Ensuring Patient Access and Effective Drug Enforcement Act of 2013

Summary: Ensuring Patient Access and Effective Drug Enforcement Act of 2013 - Amends the Controlled Substances Act to require registrants to manufacture, distribute, or dispense controlled substances to obtain a criminal background check on, and perform drug testing on, each employee with access to facility areas where controlled substances are stored. Requires such background checks to be obtained when such an employee is hired and periodically thereafter, but not more frequently than every two years. Authorizes registration suspension or revocation and a $10,000 penalty for failing to comply with such requirements.  Requires the Attorney General, before revoking or suspending a registration under such Act, to: (1) provide the registrant notice of the grounds for doing so, and where such grounds consist of a legal violation, a specific citation to such law; (2) give the registrant an opportunity to submit a corrective action plan within a reasonable time period; and (3) determine whether, in light of the plan, revocation or suspension proceedings should be discontinued or deferred or additional changes need to be made in such plan. Establishes the Combating Prescription Drug Abuse Working Group to: (1) report on federal initiatives to reduce prescription drug diversion and abuse, (2) identify gaps and opportunities to ensure the safe use of prescription drugs with the potential for diversion and abuse, (3) examine recommendations to transfer one or more controlled substances from schedule III to schedule II to evaluate the effectiveness of such a transfer in reducing diversion and abuse and any effect of such a transfer on access to prescription drugs for legitimate medical purposes, (4) make recommendations on specific ways to reduce the diversion and abuse of prescription drugs, and (5) report on its efforts to prevent or reduce prescription drug diversion and abuse to ensure that patients continue to have access to medications. 

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Ensuring Patient Access and 
Effective Drug Enforcement Act of 2013''.

SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED SUBSTANCES ACT.

    (a) Definitions.--
            (1) 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 `consistent with the public 
health and safety' means having a substantial relationship to this 
Act's purpose of preventing diversion and abuse of controlled 
substances.''.
            (2) Imminent danger.--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 term `imminent danger' means a 
significant and present risk of death or serious bodily harm that is 
more likely than not to occur in the absence of an immediate suspension 
order.''.
    (b) Criminal Background Checks and Drug Testing for Employees With 
Access to Controlled Substances.--
            (1) Requirements.--Section 303 of the Controlled Substances 
        Act (21 U.S.C. 823) is amended by inserting before subsection 
        (j) (as added by subsection (a)(1)) the following:
    ``(i)(1) The Attorney General shall require all registrants under 
subsections (a), (b), (d), or (e), as a condition of such 
registration--
            ``(A) to obtain a criminal background check on each of the 
        registrant's employees who has or will have access to facility 
        areas where controlled substances under the registrant's 
        possession or control are stored, such as a cage, vault, or 
        safe; and
            ``(B) to perform drug testing on each such employee in 
        accordance with Federal and State law.
    ``(2) The criminal background checks required by paragraph (1) 
shall be obtained--
            ``(A) periodically, but not more frequently than every 2 
        years, for all employees of the registrant who are described in 
        paragraph (1)(A); and
            ``(B) at the time of hire, for such employees who are hired 
        after the date of enactment of the Ensuring Patient Access and 
        Effective Drug Enforcement Act of 2013.
    ``(3) The term `drug testing' means testing designed to detect the 
illegal use of a controlled substance.''.
            (2) Conforming change.--Section 304(a) of the Controlled 
        Substances Act (21 U.S.C. 823(a)) is amended--
                    (A) in paragraph (4), by striking ``or'' at the 
                end;
                    (B) in paragraph (5), by striking the period at the 
                end and inserting ``; or''; and
                    (C) by adding at the end the following:
            ``(6) has failed to comply with the requirements under 
        section 303(i) (relating to criminal background checks and drug 
        testing).''.
            (3) Alternative civil penalty for failure to comply with 
        criminal background check and drug testing requirements.--
                    (A) Prohibited act.--Section 402(a) of the 
                Controlled Substances Act (21 U.S.C. 842(a)) is 
                amended--
                            (i) in paragraph (14), by striking ``or'' 
                        at the end;
                            (ii) in paragraph (15), by striking the 
                        period at the end and inserting ``; or''; and
                            (iii) by inserting after paragraph (15) the 
                        following:
            ``(16) who is a registrant to fail to comply with the 
        requirements under section 303(i) (relating to criminal 
        background checks and drug testing);''.
                    (B) Maximum civil penalty of $10,000.--Subsection 
                (c)(1)(B) of the Controlled Substances Act (21 U.S.C. 
                842(c)(1)(B)) is amended by striking ``paragraph (5) or 
                (10)'' and inserting ``paragraph (5), (10), or (16)''.
            (4) Regulations, guidance.--The Attorney General of the 
        United States shall finalize such regulations and guidance as 
        the Attorney General deems necessary to carry out the 
        amendments made by this subsection.
            (5) Applicability.--The amendments made by this subsection 
        shall apply beginning on the date that is 2 years after the 
        date of enactment of this Act.
    (c) Opportunity To Submit Corrective Action Plan Prior to 
Revocation or Suspension.--Section 304(c) of the Controlled Substances 
Act (21 U.S.C. 824(c)) is amended--
            (1) by striking ``(c) Before'' and inserting ``(c)(1) 
        Before''; and
            (2) by adding at the end the following:
    ``(2) Before revoking or suspending a registration pursuant to 
section 303, the Attorney General shall--
            ``(A) provide--
                    ``(i) notice to the registrant of the grounds for 
                revocation or suspension; and
                    ``(ii) in the case of any such grounds consisting 
                of a violation of law, a specific citation to such law;
            ``(B) give the registrant an opportunity to submit a 
        corrective action plan within a reasonable period of time to 
        demonstrate how the registrant plans to correct the grounds for 
        revocation or suspension; and
            ``(C) determine whether--
                    ``(i) in light of the plan, revocation or 
                suspension proceedings should be discontinued or 
                deferred; or
                    ``(ii) additional changes need to be made in the 
                corrective action plan.''.

SEC. 3. COMBATING PRESCRIPTION DRUG ABUSE WORKING GROUP.

    (a) Establishment.--There is established the Combating Prescription 
Drug Abuse Working Group (referred to in this section as the ``Working 
Group'').
    (b) Membership.--
            (1) Appointment.--
                    (A) In general.--Not later than 180 days after the 
                date of the enactment of this Act, the President shall 
                appoint each member of the Working Group.
                    (B) Composition.--The Working Group shall be 
                composed of not more than 20 members and shall include 
                at least 1 and not more than 3 of each of the 
                following:
                            (i) Public policy experts.
                            (ii) Representatives of the Drug 
                        Enforcement Administration.
                            (iii) Representatives of the Food and Drug 
                        Administration.
                            (iv) Representatives of the Office of 
                        National Drug Control Policy.
                            (v) Representatives of patient groups.
                            (vi) Representatives of pharmacies.
                            (vii) Representatives of manufacturers of 
                        drugs.
                            (viii) Representatives of wholesale 
                        distributors of drugs.
                            (ix) Representatives of hospitals, 
                        physicians, and other health care providers.
                            (x) Representatives of State attorneys 
                        general.
                            (xi) Representatives of law enforcement 
                        officials, including local law enforcement 
                        officials.
                            (xii) Representatives of health benefits 
                        plans and entities that provide pharmacy 
                        benefits management services on behalf of a 
                        health benefits plans.
            (2) Co-chairs.--The co-chairs shall be elected by the 
        members of the Working Group. The Working Group shall select 
        for election from the members of the Group two individuals, of 
        whom--
                    (A) one shall be a representative of the Federal 
                Government or a State government; and
                    (B) one shall be a representative of a non-
                governmental entity.
            (3) Term; vacancies.--Each member shall be appointed for 
        the life of the Working Group. Any vacancy in the Working Group 
        shall not affect the powers of the Working Group and shall be 
        filled in the same manner in which the original appointment was 
        made.
            (4) Pay prohibited.--Members of the Working Group shall 
        serve without pay.
    (c) Meetings.--The Working Group shall meet at the call of the co-
chairs. The Working Group shall conduct at least two public meetings, 
at which the Working Group shall provide opportunity for public 
comment.
    (d) Duties of the Working Group.--
            (1) In general.--The Working Group shall--
                    (A) review and report to Congress on Federal 
                initiatives with respect to efforts to reduce 
                prescription drug diversion and abuse;
                    (B) identify gaps and opportunities with respect to 
                ensuring the safe use of prescription drugs with the 
                potential for diversion and abuse;
                    (C) examine recommendations to transfer one or more 
                controlled substances from schedule III to schedule II 
                under the Controlled Substances Act (21 U.S.C. 801 et 
                seq.) to evaluate--
                            (i) the effectiveness of such a transfer in 
                        reducing diversion and abuse; and
                            (ii) any effect of such a transfer on 
                        access to prescription drugs for legitimate 
                        medical purposes; and
                    (D) make recommendations on specific ways to reduce 
                the diversion and abuse of prescription drugs.
            (2) Report.--
                    (A) In general.--Not later than one year after the 
                date of the enactment of this Act, the Working Group 
                shall issue a report to Congress that describes the 
                efforts of the Working Group to prevent or reduce 
                prescription drug diversion and abuse to ensure that 
                patients continue to have access to medications.
                    (B) Recommendations.--The report described in 
                subparagraph (A) shall include specific recommendations 
                for the Drug Enforcement Administration, the Food and 
                Drug Administration, and other Federal and State 
                agencies, as appropriate, and shall address the 
                following topics:
                            (i) Systems for prescription drug 
                        monitoring.
                            (ii) Illegal prescription drug Internet 
                        sites and facilities that distribute and fill 
                        prescriptions indiscriminately.
                            (iii) Facilitating proper disposal of 
                        prescription drugs.
                            (iv) Identifying active geographic areas in 
                        which prescription drug abuse is prevalent.
                            (v) Ensuring access to prescription drugs 
                        for legitimate medical purposes.
                            (vi) Improving collaboration among Federal 
                        agencies, especially the Drug Enforcement 
                        Administration and the Food and Drug 
                        Administration, for purposes of coordinating 
                        prevention and enforcement efforts to reduce 
                        prescription drug diversion and abuse.
                            (vii) Improving collaboration among Federal 
                        agencies and State agencies for purposes of 
                        coordinating prevention and enforcement efforts 
                        to reduce prescription drug diversion and 
                        abuse.
                            (viii) The resource needs for law 
                        enforcement with respect to prescription drug 
                        abuse.
                            (ix) The need for education of providers, 
                        patients, parents, and youth on prescription 
                        drug abuse.
                            (x) Development of abuse-resistant 
                        prescription drug products.
                            (xi) Recommendations for reducing 
                        robberies, burglaries, and cargo theft of 
                        prescription drugs.
    (e) Powers of the Working Group.--
            (1) Hearings.--The Working Group may, for the purpose of 
        carrying out this section, hold hearings, sit and act at times 
        and places, take testimony, and receive evidence as the Working 
        Group considers necessary.
            (2) Information from federal agencies.--The Working Group 
        may secure directly from any Federal department or agency such 
        information as the Working Group considers necessary to carry 
        out this section. Upon the request of the co-chairs of the 
        Working Group, the head of such department or agency shall 
        furnish such information to the Working Group in a timely 
        manner.
    (f) Termination of the Working Group.--The Working Group shall 
terminate two years after the date on which the members are appointed 
under subsection (b).