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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4709 Referred in Senate (RFS)]

113th CONGRESS
  2d Session
                                H. R. 4709

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             July 30, 2014

     Received; read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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 2014''.

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:
    ``(i) 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, in the absence of an immediate suspension 
order, controlled substances--
            ``(A) will continue to be intentionally distributed or 
        dispensed--
                    ``(i) outside the usual course of professional 
                practice; or
                    ``(ii) in a manner that poses a present or 
                foreseeable risk of serious adverse health consequences 
                or death; or
            ``(B) will continue to be intentionally diverted outside of 
        legitimate distribution channels.''.
    (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 two sentences in such subsection;
            (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 no less than thirty 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. 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 ENFORCEMENT ACTIVITIES ON 
              PATIENT ACCESS TO MEDICATIONS.

    (a) In General.--Not later than one 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 Disease Control and Prevention, and in consultation 
with the Administrator of the Drug Enforcement Administration and the 
Director of National Drug Control Policy, shall submit a report to the 
Committees 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; 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 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.

            Passed the House of Representatives July 29, 2014.

            Attest:

                                                 KAREN L. HAAS,

                                                                 Clerk.
```