I 
114TH CONGRESS 
1ST SESSION 
H. R. 471 
To improve enforcement efforts related to prescription drug diversion and 
abuse, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 22, 2015 
Mr. MARINO (for himself, Mr. WELCH, Mrs. BLACKBURN, and Ms. CHU of 
California) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
the Judiciary, 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 improve enforcement efforts related to prescription drug 
diversion and abuse, 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. 
This Act may be cited as the ‘‘Ensuring Patient Ac-
cess and Effective Drug Enforcement Act of 2015’’. 
SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED 
SUBSTANCES ACT. 
(a) DEFINITIONS.— 
VerDate Sep 11 2014 
06:46 Jan 28, 2015
Jkt 049200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H471.IH
H471
SSpencer on DSK4SPTVN1PROD with BILLS
(1) FACTORS AS MAY BE RELEVANT TO AND 
CONSISTENT WITH THE PUBLIC HEALTH AND SAFE-
TY.—Section 303 of the Controlled Substances Act 
(21 U.S.C. 823) is amended by adding at the end 
the following: 
‘‘(i) In this section, the phrase ‘factors as may be rel-
evant to and consistent with the public health and safety’ 
means factors that are relevant to and consistent with the 
findings contained in section 101.’’. 
(2) IMMINENT
DANGER
TO
THE
PUBLIC 
HEALTH OR SAFETY.—Section 304(d) of the Con-
trolled Substances Act (21 U.S.C. 824(d)) is amend-
ed— 
(A) by striking ‘‘(d) The Attorney Gen-
eral’’ and inserting ‘‘(d)(1) The Attorney Gen-
eral’’; and 
(B) by adding at the end the following: 
‘‘(2) In this subsection, the phrase ‘imminent danger 
to the public health or safety’ means that, in the absence 
of an immediate suspension order, controlled substances— 
‘‘(A) will continue to be intentionally distrib-
uted or dispensed— 
‘‘(i) outside the usual course of profes-
sional practice; or 
VerDate Sep 11 2014 
06:46 Jan 28, 2015
Jkt 049200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H471.IH
H471
SSpencer on DSK4SPTVN1PROD with BILLS
‘‘(ii) in a manner that poses a present or 
foreseeable risk of serious adverse health con-
sequences or death; or 
‘‘(B) will continue to be intentionally diverted 
outside of legitimate distribution channels.’’. 
(b) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION 
PLAN PRIOR
TO REVOCATION
OR SUSPENSION.—Sub-
section (c) of section 304 of the Controlled Substances Act 
(21 U.S.C. 824) is amended— 
(1) by striking the last two sentences in such 
subsection; 
(2) by striking ‘‘(c) Before’’ and inserting 
‘‘(c)(1) Before’’; and 
(3) by adding at the end the following: 
‘‘(2) An order to show cause under paragraph (1) 
shall— 
‘‘(A) contain a statement of the basis for the 
denial, revocation, or suspension, including specific 
citations to any laws or regulations alleged to be vio-
lated by the applicant or registrant; 
‘‘(B) direct the applicant or registrant to ap-
pear before the Attorney General at a time and 
place stated in the order, but no less than thirty 
days after the date of receipt of the order; and 
VerDate Sep 11 2014 
06:46 Jan 28, 2015
Jkt 049200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H471.IH
H471
SSpencer on DSK4SPTVN1PROD with BILLS
‘‘(C) notify the applicant or registrant of the 
opportunity to submit a corrective action plan on or 
before the date of appearance. 
‘‘(3) Upon review of any corrective action plan sub-
mitted by an applicant or registrant pursuant to para-
graph (2), the Attorney General shall determine whether 
denial, revocation or suspension proceedings should be dis-
continued, or deferred for the purposes of modification, 
amendment, or clarification to such plan. 
‘‘(4) Proceedings to deny, revoke, or suspend shall 
be conducted pursuant to this section in accordance with 
subchapter II of chapter 5 of title 5. Such proceedings 
shall be independent of, and not in lieu of, criminal pros-
ecutions or other proceedings under this title or any other 
law of the United States. 
‘‘(5) The requirements of this subsection shall not 
apply to the issuance of an immediate suspension order 
under subsection (d).’’. 
SEC. 3. REPORT TO CONGRESS ON EFFECTS OF LAW EN-
FORCEMENT ACTIVITIES ON PATIENT AC-
CESS TO MEDICATIONS. 
(a) IN GENERAL.—Not later than one year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs and the Director of the Centers for Dis-
VerDate Sep 11 2014 
06:46 Jan 28, 2015
Jkt 049200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H471.IH
H471
SSpencer on DSK4SPTVN1PROD with BILLS
ease Control and Prevention, and in consultation with the 
Administrator of the Drug Enforcement Administration 
and the Director of National Drug Control Policy, shall 
submit a report to the Committee on the Judiciary of the 
House of Representatives, the Committee on Energy and 
Commerce of the House of Representatives, the Com-
mittee on the Judiciary of the Senate, and the Committee 
on Health, Education, Labor, and Pensions of the Senate 
identifying— 
(1) obstacles to legitimate patient access to con-
trolled substances; 
(2) issues with diversion of controlled sub-
stances; and 
(3) how collaboration between Federal, State, 
local, and tribal law enforcement agencies and the 
pharmaceutical industry can benefit patients and 
prevent diversion and abuse of controlled substances. 
(b) CONSULTATION.—The report under subsection 
(a) shall incorporate feedback and recommendations from 
the following: 
(1) Patient groups. 
(2) Pharmacies. 
(3) Drug manufacturers. 
(4) Common or contract carriers and ware-
housemen. 
VerDate Sep 11 2014 
01:53 Jan 29, 2015
Jkt 049200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H471.IH
H471
SSpencer on DSK4SPTVN1PROD with BILLS
(5) Hospitals, physicians, and other health care 
providers. 
(6) State attorneys general. 
(7) Federal, State, local, and tribal law enforce-
ment agencies. 
(8) Health insurance providers and entities that 
provide pharmacy benefit management services on 
behalf of a health insurance provider. 
(9) Wholesale drug distributors. 
Æ 
VerDate Sep 11 2014 
06:46 Jan 28, 2015
Jkt 049200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6301
E:\BILLS\H471.IH
H471
SSpencer on DSK4SPTVN1PROD with BILLS