[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

[[Page 130 STAT. 355]]

        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.

[[Page 130 STAT. 356]]

    (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):
---------------------------------------------------------------------------

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.

                                  <all>