For purposes of sub-
paragraph (B), the term ‘pattern of importing 
or offering for import articles of drug’ means 
importing or offering for import articles of drug 
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described in subclause (I) or (II) of subpara-
graph (B)(ii) in an amount, frequency, or dos-
age that is inconsistent with personal or house-
hold use by the importer.’’. 
Passed the House of Representatives June 13, 2018. 
Attest: 
KAREN L. HAAS, 
Clerk. 
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