[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 1336 Introduced in Senate (IS)]
111th CONGRESS
1st Session
S. 1336
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 SENATE OF THE UNITED STATES
June 24, 2009
Mrs. Murray introduced the following bill; which was read twice and
referred to the Committee on the Judiciary
_______________________________________________________________________
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>