75th OREGON LEGISLATIVE ASSEMBLY--2009 Regular Session
NOTE: Matter within { + braces and plus signs + } in an
amended section is new. Matter within { - braces and minus
signs - } is existing law to be omitted. New sections are within
{ + braces and plus signs + } .
LC 1209
Senate Bill 598
Sponsored by COMMITTEE ON HUMAN SERVICES AND RURAL HEALTH POLICY
SUMMARY
The following summary is not prepared by the sponsors of the
measure and is not a part of the body thereof subject to
consideration by the Legislative Assembly. It is an editor's
brief statement of the essential features of the measure as
introduced.
Requires drug manufacturers to establish pharmaceutical
take-back programs approved and regulated by Department of Human
Services. Creates Advisory Committee on Pharmaceutical Take-Back
Programs.
Establishes Pharmaceutical Take-Back Program Fund in State
Treasury. Continuously appropriates moneys in fund to department
for purpose of regulating pharmaceutical take-back programs.
Declares emergency, effective on passage.
A BILL FOR AN ACT
Relating to pharmaceutical take-back programs; appropriating
money; and declaring an emergency.
Be It Enacted by the People of the State of Oregon:
SECTION 1. { + As used in sections 1 to 9 of this 2009 Act:
(1) 'Drug' has the meaning given that term in ORS 689.005.
(2) 'Manufacturer' has the meaning given that term in ORS
689.005.
(3) 'Nonprescription drugs' has the meaning given that term in
ORS 689.005.
(4) 'Pharmaceutical take-back program' means a service that
collects and disposes of a consumer's drugs.
(5) 'Prescription drug' has the meaning given that term in ORS
689.005.
(6) 'Retail drug outlet' has the meaning given that term in ORS
689.005. + }
SECTION 2. { + (1) A manufacturer of a drug may not sell the
drug or allow the drug to be sold in this state unless the
manufacturer operates a pharmaceutical take-back program approved
by the Department of Human Services. The pharmaceutical take-back
program must:
(a) Accept prescription and nonprescription drugs presented to
the program by consumers, including residents of long term care
facilities and persons enrolled in hospice, palliative care and
home health programs;
(b) Accept all prescription and nonprescription drugs sold in
this state regardless of manufacturer;
(c) Offer pharmaceutical take-back services at no cost to the
consumer, either at the time of sale of the drug or at the time
of collection of the drug;
(d) Be convenient and adequate to serve consumers in urban and
rural areas;
(e) Dispose of collected drugs by incineration or hazardous
waste disposal;
(f) Include an education and outreach program to inform
consumers, retail drug outlets, health practitioners, county
health departments, hospitals, hospice care providers and long
term care facilities of the availability of the program; and
(g) Include a method for evaluation and improvement of the
program.
(2) A manufacturer may operate its pharmaceutical take-back
program individually or collectively with other
manufacturers. + }
SECTION 3. { + (1) A manufacturer that sells drugs in this
state shall submit a plan describing the manufacturer's proposed
pharmaceutical take-back program to the Department of Human
Services for approval. The plan must:
(a) Describe how the program meets the requirements of section
2 of this 2009 Act;
(b) Include recovery goals for the first, second and third
years of the program, expressed as pounds per capita, and a plan
for action if the recovery goals are not met;
(c) Describe the proposed method for disposal of the collected
drugs;
(d) Describe how the manufacturer will coordinate with other
manufacturers to minimize consumer confusion about different
pharmaceutical take-back programs;
(e) Meet other requirements established by rule by the
Department of Human Services; and
(f) Be accompanied by a fee determined by the department under
section 8 of this 2009 Act.
(2) The Department of Human Services shall review the disposal
proposal in the plan in consultation with the Department of
Environmental Quality.
(3) Within 60 days after a manufacturer submits a plan under
subsection (1) of this section, the Department of Human Services
shall approve or reject the plan. If the plan is rejected, the
department shall provide the manufacturer with a written
statement of the reasons for the rejection, and the manufacturer
may submit a revised plan within 60 days of the date of the
written statement of rejection. The department shall approve or
reject the revised plan within 60 days of its submission.
(4) A manufacturer shall submit an updated plan to the
department annually, on or before the anniversary of the approval
of the original plan. The Department of Human Services shall
review the disposal proposal in the updated plan in consultation
with the Department of Environmental Quality, and shall approve
or reject the updated plan as provided in subsection (3) of this
section.
(5) If at the time the plan is due for submission to the
Department of Human Services there is no legal method for a
manufacturer to accept all prescription and nonprescription drugs
through the pharmaceutical take-back program, a manufacturer may
apply to the department for an extension of the time to submit
the plan. The department may grant an extension not to exceed one
year.
(6) The department may withdraw approval of a plan if a
manufacturer does not operate the manufacturer's pharmaceutical
take-back program in accordance with the approved plan. The
department shall comply with ORS chapter 183 in withdrawing
approval of a plan. + }
SECTION 4. { + The Department of Human Services shall adopt
rules requiring retail drug outlets to post a sign to inform
consumers of the availability of pharmaceutical take-back
programs. The department shall make an example of the sign
available on the Internet. + }
SECTION 5. { + The Department of Human Services shall
establish a full-time position to oversee pharmaceutical
take-back programs described in section 2 of this 2009 Act. + }
SECTION 6. { + In addition to any other liability or penalty
provided by law, the Director of Human Services may impose a
civil penalty on a person for violation of sections 2 to 4 of
this 2009 Act or of the rules adopted under sections 2 to 4 of
this 2009 Act. The director may impose a penalty of up to $250
for each violation. Civil penalties under this section shall be
imposed as provided in ORS 183.745. + }
SECTION 7. { + The Pharmaceutical Take-Back Program Fund is
established in the State Treasury, separate and distinct from the
General Fund. Interest earned by the Pharmaceutical Take-Back
Program Fund shall be credited to the fund. Moneys in the fund
are continuously appropriated to the Department of Human Services
for the purpose of regulating pharmaceutical take-back
programs. + }
SECTION 8. { + The Department of Human Services shall adopt
rules establishing the application fee for submission of a
pharmaceutical take-back program plan under section 3 of this
2009 Act. The application fee must be designed to recover the
cost to the department of regulating pharmaceutical take-back
programs, including the cost of funding the position established
under section 5 of this 2009 Act. + }
SECTION 9. { + Moneys received under sections 3 and 6 of this
2009 Act shall be paid into the State Treasury and credited to
the Pharmaceutical Take-Back Program Fund. + }
SECTION 10. { + (1) There is created the Advisory Committee on
Pharmaceutical Take-Back Programs, consisting of 11 members
appointed by the Director of Human Services.
(2) The term of office of each member is three years, but a
member serves at the pleasure of the director. Before the
expiration of the term of a member, the director shall appoint a
successor whose term begins immediately upon the expiration of
the term of the current member. A member is eligible for
reappointment for one additional term.
(3) The advisory committee shall advise the Department of Human
Services on issues relating to pharmaceutical take-back programs.
(4) A majority of the members of the advisory committee
constitutes a quorum for the transaction of business.
(5) Official action by the advisory committee requires the
approval of a majority of the members of the advisory committee.
(6) The advisory committee shall elect one of its members to
serve as chairperson.
(7) If there is a vacancy for any cause, the director shall
make an appointment to become immediately effective.
(8) The advisory committee shall meet at least four times per
year, at times and places specified by the call of the
chairperson or of a majority of the members of the advisory
committee.
(9) The advisory committee may adopt rules necessary for the
operation of the advisory committee.
(10) A member of the advisory committee is not entitled to
compensation, but in the discretion of the department may be
reimbursed from funds available to the department for actual and
necessary travel and other expenses incurred by the member in the
performance of the member's official duties in the manner and
amount provided in ORS 292.495.
(11) All agencies of state government, as defined in ORS
174.111, are directed to assist the advisory committee in the
performance of its duties and, to the extent permitted by laws
relating to confidentiality, to furnish such information and
advice as the members of the advisory committee consider
necessary to perform their duties. + }
SECTION 11. { + Notwithstanding the term of office specified
by section 10 (2) of this 2009 Act, of the members first
appointed to the advisory committee:
(1) Three shall serve for a term ending June 30, 2011.
(2) Four shall serve for a term ending June 30, 2012.
(3) Four shall serve for a term ending June 30, 2013. + }
SECTION 12. { + Section 2 of this 2009 Act applies to
manufacturers whose drugs are sold in this state on or after July
1, 2011. + }
SECTION 13. { + (1) Section 3 of this 2009 Act becomes
operative January 1, 2010.
(2) The Department of Human Services may take any action before
January 1, 2010, that is necessary to enable the department to
exercise, on and after January 1, 2010, all the duties, functions
and powers conferred on the department by section 3 of this 2009
Act. + }
SECTION 14. { + This 2009 Act being necessary for the
immediate preservation of the public peace, health and safety, an
emergency is declared to exist, and this 2009 Act takes effect on
its passage. + }
----------