BILL REQ. #: S-1187.3
State of Washington | 62nd Legislature | 2011 Regular Session |
READ FIRST TIME 02/08/11.
AN ACT Relating to providing safe collection and disposal of unwanted drugs from residential sources through a producer-provided and funded product stewardship program; amending RCW 69.41.030, 18.64.005, and 42.56.270; adding a new chapter to Title 70 RCW; creating a new section; and prescribing penalties.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:
NEW SECTION. Sec. 1 The legislature finds that Washington state
citizens benefit from the authorized use of prescription and over-the-counter medicines. The proper use of medicines helps to cure, treat,
and prevent diseases, and to prolong life. Failure to properly dispose
of leftover and expired medicines can lead to the illegal possession
and abuse of potentially addictive medicines by others, and to the
consumption of medicines by children and others, potentially causing
addiction, poisonings, overdoses, and other harmful health effects.
Moreover, disposing of medicines by flushing them down the toilet or
placing them in the garbage can lead to the contamination of
groundwater and other bodies of water, contributing to long-term harm
to the environment and to animal life. The legislature finds that
Washington residents need a safe method for disposal of medicines
through "take-back" programs that provide environmentally sound
disposal of medicines with effective controls against diversion. The
legislature intends that the costs of properly collecting and disposing
of leftover and expired medicines be included in the producer's
business costs, and further finds that the producers of the medicines
are best positioned to efficiently develop and operate programs for the
safe and convenient collection and disposal of unused medicines.
NEW SECTION. Sec. 2 The definitions in this section apply
throughout this chapter unless the context clearly requires otherwise.
(1) "Corporation" means the medicine return corporation established
in section 3 of this act.
(2)(a) "Covered drug" includes all legend and nonlegend drugs from
residential sources sold in any form. This includes brand name and
generic drugs.
(b) "Covered drug" does not include:
(i) Vitamins or supplement;
(ii) Herbal-based remedies and homeopathic drugs, products, or
remedies;
(iii) Cosmetics, shampoos, sunscreens, toothpaste, lip balm,
antiperspirants, or other personal care products that are regulated as
both cosmetics and nonlegend drugs under the federal food, drug, and
cosmetic act;
(iv) Drugs for which producers provide a take-back program as part
of a federal food and drug administration managed risk evaluation and
mitigation strategy (21 U.S.C. Sec. 355-1);
(v) Drugs that are biological products as defined by 21 C.F.R.
600.3(h) as it exists on the effective date of this section if the
producer already provides a take-back program; and
(vi) Pet pesticide products contained in pet collars, powders,
shampoos, topical applications, or other forms.
(3) "Drug wholesaler" means a corporation, individual, or other
entity which buys drugs or devices for resale and distribution to
corporations, individuals, or entities other than consumers.
(4) "Drugs" means:
(a) Articles recognized in the official United States
pharmacopoeia, the official national formulary, the official
homeopathic pharmacopoeia of the United States, or any supplement of
the formulary or those pharmacopoeias;
(b) Substances intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in humans or other animals;
(c) Substances, other than food, intended to affect the structure
or any function of the body of humans or other animals; or
(d) Substances intended for use as a component of any substances
specified in (a), (b), or (c) of this subsection, but not including
medical devices or their component parts or accessories.
(5) "Generic drug" means drugs that are chemically identical or
bioequivalent to a brand name drug in dosage form, safety, strength,
route of administration, quality, performance characteristics, and
intended use. However, inactive ingredients may vary.
(6) "Legend drug" means any drugs, including controlled substances
under chapter 69.50 RCW, that are required by any applicable federal or
state law or regulation to be dispensed by prescription only or are
restricted to use by practitioners only.
(7) "Nonlegend drug" means any drugs that may be lawfully sold
without a prescription.
(8) "Person" means a firm, sole proprietorship, corporation,
limited liability company, general partnership, limited partnership,
limited liability partnership, association, cooperative, or other
entity of any kind or nature.
(9) "Producer" means the person who:
(a) Has legal ownership of the brand, brand name, or cobrand of the
covered drug or manufactures a generic covered drug sold in Washington
state. "Producer" does not include a retailer who puts its store label
on a covered drug or a pharmacist who compounds a prescribed individual
drug product for a patient;
(b) Imports a covered drug branded or manufactured by a producer
that meets the definition under (a) of this subsection and has no
physical presence in the United States; or
(c) Sells at wholesale a covered drug, does not have legal
ownership of the brand, and elects to fulfill the responsibilities of
the producer for that covered drug.
(10) "Product stewardship program" means a statewide program for
the collection, transportation, and disposal of unwanted covered drugs
that is financed by the producers of those products and managed by the
corporation.
(11) "Residential sources" includes single and multiple-family
residences, and locations where household drugs are unused, unwanted,
disposed, or abandoned, such as hospice services, boarding homes,
schools, foster care, day care, and other locations where either people
or their pet animals, or both, reside on a temporary or permanent
basis. This does not include waste from hospitals, clinics,
pharmacies, airport security, drug seizures by law enforcement,
businesses, or other nonresidential or business sources identified by
the board of pharmacy.
(12) "Unwanted covered drug" means any covered drug no longer
wanted by its owner or that has been abandoned, discarded, or is
intended to be discarded by its owner.
NEW SECTION. Sec. 3 (1) The medicine return corporation is
established as a nonprofit product stewardship organization to finance
and operate a product stewardship program for the collection,
transportation, and disposal of unwanted covered drugs. Membership in
the corporation must be open to all producers of covered drugs sold in
the state and all producers of covered drugs sold in the state must
participate in the corporation's product stewardship program.
(2)(a) The corporation must be incorporated as a nonprofit
corporation under chapter 24.06 RCW. In its articles of incorporation,
the corporation must list as its purpose to devise and administer a
producer-funded product stewardship program to provide for the
collection, transportation, and disposal of unwanted covered drugs in
conjunction with the board of pharmacy and pursuant to chapter 70.---
RCW (the new chapter created in section 22 of this act).
(b) The corporation's articles of incorporation must be filed with
the secretary of state within sixty days of the effective date of this
section.
(3) The corporation is managed by a board of directors, initially
appointed by the secretary of the department of health. The board of
directors is to be composed of representatives of producers whose
covered drugs are sold in or into the state. Any producer of covered
drugs, or representative of the producers, may submit recommendations
for members of the board of directors to the secretary of the
department of health.
(a) The board of directors must include, at a minimum,
representatives of:
(i) Two branded legend drugmakers;
(ii) Two generic legend drugmakers;
(iii) Two nonlegend drugmakers; and
(iv) Two biotechnology sector drugmakers.
(b) Additionally, four members of the legislature shall serve on
the board as ex officio, nonvoting members, to be appointed as follows:
(i) One member from each of the two major caucuses in the senate,
appointed by the president of the senate; and
(ii) One member from each of the two major caucuses in the house of
representatives, appointed by the speaker of the house of
representatives.
(4) The board of directors of the corporation shall:
(a) Prepare and adopt articles of incorporation and bylaws, and
select a chair;
(b) Prepare and adopt a general plan of operation of procedures for
the corporation. The plan of operation must include procedures for
assessing costs and collecting funds from participating producers under
section 6 of this act. The plan of operation must include a dispute
mechanism through which a producer selling covered drugs in the state
may challenge an assessment determination by the board of directors,
and a mechanism by which the corporation may notify a producer selling
covered drugs in the state that is failing to participate in the
corporation and report such a producer to the board of pharmacy;
(c) By January 1, 2013, submit a proposed product stewardship
program to the board of pharmacy for review in accordance with section
4 of this act; the product stewardship program must be approved and
licensed by the board of pharmacy prior to collecting unwanted covered
drugs;
(d) By January 1, 2014, operate a product stewardship program in
accordance with this act;
(e) Enter into contracts and agreements with other service
providers and entities as necessary, useful, or convenient to provide
all or portions of the product stewardship program;
(f) Take any legal action necessary or proper for the recovery of
an assessment for, on behalf of, or against members of the corporation
or other participating persons; and
(g) Perform any other functions as may be necessary or proper to
provide the product stewardship program and to affect any or all of the
purposes for which the corporation is organized.
(5) The members of the board of directors, including ex officio,
nonvoting members, serve without compensation but are entitled to
reimbursement, solely from the funds of the corporation, for expenses
incurred in the discharge of their duties under this chapter. However,
no reimbursement may be provided for meals or travel expenses.
(6) The corporation shall provide the product stewardship program
described in this chapter without using state or local government
funds.
(7) The board of pharmacy may audit the activities of the
corporation as necessary. The board of pharmacy, department of
ecology, or department of health staff may access any facilities or
property of the corporation as necessary to conduct inspections or
investigate complaints.
NEW SECTION. Sec. 4 (1)(a) Meetings of the corporation are
subject to the open public meetings act, chapter 42.30 RCW, and must be
open and public and all persons must be permitted to attend any meeting
of the corporation. The corporation may hold executive sessions in
accordance with RCW 42.30.110 and as needed to protect producer-provided information exempt from the public records act under RCW
42.56.270(21), to evaluate the qualifications of an applicant for
employment, and to review contracts or services of service providers.
(b) Except as provided in RCW 42.56.270, records of the corporation
are subject to the public records act, chapter 42.56 RCW.
(2) In developing a proposed product stewardship program, the
corporation must provide opportunities for public comment, including at
least one public hearing. Notice of the public hearing must be
provided by the corporation to the department of health, the board of
pharmacy, the department of ecology, the Washington association of
sheriffs and police chiefs, covered drug retailers, substance abuse
professionals, local governments, solid waste professionals, water
quality professionals, and the general public.
(3) After public comment has been received and by January 1, 2013,
the corporation's proposed product stewardship program must be
submitted to the board of pharmacy for review. The board of pharmacy
shall consult with the department of ecology on any element of the
proposed program including transportation and disposal systems, secure
tracking and handling, package recycling, and public education. The
board of pharmacy must consult with the Washington association of
sheriffs and police chiefs on the adequacy of the proposed program's
security measures for collection, transportation, and disposal of
unwanted covered drugs.
(4) After the review and consultation under subsection (3) of this
section and within ninety days after receipt of the proposed product
stewardship program, the board of pharmacy must either approve or
reject the corporation's proposed product stewardship program and, if
rejected, provide reasons for rejection. If the program is rejected,
the corporation must:
(a) Submit a revised product stewardship program within sixty days
after receiving notice of the rejection; or
(b) Appeal the board of pharmacy's decision under the
administrative procedure act, chapter 34.05 RCW, within sixty days
after receiving notice of the rejection.
(5) The corporation shall annually invite comments from health care
facilities, health care practitioners, pharmacists, local governments,
law enforcement personnel, and citizens on their satisfaction with the
services provided by the product stewardship program. This information
must be used by the corporation in developing proposed product
stewardship program updates and revisions. This information must also
be provided to the board of pharmacy and must be used by the board of
pharmacy in reviewing proposed program updates and revisions.
(6) At least every four years, the corporation must update its
product stewardship program and submit the updated program to the board
of pharmacy for review using the process described in subsections (3)
and (4) of this section.
NEW SECTION. Sec. 5 The corporation's product stewardship
program, which must be developed and reviewed according to section 4 of
this act, must provide the following:
(1) A description of the proposed collection system. The
collection system for all unwanted covered drugs must be safe, secure,
and protect patient information. The collection system must be
convenient and adequately serve the needs of residents in both urban
and rural areas. The collection system must provide, at a minimum, one
drop-off collection site in all counties in the state and one drop-off
collection site in all cities with a population greater than ten
thousand, on an ongoing, year-round basis. However, if a drop-off
location cannot be arranged in a specific county or city, prepaid
mailing envelopes must be provided;
(2) In accordance with requirements stated in sections 6(6) and 7
of this act, the collection system shall incorporate drop-off
collection sites for unwanted covered drugs in existence on the
effective date of this section if they meet program requirements, and
additional collectors to improve convenience and availability of
services;
(3) A description of the handling and disposal system, including
identification of and contact information for collectors, transporters,
and waste disposal facilities in accordance with section 11 of this act
to be used by the product stewardship program;
(4) A description of how the corporation will use existing
providers of waste pharmaceutical services to the extent possible and
in accordance with section 11 of this act;
(5) A description of how covered drugs will be separated from
packaging to the extent possible to reduce transportation and disposal
costs and how drug packaging will be recycled to the extent feasible;
(6) The policies and procedures to be followed by persons in charge
of unwanted covered drugs collected pursuant to the product stewardship
program;
(7) A description of how the collected, unwanted covered drugs are
tracked through to final disposal and how safety and security is
maintained;
(8) A description of how patient information on drug packaging will
be kept secure during collection, transportation, and disposal;
(9) A description of the public education effort and communications
strategy required in section 10 of this act; and
(10) Contact information for all drug producers participating in
the corporation.
NEW SECTION. Sec. 6 (1) The corporation shall pay all
administrative and operational costs related to the product stewardship
program. Corporation costs must be financed by producers who sell
covered drugs in this state. The corporation's board of directors
shall determine a method for equitably apportioning costs among
producers whose covered drugs are sold in or into this state, and
determine the method and timing of assessment collection. Each
producer selling covered drugs in this state must be assessed and is
required to timely remit payment to the corporation for its share of
the corporation's total costs. Moneys remitted to the corporation
under this section must be retained by the corporation and used solely
for the administration and operation of the product stewardship
program. Administrative and operational costs related to the product
stewardship program include the following:
(a) Secure collection containers for the required minimum number of
collection sites described in section 5(1) of this act;
(b) Collection and transportation supplies for the required minimum
number of collection sites described in section 5(1) of this act;
(c) Mailers and mailings if a mail-back system is developed;
(d) Transportation of all collected pharmaceuticals to final
disposal, including costs of law enforcement escort if necessary;
(e) Environmentally sound disposal of all collected pharmaceuticals
under section 11 of this act;
(f) Program promotion under section 10 of this act;
(g) State agency and board of pharmacy oversight to administer and
enforce this chapter under subsection (7) of this section; and
(h) Reasonable costs for administration of the corporation, as
determined necessary by the corporation's board of directors.
(2) The corporation must submit its method for equitably
apportioning costs among producers and the method and timing of
assessment collection developed under subsection (1) of this section to
the board of pharmacy for its review or rejection. If rejected, the
corporation must:
(a) Submit revised methods within sixty days after receiving notice
of the rejection; or
(b) Appeal the board of pharmacy's decision under the
administrative procedure act, chapter 34.05 RCW, within sixty days
after receiving notice of the rejection.
(3) The corporation may, subject to board of pharmacy approval,
adjust the apportionment of costs under subsection (2) of this section
annually.
(4) The corporation's board of directors may offer incentives or
payments to collectors if necessary to ensure the product stewardship
program requirements for the minimum number of collection sites are
met, as described in section 5(1) of this act.
(5) Producers may not impose a visible fee on consumers when
covered drugs are purchased or returned.
(6) The total annual cost responsibility to the corporation,
notwithstanding any penalties or fines, may not exceed two million five
hundred thousand dollars per calendar year. This number must be
annually adjusted for inflation starting in 2012. The corporation
shall report actual annual expenditures and may comment on this limit
to the corporation's total annual cost responsibility in their annual
report to the board of pharmacy under section 9 of this act.
(7) The secretary of the department of health may establish fees
for administering this chapter as provided under RCW 43.70.250. The
fees may be charged to the corporation. The fees must be based on
factors relating to administering this chapter. Fees may be
established in amounts to fully recover expenses incurred by the board
of pharmacy, but must not exceed fifteen percent of the total annual
cost responsibility to the corporation under subsection (6) of this
section. The board of pharmacy may use these fee revenues to reimburse
the department of ecology for its costs. The board of pharmacy may
prioritize the work to implement this chapter if fees are not adequate
to fund all costs of administration. Fees paid under this subsection
must be deposited into the pharmaceutical product stewardship program
account under section 16 of this act.
(8) Any producer may appeal an assessment of charges or
apportionment of costs to the board of pharmacy under the
administrative procedure act, chapter 34.05 RCW.
NEW SECTION. Sec. 7 This chapter does not require any person to
serve as a collector in the product stewardship program. A person may
offer to serve as a collector, or may agree to serve as a collector in
exchange for incentives or payment offered by the corporation's board
of directors. Collectors may include law enforcement, pharmacies,
other relevant public or private locations, such as hospitals, senior
centers, community health clinics, fire stations, veterinary clinics,
or private sector collectors, and mail-back services, operating in
accordance with state and federal laws and regulations for the handling
of covered drugs and in compliance with this chapter.
NEW SECTION. Sec. 8 (1) Any proposed change to the product
stewardship program must have prior approval of the board of pharmacy.
(2) The product stewardship program must inform the board of
pharmacy of changes in collection locations in the product stewardship
program fifteen days before the changes occur.
NEW SECTION. Sec. 9 (1) By June 30, 2015, and annually
thereafter, the corporation must submit a report to the board of
pharmacy describing the program's activities during the previous
reporting period. The report must include the following:
(a) A list of producers participating in the product stewardship
program;
(b) The amount, by weight, of unwanted covered drugs collected,
including the amount by weight from each collection method used;
(c) A list of collection sites, if applicable, locations where
mailers are provided, if applicable, transporters used, and the
disposal facility or facilities used;
(d) Whether any safety or security problems occurred during
collection, transportation, or disposal of unwanted covered drugs
during the reporting period and, if so, what changes have or will be
made to policies, procedures, or tracking mechanisms to alleviate the
problem and to improve safety and security in the future;
(e) A description of the public education and outreach activities
in compliance with section 10 of this act implemented during the
reporting period;
(f) A description of how collected packaging was recycled to the
extent feasible, including the recycling facility or facilities used;
and
(g) The total expenditure of the corporation during the reporting
period, and whether the corporation foresees a need for adjustment of
the total annual cost responsibility under section 6(6) of this act as
a result of changes in volumes of collected drugs or other costs.
(2) The board of pharmacy must make reports submitted under this
section available to the public.
(3) For the purposes of this section, "reporting period" means the
period commencing January 1st and ending December 31st of the same
calendar year.
NEW SECTION. Sec. 10 (1) The corporation must promote the use of
the product stewardship program and the safe storage and proper
disposal of covered drugs so that collection options are widely
understood by customers, pharmacists, retailers of covered drugs, and
health care practitioners including doctors and other prescribers.
(2) The corporation must establish a toll-free telephone number and
web site where collection options will be publicized and prepare
educational and outreach materials describing where and how to return
unwanted covered drugs to the product stewardship program. These
materials must be provided to pharmacies, health care facilities, and
other interested parties for dissemination to residential sources.
(3) The department of health, the department of ecology, and local
governments must promote the use of the product stewardship program and
the program's toll-free telephone number and web site through existing
educational methods.
(4) The corporation must annually evaluate the effectiveness of its
outreach and program activities. At least every four years, this
evaluation must include the percentage of residents that are aware of
the program and to what extent residents find the program convenient.
NEW SECTION. Sec. 11 (1) Covered drugs collected under the
product stewardship program must be disposed of at a properly permitted
hazardous waste disposal facility, or at an in-state solid waste
incinerator facility permitted under chapter 173-434 WAC, or at a
properly permitted solid waste incinerator facility in a neighboring
state or province.
(2) Unwanted covered drugs from residential sources retain all
other generator exemptions for household hazardous waste.
(3) The corporation may petition the department of ecology for
approval to use final disposal technologies that provide superior
environmental and human health protection than provided by current the
disposal technologies in subsection (1) of this section for drugs if
and when those technologies are proven and available. The proposed
technology must provide equivalent protection in each, and superior
protection in one or more, of the following areas:
(a) Monitoring of any emissions or waste;
(b) Worker health and safety;
(c) Air, water, or land emissions contributing to persistent,
bioaccumulative, and toxic pollution; and
(d) Overall impact to the environment and human health.
NEW SECTION. Sec. 12 (1) The board of pharmacy may suspend in
whole or in part the product stewardship program if it determines that
it is necessary to protect the public from imminent danger. The board
may refuse, suspend, or revoke the license of the product stewardship
program as provided in RCW 18.64.200.
(2) If the board of pharmacy determines that the corporation is not
in compliance with this chapter or the program standards adopted by the
board of pharmacy under section 15 of this act, the board of pharmacy
may send the corporation a written warning stating the program is not
in compliance. The corporation has thirty days after receipt of the
notice to come into compliance. If the corporation is not in
compliance after thirty days, the board of pharmacy may assess a
penalty of five thousand dollars for the first violation and ten
thousand dollars for the second and each subsequent violation. A
subsequent violation occurs each thirty days of noncompliance. This
subsection does not preclude the board of pharmacy from suspending the
product stewardship program.
(3) The corporation may appeal penalties prescribed under this
section under the administrative procedure act, chapter 34.05 RCW.
(4) All penalties levied under this section must be deposited into
the pharmaceutical product stewardship program account established
under section 16 of this act.
NEW SECTION. Sec. 13 (1) The board of pharmacy shall send a
written warning and a copy of this chapter and any rules adopted to
implement this chapter to a producer who is not participating in the
product stewardship program, or who is not remitting full payment to
the corporation for its share of the corporation's total costs, and
whose covered drug is being sold in the state.
(2) A producer not participating in the product stewardship
program, or who is not remitting full payment to the corporation for
its share of the corporation's total costs, whose covered drug
continues to be sold in the state sixty days after receiving a written
warning from the board of pharmacy must be assessed a penalty of ten
thousand dollars for each calendar day that the violation continues.
(3) A producer may appeal penalties prescribed under this section
under the administrative procedure act, chapter 34.05 RCW.
(4) All penalties levied under this section must be deposited into
the pharmaceutical product stewardship program account established
under section 16 of this act.
NEW SECTION. Sec. 14 Beginning in 2012, each drug wholesaler
that sells any covered drug in the state must provide a list of
producers of covered drugs to the board of pharmacy in a form
determined by the board of pharmacy. Wholesalers must update the list
by January 15th of each year.
NEW SECTION. Sec. 15 (1) The board of pharmacy may adopt rules
necessary to implement, administer, and enforce this chapter.
(2) The board of pharmacy, in consultation with the department of
ecology, may establish performance standards for the product
stewardship program.
(3) By December 31, 2016, the board of pharmacy shall report to the
appropriate committees of the legislature concerning the status of the
product stewardship program and recommendations for changes to this
chapter.
NEW SECTION. Sec. 16 The pharmaceutical product stewardship
program account is created in the custody of the state treasurer. All
receipts from fees and penalties collected under this chapter must be
deposited into the account. Expenditures from the account may be used
only for administering this chapter. Only the secretary of the
department of health or the secretary's designee may authorize
expenditures from the account. The account is subject to allotment
procedures under chapter 43.88 RCW, but an appropriation is not
required for expenditures.
Sec. 17 RCW 69.41.030 and 2010 c 83 s 1 are each amended to read
as follows:
(1) It shall be unlawful for any person to sell, deliver, or
possess any legend drug except upon the order or prescription of a
physician under chapter 18.71 RCW, an osteopathic physician and surgeon
under chapter 18.57 RCW, an optometrist licensed under chapter 18.53
RCW who is certified by the optometry board under RCW 18.53.010, a
dentist under chapter 18.32 RCW, a podiatric physician and surgeon
under chapter 18.22 RCW, a veterinarian under chapter 18.92 RCW, a
commissioned medical or dental officer in the United States armed
forces or public health service in the discharge of his or her official
duties, a duly licensed physician or dentist employed by the veterans
administration in the discharge of his or her official duties, a
registered nurse or advanced registered nurse practitioner under
chapter 18.79 RCW when authorized by the nursing care quality assurance
commission, an osteopathic physician assistant under chapter 18.57A RCW
when authorized by the board of osteopathic medicine and surgery, a
physician assistant under chapter 18.71A RCW when authorized by the
medical quality assurance commission, or any of the following
professionals in any province of Canada that shares a common border
with the state of Washington or in any state of the United States: A
physician licensed to practice medicine and surgery or a physician
licensed to practice osteopathic medicine and surgery, a dentist
licensed to practice dentistry, a podiatric physician and surgeon
licensed to practice podiatric medicine and surgery, a licensed
advanced registered nurse practitioner, or a veterinarian licensed to
practice veterinary medicine: PROVIDED, HOWEVER, That the above
provisions shall not apply to sale, delivery, or possession by drug
wholesalers or drug manufacturers, or their agents or employees, or to
any practitioner acting within the scope of his or her license, or to
a common or contract carrier or warehouseman, or any employee thereof,
whose possession of any legend drug is in the usual course of business
or employment: PROVIDED FURTHER, That nothing in this chapter or
chapter 18.64 RCW shall prevent a family planning clinic that is under
contract with the department of social and health services from
selling, delivering, possessing, and dispensing commercially
prepackaged oral contraceptives prescribed by authorized, licensed
health care practitioners.
(2) The product stewardship program created in chapter 70.-- RCW
(the new chapter created in section 22 of this act) may possess and
transport drugs provided that the product stewardship program complies
with this chapter.
(3)(a) A violation of this section involving the sale, delivery, or
possession with intent to sell or deliver is a class B felony
punishable according to chapter 9A.20 RCW.
(b) A violation of this section involving possession is a
misdemeanor.
Sec. 18 RCW 18.64.005 and 1990 c 83 s 1 are each amended to read
as follows:
The board shall:
(1) Regulate the practice of pharmacy and enforce all laws placed
under its jurisdiction;
(2) Prepare or determine the nature of, and supervise the grading
of, examinations for applicants for pharmacists' licenses;
(3) Establish the qualifications for licensure of pharmacists or
pharmacy interns;
(4) Conduct hearings for the revocation or suspension of licenses,
permits, registrations, certificates, or any other authority to
practice granted by the board, which hearings may also be conducted by
an administrative law judge appointed under chapter 34.12 RCW;
(5) Issue subpoenas and administer oaths in connection with any
hearing, or disciplinary proceeding held under this chapter or any
other chapter assigned to the board;
(6) Assist the regularly constituted enforcement agencies of this
state in enforcing all laws pertaining to drugs, controlled substances,
and the practice of pharmacy, or any other laws or rules under its
jurisdiction;
(7) Promulgate rules for the dispensing, distribution, wholesaling,
and manufacturing of drugs and devices and the practice of pharmacy for
the protection and promotion of the public health, safety, and welfare.
Violation of any such rules shall constitute grounds for refusal,
suspension, or revocation of licenses or any other authority to
practice issued by the board;
(8) Adopt rules establishing and governing continuing education
requirements for pharmacists and other licensees applying for renewal
of licenses under this chapter;
(9) Be immune, collectively and individually, from suit in any
action, civil or criminal, based upon any disciplinary proceedings or
other official acts performed as members of such board. Such immunity
shall apply to employees of the department when acting in the course of
disciplinary proceedings;
(10) Suggest strategies for preventing, reducing, and eliminating
drug misuse, diversion, and abuse, including professional and public
education, and treatment of persons misusing and abusing drugs;
(11) Conduct or encourage educational programs to be conducted to
prevent the misuse, diversion, and abuse of drugs for health care
practitioners and licensed or certified health care facilities;
(12) Monitor trends of drug misuse, diversion, and abuse and make
periodic reports to disciplinary boards of licensed health care
practitioners and education, treatment, and appropriate law enforcement
agencies regarding these trends;
(13) Enter into written agreements with all other state and federal
agencies with any responsibility for controlling drug misuse,
diversion, or abuse and with health maintenance organizations, health
care service contractors, and health care providers to assist and
promote coordination of agencies responsible for ensuring compliance
with controlled substances laws and to monitor observance of these laws
and cooperation between these agencies. The department of social and
health services, the department of labor and industries, and any other
state agency including licensure disciplinary boards, shall refer all
apparent instances of over-prescribing by practitioners and all
apparent instances of legend drug overuse to the department. The
department shall also encourage such referral by health maintenance
organizations, health service contractors, and health care providers;
(14) Adopt rules to implement, administer, and enforce the laws on
the collection, transportation, disposal, and possession of unwanted
covered drugs from residential sources through producer-provided and
funded product stewardship programs under chapter 70.--- RCW (the new
chapter created in section 22 of this act).
Sec. 19 RCW 42.56.270 and 2009 c 394 s 3 are each amended to read
as follows:
The following financial, commercial, and proprietary information is
exempt from disclosure under this chapter:
(1) Valuable formulae, designs, drawings, computer source code or
object code, and research data obtained by any agency within five years
of the request for disclosure when disclosure would produce private
gain and public loss;
(2) Financial information supplied by or on behalf of a person,
firm, or corporation for the purpose of qualifying to submit a bid or
proposal for (a) a ferry system construction or repair contract as
required by RCW 47.60.680 through 47.60.750 or (b) highway construction
or improvement as required by RCW 47.28.070;
(3) Financial and commercial information and records supplied by
private persons pertaining to export services provided under chapters
43.163 and 53.31 RCW, and by persons pertaining to export projects
under RCW 43.23.035;
(4) Financial and commercial information and records supplied by
businesses or individuals during application for loans or program
services provided by chapters 43.325, 43.163, 43.160, 43.330, and
43.168 RCW, or during application for economic development loans or
program services provided by any local agency;
(5) Financial information, business plans, examination reports, and
any information produced or obtained in evaluating or examining a
business and industrial development corporation organized or seeking
certification under chapter 31.24 RCW;
(6) Financial and commercial information supplied to the state
investment board by any person when the information relates to the
investment of public trust or retirement funds and when disclosure
would result in loss to such funds or in private loss to the providers
of this information;
(7) Financial and valuable trade information under RCW 51.36.120;
(8) Financial, commercial, operations, and technical and research
information and data submitted to or obtained by the clean Washington
center in applications for, or delivery of, program services under
chapter 70.95H RCW;
(9) Financial and commercial information requested by the public
stadium authority from any person or organization that leases or uses
the stadium and exhibition center as defined in RCW 36.102.010;
(10)(a) Financial information, including but not limited to account
numbers and values, and other identification numbers supplied by or on
behalf of a person, firm, corporation, limited liability company,
partnership, or other entity related to an application for a horse
racing license submitted pursuant to RCW 67.16.260(1)(b), liquor
license, gambling license, or lottery retail license;
(b) Internal control documents, independent auditors' reports and
financial statements, and supporting documents: (i) Of house-banked
social card game licensees required by the gambling commission pursuant
to rules adopted under chapter 9.46 RCW; or (ii) submitted by tribes
with an approved tribal/state compact for class III gaming;
(11) Proprietary data, trade secrets, or other information that
relates to: (a) A vendor's unique methods of conducting business; (b)
data unique to the product or services of the vendor; or (c)
determining prices or rates to be charged for services, submitted by
any vendor to the department of social and health services for purposes
of the development, acquisition, or implementation of state purchased
health care as defined in RCW 41.05.011;
(12)(a) When supplied to and in the records of the department of
((community, trade, and economic development)) commerce:
(i) Financial and proprietary information collected from any person
and provided to the department of ((community, trade, and economic
development)) commerce pursuant to RCW 43.330.050(8); and
(ii) Financial or proprietary information collected from any person
and provided to the department of ((community, trade, and economic
development)) commerce or the office of the governor in connection with
the siting, recruitment, expansion, retention, or relocation of that
person's business and until a siting decision is made, identifying
information of any person supplying information under this subsection
and the locations being considered for siting, relocation, or expansion
of a business;
(b) When developed by the department of ((community, trade, and
economic development)) commerce based on information as described in
(a)(i) of this subsection, any work product is not exempt from
disclosure;
(c) For the purposes of this subsection, "siting decision" means
the decision to acquire or not to acquire a site;
(d) If there is no written contact for a period of sixty days to
the department of ((community, trade, and economic development))
commerce from a person connected with siting, recruitment, expansion,
retention, or relocation of that person's business, information
described in (a)(ii) of this subsection will be available to the public
under this chapter;
(13) Financial and proprietary information submitted to or obtained
by the department of ecology or the authority created under chapter
70.95N RCW to implement chapter 70.95N RCW;
(14) Financial, commercial, operations, and technical and research
information and data submitted to or obtained by the life sciences
discovery fund authority in applications for, or delivery of, grants
under chapter 43.350 RCW, to the extent that such information, if
revealed, would reasonably be expected to result in private loss to the
providers of this information;
(15) Financial and commercial information provided as evidence to
the department of licensing as required by RCW 19.112.110 or
19.112.120, except information disclosed in aggregate form that does
not permit the identification of information related to individual fuel
licensees;
(16) Any production records, mineral assessments, and trade secrets
submitted by a permit holder, mine operator, or landowner to the
department of natural resources under RCW 78.44.085;
(17)(a) Farm plans developed by conservation districts, unless
permission to release the farm plan is granted by the landowner or
operator who requested the plan, or the farm plan is used for the
application or issuance of a permit;
(b) Farm plans developed under chapter 90.48 RCW and not under the
federal clean water act, 33 U.S.C. Sec. 1251 et seq., are subject to
RCW 42.56.610 and 90.64.190;
(18) Financial, commercial, operations, and technical and research
information and data submitted to or obtained by a health sciences and
services authority in applications for, or delivery of, grants under
RCW 35.104.010 through 35.104.060, to the extent that such information,
if revealed, would reasonably be expected to result in private loss to
providers of this information;
(19) Information gathered under chapter 19.85 RCW or RCW 34.05.328
that can be identified to a particular business; ((and))
(20) Financial and commercial information submitted to or obtained
by the University of Washington, other than information the university
is required to disclose under RCW 28B.20.150, when the information
relates to investments in private funds, to the extent that such
information, if revealed, would reasonably be expected to result in
loss to the University of Washington consolidated endowment fund or to
result in private loss to the providers of this information; and
(21) Producer information provided to the medicine return
corporation or to the board of pharmacy under section 6 of this act to
determine apportionment costs.
NEW SECTION. Sec. 20 Nothing in this chapter changes or limits
the authority of the Washington utilities and transportation commission
to regulate collection of solid waste, including curbside collection of
residential recyclable materials, nor does this chapter change or limit
the authority of a city or town to provide the service itself or by
contract under RCW 81.77.020.
NEW SECTION. Sec. 21 Nothing in this chapter applies to
hospitals licensed under chapter 70.41 RCW, whose pharmaceutical wastes
are disposed of under rules and policies adopted by the department of
ecology.
NEW SECTION. Sec. 22 Sections 1 through 16, 20, and 21 of this
act constitute a new chapter in Title
NEW SECTION. Sec. 23 If any provision of this act or its
application to any person or circumstance is held invalid, the
remainder of the act or the application of the provision to other
persons or circumstances is not affected.
NEW SECTION. Sec. 24 This act must be liberally construed to
carry out its purposes and objectives.