I 
115TH CONGRESS 
2D SESSION 
H. R. 5228 
To strengthen the authorities of the Food and Drug Administration to address 
counterfeit drugs, illegal and synthetic opioids, and opioid-like substances, 
and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 8, 2018 
Mr. PALLONE introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
the Budget, for a period to be subsequently determined by the Speaker, 
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned 
A BILL 
To strengthen the authorities of the Food and Drug Admin-
istration to address counterfeit drugs, illegal and syn-
thetic opioids, and opioid-like substances, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Stop Counterfeit Drugs by Regulating and Enhancing 
Enforcement Now Act’’ or the ‘‘SCREEN Act’’. 
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(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. Notification, nondistribution, and recall of adulterated or misbranded 
drug products. 
Sec. 4. Seizure. 
Sec. 5. Single source pattern of shipments of adulterated or misbranded drugs. 
Sec. 6. Debarring violative individuals or companies. 
Sec. 7. Account to strengthen efforts of FDA to combat the opioid and sub-
stance use epidemic. 
SEC. 2. DETENTION, REFUSAL, AND DESTRUCTION OF 
DRUGS OFFERED FOR IMPORTATION. 
(a) CERTAIN IMPORTED PRODUCTS DEEMED TO BE 
DRUGS.—Section 201(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(g)) is amended by adding 
at the end the following: 
‘‘(3) An article being imported or offered for import 
is deemed to be a drug if it— 
‘‘(A) is or contains an active ingredient that is 
contained within— 
‘‘(i) a drug for which an approval is in ef-
fect under section 505 of this Act; or 
‘‘(ii) biological product for which a license 
is in effect under section 351 of the Public 
Health Service Act; 
‘‘(B) is or contains an active ingredient that is 
contained within a drug or biological product for 
which an investigational use exemption is in effect 
under section 505(i) of this Act or section 351(a) of 
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the Public Health Service Act, for which substantial 
clinical investigations have been instituted, and for 
which the existence of such investigations has been 
made public; or 
‘‘(C) is a chemical analog of a drug or biologi-
cal product described in clause (A) or (B).’’. 
(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 (t)), and controlled substances 
described paragraph (6) in the third sentence of this 
subsection’’. 
(2) REPEAL
OF
ANTIQUATED
REVIEW
PROC-
ESS.— 
(A) REPEAL.—The second sentence of sec-
tion 801(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)) is repealed. 
(B) TECHNICAL CHANGE TO KEEP NUM-
BERING OF SENTENCES THE SAME.—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 ‘‘the owner or consignee, 
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who may appear’’ and inserting ‘‘the owner or 
consignee. The owner or consignee may ap-
pear’’. 
(3) REFUSED ADMISSION.— 
(A) IN GENERAL.—The third sentence of 
section 801(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)) is amended— 
(i) by striking ‘‘If it appears from the 
examination’’ and inserting ‘‘Subject to 
subsection (b), if it appears from the ex-
amination’’; and 
(ii) by striking ‘‘then such article shall 
be refused admission, except as provided in 
subsection (b) of this section’’ and insert-
ing ‘‘or (5) such article is an article of con-
cern (as defined in subsection (t)), or (6) 
such article is a controlled substance (as 
defined in section 102 of the Controlled 
Substances Act) for which a listing in any 
schedule is in effect (on a temporary or 
permanent basis) under section 201 of the 
Controlled Substances Act, or (7) such ar-
ticle is being imported or offered for im-
port in violation of section 301(cc), then 
such article may be refused admission, and 
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if it appears such article may not be im-
ported into the United States pursuant to 
subsection (d) or it appears that the article 
is a counterfeit drug, then such article 
shall be refused admission’’. 
(B) DEFINITION
OF
ARTICLE
OF
CON-
CERN.—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) ARTICLE OF CONCERN DEFINED.—For purposes 
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 made a determination, following 
the publication by the Attorney General of a no-
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