[114th Congress Public Law 145]
[From the U.S. Government Publishing Office]
[[Page 353]]
ENSURING PATIENT ACCESS AND EFFECTIVE DRUG ENFORCEMENT ACT OF 2016
[[Page 130 STAT. 354]]
Public Law 114-145
114th Congress
An Act
To improve enforcement efforts related to prescription drug diversion
and abuse, and for other purposes. <<NOTE: Apr. 19, 2016 - [S. 483]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Ensuring Patient
Access and Effective Drug Enforcement Act of 2016.>>
SECTION 1. <<NOTE: 21 USC 801 note.>> 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 registrant 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 registration.''.
(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,
revocation, or suspension, including specific citations to any
laws
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or regulations alleged to be violated by the applicant or
registrant;
``(B) <<NOTE: Deadline.>> 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) <<NOTE: Notification.>> notify the applicant or
registrant of the opportunity to submit a corrective action plan
on or before the date of appearance.
``(3) <<NOTE: Determination.>> 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 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.
(a) <<NOTE: Coordination. Consultation.>> 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, the Administrator of the Substance Abuse and Mental Health
Services Administration, 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 Representatives, 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
substances;
(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
opportunities, and comprehensive clinical guidance for pain
management and opioid prescribing, and any gaps that should be
addressed;
(5) beneficial enhancements to State prescription drug
monitoring programs, including enhancements to require
comprehensive prescriber input and to expand access to the
programs for appropriate authorized users; and
(6) steps to improve reporting requirements so that the
public and Congress have more information regarding prescription
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.
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(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 warehousemen.
(5) Hospitals, physicians, and other health care providers.
(6) State attorneys general.
(7) Federal, State, local, and tribal law enforcement
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.
(11) Professional medical societies and boards.
(12) State and local public health authorities.
(13) Health services research organizations.
Approved April 19, 2016.
LEGISLATIVE HISTORY--S. 483 (H.R. 471):
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HOUSE REPORTS: No. 114-85, Pt. 1 (Comm. on Energy and Commerce)
accompanying H.R. 471.
CONGRESSIONAL RECORD, Vol. 162 (2016):
Mar. 17, considered and passed Senate.
Apr. 12, considered and passed House.
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