[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 483 Enrolled Bill (ENR)]
S.483
One Hundred Fourteenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Monday,
the fourth day of January, two thousand and sixteen
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 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
or regulations alleged to be violated by the applicant or
registrant;
``(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 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) 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.
(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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.