IIB 
114TH CONGRESS 
1ST SESSION 
H. R. 471 
IN THE SENATE OF THE UNITED STATES 
APRIL 22, 2015 
Received; read twice and referred to the Committee on the Judiciary 
AN ACT 
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, 
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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.— 
(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 
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will continue to be distributed or dispensed by a registrant 
who knows or should know through fulfilling the obliga-
tions of the registrant under this Act— 
‘‘(A) the dispensing is outside the usual course 
of professional practice; 
‘‘(B) the distribution or dispensing poses a 
present or foreseeable risk of adverse health con-
sequences or death due to the abuse or misuse of the 
controlled substances; or 
‘‘(C) the controlled substances will continue to 
be diverted outside of legitimate distribution chan-
nels.’’. 
(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; 
(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 
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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 not less than 30 days 
after the date of receipt of the order; and 
‘‘(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, United States Code. 
Such proceedings shall be independent of, and not in lieu 
of, criminal prosecutions 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).’’. 
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