HR 5228 RFS
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 
VerDate Sep 11 2014 
00:08 Jun 14, 2018
Jkt 079200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H5228.RFS
H5228
lotter on DSKBCFDHB2PROD with BILLS
HR 5228 RFS
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 
VerDate Sep 11 2014 
00:08 Jun 14, 2018
Jkt 079200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H5228.RFS
H5228
lotter on DSKBCFDHB2PROD with BILLS
HR 5228 RFS
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 
VerDate Sep 11 2014 
00:08 Jun 14, 2018
Jkt 079200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H5228.RFS
H5228
lotter on DSKBCFDHB2PROD with BILLS
HR 5228 RFS
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 
VerDate Sep 11 2014 
00:08 Jun 14, 2018
Jkt 079200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H5228.RFS
H5228
lotter on DSKBCFDHB2PROD with BILLS
HR 5228 RFS
‘‘(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— 
VerDate Sep 11 2014 
00:08 Jun 14, 2018
Jkt 079200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H5228.RFS
H5228
lotter on DSKBCFDHB2PROD with BILLS
HR 5228 RFS
‘‘(A) require periodic reports to the Sec-
retary describing the progress of the recall; and 
‘‘(B) provide for notice, including to indi-
viduals as appropriate, to persons who may be 
affected by the recall. 
‘‘(2) ASSISTANCE ALLOWED.—In providing for 
notice under paragraph (1)(B), the Secretary may 
allow for the assistance of health professionals, State 
or local officials, or other individuals designated by 
the Secretary. 
‘‘(3) NONDELEGATION.—An order under this 
section shall be ordered by the Secretary or an offi-
cial designated by the Secretary. An official may not 
be so designated under this section unless the offi-
cial is the Director of the Center for Drug Evalua-
tion and Research, is an official senior to such Di-
rector, or is so designated by such Director. 
‘‘(d) SAVINGS CLAUSE.—Nothing contained in this 
section shall be construed as limiting— 
‘‘(1) the authority of the Secretary to issue an 
order to cease distribution of, or to recall, an drug 
under any other provision of this Act or the Public 
Health Service Act; or 
‘‘(2) the ability of the Secretary to request any 
person to perform a voluntary activity related to any 
VerDate Sep 11 2014 
00:08 Jun 14, 2018
Jkt 079200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H5228.RFS
H5228
lotter on DSKBCFDHB2PROD with BILLS
HR 5228 RFS
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 
VerDate Sep 11 2014 
00:08 Jun 14, 2018
Jkt 079200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H5228.RFS
H5228
lotter on DSKBCFDHB2PROD with BILLS
HR 5228 RFS
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 
VerDate Sep 11 2014 
00:08 Jun 14, 2018
Jkt 079200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H5228.RFS
H5228
lotter on DSKBCFDHB2PROD with BILLS
HR 5228 RFS
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-
VerDate Sep 11 2014 
00:08 Jun 14, 2018
Jkt 079200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H5228.RFS
H5228
lotter on DSKBCFDHB2PROD with BILLS
HR 5228 RFS
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: 
VerDate Sep 11 2014 
00:08 Jun 14, 2018
Jkt 079200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H5228.RFS
H5228
lotter on DSKBCFDHB2PROD with BILLS
HR 5228 RFS
‘‘(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 
VerDate Sep 11 2014 
00:08 Jun 14, 2018
Jkt 079200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H5228.RFS
H5228
lotter on DSKBCFDHB2PROD with BILLS