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
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
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).’’.
SEC. 3. REPORT TO CONGRESS ON EFFECTS OF LAW EN-
FORCEMENT ACTIVITIES ON PATIENT AC-
CESS TO MEDICATIONS. 
(a) IN GENERAL.—Not later than 1 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-
ease Control and Prevention, in coordination with the Ad-
ministrator of the Drug Enforcement Administration and 
in consultation with the Secretary of Defense and the Sec-
retary of Veterans Affairs, shall submit a report to the 
Committee on the Judiciary of the House of Representa-
tives, the Committee on Energy and Commerce of the 
House of Representatives, the Committee 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. 
(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. 
(10) Veterinarians. 
Passed the House of Representatives April 21, 2015. 
Attest: 
Clerk.