[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1191 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 1191

   To amend the Controlled Substances Act to provide for disposal of 
 controlled substances by ultimate users and care takers through State 
   take-back disposal programs, to amend the Federal Food, Drug, and 
Cosmetic Act to prohibit recommendations on drug labels for disposal by 
                   flushing, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 25, 2009

    Mr. Inslee (for himself, Mr. Moran of Virginia, Mr. Dicks, Mr. 
Blumenauer, and Mr. Gene Green of Texas) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
    addition to the Committee on the Judiciary, 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 amend the Controlled Substances Act to provide for disposal of 
 controlled substances by ultimate users and care takers through State 
   take-back disposal programs, to amend the Federal Food, Drug, and 
Cosmetic Act to prohibit recommendations on drug labels for disposal by 
                   flushing, 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 ``Safe Drug Disposal Act of 2009''.

SEC. 2. STATE TAKE-BACK DISPOSAL PROGRAMS.

    (a) In General.--Part C of the Controlled Substances Act (21 U.S.C. 
821 et seq.) is amended by adding at the end the following:

``SEC. 312. STATE TAKE-BACK DISPOSAL PROGRAMS.

    ``(a) In General.--Not later than 1 year after the date of the 
enactment of this section, the Attorney General shall promulgate 
regulations to authorize an ultimate user or care taker to dispose of a 
controlled substance in accordance with a State program described in 
subsection (b).
    ``(b) State Programs.--
            ``(1) Models; individualized programs.--The regulations 
        under subsection (a) shall--
                    ``(A) include 5 model State programs under which an 
                ultimate user or care taker may dispose of an unused or 
                partially used controlled substance through delivery to 
                a designated facility; and
                    ``(B) allow a State to work with the Attorney 
                General to devise an alternative program for such 
                disposal that--
                            ``(i) best suits the State; and
                            ``(ii) as determined by the Attorney 
                        General, is consistent with this section.
            ``(2) Requirements.--Each program under paragraph (1) 
        shall--
                    ``(A) require a State to enact legislation as a 
                prerequisite to adopting and implementing such program;
                    ``(B) protect the public safety;
                    ``(C) allow ultimate users and care takers to 
                dispose of controlled substances through persons other 
                than law enforcement personnel;
                    ``(D) incorporate environmentally sound practices 
                for disposing of controlled substances (by means other 
                than flushing down a public or private wastewater 
                treatment system or disposing in a municipal solid 
                waste landfill);
                    ``(E) be cost effective for the State;
                    ``(F) include convenient take-back options for 
                urban and rural locations; and
                    ``(G) not restrict the funding which a State may 
                use to implement the program.
            ``(3) Other drugs and biologics.--A program under paragraph 
        (1) may, at the State's option, apply to a drug or biological 
        product other than a controlled substance to the same extent 
        and in the same manner as such program applies to a controlled 
        substance. For purposes of this paragraph, the terms `drug' and 
        `biological product' have the meanings given to those terms in 
        section 201 of the Federal Food, Drug, and Cosmetic Act and 
        section 351 of the Public Health Service Act, respectively.
    ``(c) Definition.--In this section, the term `care taker'--
            ``(1) means a person responsible for taking care of one or 
        more individuals or animals, including through provision of 
        controlled substances; and
            ``(2) may include a physician or other health care 
        professional, a veterinarian, a long-term care facility, a 
        nursing home, a hospital, a jail, or a school.''.
    (b) GAO Report.--The Comptroller General of the United States 
shall--
            (1) collect data on the State take-back disposal programs 
        implemented pursuant to section 312 of the Controlled 
        Substances Act, as added by subsection (a); and
            (2) not less than every 4 years, submit findings and 
        recommendations to the Congress regarding such programs.
    (c) Conforming Amendment.--The table of contents for the 
Comprehensive Drug Abuse Prevention and Control Act of 1970 (Public Law 
91-513; 84 Stat. 1236) is amended by inserting after the item relating 
to section 311 the following:

``Sec. 312. State take-back disposal programs.''.

SEC. 3. NO LABELING RECOMMENDATIONS TO DISPOSE OF DRUGS AND BIOLOGICAL 
              PRODUCTS BY FLUSHING.

    (a) Drugs.--Section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) is amended by adding at the end the following:
    ``(w) No Labeling Recommendations To Dispose by Flushing.--In 
approving an application for a drug under this section, the Secretary 
shall ensure that the labeling for such drug does not include any 
recommendation or direction to dispose of the drug by means of a public 
or private wastewater treatment system, such as by flushing down the 
toilet.''.
    (b) Biological Products.--Section 351 of the Public Health Service 
Act (42 U.S.C. 262) is amended by adding at the end the following:
    ``(k) No Labeling Recommendations To Dispose by Flushing.--In 
licensing any biological product under this section, the Secretary 
shall ensure that the labeling for such product does not include any 
recommendation or direction to dispose of the product by means of a 
public or private wastewater treatment system, such as by flushing down 
the toilet.''.
    (c) Drugs and Biological Products Already Marketed.--
            (1) Labeling revision.--With respect to drugs and 
        biological products that are legally marketed under the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) or part F 
        of title III of the Public Health Service Act (42 U.S.C. 262 et 
        seq.) as of the date of the enactment of this Act, the 
        Secretary of Health and Human Services, acting through the 
        Commissioner of Food and Drugs--
                    (A) shall conduct a review of the labeling of such 
                drugs and biological products; and
                    (B) for any such labeling that includes a 
                recommendation or direction to dispose of the drug or 
                biological product by means of a public or private 
                wastewater treatment system, such as by flushing down 
                the toilet, shall order the labeling to be revised to 
                exclude such recommendation or direction.
            (2) Penalty.--Any drug or biological product whose labeling 
        is in violation of an order issued under paragraph (1)(B) is 
        deemed to be misbranded under section 502 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 352).
            (3) Effective date.--An order issued under paragraph (1)(B) 
        shall take effect not later than 1 year after the date of the 
        enactment of this Act.
            (4) Definitions.--In this subsection:
                    (A) The term ``biological product'' has the meaning 
                given such term in section 351 of the Public Health 
                Service Act (42 U.S.C. 262).
                    (B) The terms ``drug'' and ``labeling'' have the 
                meanings given such terms in section 201 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 321).
                                 <all>