[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2939 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 2939

       To provide for the disposal of drugs pursuant to national 
      pharmaceutical stewardship programs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 15, 2011

Ms. Slaughter introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
   Ways and Means, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
       To provide for the disposal of drugs pursuant to national 
      pharmaceutical stewardship programs, 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 ``Pharmaceutical Stewardship Act of 
2011''.

SEC. 2. NATIONAL PHARMACEUTICAL STEWARDSHIP PROGRAMS.

    (a) Required Participation.--Each manufacturer and brand owner of a 
drug marketed in the United States shall participate in--
            (1) the certified national pharmaceutical stewardship 
        program of the National Pharmaceutical Stewardship 
        Organization; or
            (2) another certified national pharmaceutical stewardship 
        program.
    (b) National Pharmaceutical Stewardship Organization.--
            (1) Establishment.--There shall be established in 
        accordance with this section a nonprofit private corporation to 
        be known as the National Pharmaceutical Stewardship 
        Organization. The Organization shall not be an agency or 
        instrumentality of the Federal Government, and officers, 
        employees, and members of the board of the Organization shall 
        not, by virtue of such service, be considered officers or 
        employees of the Federal Government.
            (2) Purpose.--The purpose of the Organization shall be to 
        establish and, not later than 2 years after the date of the 
        enactment of this Act, begin implementation of a certified 
        national pharmaceutical stewardship program.
            (3) Board of directors.--The Organization shall have a 
        board of directors including representatives of manufacturers 
        and brand owners of drugs and public health stakeholders. The 
        Administrator shall appoint the initial members of the board of 
        directors.
            (4) Bylaws.--The board of directors shall establish the 
        general policies of the Organization for carrying out the 
        purpose described in paragraph (2), including the establishment 
        of the bylaws of the Organization. The board of directors shall 
        ensure that the bylaws of the Organization include bylaws for 
        the following:
                    (A) Entering into contracts and agreements with 
                service providers and entities as necessary, useful, or 
                convenient to provide all or portions of the national 
                pharmaceutical stewardship program of the Organization.
                    (B) Taking any legal action necessary or proper for 
                the recovery of an assessment for, on behalf of, or 
                against manufacturers or brand owners of a drug 
                participating in such program.
                    (C) Performing such other functions as may be 
                necessary or proper to carry out the purpose described 
                in paragraph (2).
                    (D) Ensuring that the members of the board of 
                directors serve without compensation, but are entitled 
                to reimbursement (solely from the funds of the 
                Organization) for expenses (other than meal or travel 
                expenses) incurred in the discharge of their duties as 
                members of the board of directors.
                    (E) Ensuring that the Organization does not use any 
                State or local government funds to carry out the 
                purpose described in paragraph (2).
                    (F) Allowing the Administrator--
                            (i) to audit the activities of the 
                        Organization as the Administrator deems 
                        necessary; and
                            (ii) to access any facilities or property 
                        of the Organization as the Administrator deems 
                        necessary to conduct inspections or investigate 
                        complaints.
            (5) Nonprofit status.--In carrying out the purpose 
        described in paragraph (2), the board of directors shall 
        establish such policies and bylaws under paragraph (4) as may 
        be necessary to ensure that the Organization maintains its 
        status as an organization that--
                    (A) is described in subsection (c)(3) of section 
                501 of the Internal Revenue Code of 1986; and
                    (B) is, under subsection (a) of such section, 
                exempt from taxation.
            (6) Contributions to national pharmaceutical stewardship 
        organization not treated as charitable contributions.--A 
        contribution by a manufacturer or brand owner of a drug to the 
        Organization or the Organization's national pharmaceutical 
        stewardship program shall not be treated as a charitable 
        contribution for purposes of section 170 of the Internal 
        Revenue Code of 1986.
            (7) Articles of incorporation.--The Administrator shall 
        ensure that the initial articles of incorporation of the 
        Organization are properly filed not later than 60 days after 
        the date of the enactment of this Act.
    (c) Program Requirements.--To be certified under subsection (f) or 
(g), a program shall meet each of the following:
            (1) The program is operated pursuant to an agreement among 
        the manufacturers and brand owners of drugs participating in 
        the program.
            (2) Subject to subsection (d), the costs of the program are 
        fully paid by such manufacturers and brand owners.
            (3) The program is developed with input from the public, 
        including an opportunity for public comment and at least one 
        public hearing.
            (4) The program provides a system to facilitate the 
        collection and disposal of any drug that--
                    (A) is delivered to the program by an individual in 
                the United States; and
                    (B) is household waste as defined under the 
                implementing regulations of subtitle C of title II of 
                the Solid Waste Disposal Act (42 U.S.C. 6901 et seq.; 
                commonly referred to as the ``Resource Conservation and 
                Recovery Act'').
            (5) Collection and disposal of a drug through the program's 
        system (described in paragraph (4)) occurs in a manner that--
                    (A) is safe and secure;
                    (B) results in incineration of the drug in 
                accordance with the hazardous waste incineration 
                requirements under subtitle C of title II of the Solid 
                Waste Disposal Act (42 U.S.C. 6901 et seq.);
                    (C) protects patient information;
                    (D) is accessible in every State, county, and city 
                or town, including--
                            (i) at least one collection site in every 
                        county of every State and one collection site 
                        in every city with a population of more than 
                        10,000 individuals on an ongoing, year-round 
                        basis; or
                            (ii) if collection is not feasible in a 
                        specific county or city, provision of prepaid 
                        mailing envelopes to individuals in such county 
                        or city for such collection and disposal; and
                    (E) in the case of a controlled substance, is 
                consistent with section 302(g) of the Controlled 
                Substances Act (21 U.S.C. 822(g)).
            (6) The program shall not impose any fee on individuals for 
        delivery or disposal of a drug through the program.
            (7) The program promotes the collection and disposal of 
        drugs through the program.
            (8) The program ensures that options for collection and 
        disposal of drugs through the program are widely understood by 
        customers, pharmacists, retailers, and health care 
        practitioners including doctors and other prescribers, 
        including by--
                    (A) maintaining a toll-free telephone number and a 
                Web site publicizing such collection and disposal 
                options;
                    (B) preparing educational and outreach materials--
                            (i) describing where and how to dispose of 
                        drugs through the program; and
                            (ii) addressing the risks of diversion of 
                        drugs and the importance of awareness about 
                        safe storage and disposal of drugs; and
                    (C) providing such materials to pharmacies, health 
                care facilities, and other interested parties for 
                dissemination.
            (9) The program--
                    (A) annually evaluates the effectiveness of its 
                educational and outreach activities under paragraph 
                (7); and
                    (B) at least every 4 years, includes in such 
                evaluation--
                            (i) the percentage of residents of the 
                        United States who are aware of the program; and
                            (ii) the extent to which residents of the 
                        United States find the program to be 
                        convenient.
    (d) Mechanism for Transfer of Costs Among Manufacturers and Brand 
Owners.--To be certified under subsection (f) or (g), a program shall 
include a mechanism that--
            (1) provides for receiving and transferring funds among all 
        certified national pharmaceutical stewardship programs in such 
        amounts as may be necessary to ensure that the manufacturers 
        and brand owners of drugs participating in such programs bear 
        the costs of such programs in proportion to the market shares 
        of their respective drugs; and
            (2) is specified in a written agreement among all 
        manufacturers and brand owners of drugs.
    (e) Program Reporting Requirements.--
            (1) In general.--To be certified under subsection (f) or 
        (g), a program shall agree to submit a report to the 
        Environmental Protection Agency by not later than January 1st 
        of the first calendar year following such certification, and 
        annually thereafter.
            (2) Contents.--Each report submitted by a program under 
        paragraph (1) shall describe the program's activities during 
        the preceding calendar year, including at a minimum--
                    (A) a specification of the amount, by weight, of 
                drugs collected through the program, including the 
                amount by weight from each collection method used;
                    (B) an identification of any safety or security 
                problems which occurred during collection, 
                transportation, or disposal of drugs during the 
                preceding calendar year and a description of the 
                changes which have or will be made to policies, 
                procedures, or tracking mechanisms to alleviate any 
                such problems and to improve safety and security in the 
                future;
                    (C) a description of the educational and outreach 
                activities under subsection (c)(8);
                    (D) a description of how collected packaging was 
                recycled to the extent feasible, including the 
                recycling facility or facilities used; and
                    (E) the total expenditures of the program and a 
                statement on whether the program foresees a need for 
                adjustment of the total annual cost responsibility 
                under subsection (d) of manufacturers and brand owners 
                participating in the program as a result of changes in 
                volumes of collected drugs or other costs.
            (3) Procedures.--The Administrator shall establish 
        procedures for reporting under this subsection not later than 
        the date that is one year after the date of the enactment of 
        this Act.
            (4) Public availability.--The Administrator shall make each 
        report submitted under this subsection available to the public.
    (f) Certification of National Pharmaceutical Stewardship 
Organization's Program.--
            (1) Application.--To seek certification of its program, the 
        Organization shall submit an application to the Administrator 
        containing such information as the Administrator may require.
            (2) Consideration by administrator.--Upon receipt of an 
        application under paragraph (1), the Administrator--
                    (A) shall consult with the Administrator of the 
                Drug Enforcement Agency on the adequacy of the proposed 
                program's security measures for collection, 
                transportation, and disposal of drugs, disposal 
                systems, and mechanisms for secure tracking and 
                handling; and
                    (B) within 90 days after receipt of the 
                application, shall--
                            (i) certify the program if the 
                        Administrator determines it meets the 
                        requirements of this section; or
                            (ii) reject the proposed program and 
                        provide a written explanation of the reasons 
                        for such rejection.
            (3) Response to rejection of proposed program.--If the 
        Administrator rejects the Organization's proposed program under 
        paragraph (2)(B)(ii), the rejection shall be treated as final 
        agency action, and the Organization may--
                    (A) revise its proposed program and submit a new 
                application under paragraph (1); or
                    (B) seek judicial review of the rejection not later 
                than 60 days after receiving notice of the rejection.
            (4) Solicitation of public comment to inform program 
        updates.--
                    (A) In general.--A certified national product 
                stewardship program shall--
                            (i) annually invite comments from health 
                        care facilities, health care practitioners, 
                        pharmacists, State and local governments, law 
                        enforcement personnel, and citizens on their 
                        satisfaction with the services provided by the 
                        program;
                            (ii) compile and submit the information 
                        received through such comments to the 
                        Administrator; and
                            (iii) use such information in developing 
                        updates and changes to the program.
                    (B) Use by administrator.--The Administrator shall 
                use information submitted under subparagraph (A)(ii) in 
                reviewing proposed updates and revisions to certified 
                national pharmaceutical stewardship programs.
                    (C) Guidance.--The Administrator shall issue 
                guidance on the process for complying with this 
                paragraph.
            (5) Term of certification; updates.--The term of a 
        certification under paragraph (2)(B)(i) shall be not more than 
        4 years. Not less than every 4 years, a new application, 
        including any relevant updates to the certified national 
        pharmaceutical stewardship program, shall be submitted under 
        paragraph (1) and approved under paragraph (2)(B)(i) in order 
        for a program's certification under this subsection to remain 
        in effect.
            (6) Changes to certified program.--
                    (A) In general.--Before making any significant 
                change to its certified national pharmaceutical 
                stewardship program, the Organization shall seek and 
                obtain approval for the change from the Administrator. 
                Not later than 15 days after submission of a request 
                for a change under the preceding sentence, the 
                Administrator shall approve the change or reject the 
                change and provide a written explanation of the reasons 
                for the rejection.
                    (B) Changes to collection locations.--Not less than 
                15 days after making any change to a location for the 
                collection of drugs through its certified national 
                pharmaceutical stewardship program, the Organization 
                shall inform the Administrator of the change.
            (7) Submission requirements.--
                    (A) Publication.--Not later than 6 months after the 
                date of the enactment of this Act, the Administrator 
                shall publish requirements for the submission of 
                applications under paragraph (1) and requests for 
                changes under paragraph (6), including requirements for 
                the contents of such submissions.
                    (B) Failure to publish.--If the Administrator fails 
                to publish such requirements by the deadline specified 
                in subparagraph (A), the requirements of this section 
                applicable to manufacturers and brand owners of drugs 
                shall nonetheless apply.
    (g) Certification of Other Programs.--
            (1) Application.--In lieu of participating in the certified 
        national pharmaceutical stewardship program of the 
        Organization, one or more manufacturers or brand owners of a 
        drug may submit an application to the Administrator seeking 
        certification of a separate national pharmaceutical stewardship 
        program.
            (2) Governing provisions.--The provisions of subsection (f) 
        shall apply with respect to an application for certification of 
        a program under paragraph (1) to the same extent and in the 
        same manner as such provisions apply to an application for 
        certification of a program by the Organization under subsection 
        (e), except as follows:
                    (A) The reference to 90 days in subsection 
                (f)(2)(B) (relating to the period of the 
                Administrator's review of an application) shall be 
                treated as a reference to 120 days.
                    (B) If the Administrator rejects the proposed 
                program, in lieu of submitting a new application under 
                paragraph (1) or seeking judicial review of the 
                rejection, the manufacturers or brand owners may choose 
                to participate in the certified national pharmaceutical 
                stewardship program of the Organization.
                    (C) The references to 4 years in subsection (f)(5) 
                (relating to the term of certification and to 
                submission of a new application) shall be treated as 
                references to 3 years.
    (h) Process To Change Disposal Mechanism.--
            (1) Petitions.--On petition by any person, the 
        Administrator may authorize a national pharmaceutical 
        stewardship program to use, in lieu of the disposal 
        technologies otherwise required by subsection (c)(5)(B), one of 
        more other disposal technologies described in paragraph (2).
            (2) Required levels of protection.--The Administrator may 
        authorize the use of a disposal technology under paragraph (1) 
        only if the technology--
                    (A) is proven, available, and consistent with 
                Federal and State legal requirements; and
                    (B) provides equivalent environmental and human 
                health protection in each, and superior environmental 
                and human health protection in one or more, of the 
                following areas:
                            (i) Monitoring of any emissions or waste.
                            (ii) Worker health and safety.
                            (iii) Air, water, or land emissions 
                        contributing to persistent, bioaccumulative, 
                        and toxic pollution.
                            (iv) Overall impact to the environment and 
                        human health.
    (i) Suspension of Program.--
            (1) Imminent danger.--The Administrator may suspend, in 
        whole or in part, the certification of any national 
        pharmaceutical stewardship program if the Administrator 
        determines that such action is necessary to protect the public 
        from imminent danger.
            (2) Failure to comply.--If the Administrator determines 
        that a national pharmaceutical stewardship is in violation of 
        the requirements of this section, the Administrator--
                    (A) may issue a written warning to the program 
                stating that the program is in violation of this 
                section; and
                    (B) if the program has not rectified each violation 
                identified in such warning within 30 days of receipt of 
                such warning, may suspend, in whole or in part, the 
                certification of the program.
    (j) Civil Penalties.--Beginning on the date that is 2 years after 
the date of the enactment of this Act, a manufacturer or brand owner of 
a drug shall be liable for a civil penalty of not more than $50,000 for 
each calendar day on which, as determined by the Administrator, the 
manufacturer or brand owner--
            (1) is not participating in a certified national 
        pharmaceutical program; or
            (2) is in violation of its obligation to contribute to the 
        costs of such a program under subsection (c)(2).
    (k) Regulatory Power.--The Administrator may adopt rules or 
guidance necessary to implement, administer, and enforce this section. 
The Administrator, in consultation with the Secretary of Health and 
Human Services, the Administrator of the Drug Enforcement Agency, the 
Director of National Drug Control Policy, and the Commissioner of Food 
and Drugs, may include in such regulations or guidance any performance 
standards determined appropriate for implementing the program 
requirements specified in this section.
    (l) State, Tribal, and Local Regulation.--This section does not 
preempt the authority of State, tribal, and local governments to impose 
more stringent requirements relating to the disposal of drugs.
    (m) Report to Congress.--By December 31, 2016, the Environmental 
Protection Agency shall report to the appropriate committees of the 
Congress concerning the status of the national pharmaceutical 
stewardship programs under this section, including any recommendations 
for changes to this section.
    (n) Severability.--If any provision of this section or the 
application of such provision to any person or circumstance is held to 
be unconstitutional, the remainder of this section, and the application 
of the provisions of such remainder to any person or circumstance, 
shall not be affected thereby.
    (o) Definitions.--In this section:
            (1) The term ``Administrator'' means the Administrator of 
        the Environmental Protection Agency.
            (2) The term ``board of directors'' means the board of 
        directors of the Organization.
            (3) The term ``brand owner'', with respect to a drug, means 
        the holder of an approved application for the drug under 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355).
            (4) The term ``certified national pharmaceutical 
        stewardship program'' means a national pharmaceutical 
        stewardship program with a certification in effect under 
        subsection (f) or (g).
            (5) The term ``controlled substance'' has the meaning given 
        to such term in section 102 of the Controlled Substances Act 
        (21 U.S.C. 802).
            (6) The term ``drug'' has the meaning given to such term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321) except that such term excludes any drug for which a 
        take-back program is in effect pursuant to a risk evaluation 
        and mitigation strategy under section 505-1 of such Act (21 
        U.S.C. 355-1).
            (7) The term ``Organization'' means the National 
        Pharmaceutical Stewardship Organization established in 
        accordance with subsection (b).
    (p) Fees.--The Administrator may assess and collect fees from 
manufacturers and brand owners of drugs to pay the administrative costs 
of carrying out this section. The Administrator shall allocate such 
fees among manufacturers and brand owners in proportion to the market 
shares of their respective drugs.
    (q) Authorization of Appropriations.--
            (1) In general.--There is authorized to be appropriated to 
        the Environmental Protection Agency $8,000,000 for fiscal year 
        2012 and each subsequent fiscal year to pay the administrative 
        costs of carrying out this section, including the costs of 
        certifying, evaluating, and auditing national pharmaceutical 
        stewardship programs under this section.
            (2) Source of funds.--Amounts authorized to be appropriated 
        pursuant to paragraph (1) shall be derived exclusively from 
        amounts collected as civil penalties under subsection (j) or 
        fees under subsection (p).

SEC. 3. EDUCATION CAMPAIGN ON DRUG DISPOSAL; EVALUATION OF NATIONAL 
              PHARMACEUTICAL STEWARDSHIP PROGRAM.

    (a) Education and Outreach Campaign.--Not later than 18 months 
after the date of the enactment of this Act, the Director of National 
Drug Control Policy, in consultation with the Secretary of Health and 
Human Services and the Administrator of the Environmental Protection 
Agency, shall establish and begin implementation of an education and 
outreach campaign--
            (1) to increase awareness among members of the public 
        regarding how drugs may be lawfully disposed consistent with 
        public safety, public health, and environmental protection 
        through national pharmaceutical stewardship programs under 
        section 2 and by other appropriate means; and
            (2) to link members of the public to the national and local 
        educational and outreach activities conducted by such programs.
    (b) Evaluation.--
            (1) In general.--Not later than 2 years after the date of 
        the enactment of this Act, and annually thereafter, the 
        Director of National Drug Control Policy, in consultation with 
        the Secretary of Health and Human Services and the 
        Administrator of the Environmental Protection Agency, shall 
        conduct an evaluation of the effectiveness of the national 
        pharmaceutical stewardship programs under section 2 and submit 
        a report to the Congress on the results of each such 
        evaluation, including recommendations for improving the 
        programs.
            (2) Metrics.--The evaluation under paragraph (1) shall 
        address each of the following:
                    (A) Access to national pharmaceutical stewardship 
                programs under section 2.
                    (B) Awareness of such programs, including awareness 
                of the risks of diversion of drugs and awareness of the 
                importance of safe storage and safe disposal of 
                pharmaceuticals.

SEC. 4. COMMISSION ON DRUG DISPOSAL AND ITS PUBLIC SAFETY, PUBLIC 
              HEALTH, AND ENVIRONMENTAL IMPACTS.

    (a) Establishment.--The Administrator of the Environmental 
Protection Agency shall establish an interagency commission, to be 
known as the Commission on Drug Disposal and its Public Safety, Public 
Health, and Environmental Impacts (in this section referred to as the 
``Commission'').
    (b) Membership.--The members of the Commission shall include the 
following:
            (1) The Administrator of the Environmental Protection 
        Agency.
            (2) The Director of the Centers for Disease Control and 
        Prevention.
            (3) The Director of the National Institute of Environmental 
        Health Sciences.
            (4) The Administrator of the Drug Enforcement 
        Administration.
            (5) The Commissioner of Food and Drugs.
            (6) The Secretary of Veterans Affairs.
            (7) The Administrator of the Centers for Medicare & 
        Medicaid Services.
            (8) The Director of National Drug Control Policy.
            (9) Any other Federal official with relevant expertise 
        appointed or invited to serve on the Commission by the 
        Administrator of the Environmental Protection Agency.
            (10) Such individuals with expertise in public health, 
        public safety, or the environment as may be appointed to serve 
        on the Commission by the Administrator of the Environmental 
        Protection Agency.
            (11) Such State and local officials and other stakeholders 
        as may be invited to serve on the Commission by the 
        Administrator of the Environmental Protection Agency.
    (c) Duties.--The Commission shall--
            (1) provide a forum for academic, governmental, and other 
        experts, as appropriate, to develop a strategy to--
                    (A) prevent the entry of drugs into the Nation's 
                water supply and environment consistent with current 
                public safety standards; and
                    (B) protect public health and promote public safety 
                by reducing diversion and the risk of abuse and 
                accidental overdose; and
            (2) not later than 2 years after the date of the enactment 
        of this Act, and annually thereafter, develop and submit to the 
        Congress such a strategy.
    (d) Strategy.--
            (1) Contents.--The strategy required by subsection (c) 
        shall--
                    (A) assess risk hazards and strategies for reducing 
                the risks associated with misuse of prescription drugs, 
                including diversion, overdose, and accidental 
                poisoning;
                    (B) address all sources of contamination, including 
                development, manufacturing, disposal, and metabolic 
                processing;
                    (C) include recommendations on minimum 
                environmental standards for disposing of drugs by 
                incineration and any other means determined appropriate 
                by the Administrator of the Environmental Protection 
                Agency; and
                    (D) be designed to inform the regulations and 
                guidance of the Environmental Protection Agency.
            (2) Consideration.--In preparing the strategy required by 
        subsection (c), the Commission shall take into consideration 
        the analysis and recommendations in the report under section 5.
    (e) Termination.--The Commission shall terminate on the date that 
is 5 years after the date of the enactment of this Act.

SEC. 5. REPORT ON DRUG BYPRODUCTS IN THE NATION'S WATER SUPPLY.

    (a) In General.--Not later than 1 year after the date of the 
enactment of this Act, the Comptroller General of the United States 
shall submit a report to the Congress on drugs and drug byproducts in 
surface and ground water in the United States.
    (b) Contents.--At a minimum, the report under subsection (a) shall 
include--
            (1) an analysis of--
                    (A) the quantity and distribution of drugs and drug 
                byproducts in surface and ground water in the United 
                States;
                    (B) the risks for humans and the environment 
                associated with the presence of drugs and drug 
                byproducts in such water; and
                    (C) the current efforts of Government agencies to 
                prevent the entry of drugs and drug byproducts into the 
                water supply;
            (2) recommendations for actions by the Government in order 
        to prevent the entry of drugs and drug byproducts into the 
        ground and surface waters of the United States; and
            (3) recommendations for additional research on drugs and 
        drug byproducts in surface and ground water in the United 
        States, including a budget for such research.
                                 <all>