115TH CONGRESS 
2D SESSION 
H. R. 5228 
AN ACT 
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’’. 
(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. Single source pattern of shipments of adulterated or misbranded drugs. 
Sec. 5. Fund to strengthen efforts of FDA to combat the opioid and substance 
use epidemic. 
Sec. 6. Consideration of potential for misuse and abuse required for drug ap-
proval. 
SEC. 2. DETENTION, REFUSAL, AND DESTRUCTION OF 
DRUGS OFFERED FOR IMPORTATION. 
(a) INCREASING THE MAXIMUM DOLLAR AMOUNT OF 
DRUGS SUBJECT TO DESTRUCTION.—The sixth sentence 
in section 801(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381(a)) is amended by striking ‘‘ex-
cept that the Secretary’’ and all that follows through the 
two periods at the end and inserting ‘‘except that the Sec-
retary of Health and Human Services may destroy, with-
out the opportunity for export, any drug refused admission 
under this section, if such drug is declared 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 regu-
lation pursuant to section 498(a)(1) of the Tariff Act of 
1930 or such higher amount as the Commissioner of Food
and Drugs may set based on a finding by the Commis-
sioner that the higher amount is in the interest of public 
health), or if such drug is entering the United States by 
mail, and was not brought into compliance as described 
under subsection (b).’’. 
(b) DESTRUCTION OF ARTICLES OF CONCERN.—The 
sixth sentence of section 801(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(a)), as amended 
by subsection (a), is further amended by inserting before 
the period at the end the following: ‘‘; and the Secretary 
of Health and Human Services may destroy, without the 
opportunity for export, any article refused admission 
under clause (6) of the third sentence of this subsection’’. 
(c) TECHNICAL AMENDMENTS.—The seventh, eighth, 
and ninth sentences of section 801(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(a)) are amend-
ed— 
(1) by striking ‘‘a drug’’ each place it appears 
and inserting ‘‘an article’’; and 
(2) by striking ‘‘the drug’’ each place it appears 
and inserting ‘‘the article’’. 
(d) RULE OF CONSTRUCTION.—The last sentence in 
section 801(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 381(a)) is amended to read as follows: 
‘‘Clauses (2), (5), and (6) of the third sentence of this
subsection shall not be construed to prohibit the admission 
of narcotic or nonnarcotic drugs or other substances, the 
importation of which is permitted under the Controlled 
Substances Import and Export Act.’’. 
SEC. 3. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED DRUG 
PRODUCTS. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(eee) The failure to comply with any order issued 
under section 569D.’’. 
(b) NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED DRUGS.—Subchapter 
E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by adding at 
the end the following: 
‘‘SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RE-
CALL OF ADULTERATED OR MISBRANDED 
DRUGS. 
‘‘(a) ORDER TO CEASE DISTRIBUTION
AND RE-
CALL.— 
‘‘(1) IN GENERAL.—Upon a determination that 
the use or consumption of, or exposure to, a drug 
may present an imminent or substantial hazard to
the public health, the Secretary shall issue an order 
requiring any person who distributes the drug to im-
mediately cease distribution of the drug. 
‘‘(2) HEARING.—An order under paragraph (1) 
shall provide the person subject to the order with an 
opportunity for an informal hearing, to be held not 
later than 10 days after the date of issuance of the 
order, on— 
‘‘(A) the actions required by the order; and 
‘‘(B) whether the order should be amended 
to require a recall of the drug. 
‘‘(3) INADEQUATE
GROUNDS.—If, after pro-
viding an opportunity for a hearing under paragraph 
(2), the Secretary determines that inadequate 
grounds exist to support the actions required by the 
order, the Secretary shall vacate the order. 
‘‘(4) AMENDMENT TO ORDER TO REQUIRE RE-
CALL.—If, after providing an opportunity for an in-
formal hearing under paragraph (2), the Secretary 
determines that the order should be amended to in-
clude a recall of the drug with respect to which the 
order was issued, the Secretary shall— 
‘‘(A) amend the order to require a recall; 
and
‘‘(B) after consultation with the drug 
sponsor, specify a timetable in which the recall 
will occur. 
‘‘(5) NOTICE
TO
PERSONS
AFFECTED.—An 
order under this subsection shall require any person 
who distributes the drug to provide for notice, in-
cluding to individuals as appropriate, to persons who 
may be affected by the order to cease distribution of 
or recall the drug, as applicable. 
‘‘(6) ACTION FOLLOWING ORDER.—Any person 
who is subject to an order under paragraph (1) or 
(4) shall immediately cease distribution of or recall, 
as applicable, the drug and provide notification as 
required by such order. 
‘‘(b) NOTICE TO CONSUMERS AND HEALTH OFFI-
CIALS.—The Secretary shall, as the Secretary determines 
to be necessary, provide notice of a recall order under this 
section to— 
‘‘(1) consumers to whom the drug was, or may 
have been, distributed; and 
‘‘(2) appropriate State and local health officials. 
‘‘(c) ORDER TO RECALL.— 
‘‘(1) CONTENTS.—An order to recall a drug 
under subsection (a) shall—
drug subject to this Act or the Public Health Service 
Act.’’. 
(c) DRUGS SUBJECT TO REFUSAL.—The third sen-
tence of subsection (a) of section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381) is amended by 
inserting ‘‘or (5) in the case of a drug, such drug is sub-
ject to an order under section 568 to cease distribution 
of or recall the drug,’’ before ‘‘then such article shall be 
refused admission’’. 
(d) APPLICATION.—Sections 301(eee) and 569D of 
the Federal Food, Drug, and Cosmetic Act, as added by 
subsections (a) and (b), shall apply with respect to a drug 
as of such date, not later than 1 year after the date of 
the enactment of this Act, as the Secretary of Health and 
Human Services shall specify. 
SEC. 4. SINGLE SOURCE PATTERN OF SHIPMENTS OF ADUL-
TERATED OR MISBRANDED DRUGS. 
Section 801 of the Federal Food, Drug, and Cosmetic 
Act is amended by adding at the end the following: 
‘‘(t) SINGLE SOURCE PATTERN OF SHIPMENTS OF 
ADULTERATED
OR MISBRANDED DRUGS.—If the Sec-
retary identifies a pattern of adulterated or misbranded 
drugs being offered for import from the same manufac-
turer, distributor, or importer, the Secretary may by order 
choose to treat all drugs being offered for import from
such manufacturer, distributor, or importer as adulterated 
or misbranded unless otherwise demonstrated.’’. 
SEC. 5. FUND TO STRENGTHEN EFFORTS OF FDA TO COM-
BAT THE OPIOID AND SUBSTANCE USE EPI-
DEMIC. 
Chapter X of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 1015. FUND TO STRENGTHEN EFFORTS OF FDA TO 
COMBAT THE OPIOID AND SUBSTANCE USE 
EPIDEMIC. 
‘‘(a) IN GENERAL.—The Commissioner of Food and 
Drugs shall use any funds appropriated pursuant to the 
authorization of appropriations under subsection (c) to 
carry out the programs and activities described in sub-
section (d) to strengthen and facilitate the Food and Drug 
Administration’s efforts to address the opioid and sub-
stance use epidemic. Such funds shall be in addition to 
any funds which are otherwise available to carry out such 
programs and activities. 
‘‘(b) FDA OPIOID AND SUBSTANCE USE EPIDEMIC 
RESPONSE FUND.— 
‘‘(1) ESTABLISHMENT OF FUND.—There is es-
tablished in the Treasury a fund, to be known as the 
FDA Opioid and Substance Use Epidemic Response
Fund (referred to in this subsection as the ‘Fund’), 
for purposes of funding the programs and activities 
described in subsection (d). 
‘‘(2) TRANSFER.—For the period of fiscal years 
2019 through 2023, $110,000,000 shall be trans-
ferred to the Fund from the general fund of the 
Treasury. 
‘‘(3) AMOUNTS
DEPOSITED.—Any amounts 
transferred under paragraph (2) shall remain un-
available in the Fund until such amounts are appro-
priated pursuant to subsection (c). 
‘‘(c) APPROPRIATIONS.— 
‘‘(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
For the period of fiscal years 2019 through 2023, 
there is authorized to be appropriated from the 
Fund to the Food and Drug Administration, for the 
purpose of carrying out the programs and activities 
described in subsection (d), an amount not to exceed 
the total amount transferred to the Fund under sub-
section (b)(2). Notwithstanding subsection (g), such 
funds shall remain available until expended. 
‘‘(2) OFFSETTING FUTURE APPROPRIATIONS.— 
For any of fiscal years 2019 through 2023, for any 
discretionary appropriation out of the Fund to the 
Food and Drug Administration pursuant to the au-
thorization of appropriations under paragraph (1) 
for the purpose of carrying out the programs and 
activities described in subsection (d), the total 
amount of such appropriations for the applicable fis-
cal year (not to exceed the total amount remaining 
in the Fund) shall be subtracted from the estimate 
of discretionary budget authority and the resulting 
outlays for any estimate under the Congressional 
Budget and Impoundment Control Act of 1974 or 
the Balanced Budget and Emergency Deficit Control 
Act of 1985, and the amount transferred to the 
Fund shall be reduced by the same amount. 
‘‘(d) FOOD AND DRUG ADMINISTRATION.—The en-
tirety of the funds made available pursuant to subsection 
(c)(1) shall be for the Commissioner of Food and Drugs, 
pursuant to applicable authorities in the Public Health 
Service Act (42 U.S.C. 201 et seq.) or this Act and other 
applicable Federal law, to support widespread innovation 
in non-opioid and non-addictive medical products for pain 
treatment, access to opioid addiction treatments, appro-
priate use of approved opioids, and efforts to reduce illicit 
importation of opioids. Such support may include the fol-
lowing programs and activities:
‘‘(1) Obligating contract funds beginning in fis-
cal year 2019 for an educational campaign that 
will— 
‘‘(A) educate patients and their families to 
differentiate opioid medications; 
‘‘(B) raise awareness about preferred stor-
age and disposal methods; and 
‘‘(C) inform patients, families, and commu-
nities about medication-assisted treatment op-
tions. 
‘‘(2) Building the Food and Drug Administra-
tion’s presence in international mail facilities, includ-
ing through— 
‘‘(A) improvements in equipment and in-
formation technology enhancements to identify 
unapproved, counterfeit, or other unlawful 
pharmaceuticals for destruction; 
‘‘(B) increased and improved surveillance; 
‘‘(C) renovations at international mail fa-
cility locations; and 
‘‘(D) the purchase of laboratory equip-
ment. 
‘‘(3) Enhancing the identification and targeting 
of entities offering products and products being of-
fered by such entities for import into the United
States through review and analysis of Internet 
websites, import data, and other sources of intel-
ligence for purposes of making the best use of the 
Food and Drug Administration’s inspection and ana-
lytical resources. 
‘‘(4) Increasing the number of staff of the Food 
and Drug Administration to increase the number of 
packages being examined, ensuring the safety of the 
staff undertaking such examinations, and ensuring 
that packages identified as illegal, counterfeit, mis-
branded, or adulterated are removed from commerce 
through available authorities, including administra-
tive destruction. 
‘‘(5) Enhancing the Food and Drug Adminis-
tration’s criminal investigations resources (including 
full-time equivalent employees and equipment), im-
ports surveillance, and international work. 
‘‘(6) Obtaining for the Food and Drug Admin-
istration equipment and full-time equivalent employ-
ees needed to efficiently screen and analyze products 
offered for import, including by building data librar-
ies of new substances and analogues to facilitate 
identification and evaluation of pharmaceutical- 
based agents and by purchasing screening tech-
nologies for use at international mail facilities.
‘‘(7) Operating the Food and Drug Administra-
tion’s forensic laboratory facility to ensure adequate 
laboratory space and functionality for additional 
work and full-time equivalent employees. 
‘‘(e) ACCOUNTABILITY AND OVERSIGHT.— 
‘‘(1) WORK PLAN.— 
‘‘(A) IN
GENERAL.—Not later than 180 
days after the date of enactment of this Act, 
the Commissioner of Food and Drugs shall sub-
mit to the Committee on Health, Education, 
Labor and Pensions of the Senate and the 
Committee on Energy and Commerce of the 
House of Representatives, a work plan includ-
ing the proposed allocation of funds appro-
priated pursuant to the authorization of appro-
priations under subsection (c) for each of fiscal 
years 2019 through 2023 and the contents de-
scribed in subparagraph (B). 
‘‘(B) CONTENTS.—The work plan sub-
mitted under subparagraph (A) shall include— 
‘‘(i) the amount of money to be obli-
gated or expended out of the Fund in each 
fiscal year for each program and activity 
described in subsection (d); and
‘‘(ii) a description and justification of 
each such program and activity. 
‘‘(2) REPORTS.— 
‘‘(A) ANNUAL REPORTS.—Not later than 
October 1 of each of fiscal years 2020 through 
2024, the Secretary of Health and Human 
Services shall submit to the Committee on 
Health, Education, Labor and Pensions of the 
Senate and the Committee on Energy and Com-
merce of the House of Representatives a report 
that includes— 
‘‘(i) the amount of money obligated or 
expended out of the Fund in the prior fis-
cal year for each program and activity de-
scribed in subsection (d); 
‘‘(ii) a description of all programs and 
activities using funds provided pursuant to 
the authorization of appropriations under 
subsection (c); and 
‘‘(iii) how the programs and activities 
are advancing public health. 
‘‘(B) ADDITIONAL REPORTS.—At the re-
quest of the Committee on Health, Education, 
Labor and Pensions of the Senate or the Com-
mittee on Energy and Commerce of the House
of Representatives, the Commissioner shall pro-
vide an update in the form of testimony and 
any additional reports to the respective congres-
sional committee regarding the allocation of 
funding under this section or the description of 
the programs and activities undertaken with 
such funding. 
‘‘(f) LIMITATIONS.—Notwithstanding any transfer 
authority authorized by this section or any appropriations 
Act, any funds made available pursuant to the authoriza-
tion of appropriations under subsection (c) may not be 
used for any purpose other than the programs and activi-
ties described in subsection (d) to strengthen and facilitate 
the Food and Drug Administration’s efforts to address the 
opioid and substance use epidemic. 
‘‘(g) SUNSET.—This section shall expire on Sep-
tember 30, 2022, except that— 
‘‘(1) this subsection does not apply to reporting 
under subsection (e)(2); and 
‘‘(2) this section shall remain in effect until 
such time, and to such extent, as may be necessary 
for the funds transferred by subsection (b)(2) to be 
fully expended.’’.
SEC. 6. CONSIDERATION OF POTENTIAL FOR MISUSE AND 
ABUSE REQUIRED FOR DRUG APPROVAL. 
(a) IN GENERAL.—Section 505(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) is 
amended— 
(1) in the first sentence— 
(A) by striking ‘‘or (7)’’ and inserting 
‘‘(7)’’; and 
(B) by inserting ‘‘or (8) if the drug is or 
contains a controlled substance for which a list-
ing in any schedule is in effect under the Con-
trolled Substances Act or that is permanently 
scheduled pursuant to section 201 of such Act, 
on the basis of information submitted to him as 
part of the application, or upon the basis of any 
other information before him with respect to 
such drug, the drug is unsafe for use due to the 
risks of abuse or misuse or there is insufficient 
information to show that the drug is safe for 
use considering such risks;’’ before ‘‘he shall 
issue an order refusing to approve the applica-
tion’’; and 
(2) in the second sentence, by striking ‘‘(6)’’ 
and inserting ‘‘(8)’’.
(b) WITHDRAWAL AUTHORITY.—Section 505(e) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(e)) is amended in the first sentence— 
(1) by striking ‘‘or (5)’’ and inserting ‘‘(5)’’; 
and 
(2) by inserting the following: ‘‘; or (6) that, in 
the case of a drug that is or contains a controlled 
substance for which a listing in any schedule is in 
effect under the Controlled Substances Act or that 
is permanently scheduled pursuant to section 201 of 
such Act, on the basis of new information before him 
with respect to such drug, evaluated together with 
the information available to him when the applica-
tion was approved, that the drug is unsafe for use 
due to the risks of abuse or misuse’’ after ‘‘of a ma-
terial fact’’. 
(c) RULE
OF
CONSTRUCTION.—Nothing in the 
amendments made by this section shall be construed to 
limit or narrow, in any manner, the meaning or applica-
tion of the provisions of paragraphs (1), (2), (3), (4), (5), 
and (7) of section 505(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(d)) or paragraphs (1) and 
(2) of section 505(e) of such Act (21 U.S.C. 355(e)). 
Passed the House of Representatives June 12, 2018. 
Attest: 
Clerk.
115TH CONGRESS 
2D SESSION 
H. R. 5228 
AN ACT 
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.