Ensuring Patient Access and Effective Drug Enforcement Act of 2016
PL 114-145 (S.483), enacted 04/19/2016

130 STAT. 354 
PUBLIC LAW 114–145—APR. 19, 2016 
Public Law 114–145 
114th Congress 
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 Representatives of 
the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Ensuring Patient Access and 
Effective Drug Enforcement Act of 2016’’. 
SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED SUBSTANCES 
ACT. 
(a) DEFINITIONS.— 
(1) FACTORS AS MAY BE RELEVANT TO AND CONSISTENT WITH 
THE PUBLIC HEALTH AND SAFETY.—Section 303 of the Controlled 
Substances Act (21 U.S.C. 823) is amended by adding at the 
end the following: 
‘‘(j) In this section, the phrase ‘factors as may be relevant 
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 Controlled Substances Act (21 U.S.C. 
824(d)) is amended— 
(A) by striking ‘‘(d) The Attorney General’’ and 
inserting ‘‘(d)(1) The Attorney General’’; 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, due to the failure of the reg-
istrant to maintain effective controls against diversion or otherwise 
comply with the obligations of a registrant under this title or 
title III, there is a substantial likelihood of an immediate threat 
that death, serious bodily harm, or abuse of a controlled substance 
will occur in the absence of an immediate suspension of the registra-
tion.’’. 
(b) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION PLAN PRIOR 
TO REVOCATION OR SUSPENSION.—Subsection (c) of section 304 of 
the Controlled Substances Act (21 U.S.C. 824) is amended— 
(1) by striking the last three 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, revoca-
tion, or suspension, including specific citations to any laws 
21 USC 801 note. 
Ensuring Patient 
Access and 
Effective Drug 
Enforcement Act 
of 2016. 
Apr. 19, 2016 
[S. 483] 
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130 STAT. 355 
PUBLIC LAW 114–145—APR. 19, 2016 
or regulations alleged to be violated by the applicant or reg-
istrant; 
‘‘(B) direct the applicant or registrant to appear 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 submitted by 
an applicant or registrant pursuant to paragraph (2), the Attorney 
General shall determine whether denial, revocation, or suspension 
proceedings should be discontinued, 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 inde-
pendent of, and not in lieu of, criminal prosecutions or other pro-
ceedings 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. 
(a) IN GENERAL.—Not later than 1 year after the date of enact-
ment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, the Adminis-
trator of the Substance Abuse and Mental Health Services Adminis-
tration, the Director of the Agency for Healthcare Research and 
Quality, and the Director of the Centers for Disease Control and 
Prevention, in coordination with the Administrator of the Drug 
Enforcement Administration and in consultation with the Secretary 
of Defense and the Secretary of Veterans Affairs, shall submit 
a report to the Committee on the Judiciary of the House of Rep-
resentatives, 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 controlled sub-
stances; 
(2) issues with diversion of controlled substances; 
(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; 
(4) the availability of medical education, training opportuni-
ties, and comprehensive clinical guidance for pain management 
and opioid prescribing, and any gaps that should be addressed; 
(5) beneficial enhancements to State prescription drug mon-
itoring programs, including enhancements to require com-
prehensive prescriber input and to expand access to the pro-
grams for appropriate authorized users; and 
(6) steps to improve reporting requirements so that the 
public and Congress have more information regarding prescrip-
tion opioids, such as the volume and formulation of prescription 
opioids prescribed annually, the dispensing of such prescription 
opioids, and outliers and trends within large data sets. 
Coordination. 
Consultation. 
Determination. 
Notification. 
Deadline. 
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130 STAT. 356 
PUBLIC LAW 114–145—APR. 19, 2016 
LEGISLATIVE HISTORY—S. 483 (H.R. 471): 
HOUSE REPORTS: No. 114–85, Pt. 1 (Comm. on Energy and Commerce) accom-
panying H.R. 471. 
CONGRESSIONAL RECORD, Vol. 162 (2016): 
Mar. 17, considered and passed Senate. 
Apr. 12, considered and passed House. 
(b) CONSULTATION.—The report under subsection (a) shall incor-
porate feedback and recommendations from the following: 
(1) Patient groups. 
(2) Pharmacies. 
(3) Drug manufacturers. 
(4) Common or contract carriers and warehousemen. 
(5) Hospitals, physicians, and other health care providers. 
(6) State attorneys general. 
(7) Federal, State, local, and tribal law enforcement agen-
cies. 
(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. 
(11) Professional medical societies and boards. 
(12) State and local public health authorities. 
(13) Health services research organizations. 
Approved April 19, 2016. 
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