BILL REQ. #: H-1007.1
| State of Washington | 63rd Legislature | 2013 Regular Session |
Read first time 02/01/13. Referred to Committee on Health Care & Wellness.
AN ACT Relating to the board of pharmacy; amending RCW 18.50.115, 18.53.010, 18.64.001, 18.64.003, 18.64.005, 18.64.009, 18.64.044, 18.64.046, 18.64.047, 18.64.140, 18.64.160, 18.64.165, 18.64.200, 18.64.205, 18.64.245, 18.64.246, 18.64.255, 18.64.257, 18.64.310, 18.64.360, 18.64.390, 18.64.410, 18.64.420, 18.64.450, 18.64.470, 18.64.480, 18.64.490, 18.64.500, 18.64.510, 18.64A.010, 18.64A.020, 18.64A.025, 18.64A.030, 18.64A.040, 18.64A.050, 18.64A.060, 18.64A.070, 18.64A.080, 18.92.012, 18.92.013, 18.92.015, 51.36.010, 64.44.010, 69.04.565, 69.04.730, 69.38.010, 69.38.060, 69.40.055, 69.41.010, 69.41.075, 69.41.080, 69.41.180, 69.41.210, 69.41.240, 69.41.250, 69.41.280, 69.41.310, 69.43.010, 69.43.020, 69.43.030, 69.43.035, 69.43.040, 69.43.043, 69.43.048, 69.43.050, 69.43.060, 69.43.090, 69.43.100, 69.43.105, 69.43.110, 69.43.130, 69.43.140, 69.43.165, 69.43.180, 69.45.010, 69.45.020, 69.45.060, 69.45.080, 69.45.090, 69.50.201, 69.50.203, 69.50.205, 69.50.207, 69.50.208, 69.50.209, 69.50.210, 69.50.211, 69.50.213, 69.50.214, 69.50.301, 69.50.302, 69.50.303, 69.50.304, 69.50.305, 69.50.306, 69.50.308, 69.50.310, 69.50.312, 69.50.320, 69.50.402, 69.50.501, 69.50.504, 69.50.507, 69.50.508, 69.50.601, 69.51.030, 69.51.040, 69.51.050, 69.51.060, 69.60.020, 69.60.040, 69.60.060, 69.60.080, 69.60.090, 70.24.280, 70.54.140, 70.106.150, 70.127.130, 70.225.020, and 82.04.272; reenacting and amending RCW 18.64.011, 18.64.080, 18.130.040, 18.130.040, 28B.115.020, and 42.56.360; adding a new section to chapter 69.50 RCW; providing an effective date; and providing an expiration date.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:
Sec. 1 RCW 18.50.115 and 1994 sp.s. c 9 s 707 are each amended to
read as follows:
A midwife licensed under this chapter may obtain and administer
prophylactic ophthalmic medication, postpartum oxytocic, vitamin K, Rho
immune globulin (human), and local anesthetic and may administer such
other drugs or medications as prescribed by a physician. A pharmacist
who dispenses such drugs to a licensed midwife shall not be liable for
any adverse reactions caused by any method of use by the midwife.
The secretary, after consultation with representatives of the
midwife advisory committee, the ((board of pharmacy)) pharmacy quality
assurance commission, and the medical quality assurance commission, may
adopt rules that authorize licensed midwives to purchase and use legend
drugs and devices in addition to the drugs authorized in this chapter.
Sec. 2 RCW 18.53.010 and 2006 c 232 s 1 are each amended to read
as follows:
(1) The practice of optometry is defined as the examination of the
human eye, the examination and ascertaining any defects of the human
vision system and the analysis of the process of vision. The practice
of optometry may include, but not necessarily be limited to, the
following:
(a) The employment of any objective or subjective means or method,
including the use of drugs, for diagnostic and therapeutic purposes by
those licensed under this chapter and who meet the requirements of
subsections (2) and (3) of this section, and the use of any diagnostic
instruments or devices for the examination or analysis of the human
vision system, the measurement of the powers or range of human vision,
or the determination of the refractive powers of the human eye or its
functions in general; and
(b) The prescription and fitting of lenses, prisms, therapeutic or
refractive contact lenses and the adaption or adjustment of frames and
lenses used in connection therewith; and
(c) The prescription and provision of visual therapy, therapeutic
aids, and other optical devices; and
(d) The ascertainment of the perceptive, neural, muscular, or
pathological condition of the visual system; and
(e) The adaptation of prosthetic eyes.
(2)(a) Those persons using topical drugs for diagnostic purposes in
the practice of optometry shall have a minimum of sixty hours of
didactic and clinical instruction in general and ocular pharmacology as
applied to optometry, as established by the board, and certification
from an institution of higher learning, accredited by those agencies
recognized by the United States office of education or the council on
postsecondary accreditation to qualify for certification by the
optometry board of Washington to use drugs for diagnostic purposes.
(b) Those persons using or prescribing topical drugs for
therapeutic purposes in the practice of optometry must be certified
under (a) of this subsection, and must have an additional minimum of
seventy-five hours of didactic and clinical instruction as established
by the board, and certification from an institution of higher learning,
accredited by those agencies recognized by the United States office of
education or the council on postsecondary accreditation to qualify for
certification by the optometry board of Washington to use drugs for
therapeutic purposes.
(c) Those persons using or prescribing drugs administered orally
for diagnostic or therapeutic purposes in the practice of optometry
shall be certified under (b) of this subsection, and shall have an
additional minimum of sixteen hours of didactic and eight hours of
supervised clinical instruction as established by the board, and
certification from an institution of higher learning, accredited by
those agencies recognized by the United States office of education or
the council on postsecondary accreditation to qualify for certification
by the optometry board of Washington to administer, dispense, or
prescribe oral drugs for diagnostic or therapeutic purposes.
(d) Those persons administering epinephrine by injection for
treatment of anaphylactic shock in the practice of optometry must be
certified under (b) of this subsection and must have an additional
minimum of four hours of didactic and supervised clinical instruction,
as established by the board, and certification from an institution of
higher learning, accredited by those agencies recognized by the United
States office of education or the council on postsecondary
accreditation to qualify for certification by the optometry board to
administer epinephrine by injection.
(e) Such course or courses shall be the fiscal responsibility of
the participating and attending optometrist.
(f)(i) All persons receiving their initial license under this
chapter on or after January 1, 2007, must be certified under (a), (b),
(c), and (d) of this subsection.
(ii) All persons licensed under this chapter on or after January 1,
2009, must be certified under (a) and (b) of this subsection.
(iii) All persons licensed under this chapter on or after January
1, 2011, must be certified under (a), (b), (c), and (d) of this
subsection.
(3) The board shall establish a list of topical drugs for
diagnostic and treatment purposes limited to the practice of optometry,
and no person licensed pursuant to this chapter shall prescribe,
dispense, purchase, possess, or administer drugs except as authorized
and to the extent permitted by the board.
(4) The board must establish a list of oral Schedule III through V
controlled substances and any oral legend drugs, with the approval of
and after consultation with the ((board of pharmacy)) pharmacy quality
assurance commission. No person licensed under this chapter may use,
prescribe, dispense, purchase, possess, or administer these drugs
except as authorized and to the extent permitted by the board. No
optometrist may use, prescribe, dispense, or administer oral
corticosteroids.
(a) The board, with the approval of and in consultation with the
((board of pharmacy)) pharmacy quality assurance commission, must
establish, by rule, specific guidelines for the prescription and
administration of drugs by optometrists, so that licensed optometrists
and persons filling their prescriptions have a clear understanding of
which drugs and which dosages or forms are included in the authority
granted by this section.
(b) An optometrist may not:
(i) Prescribe, dispense, or administer a controlled substance for
more than seven days in treating a particular patient for a single
trauma, episode, or condition or for pain associated with or related to
the trauma, episode, or condition; or
(ii) Prescribe an oral drug within ninety days following ophthalmic
surgery unless the optometrist consults with the treating
ophthalmologist.
(c) If treatment exceeding the limitation in (b)(i) of this
subsection is indicated, the patient must be referred to a physician
licensed under chapter 18.71 RCW.
(d) The prescription or administration of drugs as authorized in
this section is specifically limited to those drugs appropriate to
treatment of diseases or conditions of the human eye and the adnexa
that are within the scope of practice of optometry. The prescription
or administration of drugs for any other purpose is not authorized by
this section.
(5) The board shall develop a means of identification and
verification of optometrists certified to use therapeutic drugs for the
purpose of issuing prescriptions as authorized by this section.
(6) Nothing in this chapter may be construed to authorize the use,
prescription, dispensing, purchase, possession, or administration of
any Schedule I or II controlled substance. The provisions of this
subsection must be strictly construed.
(7) With the exception of the administration of epinephrine by
injection for the treatment of anaphylactic shock, no injections or
infusions may be administered by an optometrist.
(8) Nothing in this chapter may be construed to authorize
optometrists to perform ophthalmic surgery. Ophthalmic surgery is
defined as any invasive procedure in which human tissue is cut,
ablated, or otherwise penetrated by incision, injection, laser,
ultrasound, or other means, in order to: Treat human eye diseases;
alter or correct refractive error; or alter or enhance cosmetic
appearance. Nothing in this chapter limits an optometrist's ability to
use diagnostic instruments utilizing laser or ultrasound technology.
Ophthalmic surgery, as defined in this subsection, does not include
removal of superficial ocular foreign bodies, epilation of misaligned
eyelashes, placement of punctal or lacrimal plugs, diagnostic dilation
and irrigation of the lacrimal system, orthokeratology, prescription
and fitting of contact lenses with the purpose of altering refractive
error, or other similar procedures within the scope of practice of
optometry.
Sec. 3 RCW 18.64.001 and 2011 c 336 s 493 are each amended to
read as follows:
There shall be a state ((board of pharmacy)) pharmacy quality
assurance commission consisting of ((seven)) fifteen members, to be
appointed by the governor by and with the advice and consent of the
senate. ((Five)) Ten of the members shall be designated as pharmacist
members ((and two)), four of the members shall be designated a public
member, and one member shall be a pharmacy technician.
Each pharmacist member shall be a citizen of the United States and
a resident of this state, and at the time of his or her appointment
shall have been a duly registered pharmacist under the laws of this
state for a period of at least five consecutive years immediately
preceding his or her appointment and shall at all times during his or
her incumbency continue to be a duly licensed pharmacist: PROVIDED,
That subject to the availability of qualified candidates the governor
shall appoint pharmacist members representative of the areas of
practice and geographically representative of the state of Washington.
The public member shall be a citizen of the United States and a
resident of this state. The public member shall be appointed from the
public at large, but shall not be affiliated with any aspect of
pharmacy.
Members of the ((board)) commission shall hold office for a term of
four years, and the terms shall be staggered so that the terms of
office of not more than two members will expire simultaneously on the
third Monday in January of each year.
No person who has been appointed to and served for two four year
terms shall be eligible for appointment to the ((board)) commission.
Each member shall qualify by taking the usual oath of a state
officer, which shall be filed with the secretary of state, and each
member shall hold office for the term of his or her appointment and
until his or her successor is appointed and qualified.
In case of the resignation or disqualification of a member, or a
vacancy occurring from any cause, the governor shall appoint a
successor for the unexpired term.
Sec. 4 RCW 18.64.003 and 1984 c 287 s 43 are each amended to read
as follows:
Members of the ((board)) commission shall meet at such places and
times as it shall determine and as often as necessary to discharge the
duties imposed upon it. The ((board)) commission shall elect a
chairperson and a vice chairperson from among its members. Each member
shall be compensated in accordance with RCW 43.03.240 and shall be
reimbursed for travel expenses in accordance with RCW 43.03.050 and
43.03.060.
Sec. 5 RCW 18.64.005 and 1990 c 83 s 1 are each amended to read
as follows:
The ((board)) commission 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)) commission, 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)) commission;
(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)) commission;
(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)) the
commission. 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.
Sec. 6 RCW 18.64.009 and 1989 1st ex.s. c 9 s 411 are each
amended to read as follows:
Employees of the department, who are designated by the ((board))
commission as enforcement officers, are declared to be peace officers
and shall be vested with police powers to enforce chapters 18.64,
69.04, 69.36, 69.40, 69.41, and 69.50 RCW and all other laws enforced
by the ((board)) commission.
Sec. 7 RCW 18.64.011 and 2009 c 549 s 1008 are each reenacted and
amended to read as follows:
Unless the context clearly requires otherwise, definitions of terms
shall be as indicated when used in this chapter.
(1) "Administer" means the direct application of a drug or device,
whether by injection, inhalation, ingestion, or any other means, to the
body of a patient or research subject.
(2) (("Board" means the Washington state board of pharmacy.))
"Commission" means the pharmacy quality assurance commission.
(3) "Compounding" shall be the act of combining two or more
ingredients in the preparation of a prescription.
(4) "Controlled substance" means a drug or substance, or an
immediate precursor of such drug or substance, so designated under or
pursuant to the provisions of chapter 69.50 RCW.
(5) "Deliver" or "delivery" means the actual, constructive, or
attempted transfer from one person to another of a drug or device,
whether or not there is an agency relationship.
(6) "Department" means the department of health.
(7) "Device" means instruments, apparatus, and contrivances,
including their components, parts, and accessories, intended (a) for
use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in human beings or other animals, or (b) to affect the
structure or any function of the body of human beings or other animals.
(8) "Dispense" means the interpretation of a prescription or order
for a drug, biological, or device and, pursuant to that prescription or
order, the proper selection, measuring, compounding, labeling, or
packaging necessary to prepare that prescription or order for delivery.
(9) "Distribute" means the delivery of a drug or device other than
by administering or dispensing.
(10) The words "drug" and "devices" shall not include surgical or
dental instruments or laboratory materials, gas and oxygen, therapy
equipment, X-ray apparatus or therapeutic equipment, their component
parts or accessories, or equipment, instruments, apparatus, or
contrivances used to render such articles effective in medical,
surgical, or dental treatment, or for use or consumption in or for
mechanical, industrial, manufacturing, or scientific applications or
purposes, nor shall the word "drug" include any article or mixture
covered by the Washington pesticide control act (chapter 15.58 RCW), as
enacted or hereafter amended, nor medicated feed intended for and used
exclusively as a feed for animals other than human beings.
(11) "Drugs" means:
(a) Articles recognized in the official United States pharmacopoeia
or the official homeopathic pharmacopoeia of the United States;
(b) Substances intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in human beings or other animals;
(c) Substances (other than food) intended to affect the structure
or any function of the body of human beings 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
devices or their component parts or accessories.
(12) "Health care entity" means an organization that provides
health care services in a setting that is not otherwise licensed by the
state. Health care entity includes a freestanding outpatient surgery
center or a freestanding cardiac care center. It does not include an
individual practitioner's office or a multipractitioner clinic.
(13) "Labeling" shall mean the process of preparing and affixing a
label to any drug or device container. The label must include all
information required by current federal and state law and pharmacy
rules.
(14) "Legend drugs" means any drugs which are required by any
applicable federal or state law or regulation to be dispensed on
prescription only or are restricted to use by practitioners only.
(15) "Manufacture" means the production, preparation, propagation,
compounding, or processing of a drug or other substance or device or
the packaging or repackaging of such substance or device, or the
labeling or relabeling of the commercial container of such substance or
device, but does not include the activities of a practitioner who, as
an incident to his or her administration or dispensing such substance
or device in the course of his or her professional practice, prepares,
compounds, packages, or labels such substance or device.
(16) "Manufacturer" shall mean a person, corporation, or other
entity engaged in the manufacture of drugs or devices.
(17) "Master license system" means the mechanism established by
chapter 19.02 RCW by which master licenses, endorsed for individual
state-issued licenses, are issued and renewed utilizing a master
application and a master license expiration date common to each
renewable license endorsement.
(18) "Nonlegend" or "nonprescription" drugs means any drugs which
may be lawfully sold without a prescription.
(19) "Person" means an individual, corporation, government,
governmental subdivision or agency, business trust, estate, trust,
partnership or association, or any other legal entity.
(20) "Pharmacist" means a person duly licensed by the ((Washington
state board of pharmacy)) commission to engage in the practice of
pharmacy.
(21) "Pharmacy" means every place properly licensed by the ((board
of pharmacy)) commission where the practice of pharmacy is conducted.
(22) The word "poison" shall not include any article or mixture
covered by the Washington pesticide control act (chapter 15.58 RCW), as
enacted or hereafter amended.
(23) "Practice of pharmacy" includes the practice of and
responsibility for: Interpreting prescription orders; the compounding,
dispensing, labeling, administering, and distributing of drugs and
devices; the monitoring of drug therapy and use; the initiating or
modifying of drug therapy in accordance with written guidelines or
protocols previously established and approved for his or her practice
by a practitioner authorized to prescribe drugs; the participating in
drug utilization reviews and drug product selection; the proper and
safe storing and distributing of drugs and devices and maintenance of
proper records thereof; the providing of information on legend drugs
which may include, but is not limited to, the advising of therapeutic
values, hazards, and the uses of drugs and devices.
(24) "Practitioner" means a physician, dentist, veterinarian,
nurse, or other person duly authorized by law or rule in the state of
Washington to prescribe drugs.
(25) "Prescription" means an order for drugs or devices issued by
a practitioner duly authorized by law or rule in the state of
Washington to prescribe drugs or devices in the course of his or her
professional practice for a legitimate medical purpose.
(26) "Secretary" means the secretary of health or the secretary's
designee.
(27) "Wholesaler" shall mean a corporation, individual, or other
entity which buys drugs or devices for resale and distribution to
corporations, individuals, or entities other than consumers.
Sec. 8 RCW 18.64.044 and 2005 c 388 s 5 are each amended to read
as follows:
(1) A shopkeeper registered as provided in this section may sell
nonprescription drugs, if such drugs are sold in the original package
of the manufacturer.
(2) Every shopkeeper not a licensed pharmacist, desiring to secure
the benefits and privileges of this section, is hereby required to
register as a shopkeeper through the master license system, and he or
she shall pay the fee determined by the secretary for registration, and
on a date to be determined by the secretary thereafter the fee
determined by the secretary for renewal of the registration; and shall
at all times keep said registration or the current renewal thereof
conspicuously exposed in the location to which it applies. In event
such shopkeeper's registration is not renewed by the master license
expiration date, no renewal or new registration shall be issued except
upon payment of the registration renewal fee and the master license
delinquency fee under chapter 19.02 RCW. This registration fee shall
not authorize the sale of legend drugs or controlled substances.
(3) The registration fees determined by the secretary under
subsection (2) of this section shall not exceed the cost of registering
the shopkeeper.
(4) Any shopkeeper who shall vend or sell, or offer to sell to the
public any such nonprescription drug or preparation without having
registered to do so as provided in this section, shall be guilty of a
misdemeanor and each sale or offer to sell shall constitute a separate
offense.
(5) A shopkeeper who is not a licensed pharmacy may purchase
products containing any detectable quantity of ephedrine,
pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or
salts of isomers, only from a wholesaler licensed by the department
under RCW 18.64.046 or from a manufacturer licensed by the department
under RCW 18.64.045. The ((board)) commission shall issue a warning to
a shopkeeper who violates this subsection, and may suspend or revoke
the registration of the shopkeeper for a subsequent violation.
(6) A shopkeeper who has purchased products containing any
detectable quantity of ephedrine, pseudoephedrine, or
phenylpropanolamine, or their salts, isomers, or salts of isomers, in
a suspicious transaction as defined in RCW 69.43.035, is subject to the
following requirements:
(a) The shopkeeper may not sell any quantity of ephedrine,
pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or
salts of isomers, if the total monthly sales of these products exceed
ten percent of the shopkeeper's total prior monthly sales of
nonprescription drugs in March through October. In November through
February, the shopkeeper may not sell any quantity of ephedrine,
pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or
salts of isomers, if the total monthly sales of these products exceed
twenty percent of the shopkeeper's total prior monthly sales of
nonprescription drugs. For purposes of this section, "monthly sales"
means total dollars paid by buyers. The ((board)) commission may
suspend or revoke the registration of a shopkeeper who violates this
subsection.
(b) The shopkeeper shall maintain inventory records of the receipt
and disposition of nonprescription drugs, utilizing existing inventory
controls if an auditor or investigator can determine compliance with
(a) of this subsection, and otherwise in the form and manner required
by the ((board)) commission. The records must be available for
inspection by the ((board)) commission or any law enforcement agency
and must be maintained for two years. The ((board)) commission may
suspend or revoke the registration of a shopkeeper who violates this
subsection. For purposes of this subsection, "disposition" means the
return of product to the wholesaler or distributor.
Sec. 9 RCW 18.64.046 and 2005 c 388 s 6 are each amended to read
as follows:
(1) The owner of each place of business which sells legend drugs
and nonprescription drugs, or nonprescription drugs at wholesale shall
pay a license fee to be determined by the secretary, and thereafter, on
or before a date to be determined by the secretary as provided in RCW
43.70.250 and 43.70.280, a like fee to be determined by the secretary,
for which the owner shall receive a license of location from the
department, which shall entitle such owner to either sell legend drugs
and nonprescription drugs or nonprescription drugs at wholesale at the
location specified for the period ending on a date to be determined by
the secretary, and each such owner shall at the time of payment of such
fee file with the department, on a blank therefor provided, a
declaration of ownership and location, which declaration of ownership
and location so filed as aforesaid shall be deemed presumptive evidence
of the ownership of such place of business mentioned therein. It shall
be the duty of the owner to notify immediately the department of any
change of location and ownership and to keep the license of location or
the renewal thereof properly exhibited in such place of business.
(2) Failure to conform with this section is a misdemeanor, and each
day that the failure continues is a separate offense.
(3) In event the license fee remains unpaid on the date due, no
renewal or new license shall be issued except upon compliance with
administrative procedures, administrative requirements, and fees
determined as provided in RCW 43.70.250 and 43.70.280.
(4) No wholesaler may sell any quantity of drug products containing
ephedrine, pseudoephedrine, phenylpropanolamine, or their salts,
isomers, or salts of isomers, if the total monthly sales of these
products to persons within the state of Washington exceed five percent
of the wholesaler's total prior monthly sales of nonprescription drugs
to persons within the state in March through October. In November
through February, no wholesaler may sell any quantity of drug products
containing ephedrine, pseudoephedrine, or phenylpropanolamine, or their
salts, isomers, or salts of isomers if the total monthly sales of these
products to persons within the state of Washington exceed ten percent
of the wholesaler's total prior monthly sales of nonprescription drugs
to persons within the state. For purposes of this section, monthly
sales means total dollars paid by buyers. The ((board)) commission may
suspend or revoke the license of any wholesaler that violates this
section.
(5) The ((board)) commission may exempt a wholesaler from the
limitations of subsection (4) of this section if it finds that the
wholesaler distributes nonprescription drugs only through transactions
between divisions, subsidiaries, or related companies when the
wholesaler and the retailer are related by common ownership, and that
neither the wholesaler nor the retailer has a history of suspicious
transactions in precursor drugs as defined in RCW 69.43.035.
(6) The requirements for a license apply to all persons, in
Washington and outside of Washington, who sell both legend drugs and
nonprescription drugs and to those who sell only nonprescription drugs,
at wholesale to pharmacies, practitioners, and shopkeepers in
Washington.
(7)(a) No wholesaler may sell any product containing any detectable
quantity of ephedrine, pseudoephedrine, phenylpropanolamine, or their
salts, isomers, or salts of isomers, to any person in Washington other
than a pharmacy licensed under this chapter, a shopkeeper or itinerant
vendor registered under this chapter, a practitioner as defined in RCW
18.64.011, or a traditional Chinese herbal practitioner as defined in
RCW 69.43.105.
(b) A violation of this subsection is punishable as a class C
felony according to chapter 9A.20 RCW, and each sale in violation of
this subsection constitutes a separate offense.
Sec. 10 RCW 18.64.047 and 2005 c 388 s 7 are each amended to read
as follows:
(1) Any itinerant vendor or any peddler of any nonprescription drug
or preparation for the treatment of disease or injury, shall pay a
registration fee determined by the secretary on a date to be determined
by the secretary as provided in RCW 43.70.250 and 43.70.280. The
department may issue a registration to such vendor on an approved
application made to the department.
(2) Any itinerant vendor or peddler who shall vend or sell, or
offer to sell to the public any such nonprescription drug or
preparation without having registered to do so as provided in this
section, is guilty of a misdemeanor and each sale or offer to sell
shall constitute a separate offense.
(3) In event the registration fee remains unpaid on the date due,
no renewal or new registration shall be issued except upon compliance
with administrative procedures, administrative requirements, and fees
determined as provided in RCW 43.70.250 and 43.70.280. This
registration shall not authorize the sale of legend drugs or controlled
substances.
(4) An itinerant vendor may purchase products containing any
detectable quantity of ephedrine, pseudoephedrine, or
phenylpropanolamine, or their salts, isomers, or salts of isomers only
from a wholesaler licensed by the department under RCW 18.64.046 or
from a manufacturer licensed by the department under RCW 18.64.045.
The ((board)) commission shall issue a warning to an itinerant vendor
who violates this subsection, and may suspend or revoke the
registration of the vendor for a subsequent violation.
(5) An itinerant vendor who has purchased products containing any
detectable quantity of ephedrine, pseudoephedrine, or
phenylpropanolamine, or their salts, isomers, or salts of isomers, in
a suspicious transaction as defined in RCW 69.43.035, is subject to the
following requirements:
(a) The itinerant vendor may not sell any quantity of ephedrine,
pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or
salts of isomers, if the total monthly sales of these products exceed
ten percent of the vendor's total prior monthly sales of
nonprescription drugs in March through October. In November through
February, the vendor may not sell any quantity of ephedrine,
pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or
salts of isomers, if the total monthly sales of these products exceed
twenty percent of the vendor's total prior monthly sales of
nonprescription drugs. For purposes of this section, "monthly sales"
means total dollars paid by buyers. The ((board)) commission may
suspend or revoke the registration of an itinerant vendor who violates
this subsection.
(b) The itinerant vendor shall maintain inventory records of the
receipt and disposition of nonprescription drugs, utilizing existing
inventory controls if an auditor or investigator can determine
compliance with (a) of this subsection, and otherwise in the form and
manner required by the ((board)) commission. The records must be
available for inspection by the ((board)) commission or any law
enforcement agency and must be maintained for two years. The ((board))
commission may suspend or revoke the registration of an itinerant
vendor who violates this subsection. For purposes of this subsection,
"disposition" means the return of product to the wholesaler or
distributor.
Sec. 11 RCW 18.64.080 and 1989 1st ex.s. c 9 ss 403, 420 and 1989
c 352 s 3 are each reenacted and amended to read as follows:
(1) The department may license as a pharmacist any person who has
filed an application therefor, subscribed by the person under oath or
affirmation, containing such information as the ((board)) commission
may by regulation require, and who --
(a) Is at least eighteen years of age;
(b) Has satisfied the ((board)) commission that he or she is of
good moral and professional character, that he or she will carry out
the duties and responsibilities required of a pharmacist, and that he
or she is not unfit or unable to practice pharmacy by reason of the
extent or manner of his or her proven use of alcoholic beverages,
drugs, or controlled substances, or by reason of a proven physical or
mental disability;
(c) Holds a baccalaureate degree in pharmacy or a doctor of
pharmacy degree granted by a school or college of pharmacy which is
accredited by the ((board of pharmacy)) commission;
(d) Has completed or has otherwise met the internship requirements
as set forth in ((board)) commission rules;
(e) Has satisfactorily passed the necessary examinations approved
by the ((board)) commission and administered by the department.
(2) The department shall, at least once in every calendar year,
offer an examination to all applicants for a pharmacist license who
have completed their educational and internship requirements pursuant
to rules promulgated by the ((board)) commission. The examination
shall be determined by the ((board)) commission. In case of failure at
a first examination, the applicant shall have within three years the
privilege of a second and third examination. In case of failure in a
third examination, the applicant shall not be eligible for further
examination until he or she has satisfactorily completed additional
preparation as directed and approved by the ((board)) commission. The
applicant must pay the examination fee determined by the secretary for
each examination taken. Upon passing the required examinations and
complying with all the rules and regulations of the ((board))
commission and the provisions of this chapter, the department shall
grant the applicant a license as a pharmacist and issue to him or her
a certificate qualifying him or her to enter into the practice of
pharmacy.
(3) Any person enrolled as a student of pharmacy in an accredited
college may file with the department an application for registration as
a pharmacy intern in which application he or she shall be required to
furnish such information as the ((board)) commission may, by
regulation, prescribe and, simultaneously with the filing of said
application, shall pay to the department a fee to be determined by the
secretary. All certificates issued to pharmacy interns shall be valid
for a period to be determined by the ((board)) commission, but in no
instance shall the certificate be valid if the individual is no longer
making timely progress toward graduation, provided however, the
((board)) commission may issue an intern certificate to a person to
complete an internship to be eligible for initial licensure or for the
reinstatement of a previously licensed pharmacist.
(4) To assure adequate practical instruction, pharmacy internship
experience as required under this chapter shall be obtained after
registration as a pharmacy intern by practice in any licensed pharmacy
or other program meeting the requirements promulgated by regulation of
the ((board)) commission, and shall include such instruction in the
practice of pharmacy as the ((board)) commission by regulation shall
prescribe.
(5) The department may, without examination other than one in the
laws relating to the practice of pharmacy, license as a pharmacist any
person who, at the time of filing application therefor, is currently
licensed as a pharmacist in any other state, territory, or possession
of the United States. The person shall produce evidence satisfactory
to the department of having had the required secondary and professional
education and training and who was licensed as a pharmacist by
examination in another state prior to June 13, 1963, shall be required
to satisfy only the requirements which existed in this state at the
time he or she became licensed in such other state, and that the state
in which the person is licensed shall under similar conditions grant
reciprocal licenses as pharmacist without examination to pharmacists
duly licensed by examination in this state. Every application under
this subsection shall be accompanied by a fee determined by the
department.
(6) The department shall provide for, regulate, and require all
persons licensed as pharmacists to renew their license periodically,
and shall prescribe the form of such license and information required
to be submitted by all applicants.
Sec. 12 RCW 18.64.140 and 1996 c 191 s 47 are each amended to
read as follows:
Every licensed pharmacist who desires to practice pharmacy shall
secure from the department a license, the fee for which shall be
determined by the secretary under RCW 43.70.250 and 43.70.280. The
administrative procedures, administrative requirements, renewal fee,
and late renewal fee shall also be determined under RCW 43.70.250 and
43.70.280. Payment of this fee shall entitle the licensee to a
pharmacy law book, subsequent current mailings of all additions,
changes, or deletions in the pharmacy practice act, chapter 18.64 RCW,
and all additions, changes, or deletions of ((pharmacy board))
commission and department regulations. The current license shall be
conspicuously displayed to the public in the pharmacy to which it
applies. Any licensed pharmacist who desires to leave the active
practice of pharmacy in this state may secure from the department an
inactive license. The initial license and renewal fees shall be
determined by the secretary under RCW 43.70.250 and 43.70.280. The
holder of an inactive license may reactivate his or her license to
practice pharmacy in accordance with rules adopted by the ((board))
commission.
Sec. 13 RCW 18.64.160 and 1993 c 367 s 13 are each amended to
read as follows:
In addition to the grounds under RCW 18.130.170 and 18.130.180, the
((board of pharmacy)) commission may take disciplinary action against
the license of any pharmacist or intern upon proof that:
(1) His or her license was procured through fraud,
misrepresentation, or deceit;
(2) In the event that a pharmacist is determined by a court of
competent jurisdiction to be mentally incompetent, the pharmacist shall
automatically have his or her license suspended by the ((board))
commission upon the entry of the judgment, regardless of the pendency
of an appeal;
(3) He or she has knowingly violated or permitted the violation of
any provision of any state or federal law, rule, or regulation
governing the possession, use, distribution, or dispensing of drugs,
including, but not limited to, the violation of any provision of this
chapter, Title 69 RCW, or rule or regulation of the ((board))
commission;
(4) He or she has knowingly allowed any unlicensed person to take
charge of a pharmacy or engage in the practice of pharmacy, except a
pharmacy intern or pharmacy assistant acting as authorized in this
chapter or chapter 18.64A RCW in the presence of and under the
immediate supervision of a licensed pharmacist;
(5) He or she has compounded, dispensed, or caused the compounding
or dispensing of any drug or device which contains more or less than
the equivalent quantity of ingredient or ingredients specified by the
person who prescribed such drug or device: PROVIDED, HOWEVER, That
nothing herein shall be construed to prevent the pharmacist from
exercising professional judgment in the preparation or providing of
such drugs or devices.
Sec. 14 RCW 18.64.165 and 1995 c 319 s 5 are each amended to read
as follows:
The ((board)) commission shall have the power to refuse, suspend,
or revoke the license of any manufacturer, wholesaler, pharmacy,
shopkeeper, itinerant vendor, peddler, poison distributor, health care
entity, or precursor chemical distributor upon proof that:
(1) The license was procured through fraud, misrepresentation, or
deceit;
(2) The licensee has violated or has permitted any employee to
violate any of the laws of this state or the United States relating to
drugs, controlled substances, cosmetics, or nonprescription drugs, or
has violated any of the rules and regulations of the ((board of
pharmacy)) commission or has been convicted of a felony.
Sec. 15 RCW 18.64.200 and 1963 c 38 s 11 are each amended to read
as follows:
In any case of the refusal, suspension or revocation of a license
by ((said board)) the commission under the provisions of this chapter,
appeal may be taken in accordance with the Administrative Procedure
Act.
Sec. 16 RCW 18.64.205 and 1996 c 191 s 48 are each amended to
read as follows:
The ((board)) commission may adopt rules pursuant to this section
authorizing a retired active license status. An individual licensed
pursuant to this chapter, who is practicing only in emergent or
intermittent circumstances as defined by rule established by the
((board)) commission, may hold a retired active license at a reduced
renewal fee established by the secretary under RCW 43.70.250 and
43.70.280. Such a license shall meet the continuing education
requirements, if any, established by the ((board)) commission for
renewals, and is subject to the provisions of the uniform disciplinary
act, chapter 18.130 RCW. Individuals who have entered into retired
status agreements with the disciplinary authority in any jurisdiction
shall not qualify for a retired active license under this section.
Sec. 17 RCW 18.64.245 and 2003 c 53 s 135 are each amended to
read as follows:
(1) Every proprietor or manager of a pharmacy shall keep readily
available a suitable record of prescriptions which shall preserve for
a period of not less than two years the record of every prescription
dispensed at such pharmacy which shall be numbered, dated, and filed,
and shall produce the same in court or before any grand jury whenever
lawfully required to do so. The record shall be maintained either
separately from all other records of the pharmacy or in such form that
the information required is readily retrievable from ordinary business
records of the pharmacy. All recordkeeping requirements for controlled
substances must be complied with. Such record of prescriptions shall
be for confidential use in the pharmacy, only. The record of
prescriptions shall be open for inspection by the ((board of pharmacy))
commission or any officer of the law, who is authorized to enforce
chapter 18.64, 69.41, or 69.50 RCW.
(2) A person violating this section is guilty of a misdemeanor.
Sec. 18 RCW 18.64.246 and 2003 c 53 s 136 are each amended to
read as follows:
(1) To every box, bottle, jar, tube or other container of a
prescription which is dispensed there shall be fixed a label bearing
the name and address of the dispensing pharmacy, the prescription
number, the name of the prescriber, the prescriber's directions, the
name and strength of the medication, the name of the patient, the date,
and the expiration date. The security of the cover or cap on every
bottle or jar shall meet safety standards adopted by the ((state board
of pharmacy)) commission. At the prescriber's request, the name and
strength of the medication need not be shown. If the prescription is
for a combination medication product, the generic names of the
medications combined or the trade name used by the manufacturer or
distributor for the product shall be noted on the label. The
identification of the licensed pharmacist responsible for each
dispensing of medication must either be recorded in the pharmacy's
record system or on the prescription label. This section shall not
apply to the dispensing of medications to in-patients in hospitals.
(2) A person violating this section is guilty of a misdemeanor.
Sec. 19 RCW 18.64.255 and 2011 c 336 s 495 are each amended to
read as follows:
Nothing in this chapter shall operate in any manner:
(1) To restrict the scope of authorized practice of any
practitioner other than a pharmacist, duly licensed as such under the
laws of this state. However, a health care entity shall comply with
all state and federal laws and rules relating to the dispensing of
drugs and the practice of pharmacy; or
(2) In the absence of the pharmacist from the hospital pharmacy, to
prohibit a registered nurse designated by the hospital and the
responsible pharmacist from obtaining from the hospital pharmacy such
drugs as are needed in an emergency: PROVIDED, That proper record is
kept of such emergency, including the date, time, name of prescriber,
the name of the nurse obtaining the drugs, and a list of what drugs and
quantities of same were obtained; or
(3) To prevent shopkeepers, itinerant vendors, peddlers, or
salespersons from dealing in and selling nonprescription drugs, if such
drugs are sold in the original packages of the manufacturer, or in
packages put up by a licensed pharmacist in the manner provided by the
((state board of pharmacy)) commission, if such shopkeeper, itinerant
vendor, salesperson, or peddler shall have obtained a registration.
Sec. 20 RCW 18.64.257 and 1987 c 41 s 1 are each amended to read
as follows:
This chapter shall not prevent a medicare-approved dialysis center
or facility operating a medicare-approved home dialysis program from
selling, delivering, possessing, or dispensing directly to its dialysis
patients, in case or full shelf lots, if prescribed by a physician
licensed under chapter 18.57 or 18.71 RCW, those legend drugs
determined by the ((board)) commission pursuant to rule.
Sec. 21 RCW 18.64.310 and 1996 c 191 s 49 are each amended to
read as follows:
The department shall:
(1) Establish reasonable license and examination fees and fees for
services to other agencies in accordance with RCW 43.70.250 and
43.70.280. In cases where there are unanticipated demands for
services, the department may request payment for services directly from
the agencies for whom the services are performed, to the extent that
revenues or other funds are available. Drug-related investigations
regarding licensed health care practitioners shall be funded by an
appropriation to the department from the health professions account.
The payment may be made on either an advance or a reimbursable basis as
approved by the director of financial management;
(2) Employ, with confirmation by the ((board)) commission, an
executive officer, who shall be exempt from the provisions of chapter
41.06 RCW and who shall be a pharmacist licensed in Washington, and
employ inspectors, investigators, chemists, and other persons as
necessary to assist it for any purpose which it may deem necessary;
(3) Investigate and prosecute, at the direction of the ((board))
commission, including use of subpoena powers, violations of law or
regulations under its jurisdiction or the jurisdiction of the ((board
of pharmacy)) commission;
(4) Make, at the direction of the ((board)) commission, inspections
and investigations of pharmacies and other places, including dispensing
machines, in which drugs or devices are stored, held, compounded,
dispensed, sold, or administered to the ultimate consumer, to take and
analyze any drugs or devices and to seize and condemn any drugs or
devices which are adulterated, misbranded, stored, held, dispensed,
distributed, administered, or compounded in violation of or contrary to
law. The written operating agreement between the department and the
((board)) commission, as required by RCW 43.70.240 shall include
provisions for the department to involve the ((board)) commission in
carrying out its duties required by this section.
Sec. 22 RCW 18.64.360 and 2005 c 275 s 3 are each amended to read
as follows:
(1) For the purposes of this chapter any pharmacy located outside
this state that ships, mails, or delivers, in any manner, except when
delivered in person to an individual, controlled substances, legend
drugs, or devices into this state is a nonresident pharmacy, and shall
be licensed by the department of health, and shall disclose to the
department the following:
(a) The location, names, and titles of all owners including
corporate officers and all pharmacists employed by the pharmacy who are
dispensing controlled substances, legend drugs, or devices to residents
of this state. A report containing this information shall be made on
an annual basis and within ninety days after a change of location,
corporate officer, or pharmacist;
(b) Proof of compliance with all lawful directions and requests for
information from the regulatory or licensing agency of the state or
Canadian province in which it is licensed as well as with all requests
for information made by the department of health under this section.
The nonresident pharmacy shall maintain, at all times, a valid
unexpired license, permit, or registration to operate the pharmacy in
compliance with the laws of the state or Canadian province in which it
is located. As a prerequisite to be licensed by the department of
health, the nonresident pharmacy shall submit a copy of the most recent
inspection report issued by the regulatory licensing agency of the
state or Canadian province in which it is located;
(c) Proof that it maintains its records of controlled substances,
legend drugs, or devices dispensed to patients in this state so that
the records are readily retrievable from the records of other drugs
dispensed.
(2) Any pharmacy subject to this section shall, during its regular
hours of operation, provide a toll-free telephone service to facilitate
communication between patients in this state and a pharmacist at the
pharmacy who has access to the patient's records. This toll-free
number shall be disclosed on the label affixed to each container of
drugs dispensed to patients in this state.
(3) A pharmacy subject to this section shall comply with ((board))
commission rules regarding the maintenance and use of patient
medication record systems.
(4) A pharmacy subject to this section shall comply with ((board of
pharmacy)) commission rules regarding the provision of drug information
to the patient. Drug information may be contained in written form
setting forth directions for use and any additional information
necessary to assure the proper utilization of the medication
prescribed. A label bearing the expiration date of the prescription
must be affixed to each box, bottle, jar, tube, or other container of
a prescription that is dispensed in this state by a pharmacy subject to
this section.
(5) A pharmacy subject to this section shall not dispense
medication in a quantity greater than authorized by the prescriber.
(6) The license fee specified by the secretary, in accordance with
the provisions of RCW 43.70.250, shall not exceed the fee charged to a
pharmacy located in this state.
(7) The license requirements of this section apply to nonresident
pharmacies that ship, mail, or deliver controlled substances, legend
drugs, and devices into this state only under a prescription. The
((board of pharmacy)) commission may grant an exemption from licensing
under this section upon application by an out-of-state pharmacy that
restricts its dispensing activity in Washington to isolated
transactions.
(8) Each nonresident pharmacy that ships, mails, or delivers legend
drugs or devices into this state shall designate a resident agent in
Washington for service of process. The designation of such an agent
does not indicate that the nonresident pharmacy is a resident of
Washington for tax purposes.
(9) The ((board)) commission shall attempt to develop a reciprocal
licensing agreement for licensure of nonresident pharmacies with Health
Canada or an applicable Canadian province. If the ((board)) commission
is unable to develop such an agreement, the ((board)) commission shall
develop a process to license participating Canadian nonresident
pharmacies through on-site inspection and certification.
Sec. 23 RCW 18.64.390 and 1991 c 87 s 5 are each amended to read
as follows:
(1) The ((board)) commission may deny, revoke, or suspend a
nonresident pharmacy license or impose a fine not to exceed one
thousand dollars per violation for failure to comply with any
requirement of RCW 18.64.350 through 18.64.400.
(2) The ((board)) commission may deny, revoke, or suspend a
nonresident pharmacy license or impose a fine not to exceed one
thousand dollars per violation for conduct that causes serious bodily
or psychological injury to a resident of this state if the secretary
has referred the matter to the regulatory or licensing agency in the
state in which the pharmacy is located and that regulatory or licensing
agency fails to initiate an investigation within forty-five days of the
referral under this subsection or fails to make a determination on the
referral.
Sec. 24 RCW 18.64.410 and 1991 c 87 s 11 are each amended to read
as follows:
The ((board)) commission may adopt rules to implement the
provisions of RCW 18.64.350 through 18.64.400 and 18.64.420.
Sec. 25 RCW 18.64.420 and 2005 c 274 s 226 are each amended to
read as follows:
All records, reports, and information obtained by the department
from or on behalf of an entity licensed under chapter 48.20, 48.21,
48.44, or 48.46 RCW shall be confidential and exempt from inspection
and copying under chapter 42.56 RCW. Nothing in this section restricts
the investigation or the proceedings of the ((board)) commission or the
department so long as the ((board)) commission and the department
comply with the provisions of chapter 42.56 RCW. Nothing in this
section or in chapter 42.56 RCW shall restrict the ((board)) commission
or the department from complying with any mandatory reporting
requirements that exist or may exist under federal law, nor shall the
((board)) commission or the department be restricted from providing to
any person the name of any nonresident pharmacy that is or has been
licensed or disciplined under RCW 18.64.350 through 18.64.400.
Sec. 26 RCW 18.64.450 and 1995 c 319 s 3 are each amended to read
as follows:
(1) In order for a health care entity to purchase, administer,
dispense, and deliver legend drugs, the health care entity must be
licensed by the department.
(2) In order for a health care entity to purchase, administer,
dispense, and deliver controlled substances, the health care entity
must annually obtain a license from the department in accordance with
the ((board's)) commission's rules.
(3) The receipt, administration, dispensing, and delivery of legend
drugs or controlled substances by a health care entity must be
performed under the supervision or at the direction of a pharmacist.
(4) A health care entity may only administer, dispense, or deliver
legend drugs and controlled substances to patients who receive care
within the health care entity and in compliance with rules of the
((board)) commission. Nothing in this subsection shall prohibit a
practitioner, in carrying out his or her licensed responsibilities
within a health care entity, from dispensing or delivering to a patient
of the health care entity drugs for that patient's personal use in an
amount not to exceed seventy-two hours of usage.
Sec. 27 RCW 18.64.470 and 1995 c 319 s 6 are each amended to read
as follows:
Every proprietor or manager of a health care entity shall keep
readily available a suitable record of drugs, which shall preserve for
a period of not less than two years the record of every drug used at
such health care entity. The record shall be maintained either
separately from all other records of the health care entity or in such
form that the information required is readily retrievable from ordinary
business records of the health care entity. All recordkeeping
requirements for controlled substances must be complied with. Such
record of drugs shall be for confidential use in the health care
entity, only. The record of drugs shall be open for inspection by the
((board of pharmacy)) commission, who is authorized to enforce chapter
18.64, 69.41, or 69.50 RCW.
Sec. 28 RCW 18.64.480 and 2005 c 275 s 4 are each amended to read
as follows:
(1) By September 1, 2005, the ((board of pharmacy)) commission
shall, in consultation with the department and the health care
authority, submit a waiver request to the federal food and drug
administration that authorizes the importation of prescription drugs
from Canada.
(2) Upon approval of the federal waiver allowing for the
importation of prescription drugs from Canada, the ((board))
commission, in consultation with the department and the health care
authority, shall license Canadian pharmacies that provide services to
Washington residents under RCW 18.64.350 and 18.64.360.
Sec. 29 RCW 18.64.490 and 2005 c 293 s 2 are each amended to read
as follows:
(1) By September 1, 2005, the ((board)) commission shall, in
consultation with the department and the health care authority, submit
a waiver request to the federal food and drug administration that will
authorize the state of Washington to license Canadian, United Kingdom,
Irish, and other nondomestic prescription drug wholesalers under RCW
18.64.046, thereby providing retail pharmacies licensed in Washington
state the opportunity to purchase prescription drugs from approved
wholesalers and pass those savings on to consumers. The waiver shall
provide that:
(a) Canadian, United Kingdom, Irish, and other nondomestic
prescription drug wholesalers meet the requirements of RCW 18.64.046
and any rules adopted by the ((board)) commission to implement those
requirements;
(b) The ((board)) commission must ensure the integrity of the
prescription drug products being distributed by:
(i) Requiring that prescription drugs purchased from Canadian,
United Kingdom, Irish, and other nondomestic wholesalers originate only
from approved manufacturing locations;
(ii) Routinely testing prescription drugs purchased from Canadian,
United Kingdom, Irish, and other nondomestic wholesalers for safety;
(iii) Establishing safe labeling, tracking, and shipping procedures
for prescription drugs purchased from Canadian, United Kingdom, Irish,
and other nondomestic wholesalers; and
(iv) Closely monitoring compliance with RCW 18.64.046 and any rules
adopted to implement the waiver;
(c) The prescription drugs purchased from Canadian, United Kingdom,
Irish, and other nondomestic wholesalers must be limited to those that
are not temperature sensitive or infused and for which potential
savings to consumers can be demonstrated and those available through
purchase by individuals only at licensed retail pharmacies;
(d) To ensure that the program benefits those consumers without
insurance coverage for prescription drugs who are most in need of price
relief, prescription drug purchases from pharmacies under the waiver
will be limited to those not eligible for reimbursement by third party
insurance coverage, whether public or private, for the particular drug
being purchased; and
(e) Savings associated with purchasing prescription drugs from
Canadian, United Kingdom, Irish, and other nondomestic wholesalers will
be passed on to consumers.
(2) Upon approval of the federal waiver submitted in accordance
with subsection (1) of this section, the ((board)) commission, in
consultation with the department and the health care authority, shall
submit a detailed implementation plan to the governor and appropriate
committees of the legislature that details the mechanisms that the
((board)) commission will use to implement each component of the waiver
under subsection (1) of this section.
(3) The ((board)) commission shall adopt rules as necessary to
implement chapter 293, Laws of 2005.
Sec. 30 RCW 18.64.500 and 2009 c 328 s 1 are each amended to read
as follows:
(1) Effective July 1, 2010, every prescription written in this
state by a licensed practitioner must be written on a tamper-resistant
prescription pad or paper approved by the ((board)) commission.
(2) A pharmacist may not fill a written prescription from a
licensed practitioner unless it is written on an approved tamper-resistant prescription pad or paper, except that a pharmacist may
provide emergency supplies in accordance with the ((board)) commission
and other insurance contract requirements.
(3) If a hard copy of an electronic prescription is given directly
to the patient, the manually signed hard copy prescription must be on
approved tamper-resistant paper that meets the requirements of this
section.
(4) For the purposes of this section, "tamper-resistant
prescription pads or paper" means a prescription pad or paper that has
been approved by the ((board)) commission for use and contains the
following characteristics:
(a) One or more industry-recognized features designed to prevent
unauthorized copying of a completed or blank prescription form;
(b) One or more industry-recognized features designed to prevent
the erasure or modification of information written on the prescription
form by the practitioner; and
(c) One or more industry-recognized features designed to prevent
the use of counterfeit prescription forms.
(5) Practitioners shall employ reasonable safeguards to assure
against theft or unauthorized use of prescriptions.
(6) All vendors must have their tamper-resistant prescription pads
or paper approved by the ((board)) commission prior to the marketing or
sale of pads or paper in Washington state.
(7) The ((board)) commission shall create a seal of approval that
confirms that a pad or paper contains all three industry-recognized
characteristics required by this section. The seal must be affixed to
all prescription pads or paper used in this state.
(8) The ((board)) commission may adopt rules necessary for the
administration of chapter 328, Laws of 2009.
(9) The tamper-resistant prescription pad or paper requirements in
this section shall not apply to:
(a) Prescriptions that are transmitted to the pharmacy by
telephone, facsimile, or electronic means; or
(b) Prescriptions written for inpatients of a hospital, outpatients
of a hospital, residents of a nursing home, inpatients or residents of
a mental health facility, or individuals incarcerated in a local,
state, or federal correction facility, when the health care
practitioner authorized to write prescriptions writes the order into
the patient's medical or clinical record, the order is given directly
to the pharmacy, and the patient never has the opportunity to handle
the written order.
(10) All acts related to the prescribing, dispensing, and records
maintenance of all prescriptions shall be in compliance with applicable
federal and state laws, rules, and regulations.
Sec. 31 RCW 18.64.510 and 2009 c 411 s 2 are each amended to read
as follows:
Nothing in this chapter or in any provision of law shall be
interpreted to invest the ((board)) commission with the authority to
regulate or establish standards regarding a jail as defined in RCW
70.48.020 that does not operate, in whole or in part, a pharmacy or a
correctional pharmacy. This section does not limit the ((board's))
commission's authority to regulate a pharmacist that has entered into
an agreement with a jail for the provision of pharmaceutical services.
Sec. 32 RCW 18.64A.010 and 1997 c 417 s 1 are each amended to
read as follows:
Terms used in this chapter shall have the meaning set forth in this
section unless the context clearly indicates otherwise:
(1) (("Board" means the state board of pharmacy;)) "Commission"
means the pharmacy quality assurance commission;
(2) "Department" means the department of health;
(3) "Pharmacist" means a person duly licensed by the ((state board
of pharmacy)) commission to engage in the practice of pharmacy;
(4) "Pharmacy" means every place properly licensed by the ((board
of pharmacy)) commission where the practice of pharmacy is conducted;
(5) "Pharmacy ancillary personnel" means pharmacy technicians and
pharmacy assistants;
(6) "Pharmacy technician" means:
(a) A person who is enrolled in, or who has satisfactorily
completed, a ((board)) commission-approved training program designed to
prepare persons to perform nondiscretionary functions associated with
the practice of pharmacy; or
(b) A person who is a graduate with a degree in pharmacy or
medicine of a foreign school, university, or college recognized by the
((board)) commission;
(7) "Pharmacy assistant" means a person registered by the ((board))
commission to perform limited functions in the pharmacy;
(8) "Practice of pharmacy" means the definition given in RCW
18.64.011;
(9) "Secretary" means the secretary of health or the secretary's
designee.
Sec. 33 RCW 18.64A.020 and 2011 c 71 s 1 are each amended to read
as follows:
(1)(a) The ((board)) commission shall adopt, in accordance with
chapter 34.05 RCW, rules fixing the classification and qualifications
and the educational and training requirements for persons who may be
employed as pharmacy technicians or who may be enrolled in any pharmacy
technician training program. Such rules shall provide that:
(i) Licensed pharmacists shall supervise the training of pharmacy
technicians;
(ii) Training programs shall assure the competence of pharmacy
technicians to aid and assist pharmacy operations. Training programs
shall consist of instruction and/or practical training; and
(iii) Pharmacy technicians shall complete continuing education
requirements established in rule by the ((board)) commission.
(b) Such rules may include successful completion of examinations
for applicants for pharmacy technician certificates. If such
examination rules are adopted, the ((board)) commission shall prepare
or determine the nature of, and supervise the grading of the
examinations. The ((board)) commission may approve an examination
prepared or administered by a private testing agency or association of
licensing authorities.
(2) The ((board)) commission may disapprove or revoke approval of
any training program for failure to conform to ((board)) commission
rules. In the case of the disapproval or revocation of approval of a
training program by the ((board)) commission, a hearing shall be
conducted in accordance with RCW 18.64.160, and appeal may be taken in
accordance with the administrative procedure act, chapter 34.05 RCW.
Sec. 34 RCW 18.64A.025 and 2011 c 32 s 5 are each amended to read
as follows:
An applicant with military training or experience satisfies the
training and experience requirements of this chapter unless the
((board)) commission determines that the military training or
experience is not substantially equivalent to the standards of this
state.
Sec. 35 RCW 18.64A.030 and 1997 c 417 s 3 are each amended to
read as follows:
The ((board)) commission shall adopt, in accordance with chapter
34.05 RCW, rules governing the extent to which pharmacy ancillary
personnel may perform services associated with the practice of
pharmacy. These rules shall provide for the certification of pharmacy
technicians by the department at a fee determined by the secretary
under RCW 43.70.250:
(1) "Pharmacy technicians" may assist in performing, under the
supervision and control of a licensed pharmacist, manipulative,
nondiscretionary functions associated with the practice of pharmacy and
other such duties and subject to such restrictions as the ((board))
commission may by rule adopt.
(2) "Pharmacy assistants" may perform, under the supervision of a
licensed pharmacist, duties including but not limited to, typing of
prescription labels, filing, refiling, bookkeeping, pricing, stocking,
delivery, nonprofessional phone inquiries, and documentation of third
party reimbursements and other such duties and subject to such
restrictions as the ((board)) commission may by rule adopt.
Sec. 36 RCW 18.64A.040 and 1997 c 417 s 4 are each amended to
read as follows:
(1) Pharmacy ancillary personnel shall practice pharmacy in this
state only after authorization by the ((board)) commission and only to
the extent permitted by the ((board)) commission in accordance with
this chapter.
(2) A pharmacist shall be assisted by pharmacy ancillary personnel
in the practice of pharmacy in this state only after authorization by
the ((board)) commission and only to the extent permitted by the
((board)) commission in accordance with this chapter: PROVIDED, That
no pharmacist may supervise more than one pharmacy technician:
PROVIDED FURTHER, That in pharmacies operating in connection with
facilities licensed pursuant to chapter 70.41, 71.12, 71A.20, or 74.42
RCW, whether or not situated within the said facility which shall be
physically separated from any area of a pharmacy where dispensing of
prescriptions to the general public occurs, the ratio of pharmacists to
pharmacy technicians shall be as follows: In the preparation of
medicine or other materials used by patients within the facility, one
pharmacist supervising no more than three pharmacy technicians; in the
preparation of medicine or other materials dispensed to persons not
patients within the facility, one pharmacist supervising not more than
one pharmacy technician.
(3) The ((board)) commission may by rule modify the standard ratios
set out in subsection (2) of this section governing the utilization of
pharmacy technicians by pharmacies and pharmacists. Should a pharmacy
desire to use more pharmacy technicians than the standard ratios, the
pharmacy must submit to the ((board)) commission a pharmacy services
plan for approval.
(a) The pharmacy services plan shall include, at a minimum, the
following information: Pharmacy design and equipment, information
systems, workflow, and quality assurance procedures. In addition, the
pharmacy services plan shall demonstrate how it facilitates the
provision of pharmaceutical care by the pharmacy.
(b) Prior to approval of a pharmacy services plan, the ((board))
commission may require additional information to ensure appropriate
oversight of pharmacy ancillary personnel.
(c) The ((board)) commission may give conditional approval for
pilot or demonstration projects.
(d) Variance from the approved pharmacy services plan is grounds
for disciplinary action under RCW 18.64A.050.
Sec. 37 RCW 18.64A.050 and 1997 c 417 s 5 are each amended to
read as follows:
In addition to the grounds under RCW 18.130.170 and 18.130.180, the
((board of pharmacy)) commission may take disciplinary action against
the certificate of any pharmacy technician upon proof that:
(1) His or her certificate was procured through fraud,
misrepresentation or deceit;
(2) He or she has been found guilty of any offense in violation of
the laws of this state relating to drugs, poisons, cosmetics or drug
sundries by any court of competent jurisdiction. Nothing herein shall
be construed to affect or alter the provisions of RCW 9.96A.020;
(3) He or she has exhibited gross incompetency in the performance
of his or her duties;
(4) He or she has willfully or repeatedly violated any of the rules
and regulations of the ((board of pharmacy)) commission or of the
department;
(5) He or she has willfully or repeatedly performed duties beyond
the scope of his or her certificate in violation of the provisions of
this chapter; or
(6) He or she has impersonated a licensed pharmacist.
Sec. 38 RCW 18.64A.060 and 1997 c 417 s 6 are each amended to
read as follows:
No pharmacy licensed in this state shall utilize the services of
pharmacy ancillary personnel without approval of the ((board))
commission.
Any pharmacy licensed in this state may apply to the ((board))
commission for permission to use the services of pharmacy ancillary
personnel. The application shall be accompanied by a fee and shall
comply with administrative procedures and administrative requirements
set pursuant to RCW 43.70.250 and 43.70.280, shall detail the manner
and extent to which the pharmacy ancillary personnel would be used and
supervised, and shall provide other information in such form as the
secretary may require.
The ((board)) commission may approve or reject such applications.
In addition, the ((board)) commission may modify the proposed
utilization of pharmacy ancillary personnel and approve the application
as modified. Whenever it appears to the ((board)) commission that
pharmacy ancillary personnel are being utilized in a manner
inconsistent with the approval granted, the ((board)) commission may
withdraw such approval. In the event a hearing is requested upon the
rejection of an application, or upon the withdrawal of approval, a
hearing shall be conducted in accordance with chapter 18.64 RCW, as now
or hereafter amended, and appeal may be taken in accordance with the
Administrative Procedure Act, chapter 34.05 RCW.
Sec. 39 RCW 18.64A.070 and 1997 c 417 s 7 are each amended to
read as follows:
(1) Persons presently assisting a pharmacist by performing the
functions of a pharmacy technician may continue to do so under the
supervision of a licensed pharmacist: PROVIDED, That within eighteen
months after May 28, 1977, such persons shall be in compliance with the
provisions of this chapter.
(2) Pharmacies presently employing persons to perform the functions
of a pharmacy technician may continue to do so while obtaining
((board)) commission approval for the use of certified pharmacy
technicians: PROVIDED, That within eighteen months after May 28, 1977,
such pharmacies shall be in compliance with the provisions of this
chapter.
Sec. 40 RCW 18.64A.080 and 1997 c 417 s 8 are each amended to
read as follows:
A pharmacy or pharmacist which utilizes the services of pharmacy
ancillary personnel with approval by the ((board)) commission, is not
aiding and abetting an unlicensed person to practice pharmacy within
the meaning of chapter 18.64 RCW: PROVIDED, HOWEVER, That the pharmacy
or pharmacist shall retain responsibility for any act performed by
pharmacy ancillary personnel in the course of employment.
Sec. 41 RCW 18.92.012 and 1991 c 47 s 1 are each amended to read
as follows:
A veterinarian licensed under this chapter may dispense veterinary
legend drugs prescribed by other veterinarians licensed under this
chapter, so long as, during any year, the total drugs so dispensed do
not constitute more than five percent of the total dosage units of
legend drugs the veterinarian dispenses and the veterinarian maintains
records of his or her dispensing activities consistent with the
requirements of chapters 18.64, 69.04, 69.41, and 69.50 RCW. For
purposes of this section, a "veterinary legend drug" is a legend drug,
as defined in chapter 69.41 RCW, which is either: (1) Restricted to
use by licensed veterinarians by any law or regulation of the federal
government, or (2) designated by rule by the ((state board of
pharmacy)) pharmacy quality assurance commission as being a legend drug
that one licensed veterinarian may dispense for another licensed
veterinarian under this section.
Sec. 42 RCW 18.92.013 and 2009 c 136 s 1 are each amended to read
as follows:
(1) A veterinarian legally prescribing drugs may delegate to a
registered veterinary medication clerk, while under the veterinarian's
direct supervision, certain nondiscretionary functions defined by the
board and used in the preparing of legend and nonlegend drugs (except
controlled substances as defined in or under chapter 69.50 RCW)
associated with the practice of veterinary medicine. A veterinarian
legally prescribing drugs may delegate to a licensed veterinary
technician, while under the veterinarian's indirect supervision,
certain nondiscretionary functions defined by the board and used in the
preparing of legend drugs, nonlegend drugs, and controlled substances
associated with the practice of veterinary medicine. Upon final
approval of the packaged prescription following a direct physical
inspection of the packaged prescription for proper formulation,
packaging, and labeling by the veterinarian, the veterinarian may
delegate the delivery of the prescription to a registered veterinary
medication clerk or licensed veterinary technician, while under the
veterinarian's indirect supervision. Dispensing of drugs by
veterinarians, licensed veterinary technicians, and registered
veterinary medication clerks shall meet the applicable requirements of
chapters 18.64, 69.40, 69.41, and 69.50 RCW and is subject to
inspection by the ((board of pharmacy)) pharmacy quality assurance
commission investigators.
(2) A licensed veterinary technician may administer legend drugs
under chapter 69.41 RCW and controlled substances under chapter 69.50
RCW under indirect supervision of a veterinarian.
(3) For the purposes of this section:
(a) "Direct supervision" means the veterinarian is on the premises
and is quickly and easily available; and
(b) "Indirect supervision" means the veterinarian is not on the
premises but has given written or oral instructions for the delegated
task.
Sec. 43 RCW 18.92.015 and 2007 c 235 s 1 are each amended to read
as follows:
The definitions in this section apply throughout this chapter
unless the context clearly requires otherwise.
(1) "Board" means the Washington state veterinary board of
governors.
(2) "Department" means the department of health.
(3) "Secretary" means the secretary of the department of health.
(4) "Veterinary medication clerk" means a person who has
satisfactorily completed a board-approved training program developed in
consultation with the ((board of pharmacy)) pharmacy quality assurance
commission and designed to prepare persons to perform certain
nondiscretionary functions defined by the board and used in the
dispensing of legend and nonlegend drugs (except controlled substances
as defined in or under chapter 69.50 RCW) associated with the practice
of veterinary medicine.
(5) "Veterinary technician" means a person who is licensed by the
board upon meeting the requirements of RCW 18.92.128.
Sec. 44 RCW 18.130.040 and 2012 c 208 s 10, 2012 c 153 s 16, 2012
c 137 s 19, and 2012 c 23 s 6 are each reenacted and amended to read as
follows:
(1) This chapter applies only to the secretary and the boards and
commissions having jurisdiction in relation to the professions licensed
under the chapters specified in this section. This chapter does not
apply to any business or profession not licensed under the chapters
specified in this section.
(2)(a) The secretary has authority under this chapter in relation
to the following professions:
(i) Dispensing opticians licensed and designated apprentices under
chapter 18.34 RCW;
(ii) Midwives licensed under chapter 18.50 RCW;
(iii) Ocularists licensed under chapter 18.55 RCW;
(iv) Massage practitioners and businesses licensed under chapter
18.108 RCW;
(v) Dental hygienists licensed under chapter 18.29 RCW;
(vi) East Asian medicine practitioners licensed under chapter 18.06
RCW;
(vii) Radiologic technologists certified and X-ray technicians
registered under chapter 18.84 RCW;
(viii) Respiratory care practitioners licensed under chapter 18.89
RCW;
(ix) Hypnotherapists and agency affiliated counselors registered
and advisors and counselors certified under chapter 18.19 RCW;
(x) Persons licensed as mental health counselors, mental health
counselor associates, marriage and family therapists, marriage and
family therapist associates, social workers, social work associates--advanced, and social work associates -- independent clinical under
chapter 18.225 RCW;
(xi) Persons registered as nursing pool operators under chapter
18.52C RCW;
(xii) Nursing assistants registered or certified or medication
assistants endorsed under chapter 18.88A RCW;
(xiii) Health care assistants certified under chapter 18.135 RCW;
(xiv) Dietitians and nutritionists certified under chapter 18.138
RCW;
(xv) Chemical dependency professionals and chemical dependency
professional trainees certified under chapter 18.205 RCW;
(xvi) Sex offender treatment providers and certified affiliate sex
offender treatment providers certified under chapter 18.155 RCW;
(xvii) Persons licensed and certified under chapter 18.73 RCW or
RCW 18.71.205;
(xviii) Denturists licensed under chapter 18.30 RCW;
(xix) Orthotists and prosthetists licensed under chapter 18.200
RCW;
(xx) Surgical technologists registered under chapter 18.215 RCW;
(xxi) Recreational therapists under chapter 18.230 RCW;
(xxii) Animal massage practitioners certified under chapter 18.240
RCW;
(xxiii) Athletic trainers licensed under chapter 18.250 RCW;
(xxiv) Home care aides certified under chapter 18.88B RCW;
(xxv) Genetic counselors licensed under chapter 18.290 RCW; ((and))
(xxvi) Reflexologists certified under chapter 18.108 RCW; and
(xxvii) Medical assistants-certified, medical assistants-hemodialysis technician, medical assistants-phlebotomist, and medical
assistants-registered certified and registered under chapter 18.360
RCW.
(b) The boards and commissions having authority under this chapter
are as follows:
(i) The podiatric medical board as established in chapter 18.22
RCW;
(ii) The chiropractic quality assurance commission as established
in chapter 18.25 RCW;
(iii) The dental quality assurance commission as established in
chapter 18.32 RCW governing licenses issued under chapter 18.32 RCW,
licenses and registrations issued under chapter 18.260 RCW, and
certifications issued under chapter 18.350 RCW;
(iv) The board of hearing and speech as established in chapter
18.35 RCW;
(v) The board of examiners for nursing home administrators as
established in chapter 18.52 RCW;
(vi) The optometry board as established in chapter 18.54 RCW
governing licenses issued under chapter 18.53 RCW;
(vii) The board of osteopathic medicine and surgery as established
in chapter 18.57 RCW governing licenses issued under chapters 18.57 and
18.57A RCW;
(viii) The ((board of pharmacy)) pharmacy quality assurance
commission as established in chapter 18.64 RCW governing licenses
issued under chapters 18.64 and 18.64A RCW;
(ix) The medical quality assurance commission as established in
chapter 18.71 RCW governing licenses and registrations issued under
chapters 18.71 and 18.71A RCW;
(x) The board of physical therapy as established in chapter 18.74
RCW;
(xi) The board of occupational therapy practice as established in
chapter 18.59 RCW;
(xii) The nursing care quality assurance commission as established
in chapter 18.79 RCW governing licenses and registrations issued under
that chapter;
(xiii) The examining board of psychology and its disciplinary
committee as established in chapter 18.83 RCW;
(xiv) The veterinary board of governors as established in chapter
18.92 RCW; and
(xv) The board of naturopathy established in chapter 18.36A RCW.
(3) In addition to the authority to discipline license holders, the
disciplining authority has the authority to grant or deny licenses.
The disciplining authority may also grant a license subject to
conditions.
(4) All disciplining authorities shall adopt procedures to ensure
substantially consistent application of this chapter, the uniform
disciplinary act, among the disciplining authorities listed in
subsection (2) of this section.
Sec. 45 RCW 18.130.040 and 2012 c 208 s 10, 2012 c 153 s 17, 2012
c 137 s 19, and 2012 c 23 s 6 are each reenacted and amended to read as
follows:
(1) This chapter applies only to the secretary and the boards and
commissions having jurisdiction in relation to the professions licensed
under the chapters specified in this section. This chapter does not
apply to any business or profession not licensed under the chapters
specified in this section.
(2)(a) The secretary has authority under this chapter in relation
to the following professions:
(i) Dispensing opticians licensed and designated apprentices under
chapter 18.34 RCW;
(ii) Midwives licensed under chapter 18.50 RCW;
(iii) Ocularists licensed under chapter 18.55 RCW;
(iv) Massage practitioners and businesses licensed under chapter
18.108 RCW;
(v) Dental hygienists licensed under chapter 18.29 RCW;
(vi) East Asian medicine practitioners licensed under chapter 18.06
RCW;
(vii) Radiologic technologists certified and X-ray technicians
registered under chapter 18.84 RCW;
(viii) Respiratory care practitioners licensed under chapter 18.89
RCW;
(ix) Hypnotherapists and agency affiliated counselors registered
and advisors and counselors certified under chapter 18.19 RCW;
(x) Persons licensed as mental health counselors, mental health
counselor associates, marriage and family therapists, marriage and
family therapist associates, social workers, social work associates--advanced, and social work associates -- independent clinical under
chapter 18.225 RCW;
(xi) Persons registered as nursing pool operators under chapter
18.52C RCW;
(xii) Nursing assistants registered or certified or medication
assistants endorsed under chapter 18.88A RCW;
(xiii) Dietitians and nutritionists certified under chapter 18.138
RCW;
(xiv) Chemical dependency professionals and chemical dependency
professional trainees certified under chapter 18.205 RCW;
(xv) Sex offender treatment providers and certified affiliate sex
offender treatment providers certified under chapter 18.155 RCW;
(xvi) Persons licensed and certified under chapter 18.73 RCW or RCW
18.71.205;
(xvii) Denturists licensed under chapter 18.30 RCW;
(xviii) Orthotists and prosthetists licensed under chapter 18.200
RCW;
(xix) Surgical technologists registered under chapter 18.215 RCW;
(xx) Recreational therapists under chapter 18.230 RCW;
(xxi) Animal massage practitioners certified under chapter 18.240
RCW;
(xxii) Athletic trainers licensed under chapter 18.250 RCW;
(xxiii) Home care aides certified under chapter 18.88B RCW;
(xxiv) Genetic counselors licensed under chapter 18.290 RCW;
((and))
(xxv) Reflexologists certified under chapter 18.108 RCW; and
(xxvi) Medical assistants-certified, medical assistants-hemodialysis technician, medical assistants-phlebotomist, and medical
assistants-registered certified and registered under chapter 18.360
RCW.
(b) The boards and commissions having authority under this chapter
are as follows:
(i) The podiatric medical board as established in chapter 18.22
RCW;
(ii) The chiropractic quality assurance commission as established
in chapter 18.25 RCW;
(iii) The dental quality assurance commission as established in
chapter 18.32 RCW governing licenses issued under chapter 18.32 RCW,
licenses and registrations issued under chapter 18.260 RCW, and
certifications issued under chapter 18.350 RCW;
(iv) The board of hearing and speech as established in chapter
18.35 RCW;
(v) The board of examiners for nursing home administrators as
established in chapter 18.52 RCW;
(vi) The optometry board as established in chapter 18.54 RCW
governing licenses issued under chapter 18.53 RCW;
(vii) The board of osteopathic medicine and surgery as established
in chapter 18.57 RCW governing licenses issued under chapters 18.57 and
18.57A RCW;
(viii) The ((board of pharmacy)) pharmacy quality assurance
commission as established in chapter 18.64 RCW governing licenses
issued under chapters 18.64 and 18.64A RCW;
(ix) The medical quality assurance commission as established in
chapter 18.71 RCW governing licenses and registrations issued under
chapters 18.71 and 18.71A RCW;
(x) The board of physical therapy as established in chapter 18.74
RCW;
(xi) The board of occupational therapy practice as established in
chapter 18.59 RCW;
(xii) The nursing care quality assurance commission as established
in chapter 18.79 RCW governing licenses and registrations issued under
that chapter;
(xiii) The examining board of psychology and its disciplinary
committee as established in chapter 18.83 RCW;
(xiv) The veterinary board of governors as established in chapter
18.92 RCW; and
(xv) The board of naturopathy established in chapter 18.36A RCW.
(3) In addition to the authority to discipline license holders, the
disciplining authority has the authority to grant or deny licenses.
The disciplining authority may also grant a license subject to
conditions.
(4) All disciplining authorities shall adopt procedures to ensure
substantially consistent application of this chapter, the uniform
disciplinary act, among the disciplining authorities listed in
subsection (2) of this section.
Sec. 46 RCW 28B.115.020 and 2011 1st sp.s. c 11 s 204 are each
reenacted and amended to read as follows:
Unless the context clearly requires otherwise, the definitions in
this section apply throughout this chapter.
(1) "Credentialed health care profession" means a health care
profession regulated by a disciplining authority in the state of
Washington under RCW 18.130.040 or by the ((state board of pharmacy))
pharmacy quality assurance commission under chapter 18.64 RCW and
designated by the department in RCW 28B.115.070 as a profession having
shortages of credentialed health care professionals in the state.
(2) "Credentialed health care professional" means a person
regulated by a disciplining authority in the state of Washington to
practice a health care profession under RCW 18.130.040 or by the
((state board of pharmacy)) pharmacy quality assurance commission under
chapter 18.64 RCW.
(3) "Department" means the state department of health.
(4) "Eligible education and training programs" means education and
training programs approved by the department that lead to eligibility
for a credential as a credentialed health care professional.
(5) "Eligible expenses" means reasonable expenses associated with
the costs of acquiring an education such as tuition, books, equipment,
fees, room and board, and other expenses determined by the office.
(6) "Eligible student" means a student who has been accepted into
an eligible education or training program and has a declared intention
to serve in a health professional shortage area upon completion of the
education or training program.
(7) "Forgiven" or "to forgive" or "forgiveness" means to render
health care services in a health professional shortage area in the
state of Washington in lieu of monetary repayment.
(8) "Health professional shortage areas" means those areas where
credentialed health care professionals are in short supply as a result
of geographic maldistribution or as the result of a short supply of
credentialed health care professionals in specialty health care areas
and where vacancies exist in serious numbers that jeopardize patient
care and pose a threat to the public health and safety. The department
shall determine health professional shortage areas as provided for in
RCW 28B.115.070. In making health professional shortage area
designations in the state the department may be guided by applicable
federal standards for "health manpower shortage areas," and "medically
underserved areas," and "medically underserved populations."
(9) "Loan repayment" means a loan that is paid in full or in part
if the participant renders health care services in a health
professional shortage area as defined by the department.
(10) "Nonshortage rural area" means a nonurban area of the state of
Washington that has not been designated as a rural physician shortage
area. The department shall identify the nonshortage rural areas of the
state.
(11) "Office" means the office of student financial assistance.
(12) "Participant" means a credentialed health care professional
who has received a loan repayment award and has commenced practice as
a credentialed health care provider in a designated health professional
shortage area or an eligible student who has received a scholarship
under this program.
(13) "Program" means the health professional loan repayment and
scholarship program.
(14) "Required service obligation" means an obligation by the
participant to provide health care services in a health professional
shortage area for a period to be established as provided for in this
chapter.
(15) "Rural physician shortage area" means rural geographic areas
where primary care physicians are in short supply as a result of
geographic maldistributions and where their limited numbers jeopardize
patient care and pose a threat to public health and safety. The
department shall designate rural physician shortage areas.
(16) "Satisfied" means paid-in-full.
(17) "Scholarship" means a loan that is forgiven in whole or in
part if the recipient renders health care services in a health
professional shortage area.
(18) "Sponsoring community" means a rural hospital or hospitals as
authorized in chapter 70.41 RCW, a rural health care facility or
facilities as authorized in chapter 70.175 RCW, or a city or county
government or governments.
Sec. 47 RCW 42.56.360 and 2010 c 128 s 3 and 2010 c 52 s 6 are
each reenacted and amended to read as follows:
(1) The following health care information is exempt from disclosure
under this chapter:
(a) Information obtained by the ((board of pharmacy)) pharmacy
quality assurance commission as provided in RCW 69.45.090;
(b) Information obtained by the ((board of pharmacy)) pharmacy
quality assurance commission or the department of health and its
representatives as provided in RCW 69.41.044, 69.41.280, and 18.64.420;
(c) Information and documents created specifically for, and
collected and maintained by a quality improvement committee under RCW
43.70.510, 70.230.080, or 70.41.200, or by a peer review committee
under RCW 4.24.250, or by a quality assurance committee pursuant to RCW
74.42.640 or 18.20.390, or by a hospital, as defined in RCW 43.70.056,
for reporting of health care-associated infections under RCW 43.70.056,
a notification of an incident under RCW 70.56.040(5), and reports
regarding adverse events under RCW 70.56.020(2)(b), regardless of which
agency is in possession of the information and documents;
(d)(i) Proprietary financial and commercial information that the
submitting entity, with review by the department of health,
specifically identifies at the time it is submitted and that is
provided to or obtained by the department of health in connection with
an application for, or the supervision of, an antitrust exemption
sought by the submitting entity under RCW 43.72.310;
(ii) If a request for such information is received, the submitting
entity must be notified of the request. Within ten business days of
receipt of the notice, the submitting entity shall provide a written
statement of the continuing need for confidentiality, which shall be
provided to the requester. Upon receipt of such notice, the department
of health shall continue to treat information designated under this
subsection (1)(d) as exempt from disclosure;
(iii) If the requester initiates an action to compel disclosure
under this chapter, the submitting entity must be joined as a party to
demonstrate the continuing need for confidentiality;
(e) Records of the entity obtained in an action under RCW 18.71.300
through 18.71.340;
(f) Complaints filed under chapter 18.130 RCW after July 27, 1997,
to the extent provided in RCW 18.130.095(1);
(g) Information obtained by the department of health under chapter
70.225 RCW;
(h) Information collected by the department of health under chapter
70.245 RCW except as provided in RCW 70.245.150;
(i) Cardiac and stroke system performance data submitted to
national, state, or local data collection systems under RCW
70.168.150(2)(b); and
(j) All documents, including completed forms, received pursuant to
a wellness program under RCW 41.04.362, but not statistical reports
that do not identify an individual.
(2) Chapter 70.02 RCW applies to public inspection and copying of
health care information of patients.
(3)(a) Documents related to infant mortality reviews conducted
pursuant to RCW 70.05.170 are exempt from disclosure as provided for in
RCW 70.05.170(3).
(b)(i) If an agency provides copies of public records to another
agency that are exempt from public disclosure under this subsection
(3), those records remain exempt to the same extent the records were
exempt in the possession of the originating entity.
(ii) For notice purposes only, agencies providing exempt records
under this subsection (3) to other agencies may mark any exempt records
as "exempt" so that the receiving agency is aware of the exemption,
however whether or not a record is marked exempt does not affect
whether the record is actually exempt from disclosure.
Sec. 48 RCW 51.36.010 and 2011 c 6 s 1 are each amended to read
as follows:
(1) The legislature finds that high quality medical treatment and
adherence to occupational health best practices can prevent disability
and reduce loss of family income for workers, and lower labor and
insurance costs for employers. Injured workers deserve high quality
medical care in accordance with current health care best practices. To
this end, the department shall establish minimum standards for
providers who treat workers from both state fund and self-insured
employers. The department shall establish a health care provider
network to treat injured workers, and shall accept providers into the
network who meet those minimum standards. The department shall convene
an advisory group made up of representatives from or designees of the
workers' compensation advisory committee and the industrial insurance
medical and chiropractic advisory committees to consider and advise the
department related to implementation of this section, including
development of best practices treatment guidelines for providers in the
network. The department shall also seek the input of various health
care provider groups and associations concerning the network's
implementation. Network providers must be required to follow the
department's evidence-based coverage decisions and treatment
guidelines, policies, and must be expected to follow other national
treatment guidelines appropriate for their patient. The department, in
collaboration with the advisory group, shall also establish additional
best practice standards for providers to qualify for a second tier
within the network, based on demonstrated use of occupational health
best practices. This second tier is separate from and in addition to
the centers for occupational health and education established under
subsection (5) of this section.
(2)(a) Upon the occurrence of any injury to a worker entitled to
compensation under the provisions of this title, he or she shall
receive proper and necessary medical and surgical services at the hands
of a physician or licensed advanced registered nurse practitioner of
his or her own choice, if conveniently located, except as provided in
(b) of this subsection, and proper and necessary hospital care and
services during the period of his or her disability from such injury.
(b) Once the provider network is established in the worker's
geographic area, an injured worker may receive care from a nonnetwork
provider only for an initial office or emergency room visit. However,
the department or self-insurer may limit reimbursement to the
department's standard fee for the services. The provider must comply
with all applicable billing policies and must accept the department's
fee schedule as payment in full.
(c) The department, in collaboration with the advisory group, shall
adopt policies for the development, credentialing, accreditation, and
continued oversight of a network of health care providers approved to
treat injured workers. Health care providers shall apply to the
network by completing the department's provider application which shall
have the force of a contract with the department to treat injured
workers. The advisory group shall recommend minimum network standards
for the department to approve a provider's application, to remove a
provider from the network, or to require peer review such as, but not
limited to:
(i) Current malpractice insurance coverage exceeding a dollar
amount threshold, number, or seriousness of malpractice suits over a
specific time frame;
(ii) Previous malpractice judgments or settlements that do not
exceed a dollar amount threshold recommended by the advisory group, or
a specific number or seriousness of malpractice suits over a specific
time frame;
(iii) No licensing or disciplinary action in any jurisdiction or
loss of treating or admitting privileges by any board, commission,
agency, public or private health care payer, or hospital;
(iv) For some specialties such as surgeons, privileges in at least
one hospital;
(v) Whether the provider has been credentialed by another health
plan that follows national quality assurance guidelines; and
(vi) Alternative criteria for providers that are not credentialed
by another health plan.
The department shall develop alternative criteria for providers
that are not credentialed by another health plan or as needed to
address access to care concerns in certain regions.
(d) Network provider contracts will automatically renew at the end
of the contract period unless the department provides written notice of
changes in contract provisions or the department or provider provides
written notice of contract termination. The industrial insurance
medical advisory committee shall develop criteria for removal of a
provider from the network to be presented to the department and
advisory group for consideration in the development of contract terms.
(e) In order to monitor quality of care and assure efficient
management of the provider network, the department shall establish
additional criteria and terms for network participation including, but
not limited to, requiring compliance with administrative and billing
policies.
(f) The advisory group shall recommend best practices standards to
the department to use in determining second tier network providers.
The department shall develop and implement financial and nonfinancial
incentives for network providers who qualify for the second tier. The
department is authorized to certify and decertify second tier
providers.
(3) The department shall work with self-insurers and the department
utilization review provider to implement utilization review for the
self-insured community to ensure consistent quality, cost-effective
care for all injured workers and employers, and to reduce
administrative burden for providers.
(4) The department for state fund claims shall pay, in accordance
with the department's fee schedule, for any alleged injury for which a
worker files a claim, any initial prescription drugs provided in
relation to that initial visit, without regard to whether the worker's
claim for benefits is allowed. In all accepted claims, treatment shall
be limited in point of duration as follows:
In the case of permanent partial disability, not to extend beyond
the date when compensation shall be awarded him or her, except when the
worker returned to work before permanent partial disability award is
made, in such case not to extend beyond the time when monthly
allowances to him or her shall cease; in case of temporary disability
not to extend beyond the time when monthly allowances to him or her
shall cease: PROVIDED, That after any injured worker has returned to
his or her work his or her medical and surgical treatment may be
continued if, and so long as, such continuation is deemed necessary by
the supervisor of industrial insurance to be necessary to his or her
more complete recovery; in case of a permanent total disability not to
extend beyond the date on which a lump sum settlement is made with him
or her or he or she is placed upon the permanent pension roll:
PROVIDED, HOWEVER, That the supervisor of industrial insurance, solely
in his or her discretion, may authorize continued medical and surgical
treatment for conditions previously accepted by the department when
such medical and surgical treatment is deemed necessary by the
supervisor of industrial insurance to protect such worker's life or
provide for the administration of medical and therapeutic measures
including payment of prescription medications, but not including those
controlled substances currently scheduled by the ((state board of
pharmacy)) pharmacy quality assurance commission as Schedule I, II,
III, or IV substances under chapter 69.50 RCW, which are necessary to
alleviate continuing pain which results from the industrial injury. In
order to authorize such continued treatment the written order of the
supervisor of industrial insurance issued in advance of the
continuation shall be necessary.
The supervisor of industrial insurance, the supervisor's designee,
or a self-insurer, in his or her sole discretion, may authorize
inoculation or other immunological treatment in cases in which a work-related activity has resulted in probable exposure of the worker to a
potential infectious occupational disease. Authorization of such
treatment does not bind the department or self-insurer in any
adjudication of a claim by the same worker or the worker's beneficiary
for an occupational disease.
(5)(a) The legislature finds that the department and its business
and labor partners have collaborated in establishing centers for
occupational health and education to promote best practices and prevent
preventable disability by focusing additional provider-based resources
during the first twelve weeks following an injury. The centers for
occupational health and education represent innovative accountable care
systems in an early stage of development consistent with national
health care reform efforts. Many Washington workers do not yet have
access to these innovative health care delivery models.
(b) To expand evidence-based occupational health best practices,
the department shall establish additional centers for occupational
health and education, with the goal of extending access to at least
fifty percent of injured and ill workers by December 2013 and to all
injured workers by December 2015. The department shall also develop
additional best practices and incentives that span the entire period of
recovery, not only the first twelve weeks.
(c) The department shall certify and decertify centers for
occupational health and education based on criteria including
institutional leadership and geographic areas covered by the center for
occupational health and education, occupational health leadership and
education, mix of participating health care providers necessary to
address the anticipated needs of injured workers, health services
coordination to deliver occupational health best practices, indicators
to measure the success of the center for occupational health and
education, and agreement that the center's providers shall, if
feasible, treat certain injured workers if referred by the department
or a self-insurer.
(d) Health care delivery organizations may apply to the department
for certification as a center for occupational health and education.
These may include, but are not limited to, hospitals and affiliated
clinics and providers, multispecialty clinics, health maintenance
organizations, and organized systems of network physicians.
(e) The centers for occupational health and education shall
implement benchmark quality indicators of occupational health best
practices for individual providers, developed in collaboration with the
department. A center for occupational health and education shall
remove individual providers who do not consistently meet these quality
benchmarks.
(f) The department shall develop and implement financial and
nonfinancial incentives for center for occupational health and
education providers that are based on progressive and measurable gains
in occupational health best practices, and that are applicable
throughout the duration of an injured or ill worker's episode of care.
(g) The department shall develop electronic methods of tracking
evidence-based quality measures to identify and improve outcomes for
injured workers at risk of developing prolonged disability. In
addition, these methods must be used to provide systematic feedback to
physicians regarding quality of care, to conduct appropriate objective
evaluation of progress in the centers for occupational health and
education, and to allow efficient coordination of services.
(6) If a provider fails to meet the minimum network standards
established in subsection (2) of this section, the department is
authorized to remove the provider from the network or take other
appropriate action regarding a provider's participation. The
department may also require remedial steps as a condition for a
provider to participate in the network. The department, with input
from the advisory group, shall establish waiting periods that may be
imposed before a provider who has been denied or removed from the
network may reapply.
(7) The department may permanently remove a provider from the
network or take other appropriate action when the provider exhibits a
pattern of conduct of low quality care that exposes patients to risk of
physical or psychiatric harm or death. Patterns that qualify as risk
of harm include, but are not limited to, poor health care outcomes
evidenced by increased, chronic, or prolonged pain or decreased
function due to treatments that have not been shown to be curative,
safe, or effective or for which it has been shown that the risks of
harm exceed the benefits that can be reasonably expected based on peer-reviewed opinion.
(8) The department may not remove a health care provider from the
network for an isolated instance of poor health and recovery outcomes
due to treatment by the provider.
(9) When the department terminates a provider from the network, the
department or self-insurer shall assist an injured worker currently
under the provider's care in identifying a new network provider or
providers from whom the worker can select an attending or treating
provider. In such a case, the department or self-insurer shall notify
the injured worker that he or she must choose a new attending or
treating provider.
(10) The department may adopt rules related to this section.
(11) The department shall report to the workers' compensation
advisory committee and to the appropriate committees of the legislature
on each December 1st, beginning in 2012 and ending in 2016, on the
implementation of the provider network and expansion of the centers for
occupational health and education. The reports must include a summary
of actions taken, progress toward long-term goals, outcomes of key
initiatives, access to care issues, results of disputes or
controversies related to new provisions, and whether any changes are
needed to further improve the occupational health best practices care
of injured workers.
Sec. 49 RCW 64.44.010 and 2006 c 339 s 201 are each amended to
read as follows:
The words and phrases defined in this section shall have the
following meanings when used in this chapter unless the context clearly
indicates otherwise.
(1) "Authorized contractor" means a person who decontaminates,
demolishes, or disposes of contaminated property as required by this
chapter who is certified by the department as provided for in RCW
64.44.060.
(2) "Contaminated" or "contamination" means polluted by hazardous
chemicals so that the property is unfit for human habitation or use due
to immediate or long-term hazards. Property that at one time was
contaminated but has been satisfactorily decontaminated according to
procedures established by the state board of health is not
"contaminated."
(3) "Department" means the department of health.
(4) "Hazardous chemicals" means the following substances associated
with the illegal manufacture of controlled substances: (a) Hazardous
substances as defined in RCW 70.105D.020; (b) precursor substances as
defined in RCW 69.43.010 which the state board of health, in
consultation with the ((state board of pharmacy)) pharmacy quality
assurance commission, has determined present an immediate or long-term
health hazard to humans; and (c) the controlled substance or substances
being manufactured, as defined in RCW 69.50.101.
(5) "Officer" means a local health officer authorized under
chapters 70.05, 70.08, and 70.46 RCW.
(6) "Property" means any real or personal property, or segregable
part thereof, that is involved in or affected by the unauthorized
manufacture, distribution, or storage of hazardous chemicals. This
includes but is not limited to single-family residences, units of
multiplexes, condominiums, apartment buildings, boats, motor vehicles,
trailers, manufactured housing, any shop, booth, garden, or storage
shed, and all contents of the items referenced in this subsection.
Sec. 50 RCW 69.04.565 and 1981 c 50 s 1 are each amended to read
as follows:
Notwithstanding any other provision of state law, DMSO (dimethyl
sulfoxide) may be introduced into intrastate commerce as long as (1) it
is manufactured or distributed by persons licensed pursuant to chapter
18.64 RCW or chapter 18.92 RCW, and (2) it is used, or intended to be
used, in the treatment of human beings or animals for any ailment or
adverse condition: PROVIDED, That DMSO intended for topical
application, consistent with rules governing purity and labeling
promulgated by the ((state board of pharmacy)) pharmacy quality
assurance commission, shall not be considered a legend drug and may be
sold by any retailer.
Sec. 51 RCW 69.04.730 and 1947 c 25 s 91 are each amended to read
as follows:
The authority to promulgate regulations for the efficient
enforcement of this chapter is hereby vested in the director:
PROVIDED, HOWEVER, That the director shall designate the ((Washington
state board of pharmacy)) pharmacy quality assurance commission to
carry out all the provisions of this chapter pertaining to drugs and
cosmetics, with authority to promulgate regulations for the efficient
enforcement thereof.
Sec. 52 RCW 69.38.010 and 1987 c 34 s 1 are each amended to read
as follows:
As used in this chapter "poison" means:
(1) Arsenic and its preparations;
(2) Cyanide and its preparations, including hydrocyanic acid;
(3) Strychnine; and
(4) Any other substance designated by the ((state board of
pharmacy)) pharmacy quality assurance commission which, when introduced
into the human body in quantities of sixty grains or less, causes
violent sickness or death.
Sec. 53 RCW 69.38.060 and 1989 1st ex.s. c 9 s 440 are each
amended to read as follows:
The ((state board of pharmacy)) pharmacy quality assurance
commission, after consulting with the department of health, shall
require and provide for the annual licensure of every person now or
hereafter engaged in manufacturing or selling poisons within this
state. Upon a payment of a fee as set by the department, the
department shall issue a license in such form as it may prescribe to
such manufacturer or seller. Such license shall be displayed in a
conspicuous place in such manufacturer's or seller's place of business
for which it is issued.
Any person manufacturing or selling poison within this state
without a license is guilty of a misdemeanor.
Sec. 54 RCW 69.40.055 and 1981 c 147 s 4 are each amended to read
as follows:
It shall be unlawful for any person to sell at retail or furnish
any repackaged poison drug or product without affixing or causing to be
affixed to the bottle, box, vessel, or package a label containing the
name of the article, all labeling required by the Food and Drug
Administration and other federal or state laws or regulations, and the
word "poison" distinctly shown with the name and place of the business
of the seller.
This section shall not apply to the dispensing of drugs or poisons
on the prescription of a practitioner.
The ((board of pharmacy)) pharmacy quality assurance commission
shall have the authority to promulgate rules for the enforcement and
implementation of this section.
Every person who shall violate any of the provisions of this
section shall be guilty of a misdemeanor.
Sec. 55 RCW 69.41.010 and 2012 c 10 s 44 are each amended to read
as follows:
As used in this chapter, the following terms have the meanings
indicated unless the context clearly requires otherwise:
(1) "Administer" means the direct application of a legend drug
whether by injection, inhalation, ingestion, or any other means, to the
body of a patient or research subject by:
(a) A practitioner; or
(b) The patient or research subject at the direction of the
practitioner.
(2) "Community-based care settings" include: Community residential
programs for the developmentally disabled, certified by the department
of social and health services under chapter 71A.12 RCW; adult family
homes licensed under chapter 70.128 RCW; and assisted living facilities
licensed under chapter 18.20 RCW. Community-based care settings do not
include acute care or skilled nursing facilities.
(3) "Deliver" or "delivery" means the actual, constructive, or
attempted transfer from one person to another of a legend drug, whether
or not there is an agency relationship.
(4) "Department" means the department of health.
(5) "Dispense" means the interpretation of a prescription or order
for a legend drug and, pursuant to that prescription or order, the
proper selection, measuring, compounding, labeling, or packaging
necessary to prepare that prescription or order for delivery.
(6) "Dispenser" means a practitioner who dispenses.
(7) "Distribute" means to deliver other than by administering or
dispensing a legend drug.
(8) "Distributor" means a person who distributes.
(9) "Drug" means:
(a) Substances recognized as drugs in the official United States
pharmacopoeia, official homeopathic pharmacopoeia of the United States,
or official national formulary, or any supplement to any of them;
(b) Substances intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in human beings or animals;
(c) Substances (other than food, minerals or vitamins) intended to
affect the structure or any function of the body of human beings or
animals; and
(d) Substances intended for use as a component of any article
specified in (a), (b), or (c) of this subsection. It does not include
devices or their components, parts, or accessories.
(10) "Electronic communication of prescription information" means
the communication of prescription information by computer, or the
transmission of an exact visual image of a prescription by facsimile,
or other electronic means for original prescription information or
prescription refill information for a legend drug between an authorized
practitioner and a pharmacy or the transfer of prescription information
for a legend drug from one pharmacy to another pharmacy.
(11) "In-home care settings" include an individual's place of
temporary and permanent residence, but does not include acute care or
skilled nursing facilities, and does not include community-based care
settings.
(12) "Legend drugs" means any drugs which are required by state law
or regulation of the ((state board of pharmacy)) pharmacy quality
assurance commission to be dispensed on prescription only or are
restricted to use by practitioners only.
(13) "Legible prescription" means a prescription or medication
order issued by a practitioner that is capable of being read and
understood by the pharmacist filling the prescription or the nurse or
other practitioner implementing the medication order. A prescription
must be hand printed, typewritten, or electronically generated.
(14) "Medication assistance" means assistance rendered by a
nonpractitioner to an individual residing in a community-based care
setting or in-home care setting to facilitate the individual's self-administration of a legend drug or controlled substance. It includes
reminding or coaching the individual, handing the medication container
to the individual, opening the individual's medication container, using
an enabler, or placing the medication in the individual's hand, and
such other means of medication assistance as defined by rule adopted by
the department. A nonpractitioner may help in the preparation of
legend drugs or controlled substances for self-administration where a
practitioner has determined and communicated orally or by written
direction that such medication preparation assistance is necessary and
appropriate. Medication assistance shall not include assistance with
intravenous medications or injectable medications, except prefilled
insulin syringes.
(15) "Person" means individual, corporation, government or
governmental subdivision or agency, business trust, estate, trust,
partnership or association, or any other legal entity.
(16) "Practitioner" means:
(a) A physician under chapter 18.71 RCW, an osteopathic physician
or an osteopathic physician and surgeon under chapter 18.57 RCW, 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
registered nurse, advanced registered nurse practitioner, or licensed
practical nurse under chapter 18.79 RCW, an optometrist under chapter
18.53 RCW who is certified by the optometry board under RCW 18.53.010,
an osteopathic physician assistant under chapter 18.57A RCW, a
physician assistant under chapter 18.71A RCW, a naturopath licensed
under chapter 18.36A RCW, a pharmacist under chapter 18.64 RCW, or,
when acting under the required supervision of a dentist licensed under
chapter 18.32 RCW, a dental hygienist licensed under chapter 18.29 RCW;
(b) A pharmacy, hospital, or other institution licensed,
registered, or otherwise permitted to distribute, dispense, conduct
research with respect to, or to administer a legend drug in the course
of professional practice or research in this state; and
(c) A physician licensed to practice medicine and surgery or a
physician licensed to practice osteopathic medicine and surgery in any
state, or province of Canada, which shares a common border with the
state of Washington.
(17) "Secretary" means the secretary of health or the secretary's
designee.
Sec. 56 RCW 69.41.075 and 1989 1st ex.s. c 9 s 427 are each
amended to read as follows:
The ((state board of pharmacy)) pharmacy quality assurance
commission may make such rules for the enforcement of this chapter as
are deemed necessary or advisable. The ((board)) commission shall
identify, by rule-making pursuant to chapter 34.05 RCW, those drugs
which may be dispensed only on prescription or are restricted to use by
practitioners, only. In so doing the ((board)) commission shall
consider the toxicity or other potentiality for harmful effect of the
drug, the method of its use, and any collateral safeguards necessary to
its use. The ((board)) commission shall classify a drug as a legend
drug where these considerations indicate the drug is not safe for use
except under the supervision of a practitioner.
In identifying legend drugs the ((board)) commission may
incorporate in its rules lists of drugs contained in commercial
pharmaceutical publications by making specific reference to each such
list and the date and edition of the commercial publication containing
it. Any such lists so incorporated shall be available for public
inspection at the headquarters of the department of health and shall be
available on request from the department of health upon payment of a
reasonable fee to be set by the department.
Sec. 57 RCW 69.41.080 and 1989 c 242 s 1 are each amended to read
as follows:
Humane societies and animal control agencies registered with the
((state board of pharmacy)) pharmacy quality assurance commission under
chapter 69.50 RCW and authorized to euthanize animals may purchase,
possess, and administer approved legend drugs for the sole purpose of
sedating animals prior to euthanasia, when necessary, and for use in
chemical capture programs. For the purposes of this section, "approved
legend drugs" means those legend drugs designated by the ((board))
commission by rule as being approved for use by such societies and
agencies for animal sedating or capture and does not include any
substance regulated under chapter 69.50 RCW. Any society or agency so
registered shall not permit persons to administer any legend drugs
unless such person has demonstrated to the satisfaction of the
((board)) commission adequate knowledge of the potential hazards
involved in and the proper techniques to be used in administering the
drugs.
The ((board)) commission shall promulgate rules to regulate the
purchase, possession, and administration of legend drugs by such
societies and agencies and to insure strict compliance with the
provisions of this section. Such rules shall require that the storage,
inventory control, administration, and recordkeeping for approved
legend drugs conform to the standards adopted by the ((board))
commission under chapter 69.50 RCW to regulate the use of controlled
substances by such societies and agencies. The ((board)) commission
may suspend or revoke a registration under chapter 69.50 RCW upon a
determination by the ((board)) commission that the person administering
legend drugs has not demonstrated adequate knowledge as herein
provided. This authority is granted in addition to any other power to
suspend or revoke a registration as provided by law.
Sec. 58 RCW 69.41.180 and 1979 c 110 s 7 are each amended to read
as follows:
The ((state board of pharmacy)) pharmacy quality assurance
commission may adopt any necessary rules under chapter 34.05 RCW for
the implementation, continuation, or enforcement of RCW 69.41.100
through 69.41.180, including, but not limited to, a list of
therapeutically or nontherapeutically equivalent drugs which, when
adopted, shall be provided to all registered pharmacists in the state
and shall be updated as necessary.
Sec. 59 RCW 69.41.210 and 1980 c 83 s 2 are each amended to read
as follows:
The terms defined in this section shall have the meanings indicated
when used in RCW 69.41.200 through 69.41.260.
(1) "Distributor" means any corporation, person, or other entity
which distributes for sale a legend drug under its own label even
though it is not the actual manufacturer of the legend drug.
(2) "Solid dosage form" means capsules or tablets or similar legend
drug products intended for administration and which could be ingested
orally.
(3) "Legend drug" means any drugs which are required by state law
or regulation of the ((board)) commission to be dispensed as
prescription only or are restricted to use by prescribing practitioners
only and shall include controlled substances in Schedules II through V
of chapter 69.50 RCW.
(4) (("Board" means the state board of pharmacy.)) "Commission"
means the pharmacy quality assurance commission.
Sec. 60 RCW 69.41.240 and 1980 c 83 s 5 are each amended to read
as follows:
The ((board)) commission shall have authority to promulgate rules
and regulations for the enforcement and implementation of RCW 69.41.050
and 69.41.200 through 69.41.260.
Sec. 61 RCW 69.41.250 and 1980 c 83 s 6 are each amended to read
as follows:
(1) The ((board)) commission, upon application of a manufacturer,
may exempt a particular legend drug from the requirements of RCW
69.41.050 and 69.41.200 through 69.41.260 on the grounds that
imprinting is infeasible because of size, texture, or other unique
characteristics.
(2) The provisions of RCW 69.41.050 and 69.41.200 through 69.41.260
shall not apply to any legend drug which is prepared or manufactured by
a pharmacy in this state and is for the purpose of retail sale from
such pharmacy and not intended for resale.
Sec. 62 RCW 69.41.280 and 2005 c 274 s 329 are each amended to
read as follows:
All records, reports, and information obtained by the ((board))
pharmacy quality assurance commission or its authorized representatives
from or on behalf of a pharmaceutical manufacturer, representative of
a manufacturer, wholesaler, pharmacy, or practitioner who purchases,
dispenses, or distributes legend drugs under this chapter are
confidential and exempt from public inspection and copying under
chapter 42.56 RCW. Nothing in this section restricts the
investigations or the proceedings of the ((board)) commission so long
as the ((board)) commission and its authorized representatives comply
with the provisions of chapter 42.56 RCW.
Sec. 63 RCW 69.41.310 and 1989 c 369 s 2 are each amended to read
as follows:
The ((state board of pharmacy)) pharmacy quality assurance
commission shall specify by rule drugs to be classified as steroids as
defined in RCW 69.41.300.
On or before December 1 of each year, the ((board)) commission
shall inform the appropriate legislative committees of reference of the
drugs that the ((board)) commission has added to the steroids in RCW
69.41.300. The ((board)) commission shall submit a statement of
rationale for the changes.
Sec. 64 RCW 69.43.010 and 2001 c 96 s 2 are each amended to read
as follows:
(1) A report to the ((state board of pharmacy)) pharmacy quality
assurance commission shall be submitted in accordance with this chapter
by a manufacturer, wholesaler, retailer, or other person who sells,
transfers, or otherwise furnishes to any person any of the following
substances or their salts or isomers:
(a) Anthranilic acid;
(b) Barbituric acid;
(c) Chlorephedrine;
(d) Diethyl malonate;
(e) D-lysergic acid;
(f) Ephedrine;
(g) Ergotamine tartrate;
(h) Ethylamine;
(i) Ethyl malonate;
(j) Ethylephedrine;
(k) Lead acetate;
(l) Malonic acid;
(m) Methylamine;
(n) Methylformamide;
(o) Methylephedrine;
(p) Methylpseudoephedrine;
(q) N-acetylanthranilic acid;
(r) Norpseudoephedrine;
(s) Phenylacetic acid;
(t) Phenylpropanolamine;
(u) Piperidine;
(v) Pseudoephedrine; and
(w) Pyrrolidine.
(2) The ((state board of pharmacy)) pharmacy quality assurance
commission shall administer this chapter and may, by rule adopted
pursuant to chapter 34.05 RCW, add a substance to or remove a substance
from the list in subsection (1) of this section. In determining
whether to add or remove a substance, the ((board)) commission shall
consider the following:
(a) The likelihood that the substance is useable as a precursor in
the illegal production of a controlled substance as defined in chapter
69.50 RCW;
(b) The availability of the substance;
(c) The relative appropriateness of including the substance in this
chapter or in chapter 69.50 RCW; and
(d) The extent and nature of legitimate uses for the substance.
(3)(a) Any manufacturer, wholesaler, retailer, or other person
shall, before selling, transferring, or otherwise furnishing any
substance specified in subsection (1) of this section to any person,
require proper identification from the purchaser.
(b) For the purposes of this subsection, "proper identification"
means:
(i) A motor vehicle operator's license or other official state-issued identification of the purchaser containing a photograph of the
purchaser, and includes the residential or mailing address of the
purchaser, other than a post office box number;
(ii) The motor vehicle license number of any motor vehicle owned or
operated by the purchaser;
(iii) A letter of authorization from any business for which any
substance specified in subsection (1) of this section is being
furnished, which includes the business license number and address of
the business;
(iv) A description of how the substance is to be used; and
(v) The signature of the purchaser.
The person selling, transferring, or otherwise furnishing any
substance specified in subsection (1) of this section shall affix his
or her signature as a witness to the signature and identification of
the purchaser.
(c) A violation of or a failure to comply with this subsection is
a misdemeanor.
(4) Any manufacturer, wholesaler, retailer, or other person who
sells, transfers, or otherwise furnishes the substance specified in
subsection (1) of this section to any person shall, not less than
twenty-one days before delivery of the substance, submit a report of
the transaction, which includes the identification information
specified in subsection (3) of this section to the ((state board of
pharmacy)) pharmacy quality assurance commission. However, the ((state
board of pharmacy)) pharmacy quality assurance commission may authorize
the submission of the reports on a monthly basis with respect to
repeated, regular transactions between the furnisher and the recipient
involving the same substance if the ((state board of pharmacy))
pharmacy quality assurance commission determines that either of the
following exist:
(a) A pattern of regular supply of the substance exists between the
manufacturer, wholesaler, retailer, or other person who sells,
transfers, or otherwise furnishes such substance and the recipient of
the substance; or
(b) The recipient has established a record of using the substance
for lawful purposes.
(5) Any person specified in subsection (4) of this section who does
not submit a report as required by subsection (4) of this section is
guilty of a gross misdemeanor.
Sec. 65 RCW 69.43.020 and 2001 c 96 s 3 are each amended to read
as follows:
(1) Any manufacturer, wholesaler, retailer, or other person who
receives from a source outside of this state any substance specified in
RCW 69.43.010(1) shall submit a report of such transaction to the
((state board of pharmacy)) pharmacy quality assurance commission under
rules adopted by the ((board)) commission.
(2) Any person specified in subsection (1) of this section who does
not submit a report as required by subsection (1) of this section is
guilty of a gross misdemeanor.
Sec. 66 RCW 69.43.030 and 1988 c 147 s 3 are each amended to read
as follows:
RCW 69.43.010 and 69.43.020 do not apply to any of the following:
(1) Any pharmacist or other authorized person who sells or
furnishes a substance upon the prescription of a practitioner, as
defined in chapter 69.41 RCW;
(2) Any practitioner who administers or furnishes a substance to
his or her patients;
(3) Any manufacturer or wholesaler licensed by the ((state board of
pharmacy)) pharmacy quality assurance commission who sells, transfers,
or otherwise furnishes a substance to a licensed pharmacy or
practitioner;
(4) Any sale, transfer, furnishing, or receipt of any drug that
contains ephedrine, phenylpropanolamine, or pseudoephedrine, or of any
cosmetic that contains a substance specified in RCW 69.43.010(1), if
such drug or cosmetic is lawfully sold, transferred, or furnished, over
the counter without a prescription under chapter 69.04 or 69.41 RCW.
Sec. 67 RCW 69.43.035 and 2004 c 52 s 6 are each amended to read
as follows:
(1) Any manufacturer or wholesaler who sells, transfers, or
otherwise furnishes any substance specified in RCW 69.43.010(1) to any
person in a suspicious transaction shall report the transaction in
writing to the ((state board of pharmacy)) pharmacy quality assurance
commission.
(2) Any person specified in subsection (1) of this section who does
not submit a report as required by subsection (1) of this section is
guilty of a gross misdemeanor.
(3) For the purposes of this section, "suspicious transaction"
means a sale or transfer to which any of the following applies:
(a) The circumstances of the sale or transfer would lead a
reasonable person to believe that the substance is likely to be used
for the purpose of unlawfully manufacturing a controlled substance
under chapter 69.50 RCW, based on such factors as the amount involved,
the method of payment, the method of delivery, and any past dealings
with any participant in the transaction. The ((state board of
pharmacy)) pharmacy quality assurance commission shall adopt by rule
criteria for determining whether a transaction is suspicious, taking
into consideration the recommendations in appendix A of the report to
the United States attorney general by the suspicious orders task force
under the federal comprehensive methamphetamine control act of 1996.
(b) The transaction involves payment for any substance specified in
RCW 69.43.010(1) in cash or money orders in a total amount of more than
two hundred dollars.
(4) The ((board of pharmacy)) pharmacy quality assurance commission
shall transmit to the department of revenue a copy of each report of a
suspicious transaction that it receives under this section.
Sec. 68 RCW 69.43.040 and 2001 c 96 s 7 are each amended to read
as follows:
(1) The department of health, in accordance with rules developed by
the ((state board of pharmacy)) pharmacy quality assurance commission
shall provide a common reporting form for the substances in RCW
69.43.010 that contains at least the following information:
(a) Name of the substance;
(b) Quantity of the substance sold, transferred, or furnished;
(c) The date the substance was sold, transferred, or furnished;
(d) The name and address of the person buying or receiving the
substance; and
(e) The name and address of the manufacturer, wholesaler, retailer,
or other person selling, transferring, or furnishing the substance.
(2) Monthly reports authorized under RCW 69.43.010(4) may be
computer-generated in accordance with rules adopted by the department.
Sec. 69 RCW 69.43.043 and 2001 c 96 s 5 are each amended to read
as follows:
(1) Any manufacturer or wholesaler who sells, transfers, or
otherwise furnishes any substance specified in RCW 69.43.010(1) to any
person shall maintain a record of each such sale or transfer. The
records must contain:
(a) The name of the substance;
(b) The quantity of the substance sold, transferred, or furnished;
(c) The date the substance was sold, transferred, or furnished;
(d) The name and address of the person buying or receiving the
substance; and
(e) The method of and amount of payment for the substance.
(2) The records of sales and transfers required by this section
shall be available for inspection by the ((state board of pharmacy))
pharmacy quality assurance commission and its authorized
representatives and shall be maintained for two years.
(3) A violation of this section is a gross misdemeanor.
Sec. 70 RCW 69.43.048 and 2001 c 96 s 6 are each amended to read
as follows:
A manufacturer, wholesaler, retailer, or other person who sells,
transfers, or otherwise furnishes any substance specified in RCW
69.43.010(1) and who is subject to the reporting or recordkeeping
requirements of this chapter may satisfy the requirements by submitting
to the ((state board of pharmacy)) pharmacy quality assurance
commission, and its authorized representatives:
(1) Computer readable data from which all of the required
information may be readily derived; or
(2) Copies of reports that are filed under federal law that contain
all of the information required by the particular reporting or
recordkeeping requirement of this chapter which it is submitted to
satisfy.
Sec. 71 RCW 69.43.050 and 1989 1st ex.s. c 9 s 442 are each
amended to read as follows:
(1) The ((state board of pharmacy)) pharmacy quality assurance
commission may adopt all rules necessary to carry out this chapter.
(2) Notwithstanding subsection (1) of this section, the department
of health may adopt rules necessary for the administration of this
chapter.
Sec. 72 RCW 69.43.060 and 1988 c 147 s 6 are each amended to read
as follows:
(1) The theft or loss of any substance under RCW 69.43.010
discovered by any person regulated by this chapter shall be reported to
the ((state board of pharmacy)) pharmacy quality assurance commission
within seven days after such discovery.
(2) Any difference between the quantity of any substance under RCW
69.43.010 received and the quantity shipped shall be reported to the
((state board of pharmacy)) pharmacy quality assurance commission
within seven days of the receipt of actual knowledge of the
discrepancy. When applicable, any report made pursuant to this
subsection shall also include the name of any common carrier or person
who transported the substance and the date of shipment of the
substance.
Sec. 73 RCW 69.43.090 and 2001 c 96 s 8 are each amended to read
as follows:
(1) Any manufacturer, wholesaler, retailer, or other person who
sells, transfers, or otherwise furnishes any substance specified in RCW
69.43.010 to any person or who receives from a source outside of the
state any substance specified in RCW 69.43.010 shall obtain a permit
for the conduct of that business from the ((state board of pharmacy))
pharmacy quality assurance commission. However, a permit shall not be
required of any manufacturer, wholesaler, retailer, or other person for
the sale, transfer, furnishing, or receipt of any drug that contains
ephedrine, phenylpropanolamine, or pseudoephedrine, or of any cosmetic
that contains a substance specified in RCW 69.43.010(1), if such drug
or cosmetic is lawfully sold, transferred, or furnished over the
counter without a prescription or by a prescription under chapter 69.04
or 69.41 RCW.
(2) Applications for permits shall be filed with the department in
writing and signed by the applicant, and shall set forth the name of
the applicant, the business in which the applicant is engaged, the
business address of the applicant, and a full description of any
substance sold, transferred, or otherwise furnished, or received.
(3) The ((board)) commission may grant permits on forms prescribed
by it. The permits shall be effective for not more than one year from
the date of issuance.
(4) Each applicant shall pay at the time of filing an application
for a permit a fee determined by the department.
(5) A permit granted under this chapter may be renewed on a date to
be determined by the ((board)) commission, and annually thereafter,
upon the filing of a renewal application and the payment of a permit
renewal fee determined by the department.
(6) Permit fees charged by the department shall not exceed the
costs incurred by the department in administering this chapter.
(7) Selling, transferring, or otherwise furnishing, or receiving
any substance specified in RCW 69.43.010 without a required permit, is
a gross misdemeanor.
Sec. 74 RCW 69.43.100 and 1988 c 147 s 10 are each amended to
read as follows:
The ((board)) pharmacy quality assurance commission shall have the
power to refuse, suspend, or revoke the permit of any manufacturer or
wholesaler upon proof that:
(1) The permit was procured through fraud, misrepresentation, or
deceit;
(2) The permittee has violated or has permitted any employee to
violate any of the laws of this state relating to drugs, controlled
substances, cosmetics, or nonprescription drugs, or has violated any of
the rules and regulations of the ((board of pharmacy)) pharmacy quality
assurance commission.
Sec. 75 RCW 69.43.105 and 2010 c 182 s 1 are each amended to read
as follows:
(1) For purposes of this section, "traditional Chinese herbal
practitioner" means a person who is certified as a diplomate in Chinese
herbology from the national certification commission for acupuncture
and oriental medicine or who has received a certificate in Chinese
herbology from a school accredited by the accreditation council on
acupuncture and oriental medicine.
(2) A pharmacy licensed by, or shopkeeper or itinerant vendor
registered with, the department of health under chapter 18.64 RCW, or
an employee thereof, a practitioner as defined in RCW 18.64.011, or a
traditional Chinese herbal practitioner may not knowingly sell,
transfer, or otherwise furnish to any person a product at retail that
he or she knows to contain any detectable quantity of ephedrine,
pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or
salts of isomers, without first obtaining photo identification of the
person that shows the date of birth of the person.
(3) A person buying or receiving a product at retail containing any
detectable quantity of ephedrine, pseudoephedrine, or
phenylpropanolamine, or their salts, isomers, or salts of isomers, from
a pharmacy licensed by, or shopkeeper or itinerant vendor registered
with, the department of health under chapter 18.64 RCW, or an employee
thereof, a practitioner as defined in RCW 18.64.011, or a traditional
Chinese herbal practitioner must first produce photo identification of
the person that shows the date of birth of the person.
(4) Any product containing any detectable quantity of ephedrine,
pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or
salts of isomers, shall be kept (a) behind a counter where the public
is not permitted, or (b) in a locked display case so that a customer
wanting access must ask an employee of the merchant for assistance.
(5) No pharmacy licensed by, or shopkeeper or itinerant vendor
registered with, the department of health under chapter 18.64 RCW, or
an employee thereof, a practitioner as defined in RCW 18.64.011, or a
traditional Chinese herbal practitioner may sell any product containing
any detectable quantity of ephedrine, pseudoephedrine, or
phenylpropanolamine, or their salts, isomers, or salts of isomers, to
a person that is not at least eighteen years old.
(6) A pharmacy licensed by, or shopkeeper or itinerant vendor
registered with, the department of health under chapter 18.64 RCW
selling a nonprescription drug containing ephedrine, pseudoephedrine,
phenylpropanolamine, or their salts, isomers, or salts of isomers shall
require the purchaser to electronically or manually sign a record of
the transaction. The record must include the name and address of the
purchaser, the date and time of the sale, the name and initials of the
shopkeeper, itinerant vendor, pharmacist, pharmacy technician, or
employee conducting the transaction, the name of the product being
sold, as well as the total quantity in grams, of ephedrine,
pseudoephedrine, phenylpropanolamine, or their salts, isomers, or salts
of isomers, being sold.
(7) The ((board of pharmacy)) pharmacy quality assurance
commission, by rule, may exempt products containing ephedrine,
pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or
salts of isomers, in combination with another active ingredient from
the requirements of this section if they are found not to be used in
the illegal manufacture of methamphetamine or other controlled
dangerous substances. A manufacturer of a drug product may apply for
removal of the product from the requirements of this section if the
product is determined by the ((board)) commission to have been
formulated in such a way as to effectively prevent the conversion of
the active ingredient into methamphetamine. The burden of proof for
exemption is upon the person requesting the exemption. The petitioner
shall provide the ((board)) commission with evidence that the product
has been formulated in such a way as to serve as an effective general
deterrent to the conversion of pseudoephedrine into methamphetamine.
The evidence must include the furnishing of a valid scientific study,
conducted by an independent, professional laboratory and evincing
professional quality chemical analysis. Factors to be considered in
whether a product should be excluded from this section include but are
not limited to:
(a) Ease with which the product can be converted to
methamphetamine;
(b) Ease with which ephedrine, pseudoephedrine, or
phenylpropanolamine is extracted from the substance and whether it
forms an emulsion, salt, or other form;
(c) Whether the product contains a "molecular lock" that renders it
incapable of being converted into methamphetamine;
(d) Presence of other ingredients that render the product less
likely to be used in the manufacture of methamphetamine; and
(e) Any pertinent data that can be used to determine the risk of
the substance being used in the illegal manufacture of methamphetamine
or any other controlled substance.
(8) Nothing in this section applies:
(a) To any product containing ephedrine, pseudoephedrine, or
phenylpropanolamine, or their salts, isomers, or salts of isomers that
is not the only active ingredient and that is in liquid, liquid
capsule, or gel capsule form;
(b) To the sale of a product that may only be sold upon the
presentation of a prescription;
(c) To the sale of a product by a traditional Chinese herbal
practitioner to a patient; or
(d) When the details of the transaction are recorded in a pharmacy
profile individually identified with the recipient and maintained by a
licensed pharmacy.
(9)(a) No pharmacy licensed by, or shopkeeper or itinerant vendor
registered with, the department of health under chapter 18.64 RCW, a
practitioner as defined in RCW 18.64.011, or a traditional Chinese
herbal practitioner may retaliate against any employee that has made a
good faith attempt to comply with the requirements of this section by
requesting that a customer present photo identification, making a
reasonable effort to determine the customer's age.
(b) No pharmacy licensed by, or shopkeeper or itinerant vendor
registered with, the department of health under chapter 18.64 RCW, a
practitioner as defined in RCW 18.64.011, or a traditional Chinese
herbal practitioner is subject to prosecution under subsection (10) of
this section if they made a good faith attempt to comply with the
requirements of this section by requesting that a customer present
photo identification, making a reasonable effort to determine the
customer's age.
(10) A violation of this section is a gross misdemeanor.
Sec. 76 RCW 69.43.110 and 2010 c 182 s 2 are each amended to read
as follows:
(1) It is unlawful for a pharmacy licensed by, or shopkeeper or
itinerant vendor registered with, the department of health under
chapter 18.64 RCW, or an employee thereof, or a practitioner as defined
in RCW 18.64.011, knowingly to sell, transfer, or to otherwise furnish,
in a single transaction a total of more than 3.6 grams of ephedrine,
pseudoephedrine, or phenylpropanolamine, their salts, isomers, or salts
of isomers, in any twenty-four hour period or more than a total of nine
grams per purchaser in any thirty-day period.
(2) It is unlawful for a person who is not a manufacturer,
wholesaler, pharmacy, practitioner, shopkeeper, or itinerant vendor
licensed by or registered with the department of health under chapter
18.64 RCW to purchase or acquire more than 3.6 grams in any twenty-four
hour period, or more than a total of nine grams in any thirty-day
period, of the substances specified in subsection (1) of this section.
(3) It is unlawful for any person to sell or distribute any of the
substances specified in subsection (1) of this section unless the
person is licensed by or registered with the department of health under
chapter 18.64 RCW, or is a practitioner as defined in RCW 18.64.011.
(4)(a) Beginning July 1, 2011, or the date upon which the
electronic sales tracking system established under RCW 69.43.165 is
available, whichever is later, a pharmacy licensed by, or shopkeeper or
itinerant vendor registered with, the department of health under
chapter 18.64 RCW shall, before completing a sale under this section,
submit the required information to the electronic sales tracking system
established under RCW 69.43.165, as long as such a system is available
without cost to the pharmacy, shopkeeper, or itinerant vendor for
accessing the system. The pharmacy, shopkeeper, or itinerant vendor
may not complete the sale if the system generates a stop sale alert,
except as permitted in RCW 69.43.165.
(b) If a pharmacy, shopkeeper, or itinerant vendor selling a
nonprescription drug containing ephedrine, pseudoephedrine, or
phenylpropanolamine, or their salts, isomers, or salts of isomers
experiences mechanical or electronic failure of the electronic sales
tracking system and is unable to comply with the electronic sales
tracking requirement, he or she shall maintain a written log or an
alternative electronic recordkeeping mechanism until such time as he or
she is able to comply with the electronic sales tracking requirement.
(c) A pharmacy, shopkeeper, or itinerant vendor selling a
nonprescription drug containing ephedrine, pseudoephedrine, or
phenylpropanolamine, or their salts, isomers, or salts of isomers may
seek an exemption from submitting transactions to the electronic sales
tracking system in writing to the ((board of pharmacy)) pharmacy
quality assurance commission stating the reasons for the exemption.
The ((board)) commission may grant an exemption for good cause shown,
but in no event shall a granted exemption exceed one hundred eighty
days. The ((board)) commission may grant multiple exemptions for any
pharmacy, shopkeeper, or itinerant vendor if the good cause shown
indicates significant hardship for compliance with this section. A
pharmacy, shopkeeper, or itinerant vendor that receives an exemption
shall maintain a logbook in hardcopy form and must require the
purchaser to provide the information required under this section before
the completion of any sale. The logbook shall be maintained as a
record of each sale for inspection by any law enforcement officer or
((board)) commission inspector during normal business hours in
accordance with any rules adopted pursuant to RCW 69.43.165. For
purposes of this subsection (4)(c), "good cause" includes, but is not
limited to, situations where the installation of the necessary
equipment to access the system is unavailable or cost prohibitive to
the pharmacy, shopkeeper, or itinerant vendor.
(d) A pharmacy, shopkeeper, or itinerant vendor may withdraw from
participating in the electronic sales tracking system if the system is
no longer being furnished without cost for accessing the system. A
pharmacy, shopkeeper, or itinerant vendor who withdraws from the
electronic sales tracking system is subject to the same requirements as
a pharmacy, shopkeeper, or itinerant vendor who has been granted an
exemption under (c) of this subsection.
(e) For the purposes of this subsection (4) and RCW 69.43.165:
(i) "Cost for accessing the system" means costs relating to:
(A) Access to the web-based electronic sales tracking software,
including inputting and retrieving data;
(B) The web-based software known as software as a service;
(C) Training; and
(D) Technical support to integrate to point of sale vendors, if
necessary.
(ii) "Cost for accessing the system" does not include:
(A) Costs relating to required internet access;
(B) Optional hardware that a pharmacy may choose to purchase for
work flow purposes; or
(C) Other equipment.
(5) A violation of this section is a gross misdemeanor.
Sec. 77 RCW 69.43.130 and 2004 c 52 s 7 are each amended to read
as follows:
RCW 69.43.110 and 69.43.120 do not apply to:
(1) Pediatric products primarily intended for administration to
children under twelve years of age, according to label instructions,
either: (a) In solid dosage form whose individual dosage units do not
exceed fifteen milligrams of ephedrine, pseudoephedrine, or
phenylpropanolamine; or (b) in liquid form whose recommended dosage,
according to label instructions, does not exceed fifteen milligrams of
ephedrine, pseudoephedrine, or phenylpropanolamine per five milliliters
of liquid product;
(2) Pediatric liquid products primarily intended for administration
to children under two years of age for which the recommended dosage
does not exceed two milliliters and the total package content does not
exceed one fluid ounce;
(3) Products that the ((state board of pharmacy)) pharmacy quality
assurance commission, upon application of a manufacturer, exempts by
rule from RCW 69.43.110 and 69.43.120 because the product has been
formulated in such a way as to effectively prevent the conversion of
the active ingredient into methamphetamine, or its salts or precursors;
or
(4) Products, as packaged, that the ((board of pharmacy)) pharmacy
quality assurance commission, upon application of a manufacturer,
exempts from RCW 69.43.110(1)(((b))) and 69.43.120 because:
(a) The product meets the federal definition of an ordinary over-the-counter pseudoephedrine product as defined in 21 U.S.C. 802;
(b) The product is a salt, isomer, or salts of isomers of
pseudoephedrine and, as packaged, has a total weight of more than three
grams but the net weight of the pseudoephedrine base is equal to or
less than three grams; and
(c) The ((board of pharmacy)) pharmacy quality assurance commission
determines that the value to the people of the state of having the
product, as packaged, available for sale to consumers outweighs the
danger, and the product, as packaged, has not been used in the illegal
manufacture of methamphetamine.
Sec. 78 RCW 69.43.140 and 2001 c 96 s 12 are each amended to read
as follows:
(1) In addition to the other penalties provided for in this chapter
or in chapter 18.64 RCW, the ((state board of pharmacy)) pharmacy
quality assurance commission may impose a civil penalty, not to exceed
ten thousand dollars for each violation, on any licensee or registrant
who has failed to comply with this chapter or the rules adopted under
this chapter. In the case of a continuing violation, every day the
violation continues shall be considered a separate violation.
(2) The ((state board of pharmacy)) pharmacy quality assurance
commission may waive the suspension or revocation of a license or
registration issued under chapter 18.64 RCW, or waive any civil penalty
under this chapter, if the licensee or registrant establishes that he
or she acted in good faith to prevent violations of this chapter, and
the violation occurred despite the licensee's or registrant's exercise
of due diligence. In making such a determination, the ((state board of
pharmacy)) pharmacy quality assurance commission may consider evidence
that an employer trained employees on how to sell, transfer, or
otherwise furnish substances specified in RCW 69.43.010(1) in
accordance with applicable laws.
Sec. 79 RCW 69.43.165 and 2010 c 182 s 3 are each amended to read
as follows:
(1) The ((board of pharmacy)) pharmacy quality assurance commission
shall implement a real-time electronic sales tracking system to monitor
the nonprescription sale of products in this state containing any
detectable quantity of ephedrine, pseudoephedrine, phenylpropanolamine,
or their salts, isomers, or salts of isomers, provided that the system
is available to the state without cost for accessing the system to the
state or retailers. The ((board)) commission is authorized to enter
into a public-private partnership, through a memorandum of
understanding or similar arrangement, to make the system available.
(2) The records submitted to the tracking system are for the
confidential use of the pharmacy, shopkeeper, or itinerant vendor who
submitted them, except that:
(a) The records must be produced in court when lawfully required;
(b) The records must be open for inspection by the ((board of
pharmacy)) pharmacy quality assurance commission; and
(c) The records must be available to any general or limited
authority Washington peace officer to enforce the provisions of this
chapter or to federal law enforcement officers in accordance with rules
adopted by the ((board of pharmacy)) pharmacy quality assurance
commission regarding the privacy of the purchaser of products covered
by chapter 182, Laws of 2010 and law enforcement access to the records
submitted to the tracking system as provided in this section consistent
with the federal combat meth act.
(3) The electronic sales tracking system shall be capable of
generating a stop sale alert, which shall be a notification that
completion of the sale would result in the seller or purchaser
violating the quantity limits in RCW 69.43.110 (1) and (2). The system
shall contain an override function for use by a dispenser of ephedrine,
pseudoephedrine, phenylpropanolamine, or their salts, isomers, or salts
of isomers, who has a reasonable fear of imminent bodily harm. Each
instance in which the override function is utilized shall be logged by
the system.
(4) The ((board of pharmacy)) pharmacy quality assurance commission
shall have the authority to adopt rules necessary to implement and
enforce the provisions of this section. The ((board of pharmacy))
pharmacy quality assurance commission shall adopt rules regarding the
privacy of the purchaser of products covered by chapter 182, Laws of
2010, and any public or law enforcement access to the records submitted
to the tracking system as provided in subsection (2)(c) of this section
consistent with the federal combat meth act.
(5) The ((board of pharmacy)) pharmacy quality assurance commission
may not raise licensing or registration fees to fund the rule making or
implementation of this section.
Sec. 80 RCW 69.43.180 and 2005 c 388 s 3 are each amended to read
as follows:
(1) The Washington association of sheriffs and police chiefs or the
Washington state patrol may petition the ((state board of pharmacy))
pharmacy quality assurance commission to apply the log requirements in
RCW 69.43.170 to one or more products that contain ephedrine,
pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or
salts of isomers, that is not the only active ingredient and that is in
liquid, liquid capsule, or gel capsule form. The petition shall
establish that:
(a) Ephedrine, pseudoephedrine, or phenylpropanolamine can be
effectively extracted from the product and converted into
methamphetamine or another controlled dangerous substance; and
(b) Law enforcement, the Washington state patrol, or the department
of ecology are finding substantial evidence that the product is being
used for the illegal manufacture of methamphetamine or another
controlled dangerous substance.
(2) The ((board of pharmacy)) pharmacy quality assurance commission
shall adopt rules when a petition establishes that requiring the
application of the log requirements in RCW 69.43.170 to the sale of the
product at retail is warranted based upon the effectiveness and extent
of use of the product for the illegal manufacture of methamphetamine or
other controlled dangerous substances and the extent of the burden of
any restrictions upon consumers. The ((board of pharmacy)) pharmacy
quality assurance commission may adopt emergency rules to apply the log
requirements to the sale of a product when the petition establishes
that the immediate restriction of the product is necessary in order to
protect public health and safety.
Sec. 81 RCW 69.45.010 and 1994 sp.s. c 9 s 738 are each amended
to read as follows:
The definitions in this section apply throughout this chapter.
(1) (("Board" means the board of pharmacy.)) "Commission" means the
pharmacy quality assurance commission.
(2) "Drug samples" means any federal food and drug administration
approved controlled substance, legend drug, or products requiring
prescriptions in this state, which is distributed at no charge to a
practitioner by a manufacturer or a manufacturer's representative,
exclusive of drugs under clinical investigations approved by the
federal food and drug administration.
(3) "Controlled substance" means a drug, substance, or immediate
precursor of such drug or substance, so designated under or pursuant to
chapter 69.50 RCW, the uniform controlled substances act.
(4) "Deliver" or "delivery" means the actual, constructive, or
attempted transfer from one person to another of a drug or device,
whether or not there is an agency relationship.
(5) "Dispense" means the interpretation of a prescription or order
for a drug, biological, or device and, pursuant to that prescription or
order, the proper selection, measuring, compounding, labeling, or
packaging necessary to prepare that prescription or order for delivery.
(6) "Distribute" means to deliver, other than by administering or
dispensing, a legend drug.
(7) "Legend drug" means any drug that is required by state law or
by regulations of the ((board)) commission to be dispensed on
prescription only or is restricted to use by practitioners only.
(8) "Manufacturer" means a person or other entity engaged in the
manufacture or distribution of drugs or devices, but does not include
a manufacturer's representative.
(9) "Person" means any individual, corporation, government or
governmental subdivision or agency, business trust, estate, trust,
partnership, association, or any other legal entity.
(10) "Practitioner" means a physician under chapter 18.71 RCW, an
osteopathic physician or an osteopathic physician and surgeon under
chapter 18.57 RCW, 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 pharmacist under chapter 18.64 RCW, a commissioned
medical or dental officer in the United States armed forces or the
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 to prescribe 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, or a physician assistant under chapter 18.71A RCW when
authorized by the medical quality assurance commission.
(11) "Manufacturer's representative" means an agent or employee of
a drug manufacturer who is authorized by the drug manufacturer to
possess drug samples for the purpose of distribution in this state to
appropriately authorized health care practitioners.
(12) "Reasonable cause" means a state of facts found to exist that
would warrant a reasonably intelligent and prudent person to believe
that a person has violated state or federal drug laws or regulations.
(13) "Department" means the department of health.
(14) "Secretary" means the secretary of health or the secretary's
designee.
Sec. 82 RCW 69.45.020 and 1989 1st ex.s. c 9 s 445 are each
amended to read as follows:
A manufacturer that intends to distribute drug samples in this
state shall register annually with the department, providing the name
and address of the manufacturer, and shall:
(1) Provide a twenty-four hour telephone number and the name of the
individual(s) who shall respond to reasonable official inquiries from
the department, as directed by the ((board)) commission, based on
reasonable cause, regarding required records, reports, or requests for
information pursuant to a specific investigation of a possible
violation. Each official request by the department and each response
by a manufacturer shall be limited to the information specifically
relevant to the particular official investigation. Requests for the
address of sites in this state at which drug samples are stored by the
manufacturer's representative and the names and addresses of the
individuals who are responsible for the storage or distribution of the
drug samples shall be responded to as soon as possible but not later
than the close of business on the next business day following the
request; or
(2) If a twenty-four hour telephone number is not available,
provide the addresses of sites in this state at which drug samples are
stored by the manufacturer's representative, and the names and
addresses of the individuals who are responsible for the storage or
distribution of the drug samples. The manufacturer shall annually
submit a complete updated list of the sites and individuals to the
department.
Sec. 83 RCW 69.45.060 and 1987 c 411 s 6 are each amended to read
as follows:
Surplus, outdated, or damaged drug samples shall be disposed of as
follows:
(1) Returned to the manufacturer; or
(2) Witnessed destruction by such means as to assure that the drug
cannot be retrieved. However, controlled substances shall be returned
to the manufacturer or disposed of in accordance with rules adopted by
the ((board)) commission: PROVIDED, That the ((board)) commission
shall adopt by rule the regulations of the federal drug enforcement
administration or its lawful successor unless, stating reasonable
grounds, it adopts rules consistent with such regulations.
Sec. 84 RCW 69.45.080 and 1987 c 411 s 8 are each amended to read
as follows:
(1) The manufacturer is responsible for the actions and conduct of
its representatives with regard to drug samples.
(2) The ((board)) commission may hold a public hearing to examine
a possible violation and may require a designated representative of the
manufacturer to attend.
(3) If a manufacturer fails to comply with this chapter following
notification by the ((board)) commission, the ((board)) commission may
impose a civil penalty of up to five thousand dollars. The ((board))
commission shall take no action to impose any civil penalty except
pursuant to a hearing held in accordance with chapter 34.05 RCW.
(4) Specific drug samples which are distributed in this state in
violation of this chapter, following notification by the ((board))
commission, shall be subject to seizure following the procedures set
out in RCW 69.41.060.
Sec. 85 RCW 69.45.090 and 2005 c 274 s 330 are each amended to
read as follows:
All records, reports, and information obtained by the ((board))
commission from or on behalf of a manufacturer or manufacturer's
representative under this chapter are confidential and exempt from
public inspection and copying under chapter 42.56 RCW. This section
does not apply to public disclosure of the identity of persons found by
the ((board)) commission to have violated state or federal law, rules,
or regulations. This section is not intended to restrict the
investigations and proceedings of the ((board)) commission so long as
the ((board)) commission maintains the confidentiality required by this
section.
NEW SECTION. Sec. 86 A new section is added to chapter 69.50 RCW
to read as follows:
"Commission" means the pharmacy quality assurance commission.
Sec. 87 RCW 69.50.201 and 1998 c 245 s 108 are each amended to
read as follows:
(a) The ((state board of pharmacy)) commission shall enforce this
chapter and may add substances to or delete or reschedule substances
listed in RCW 69.50.204, 69.50.206, 69.50.208, 69.50.210, or 69.50.212
pursuant to the procedures of chapter 34.05 RCW.
(1) In making a determination regarding a substance, the ((board))
commission shall consider the following:
(i) the actual or relative potential for abuse;
(ii) the scientific evidence of its pharmacological effect, if
known;
(iii) the state of current scientific knowledge regarding the
substance;
(iv) the history and current pattern of abuse;
(v) the scope, duration, and significance of abuse;
(vi) the risk to the public health;
(vii) the potential of the substance to produce psychic or
physiological dependence liability; and
(viii) whether the substance is an immediate precursor of a
controlled substance.
(2) The ((board)) commission may consider findings of the federal
Food and Drug Administration or the Drug Enforcement Administration as
prima facie evidence relating to one or more of the determinative
factors.
(b) After considering the factors enumerated in subsection (a) of
this section, the ((board)) commission shall make findings with respect
thereto and adopt and cause to be published a rule controlling the
substance upon finding the substance has a potential for abuse.
(c) The ((board)) commission, without regard to the findings
required by subsection (a) of this section or RCW 69.50.203, 69.50.205,
69.50.207, 69.50.209, and 69.50.211 or the procedures prescribed by
subsections (a) and (b) of this section, may place an immediate
precursor in the same schedule in which the controlled substance of
which it is an immediate precursor is placed or in any other schedule.
If the ((board)) commission designates a substance as an immediate
precursor, substances that are precursors of the controlled precursor
are not subject to control solely because they are precursors of the
controlled precursor.
(d) If a substance is designated, rescheduled, or deleted as a
controlled substance under federal law, the ((board)) commission shall
similarly control the substance under this chapter after the expiration
of thirty days from the date of publication in the federal register of
a final order designating the substance as a controlled substance or
rescheduling or deleting the substance or from the date of issuance of
an order of temporary scheduling under Section 508 of the federal
Dangerous Drug Diversion Control Act of 1984, 21 U.S.C. Sec. 811(h),
unless within that thirty-day period, the ((board)) commission or an
interested party objects to inclusion, rescheduling, temporary
scheduling, or deletion. If no objection is made, the ((board))
commission shall adopt and cause to be published, without the necessity
of making determinations or findings as required by subsection (a) of
this section or RCW 69.50.203, 69.50.205, 69.50.207, 69.50.209, and
69.50.211, a final rule, for which notice of proposed rule making is
omitted, designating, rescheduling, temporarily scheduling, or deleting
the substance. If an objection is made, the ((board)) commission shall
make a determination with respect to the designation, rescheduling, or
deletion of the substance as provided by subsection (a) of this
section. Upon receipt of an objection to inclusion, rescheduling, or
deletion under this chapter by the ((board)) commission, the ((board))
commission shall publish notice of the receipt of the objection, and
control under this chapter is stayed until the ((board)) commission
adopts a rule as provided by subsection (a) of this section.
(e) The ((board)) commission, by rule and without regard to the
requirements of subsection (a) of this section, may schedule a
substance in Schedule I regardless of whether the substance is
substantially similar to a controlled substance in Schedule I or II if
the ((board)) commission finds that scheduling of the substance on an
emergency basis is necessary to avoid an imminent hazard to the public
safety and the substance is not included in any other schedule or no
exemption or approval is in effect for the substance under Section 505
of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sec. 355. Upon
receipt of notice under RCW 69.50.214, the ((board)) commission shall
initiate scheduling of the controlled substance analog on an emergency
basis pursuant to this subsection. The scheduling of a substance under
this subsection expires one year after the adoption of the scheduling
rule. With respect to the finding of an imminent hazard to the public
safety, the ((board)) commission shall consider whether the substance
has been scheduled on a temporary basis under federal law or factors
set forth in subsection (a)(1)(iv), (v), and (vi) of this section, and
may also consider clandestine importation, manufacture, or
distribution, and, if available, information concerning the other
factors set forth in subsection (a)(1) of this section. A rule may not
be adopted under this subsection until the ((board)) commission
initiates a rule-making proceeding under subsection (a) of this section
with respect to the substance. A rule adopted under this subsection
must be vacated upon the conclusion of the rule-making proceeding
initiated under subsection (a) of this section with respect to the
substance.
(((g) [(f)])) (f) Authority to control under this section does not
extend to distilled spirits, wine, malt beverages, or tobacco as those
terms are defined or used in Titles 66 and 26 RCW.
Sec. 88 RCW 69.50.203 and 1993 c 187 s 3 are each amended to read
as follows:
(a) The ((state board of pharmacy)) commission shall place a
substance in Schedule I upon finding that the substance:
(1) has high potential for abuse;
(2) has no currently accepted medical use in treatment in the
United States; and
(3) lacks accepted safety for use in treatment under medical
supervision.
(b) The ((board)) commission may place a substance in Schedule I
without making the findings required by subsection (a) of this section
if the substance is controlled under Schedule I of the federal
Controlled Substances Act by a federal agency as the result of an
international treaty, convention, or protocol.
Sec. 89 RCW 69.50.205 and 1993 c 187 s 5 are each amended to read
as follows:
(a) The ((state board of pharmacy)) commission shall place a
substance in Schedule II upon finding that:
(1) the substance has high potential for abuse;
(2) the substance has currently accepted medical use in treatment
in the United States, or currently accepted medical use with severe
restrictions; and
(3) the abuse of the substance may lead to severe psychological or
physical dependence.
(b) The ((state board of pharmacy)) commission may place a sub-
stance in Schedule II without making the findings required by
subsection (a) of this section if the substance is controlled under
Schedule II of the federal Controlled Substances Act by a federal
agency as the result of an international treaty, convention, or
protocol.
Sec. 90 RCW 69.50.207 and 1993 c 187 s 7 are each amended to read
as follows:
(a) The ((state board of pharmacy)) commission shall place a
substance in Schedule III upon finding that:
(1) the substance has a potential for abuse less than the
substances included in Schedules I and II;
(2) the substance has currently accepted medical use in treatment
in the United States; and
(3) abuse of the substance may lead to moderate or low physical
dependence or high psychological dependence.
(b) The ((state board of pharmacy)) commission may place a sub-
stance in Schedule III without making the findings required by
subsection (a) of this section if the substance is controlled under
Schedule III of the federal Controlled Substances Act by a federal
agency as the result of an international treaty, convention, or
protocol.
Sec. 91 RCW 69.50.208 and 2010 c 177 s 4 are each amended to read
as follows:
Unless specifically excepted by state or federal law or regulation
or more specifically included in another schedule, the following
controlled substances are listed in Schedule III:
(a) Stimulants. Any material, compound, mixture, or preparation
containing any quantity of the following substances having a stimulant
effect on the central nervous system, including their salts, isomers,
whether optical, position, or geometric, and salts of isomers whenever
the existence of those salts, isomers, and salts of isomers is possible
within the specific chemical designation:
(1) Any compound, mixture, or preparation in dosage unit form
containing any stimulant substance included in Schedule II and which
was listed as an excepted compound on August 25, 1971, pursuant to the
federal Controlled Substances Act, and any other drug of the
quantitative composition shown in that list for those drugs or which is
the same except for containing a lesser quantity of controlled
substances;
(2) Benzphetamine;
(3) Chlorphentermine;
(4) Clortermine;
(5) Phendimetrazine.
(b) Depressants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a depressant
effect on the central nervous system:
(1) Any compound, mixture, or preparation containing:
(i) Amobarbital;
(ii) Secobarbital;
(iii) Pentobarbital;
or any salt thereof and one or more other active medicinal ingredients
which are not listed in any schedule;
(2) Any suppository dosage form containing:
(i) Amobarbital;
(ii) Secobarbital;
(iii) Pentobarbital;
or any salt of any of these drugs and approved by the Food and Drug
Administration for marketing only as a suppository;
(3) Any substance which contains any quantity of a derivative of
barbituric acid, or any salt of a derivative of barbituric acid;
(4) Chlorhexadol;
(5) Embutramide;
(6) Any drug product containing gamma hydroxybutyric acid,
including its salts, isomers, and salts of isomers, for which an
application is approved under section 505 of the federal food, drug,
and cosmetic act;
(7) Ketamine, its salts, isomers, and salts of isomers, some other
names for ketamine: (
(8) Lysergic acid;
(9) Lysergic acid amide;
(10) Methyprylon;
(11) Sulfondiethylmethane;
(12) Sulfonethylmethane;
(13) Sulfonmethane;
(14) Tiletamine and zolazepam or any of their salts—
(c) Nalorphine.
(d) Narcotic drugs. Unless specifically excepted or unless listed
in another schedule, any material, compound, mixture, or preparation
containing limited quantities of any of the following narcotic drugs,
or any salts thereof calculated as the free anhydrous base or alkaloid,
in limited quantities as set forth in this subsection:
(1) Not more than 1.8 grams of codeine per 100 milliliters or not
more than 90 milligrams per dosage unit, with an equal or greater
quantity of an isoquinoline alkaloid of opium;
(2) Not more than 1.8 grams of codeine per 100 milliliters or not
more than 90 milligrams per dosage unit, with one or more active,
nonnarcotic ingredients in recognized therapeutic amounts;
(3) Not more than 300 milligrams of dihydrocodeinone (hydrocodone)
per 100 milliliters or not more than 15 milligrams per dosage unit,
with a fourfold or greater quantity of an isoquinoline alkaloid of
opium;
(4) Not more than 300 milligrams of dihydrocodeinone (hydrocodone)
per 100 milliliters or not more than 15 milligrams per dosage unit,
with one or more active, nonnarcotic ingredients in recognized
therapeutic amounts;
(5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters
or not more than 90 milligrams per dosage unit, with one or more
active, nonnarcotic ingredients in recognized therapeutic amounts;
(6) Not more than 300 milligrams of ethylmorphine per 100
milliliters or not more than 15 milligrams per dosage unit, with one or
more active, nonnarcotic ingredients in recognized therapeutic amounts;
(7) Not more than 500 milligrams of opium per 100 milliliters or
per 100 grams, or not more than 25 milligrams per dosage unit, with one
or more active, nonnarcotic ingredients in recognized therapeutic
amounts; and
(8) Not more than 50 milligrams of morphine per 100 milliliters or
per 100 grams with one or more active, nonnarcotic ingredients in
recognized therapeutic amounts.
(e) Any material, compound, mixture, or preparation containing any
of the following narcotic drugs or their salts: Buprenorphine.
(f) Hallucinogenic substances. Dronabinol (synthetic) in sesame
oil and encapsulated in a soft gelatin capsule in a United States food
and drug administration approved product. Some other names for
dronabinol: [6a R-trans]-6a,7,8, 10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d] pyran-i-ol, or (-)-delta-9-(trans)-tetrahydrocannabinol.
(g) Anabolic steroids. The term "anabolic steroids" means any drug
or hormonal substance, chemically and pharmacologically related to
testosterone, other than estrogens, progestins, corticosteroids, and
dehydroepiandrosterone, that promotes muscle growth and includes:
(1) 3β,17-dihydroxy-5a-androstane;
(2) 3α,17β-dihydroxy-5a-androstane;
(3) 5α-androstan-3,17-dione;
(4) 1-androstenediol (3β,17β-dihydroxy-5α-androst-1-ene);
(5) 1-androstenediol (3α,17β-dihydroxy-5α-androst-1-ene);
(6) 4-androstenediol (3β,17β-dihydroxy-androst-4-ene);
(7) 5-androstenediol (3β,17β-dihydroxy-androst-5-ene);
(8) 1-androstenedione ([5α]-androst-1-en-3,17-dione);
(9) 4-androstenedione (androst-4-en-3,17-dione);
(10) 5-androstenedione (androst-5-en-3,17-dione);
(11) Bolasterone (7α,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);
(12) Boldenone (17β-hydroxyandrost-1,4,-diene-3-one);
(13) Calusterone (7β,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);
(14) Clostebol (4-chloro-17β-hydroxyandrost-4-en-3-one);
(15) Dehydrochloromethyltestosterone (4-chloro-17β-hydroxy-17α-methyl-androst-1,4-dien-3-one);
(16) Δ1-dihydrotestosterone (a.k.a. '1-testosterone') (17β-hydroxy-5α-androst-1-en-3-one);
(17) 4-dihydrotestosterone (17β-hydroxy-androstan-3-one);
(18) Drostanolone (17β-hydroxy-2α-methyl-5α-androstan-3-one);
(19) Ethylestrenol (17α-ethyl-17β-hydroxyestr-4-ene);
(20) Fluoxymesterone (9-fluoro-17α-methyl-11β,17β-dihydroxyandrost-4-en-3-one);
(21) Formebolone (2-formyl-17α-methyl-11α,17β-dihydroxyandrost-1,4-dien-3-one);
(22) Furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c]-furazan);
(23) 13β-ethyl-17β-hydroxygon-4-en-3-one;
(24) 4-hydroxytestosterone (4,17β-dihydroxy-androst-4-en-3-one);
(25) 4-hydroxy-19-nortestosterone (4,17β-dihydroxy-estr-4-en-3-one);
(26) Mestanolone (17α-methyl-17β-hydroxy-5-androstan-3-one);
(27) Mesterolone (1α methyl-17β-hydroxy-[5α]-androstan-3-one);
(28) Methandienone (17α-methyl-17β-hydroxyandrost-1,4-dien-3-one);
(29) Methandriol (17α-methyl-3β,17β-dihydroxyandrost-5-ene);
(30) Methenolone (1-methyl-17β-hydroxy-5α-androst-1-en-3-one);
(31) 17α-methyl-3β,17β-dihydroxy-5a-androstane;
(32) 17α-methyl-3α,17β-dihydroxy-5a-androstane;
(33) 17α-methyl-3β,17β-dihydroxyandrost-4-ene;
(34) 17α-methyl-4-hydroxynandrolone (17α-methyl-4-hydroxy-17β-hydroxyestr-4-en-3-one);
(35) Methyldienolone (17α-methyl-17β-hydroxyestra-4,9(10)-dien-3-one);
(36) Methyltrienolone (17α-methyl-17β-hydroxyestra-4,9-11-trien-3-one);
(37) Methyltestosterone (17α-methyl-17β-hydroxyandrost-4-en-3-one);
(38) Mibolerone (7α,17α-dimethyl-17β-hydroxyestr-4-en-3-one);
(39) 17α-methyl-Δ1-dihydrotestosterone (17bβ-hydroxy-17α-methyl-5α-androst-1-en-3-one) (also known as '17-α-methyl-1-testosterone');
(40) Nandrolone (17β-hydroxyestr-4-en-3-one);
(41) 19-nor-4-androstenediol (3β, 17β-dihydroxyestr-4-ene);
(42) 19-nor-4-androstenediol (3α, 17β-dihydroxyestr-4-ene);
(43) 19-nor-5-androstenediol (3β, 17β-dihydroxyestr-5-ene);
(44) 19-nor-5-androstenediol (3α, 17β-dihydroxyestr-5-ene);
(45) 19-nor-4-androstenedione (estr-4-en-3,17-dione);
(46) 19-nor-5-androstenedione (estr-5-en-3,17-dione);
(47) Norbolethone (13β, 17α-diethyl-17β-hydroxygon-4-en-3-one);
(48) Norclostebol (4-chloro-17β-hydroxyestr-4-en-3-one);
(49) Norethandrolone (17α-ethyl-17β-hydroxyestr-4-en-3-one);
(50) Normethandrolone (17α-methyl-17β-hydroxyestr-4-en-3-one);
(51) Oxandrolone (17α-methyl-17β-hydroxy-2-oxa-[5α]-androstan-3-one);
(52) Oxymesterone (17α-methyl-4,17β-dihydroxyandrost-4-en-3-one);
(53) Oxymetholone (17α-methyl-2-hydroxymethylene-17β-hydroxy-[5α]-androstan-3-one);
(54) Stanozolol (17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);
(55) Stenbolone (17β-hydroxy-2-methyl-[5α]-androst-1-en-3-one);
(56) Testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone);
(57) Testosterone (17β-hydroxyandrost-4-en-3-one);
(58) Tetrahydrogestrinone (13β, 17α-diethyl-17β-hydroxygon-4,9,11-trien-3-one);
(59) Trenbolone (17β-hydroxyestr-4,9,11-trien-3-one); and
(60) Any salt, ester, or ether of a drug or substance described in
this section. Such term does not include an anabolic steroid that is
expressly intended for administration through implants to cattle or
other nonhuman species and that has been approved by the secretary of
the department of health and human services for such administration.
If any person prescribes, dispenses, or distributes such steroid for
human use, the person shall be considered to have prescribed,
dispensed, or distributed an anabolic steroid within the meaning of
this section.
The ((state board of pharmacy)) commission may except by rule any
compound, mixture, or preparation containing any stimulant or
depressant substance listed in subsection (a)(1) and (2) of this
section from the application of all or any part of this chapter if the
compound, mixture, or preparation contains one or more active medicinal
ingredients not having a stimulant or depressant effect on the central
nervous system, and if the admixtures are in combinations, quantity,
proportion, or concentration that vitiate the potential for abuse of
the substances having a stimulant or depressant effect on the central
nervous system.
The controlled substances listed in this section may be added,
rescheduled, or deleted as provided for in RCW 69.50.201.
Sec. 92 RCW 69.50.209 and 1993 c 187 s 9 are each amended to read
as follows:
(a) The ((state board of pharmacy)) commission shall place a
substance in Schedule IV upon finding that:
(1) the substance has a low potential for abuse relative to
substances in Schedule III;
(2) the substance has currently accepted medical use in treatment
in the United States; and
(3) abuse of the substance may lead to limited physical dependence
or psychological dependence relative to the substances included in
Schedule III.
(b) The ((state board of pharmacy)) commission may place a sub-
stance in Schedule IV without making the findings required by
subsection (a) of this section if the substance is controlled under
Schedule IV of the federal Controlled Substances Act by a federal
agency as the result of an international treaty, convention, or
protocol.
Sec. 93 RCW 69.50.210 and 2010 c 177 s 5 are each amended to read
as follows:
Unless specifically excepted by state or federal law or regulation
or more specifically included in another schedule, the following
controlled substances are listed in Schedule IV:
(a) Any material, compound, mixture, or preparation containing any
of the following narcotic drugs, or their salts calculated as the free
anhydrous base or alkaloid, in limited quantities as set forth below:
(1) Not more than 1 milligram of difenoxin and not less than 25
micrograms of atropine sulfate per dosage unit.
(2) Dextropropoxyphene (alpha-(+)-4-dimethylamino-1,2-diphenyl-3-methyl-2-propionoxybutane).
(b) Depressants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation
containing any quantity of the following substances having a depressant
effect on the central nervous system, including their salts, isomers,
and salts of isomers whenever the existence of those salts, isomers,
and salts of isomers is possible within the specific chemical
designation:
(1) Alprazolam;
(2) Barbital;
(3) Bromazepam;
(4) Camazepam;
(5) Carisoprodol;
(6) Chloral betaine;
(7) Chloral hydrate;
(8) Chlordiazepoxide;
(9) Clobazam;
(10) Clonazepam;
(11) Clorazepate;
(12) Clotiazepam;
(13) Cloxazolam;
(14) Delorazepam;
(15) Diazepam;
(16) Dichloralphenazone;
(17) Estazolam;
(18) Ethchlorvynol;
(19) Ethinamate;
(20) Ethyl loflazepate;
(21) Fludiazepam;
(22) Flunitrazepam;
(23) Flurazepam;
(24) Halazepam;
(25) Haloxazolam;
(26) Ketazolam;
(27) Loprazolam;
(28) Lorazepam;
(29) Lormetazepam;
(30) Mebutamate;
(31) Medazepam;
(32) Meprobamate;
(33) Methohexital;
(34) Methylphenobarbital (mephobarbital);
(35) Midazolam;
(36) Nimetazepam;
(37) Nitrazepam;
(38) Nordiazepam;
(39) Oxazepam;
(40) Oxazolam;
(41) Paraldehyde;
(42) Petrichloral;
(43) Phenobarbital;
(44) Pinazepam;
(45) Prazepam;
(46) Quazepam;
(47) Temazepam;
(48) Tetrazepam;
(49) Triazolam;
(50) Zaleplon;
(51) Zolpidem; and
(52) Zopiclone.
(c) Fenfluramine. Any material, compound, mixture, or preparation
containing any quantity of the following substance, including its
salts, isomers, and salts of such isomers, whenever the existence of
such salts, isomers, and salts of isomers is possible: Fenfluramine.
(d) Stimulants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation
containing any quantity of the following substances having a stimulant
effect on the central nervous system, including their salts, isomers,
and salts of isomers:
(1) Cathine((+)norpseudoephedrine);
(2) Diethylpropion;
(3) Fencamfamin;
(4) Fenproporex;
(5) Mazindol;
(6) Mefenorex;
(7) Modafinil;
(8) Pemoline (including organometallic complexes and chelates
thereof);
(9) Phentermine;
(10) Pipradrol;
(11) Sibutramine;
(12) SPA ((-)-1-dimethylamino-1, 2-dephenylethane).
(e) Other substances. Unless specifically excepted or unless
listed in another schedule, any material, compound, mixture, or
preparation containing any quantity of the following substance,
including its salts:
(1) Pentazocine;
(2) Butorphanol, including its optical isomers.
The ((state board of pharmacy)) commission may except by rule any
compound, mixture, or preparation containing any depressant substance
listed in subsection (b) of this section from the application of all or
any part of this chapter if the compound, mixture, or preparation
contains one or more active medicinal ingredients not having a
depressant effect on the central nervous system, and if the admixtures
are in combinations, quantity, proportion, or concentration that
vitiate the potential for abuse of the substances having a depressant
effect on the central nervous system.
The controlled substances listed in this section may be added,
rescheduled, or deleted as provided for in RCW 69.50.201.
Sec. 94 RCW 69.50.211 and 1993 c 187 s 11 are each amended to
read as follows:
(a) The ((state board of pharmacy)) commission shall place a
substance in Schedule V upon finding that:
(1) the substance has low potential for abuse relative to the
controlled substances included in Schedule IV;
(2) the substance has currently accepted medical use in treatment
in the United States; and
(3) abuse of the substance may lead to limited physical dependence
or psychological dependence relative to the substances included in
Schedule IV.
(b) The ((state board of pharmacy)) commission may place a sub-
stance in Schedule V without being required to make the findings
required by subsection (a) of this section if the substance is
controlled under Schedule V of the federal Controlled Substances Act by
a federal agency as the result of an international treaty, convention,
or protocol.
Sec. 95 RCW 69.50.213 and 1993 c 187 s 13 are each amended to
read as follows:
The ((state board of pharmacy)) commission shall publish updated
schedules annually. Failure to publish updated schedules is not a
defense in any administrative or judicial proceeding under this
chapter.
Sec. 96 RCW 69.50.214 and 1993 c 187 s 14 are each amended to
read as follows:
A controlled substance analog, to the extent intended for human
consumption, shall be treated, for the purposes of this chapter, as a
substance included in Schedule I. Within thirty days after the
initiation of prosecution with respect to a controlled substance analog
by indictment or information, the prosecuting attorney shall notify the
((state board of pharmacy)) commission of information relevant to
emergency scheduling as provided for in RCW 69.50.201(((f))) (e).
After final determination that the controlled substance analog should
not be scheduled, no prosecution relating to that substance as a con-
trolled substance analog may continue or take place.
Sec. 97 RCW 69.50.301 and 1993 c 187 s 15 are each amended to
read as follows:
The ((board)) commission may adopt rules and the department may
charge reasonable fees, relating to the registration and control of the
manufacture, distribution, and dispensing of controlled substances
within this state.
Sec. 98 RCW 69.50.302 and 2011 c 336 s 839 are each amended to
read as follows:
(a) Every person who manufactures, distributes, or dispenses any
controlled substance within this state or who proposes to engage in the
manufacture, distribution, or dispensing of any controlled substance
within this state, shall obtain annually a registration issued by the
department in accordance with the ((board's)) commission's rules.
(b) A person registered by the department under this chapter to
manufacture, distribute, dispense, or conduct research with controlled
substances may possess, manufacture, distribute, dispense, or conduct
research with those substances to the extent authorized by the
registration and in conformity with this Article.
(c) The following persons need not register and may lawfully
possess controlled substances under this chapter:
(1) An agent or employee of any registered manufacturer,
distributor, or dispenser of any controlled substance if the agent or
employee is acting in the usual course of business or employment. This
exemption shall not include any agent or employee distributing sample
controlled substances to practitioners without an order;
(2) A common or contract carrier or warehouse operator, or an
employee thereof, whose possession of any controlled substance is in
the usual course of business or employment;
(3) An ultimate user or a person in possession of any controlled
substance pursuant to a lawful order of a practitioner or in lawful
possession of a substance included in Schedule V.
(d) The ((board)) commission may waive by rule the requirement for
registration of certain manufacturers, distributors, or dispensers upon
finding it consistent with the public health and safety. Personal
practitioners licensed or registered in the state of Washington under
the respective professional licensing acts shall not be required to be
registered under this chapter unless the specific exemption is denied
pursuant to RCW 69.50.305 for violation of any provisions of this
chapter.
(e) A separate registration is required at each principal place of
business or professional practice where the applicant manufactures,
distributes, or dispenses controlled substances.
(f) The department may inspect the establishment of a registrant or
applicant for registration in accordance with rules adopted by the
((board)) commission.
Sec. 99 RCW 69.50.303 and 1993 c 187 s 17 are each amended to
read as follows:
(a) The department shall register an applicant to manufacture or
distribute controlled substances included in RCW 69.50.204, 69.50.206,
69.50.208, 69.50.210, and 69.50.212 unless the ((board)) commission
determines that the issuance of that registration would be inconsistent
with the public interest. In determining the public interest, the
((board)) commission shall consider the following factors:
(1) maintenance of effective controls against diversion of
controlled substances into other than legitimate medical, scientific,
research, or industrial channels;
(2) compliance with applicable state and local law;
(3) promotion of technical advances in the art of manufacturing
controlled substances and the development of new substances;
(4) any convictions of the applicant under any laws of another
country or federal or state laws relating to any controlled substance;
(5) past experience in the manufacture or distribution of
controlled substances, and the existence in the applicant's
establishment of effective controls against diversion of controlled
substances into other than legitimate medical, scientific, research, or
industrial channels;
(6) furnishing by the applicant of false or fraudulent material in
any application filed under this chapter;
(7) suspension or revocation of the applicant's federal
registration to manufacture, distribute, or dispense controlled
substances as authorized by federal law; and
(8) any other factors relevant to and consistent with the public
health and safety.
(b) Registration under subsection (a) of this section does not
entitle a registrant to manufacture or distribute controlled substances
included in Schedule I or II other than those specified in the
registration.
(c) Practitioners must be registered, or exempted under RCW
69.50.302(d), to dispense any controlled substances or to conduct
research with controlled substances included in Schedules II through V
if they are authorized to dispense or conduct research under the law of
this state. The ((board)) commission need not require separate
registration under this Article for practitioners engaging in research
with nonnarcotic substances included in Schedules II through V where
the registrant is already registered under this Article in another
capacity. Practitioners registered under federal law to conduct
research with substances included in Schedule I may conduct research
with substances included in Schedule I within this state upon
furnishing the ((board)) commission evidence of that federal
registration.
(d) A manufacturer or distributor registered under the federal
Controlled Substances Act, 21 U.S.C. Sec. 801 et seq., may submit a
copy of the federal application as an application for registration as
a manufacturer or distributor under this section. The ((board))
commission may require a manufacturer or distributor to submit
information in addition to the application for registration under the
federal act.
Sec. 100 RCW 69.50.304 and 1993 c 187 s 18 are each amended to
read as follows:
(a) A registration, or exemption from registration, under RCW
69.50.303 to manufacture, distribute, or dispense a controlled
substance may be suspended or revoked by the ((state board of
pharmacy)) commission upon finding that the registrant has:
(1) furnished false or fraudulent material information in any
application filed under this chapter;
(2) been convicted of a felony under any state or federal law
relating to any controlled substance;
(3) had the registrant's federal registration suspended or revoked
and is no longer authorized by federal law to manufacture, distribute,
or dispense controlled substances; or
(4) committed acts that would render registration under RCW
69.50.303 inconsistent with the public interest as determined under
that section.
(b) The ((board)) commission may limit revocation or suspension of
a registration to the particular controlled substance or schedule of
controlled substances, with respect to which grounds for revocation or
suspension exist.
(c) If the ((board)) commission suspends or revokes a registration,
all controlled substances owned or possessed by the registrant at the
time of suspension or the effective date of the revocation order may be
placed under seal. No disposition may be made of substances under seal
until the time for taking an appeal has elapsed or until all appeals
have been concluded unless a court, upon application, orders the sale
of perishable substances and the deposit of the proceeds of the sale
with the court. Upon a revocation order becoming final, all controlled
substances may be forfeited to the state.
(d) The department may seize or place under seal any controlled
substance owned or possessed by a registrant whose registration has
expired or who has ceased to practice or do business in the manner
contemplated by the registration. The controlled substance must be
held for the benefit of the registrant or the registrant's successor in
interest. The department shall notify a registrant, or the
registrant's successor in interest, who has any controlled substance
seized or placed under seal, of the procedures to be followed to secure
the return of the controlled substance and the conditions under which
it will be returned. The department may not dispose of any controlled
substance seized or placed under seal under this subsection until the
expiration of one hundred eighty days after the controlled substance
was seized or placed under seal. The costs incurred by the department
in seizing, placing under seal, maintaining custody, and disposing of
any controlled substance under this subsection may be recovered from
the registrant, any proceeds obtained from the disposition of the
controlled substance, or from both. Any balance remaining after the
costs have been recovered from the proceeds of any disposition must be
delivered to the registrant or the registrant's successor in interest.
(e) The department shall promptly notify the drug enforcement
administration of all orders restricting, suspending, or revoking
registration and all forfeitures of controlled substances.
Sec. 101 RCW 69.50.305 and 1971 ex.s. c 308 s 69.50.305 are each
amended to read as follows:
(a) Any registration, or exemption from registration, issued
pursuant to the provisions of this chapter shall not be denied,
suspended, or revoked unless the ((board)) commission denies, suspends,
or revokes such registration, or exemption from registration, by
proceedings consistent with the administrative procedure act, chapter
34.05 RCW.
(b) The ((board)) commission may suspend any registration
simultaneously with the institution of proceedings under RCW 69.50.304,
or where renewal of registration is refused, if it finds that there is
an imminent danger to the public health or safety which warrants this
action. The suspension shall continue in effect until the conclusion
of the proceedings, including judicial review thereof, unless sooner
withdrawn by the ((board)) commission or dissolved by a court of
competent jurisdiction.
Sec. 102 RCW 69.50.306 and 1971 ex.s. c 308 s 69.50.306 are each
amended to read as follows:
Persons registered, or exempted from registration under RCW
69.50.302(d), to manufacture, distribute, dispense, or administer
controlled substances under this chapter shall keep records and
maintain inventories in conformance with the recordkeeping and
inventory requirements of federal law and with any additional rules the
((state board of pharmacy)) commission issues.
Sec. 103 RCW 69.50.308 and 2012 c 10 s 46 are each amended to
read as follows:
(a) A controlled substance may be dispensed only as provided in
this section.
(b) Except when dispensed directly by a practitioner authorized to
prescribe or administer a controlled substance, other than a pharmacy,
to an ultimate user, a substance included in Schedule II may not be
dispensed without the written prescription of a practitioner.
(1) Schedule II narcotic substances may be dispensed by a pharmacy
pursuant to a facsimile prescription under the following circumstances:
(i) The facsimile prescription is transmitted by a practitioner to
the pharmacy; and
(ii) The facsimile prescription is for a patient in a long-term
care facility. "Long-term care facility" means nursing homes licensed
under chapter 18.51 RCW, assisted living facilities licensed under
chapter 18.20 RCW, and adult family homes licensed under chapter 70.128
RCW; or
(iii) The facsimile prescription is for a patient of a hospice
program certified or paid for by medicare under Title XVIII; or
(iv) The facsimile prescription is for a patient of a hospice
program licensed by the state; and
(v) The practitioner or the practitioner's agent notes on the
facsimile prescription that the patient is a long-term care or hospice
patient.
(2) Injectable Schedule II narcotic substances that are to be
compounded for patient use may be dispensed by a pharmacy pursuant to
a facsimile prescription if the facsimile prescription is transmitted
by a practitioner to the pharmacy.
(3) Under (1) and (2) of this subsection the facsimile prescription
shall serve as the original prescription and shall be maintained as
other Schedule II narcotic substances prescriptions.
(c) In emergency situations, as defined by rule of the ((state
board of pharmacy)) commission, a substance included in Schedule II may
be dispensed upon oral prescription of a practitioner, reduced promptly
to writing and filed by the pharmacy. Prescriptions shall be retained
in conformity with the requirements of RCW 69.50.306. A prescription
for a substance included in Schedule II may not be refilled.
(d) Except when dispensed directly by a practitioner authorized to
prescribe or administer a controlled substance, other than a pharmacy,
to an ultimate user, a substance included in Schedule III or IV, which
is a prescription drug as determined under RCW 69.04.560, may not be
dispensed without a written or oral prescription of a practitioner.
Any oral prescription must be promptly reduced to writing. The
prescription shall not be filled or refilled more than six months after
the date thereof or be refilled more than five times, unless renewed by
the practitioner.
(e) A valid prescription or lawful order of a practitioner, in
order to be effective in legalizing the possession of controlled
substances, must be issued in good faith for a legitimate medical
purpose by one authorized to prescribe the use of such controlled
substance. An order purporting to be a prescription not in the course
of professional treatment is not a valid prescription or lawful order
of a practitioner within the meaning and intent of this chapter; and
the person who knows or should know that the person is filling such an
order, as well as the person issuing it, can be charged with a
violation of this chapter.
(f) A substance included in Schedule V must be distributed or
dispensed only for a medical purpose.
(g) A practitioner may dispense or deliver a controlled substance
to or for an individual or animal only for medical treatment or
authorized research in the ordinary course of that practitioner's
profession. Medical treatment includes dispensing or administering a
narcotic drug for pain, including intractable pain.
(h) No administrative sanction, or civil or criminal liability,
authorized or created by this chapter may be imposed on a pharmacist
for action taken in reliance on a reasonable belief that an order
purporting to be a prescription was issued by a practitioner in the
usual course of professional treatment or in authorized research.
(i) An individual practitioner may not dispense a substance
included in Schedule II, III, or IV for that individual practitioner's
personal use.
Sec. 104 RCW 69.50.310 and 1989 1st ex.s. c 9 s 435 are each
amended to read as follows:
On and after September 21, 1977, a humane society and animal
control agency may apply to the department for registration pursuant to
the applicable provisions of this chapter for the sole purpose of being
authorized to purchase, possess, and administer sodium pentobarbital to
euthanize injured, sick, homeless, or unwanted domestic pets and
animals. Any agency so registered shall not permit a person to
administer sodium pentobarbital unless such person has demonstrated
adequate knowledge of the potential hazards and proper techniques to be
used in administering this drug.
The department may issue a limited registration to carry out the
provisions of this section. The ((board)) commission shall promulgate
such rules as it deems necessary to insure strict compliance with the
provisions of this section. The ((board)) commission may suspend or
revoke registration upon determination that the person administering
sodium pentobarbital has not demonstrated adequate knowledge as herein
provided. This authority is granted in addition to any other power to
suspend or revoke registration as provided by law.
Sec. 105 RCW 69.50.312 and 1998 c 222 s 4 are each amended to
read as follows:
(1) Information concerning an original prescription or information
concerning a prescription refill for a controlled substance may be
electronically communicated to a pharmacy of the patient's choice
pursuant to the provisions of this chapter if the electronically
communicated prescription information complies with the following:
(a) Electronically communicated prescription information must
comply with all applicable statutes and rules regarding the form,
content, recordkeeping, and processing of a prescription for a legend
drug;
(b) The system used for transmitting electronically communicated
prescription information and the system used for receiving
electronically communicated prescription information must be approved
by the ((board)) commission. This subsection does not apply to
currently used facsimile equipment transmitting an exact visual image
of the prescription. The ((board)) commission shall maintain and
provide, upon request, a list of systems used for electronically
communicating prescription information currently approved by the
((board)) commission;
(c) An explicit opportunity for practitioners must be made to
indicate their preference on whether a therapeutically equivalent
generic drug may be substituted;
(d) Prescription drug orders are confidential health information,
and may be released only to the patient or the patient's authorized
representative, the prescriber or other authorized practitioner then
caring for the patient, or other persons specifically authorized by law
to receive such information;
(e) To maintain confidentiality of prescription records, the
electronic system shall have adequate security and systems safeguards
designed to prevent and detect unauthorized access, modification, or
manipulation of these records. The pharmacist in charge shall
establish or verify the existence of policies and procedures which
ensure the integrity and confidentiality of prescription information
transmitted to the pharmacy by electronic means. All managers,
employees, and agents of the pharmacy are required to read, sign, and
comply with the established policies and procedures; and
(f) The pharmacist shall exercise professional judgment regarding
the accuracy, validity, and authenticity of the prescription drug order
received by way of electronic transmission, consistent with federal and
state laws and rules and guidelines of the ((board)) commission.
(2) The ((board)) commission may adopt rules implementing this
section.
Sec. 106 RCW 69.50.320 and 2003 c 175 s 2 are each amended to
read as follows:
The department of fish and wildlife may apply to the department of
health for registration pursuant to the applicable provisions of this
chapter to purchase, possess, and administer controlled substances for
use in chemical capture programs. The department of fish and wildlife
must not permit a person to administer controlled substances unless the
person has demonstrated adequate knowledge of the potential hazards and
proper techniques to be used in administering controlled substances.
The department of health may issue a limited registration to carry
out the provisions of this section. The ((board)) commission may adopt
rules to ensure strict compliance with the provisions of this section.
The ((board)) commission, in consultation with the department of fish
and wildlife, must by rule add or remove additional controlled
substances for use in chemical capture programs. The ((board))
commission shall suspend or revoke registration upon determination that
the person administering controlled substances has not demonstrated
adequate knowledge as required by this section. This authority is
granted in addition to any other power to suspend or revoke
registration as provided by law.
Sec. 107 RCW 69.50.402 and 2010 c 177 s 7 are each amended to
read as follows:
(1) It is unlawful for any person:
(a) Who is subject to Article III to distribute or dispense a
controlled substance in violation of RCW 69.50.308;
(b) Who is a registrant, to manufacture a controlled substance not
authorized by his or her registration, or to distribute or dispense a
controlled substance not authorized by his or her registration to
another registrant or other authorized person;
(c) Who is a practitioner, to prescribe, order, dispense,
administer, supply, or give to any person:
(i) Any amphetamine, including its salts, optical isomers, and
salts of optical isomers classified as a schedule II controlled
substance by the ((board of pharmacy)) commission pursuant to chapter
34.05 RCW; or
(ii) Any nonnarcotic stimulant classified as a schedule II
controlled substance and designated as a nonnarcotic stimulant by the
((board of pharmacy)) commission pursuant to chapter 34.05 RCW;
except for the treatment of narcolepsy or for the treatment of
hyperkinesis, or for the treatment of drug-induced brain dysfunction,
or for the treatment of epilepsy, or for the differential diagnostic
psychiatric evaluation of depression, or for the treatment of
depression shown to be refractory to other therapeutic modalities, or
for the treatment of multiple sclerosis, or for the clinical
investigation of the effects of such drugs or compounds, in which case
an investigative protocol therefor shall have been submitted to and
reviewed and approved by the ((state board of pharmacy)) commission
before the investigation has been begun: PROVIDED, That the ((board of
pharmacy)) commission, in consultation with the medical quality
assurance commission and the osteopathic disciplinary board, may
establish by rule, pursuant to chapter 34.05 RCW, disease states or
conditions in addition to those listed in this subsection for the
treatment of which Schedule II nonnarcotic stimulants may be
prescribed, ordered, dispensed, administered, supplied, or given to
patients by practitioners: AND PROVIDED, FURTHER, That investigations
by the ((board of pharmacy)) commission of abuse of prescriptive
authority by physicians, licensed pursuant to chapter 18.71 RCW,
pursuant to subsection (1)(c) of this section shall be done in
consultation with the medical quality assurance commission;
(d) To refuse or fail to make, keep or furnish any record,
notification, order form, statement, invoice, or information required
under this chapter;
(e) To refuse an entry into any premises for any inspection
authorized by this chapter; or
(f) Knowingly to keep or maintain any store, shop, warehouse,
dwelling, building, vehicle, boat, aircraft, or other structure or
place, which is resorted to by persons using controlled substances in
violation of this chapter for the purpose of using these substances, or
which is used for keeping or selling them in violation of this chapter.
(2) Any person who violates this section is guilty of a class C
felony and upon conviction may be imprisoned for not more than two
years, fined not more than two thousand dollars, or both.
Sec. 108 RCW 69.50.501 and 1971 ex.s. c 308 s 69.50.501 are each
amended to read as follows:
The ((state board of pharmacy)) commission may make administrative
inspections of controlled premises in accordance with the following
provisions:
(1) For purposes of this section only, "controlled premises" means:
(a) places where persons registered or exempted from registration
requirements under this chapter are required to keep records; and
(b) places including factories, warehouses, establishments, and
conveyances in which persons registered or exempted from registration
requirements under this chapter are permitted to hold, manufacture,
compound, process, sell, deliver, or otherwise dispose of any
controlled substance.
(2) When authorized by an administrative inspection warrant issued
pursuant to RCW 69.50.502 an officer or employee designated by the
((board)) commission, upon presenting the warrant and appropriate
credentials to the owner, operator, or agent in charge, may enter
controlled premises for the purpose of conducting an administrative
inspection.
(3) When authorized by an administrative inspection warrant, an
officer or employee designated by the ((board)) commission may:
(a) inspect and copy records required by this chapter to be kept;
(b) inspect, within reasonable limits and in a reasonable manner,
controlled premises and all pertinent equipment, finished and
unfinished material, containers and labeling found therein, and, except
as provided in subsection (5) of this section, all other things
therein, including records, files, papers, processes, controls, and
facilities bearing on violation of this chapter; and
(c) inventory any stock of any controlled substance therein and
obtain samples thereof;
(4) This section does not prevent the inspection without a warrant
of books and records pursuant to an administrative subpoena issued in
accordance with chapter 34.05 RCW, nor does it prevent entries and
administrative inspections, including seizures of property, without a
warrant:
(a) if the owner, operator, or agent in charge of the controlled
premises consents;
(b) in situations presenting imminent danger to health or safety;
(c) in situations involving inspection of conveyances if there is
reasonable cause to believe that the mobility of the conveyance makes
it impracticable to obtain a warrant;
(d) in any other exceptional or emergency circumstance where time
or opportunity to apply for a warrant is lacking; or,
(e) in all other situations in which a warrant is not
constitutionally required;
(5) An inspection authorized by this section shall not extend to
financial data, sales data, other than shipment data, or pricing data
unless the owner, operator, or agent in charge of the controlled
premises consents in writing.
Sec. 109 RCW 69.50.504 and 1971 ex.s. c 308 s 69.50.504 are each
amended to read as follows:
The ((state board of pharmacy)) commission shall cooperate with
federal and other state agencies in discharging its responsibilities
concerning traffic in controlled substances and in suppressing the
abuse of controlled substances.
Sec. 110 RCW 69.50.507 and 2012 c 117 s 371 are each amended to
read as follows:
All final determinations, findings, and conclusions of the ((state
board of pharmacy)) commission under this chapter are final and
conclusive decisions of the matters involved. Any person aggrieved by
the decision may obtain review of the decision in the superior court
wherein he or she resides or in the superior court of Thurston county,
such review to be in conformity with the administrative procedure act,
chapter 34.05 RCW.
Sec. 111 RCW 69.50.508 and 1971 ex.s. c 308 s 69.50.508 are each
amended to read as follows:
(a) The ((state board of pharmacy)) commission may carry out
educational programs designed to prevent and deter misuse and abuse of
controlled substances. In connection with these programs it may:
(1) promote better recognition of the problems of misuse and abuse
of controlled substances within the regulated industry and among
interested groups and organizations;
(2) assist the regulated industry and interested groups and
organizations in contributing to the reduction of misuse and abuse of
controlled substances;
(3) consult with interested groups and organizations to aid them in
solving administrative and organizational problems;
(4) evaluate procedures, projects, techniques, and controls
conducted or proposed as part of educational programs on misuse and
abuse of controlled substances;
(5) disseminate the results of research on misuse and abuse of
controlled substances to promote a better public understanding of what
problems exist and what can be done to combat them; and
(6) assist in the education and training of state and local law
enforcement officials in their efforts to control misuse and abuse of
controlled substances.
(b) The ((board)) commission may encourage research on misuse and
abuse of controlled substances. In connection with the research, and
in furtherance of the enforcement of this chapter, it may:
(1) establish methods to assess accurately the effects of
controlled substances and identify and characterize those with
potential for abuse;
(2) make studies and undertake programs of research to:
(i) develop new or improved approaches, techniques, systems,
equipment and devices to strengthen the enforcement of this chapter;
(ii) determine patterns of misuse and abuse of controlled
substances and the social effects thereof; and,
(iii) improve methods for preventing, predicting, understanding and
dealing with the misuse and abuse of controlled substances; and,
(3) enter into contracts with public agencies, institutions of
higher education, and private organizations or individuals for the
purpose of conducting research, demonstrations, or special projects
which bear directly on misuse and abuse of controlled substances.
(c) The ((board)) commission may enter into contracts for
educational and research activities without performance bonds.
(d) The ((board)) commission may authorize persons engaged in
research on the use and effects of controlled substances to withhold
the names and other identifying characteristics of individuals who are
the subjects of the research. Persons who obtain this authorization
are not compelled in any civil, criminal, administrative, legislative,
or other proceeding to identify the individuals who are the subjects of
research for which the authorization was obtained.
(e) The ((board)) commission may authorize the possession and
distribution of controlled substances by persons engaged in research.
Persons who obtain this authorization are exempt from state prosecution
for possession and distribution of controlled substances to the extent
of the authorization.
Sec. 112 RCW 69.50.601 and 1971 ex.s. c 308 s 69.50.601 are each
amended to read as follows:
(a) Prosecution for any violation of law occurring prior to May 21,
1971 is not affected or abated by this chapter. If the offense being
prosecuted is similar to one set out in Article IV of this chapter,
then the penalties under Article IV apply if they are less than those
under prior law.
(b) Civil seizures or forfeitures and injunctive proceedings
commenced prior to May 21, 1971 are not affected by this chapter.
(c) All administrative proceedings pending under prior laws which
are superseded by this chapter shall be continued and brought to a
final determination in accord with the laws and rules in effect prior
to May 21, 1971. Any substance controlled under prior law which is not
listed within Schedules I through V, is automatically controlled
without further proceedings and shall be listed in the appropriate
schedule.
(d) The ((state board of pharmacy)) commission shall initially
permit persons to register who own or operate any establishment engaged
in the manufacture, distribution, or dispensing of any controlled
substance prior to May 21, 1971 and who are registered or licensed by
the state.
(e) This chapter applies to violations of law, seizures and
forfeiture, injunctive proceedings, administrative proceedings and
investigations which occur following May 21, 1971.
Sec. 113 RCW 69.51.030 and 1989 1st ex.s. c 9 s 438 are each
amended to read as follows:
As used in this chapter:
(1) (("Board" means the state board of pharmacy;)) "Commission"
means the pharmacy quality assurance commission;
(2) "Department" means the department of health((.));
(3) "Marijuana" means all parts of the plant of the genus Cannabis
L., whether growing or not, the seeds thereof, the resin extracted from
any part of the plant, and every compound, manufacture, salt,
derivative, mixture, or preparation of the plant, its seeds, or resin;
and
(4) "Practitioner" means a physician licensed pursuant to chapter
18.71 or 18.57 RCW.
Sec. 114 RCW 69.51.040 and 1989 1st ex.s. c 9 s 439 are each
amended to read as follows:
(1) There is established in the ((board)) commission the controlled
substances therapeutic research program. The program shall be
administered by the department. The ((board)) commission shall
promulgate rules necessary for the proper administration of the
Controlled Substances Therapeutic Research Act. In such promulgation,
the ((board)) commission shall take into consideration those pertinent
rules promulgated by the United States drug enforcement agency, the
food and drug administration, and the national institute on drug abuse.
(2) Except as provided in RCW 69.51.050(4), the controlled
substances therapeutic research program shall be limited to cancer
chemotherapy and radiology patients and glaucoma patients, who are
certified to the patient qualification review committee by a
practitioner as being involved in a life-threatening or sense-threatening situation. No patient may be admitted to the controlled
substances therapeutic research program without full disclosure by the
practitioner of the experimental nature of this program and of the
possible risks and side effects of the proposed treatment in accordance
with the informed consent provisions of chapter 7.70 RCW.
(3) The ((board)) commission shall provide by rule for a program of
registration with the department of bona fide controlled substance
therapeutic research projects.
Sec. 115 RCW 69.51.050 and 1979 c 136 s 5 are each amended to
read as follows:
(1) The ((board)) commission shall appoint a patient qualification
review committee to serve at its pleasure. The patient qualification
review committee shall be comprised of:
(a) A physician licensed to practice medicine in Washington state
and specializing in the practice of ophthalmology;
(b) A physician licensed to practice medicine in Washington state
and specializing in the subspecialty of medical oncology;
(c) A physician licensed to practice medicine in Washington state
and specializing in the practice of psychiatry; and
(d) A physician licensed to practice medicine in Washington state
and specializing in the practice of radiology.
Members of the committee shall be compensated at the rate of fifty
dollars per day for each day spent in the performance of their official
duties, and shall receive reimbursement for their travel expenses as
provided in RCW 43.03.050 and 43.03.060.
(2) The patient qualification review committee shall review all
applicants for the controlled substance therapeutic research program
and their licensed practitioners and certify their participation in the
program.
(3) The patient qualification review committee and the ((board))
commission shall insure that the privacy of individuals who participate
in the controlled substance therapeutic research program is protected
by withholding from all persons not connected with the conduct of the
research the names and other identifying characteristics of such
individuals. Persons authorized to engage in research under the
controlled substance therapeutic research program may not be compelled
in any civil, criminal, administrative, legislative, or other
proceeding to identify the individuals who are the subjects of research
for which the authorization was granted, except to the extent necessary
to permit the ((board)) commission to determine whether the research is
being conducted in accordance with the authorization.
(4) The patient qualification review committee may include other
disease groups for participation in the controlled substances
therapeutic research program after pertinent medical data have been
presented by a practitioner to both the committee and the ((board))
commission, and after approval for such participation has been granted
pursuant to pertinent rules promulgated by the United States drug
enforcement agency, the food and drug administration, and the national
institute on drug abuse.
Sec. 116 RCW 69.51.060 and 1979 c 136 s 6 are each amended to
read as follows:
(1) The ((board)) commission shall obtain marijuana through
whatever means it deems most appropriate and consistent with
regulations promulgated by the United States food and drug
administration, the drug enforcement agency, and the national institute
on drug abuse, and pursuant to the provisions of this chapter.
(2) The ((board)) commission may use marijuana which has been
confiscated by local or state law enforcement agencies and has been
determined to be free from contamination.
(3) The ((board)) commission shall distribute the analyzed
marijuana to approved practitioners and/or institutions in accordance
with rules promulgated by the ((board)) commission.
Sec. 117 RCW 69.60.020 and 1989 c 247 s 3 are each amended to
read as follows:
The terms defined in this section shall have the meanings indicated
when used in this chapter.
(1) "Solid dosage form" means capsules or tablets or similar over-the-counter medication products intended for administration and which
could be ingested orally.
(2) "Over-the-counter medication" means a drug that can be obtained
without a prescription and is not restricted to use by prescribing
practitioners. For purposes of this chapter, over-the-counter
medication does not include vitamins.
(3) (("Board" means the state board of pharmacy.)) "Commission"
means the pharmacy quality assurance commission.
(4) "Purveyor" means any corporation, person, or other entity that
offers over-the-counter medications for wholesale, retail, or other
type of sale.
Sec. 118 RCW 69.60.040 and 1989 c 247 s 4 are each amended to
read as follows:
Each manufacturer shall publish and provide to the ((board))
commission printed material which will identify each current imprint
used by the manufacturer and the ((board)) commission shall be notified
of any change. This information shall be provided by the ((board))
commission to all pharmacies licensed in the state of Washington,
poison control centers, and hospital emergency rooms.
Sec. 119 RCW 69.60.060 and 1989 c 247 s 6 are each amended to
read as follows:
The ((board)) commission shall have authority to promulgate rules
for the enforcement and implementation of this chapter.
Sec. 120 RCW 69.60.080 and 1989 c 247 s 8 are each amended to
read as follows:
The ((board)) commission, upon application of a manufacturer, may
exempt an over-the-counter drug from the requirements of chapter 69.60
RCW on the grounds that imprinting is infeasible because of size,
texture, or other unique characteristics.
Sec. 121 RCW 69.60.090 and 1993 c 135 s 3 are each amended to
read as follows:
Before January 1, 1994, the ((board of pharmacy)) commission will
consult with the state toxicologist to determine whether the federal
government has established a legally enforceable system that is
substantially equivalent to the requirements of this chapter that
govern the imprinting of solid dosage form over-the-counter medication.
To be substantially equivalent, the effective dates for implementation
of the federal system for imprinting solid dosage form over-the-counter
medication must be the same or earlier than the dates of implementation
set out in the state system for imprinting solid dosage form over-the-counter medication. If the ((board)) commission determines that the
federal system for imprinting solid dosage form over-the-counter
medication is substantially equivalent to the state system for
imprinting solid dosage form over-the-counter medication, this chapter
will cease to exist on January 1, 1994. If the ((board)) commission
determines that the federal system is substantially equivalent, except
that the federal dates for implementation are later than the Washington
state dates, this chapter will cease to exist when the federal system
is implemented.
Sec. 122 RCW 70.24.280 and 1988 c 206 s 605 are each amended to
read as follows:
The ((state board of pharmacy)) pharmacy quality assurance
commission shall adopt rules that require appropriate education and
training for licensees on the prevention, transmission, and treatment
of AIDS. The ((board)) commission shall work with the office on AIDS
under RCW 70.24.250 to develop the training and educational material
necessary for health professionals.
Sec. 123 RCW 70.54.140 and 1977 ex.s. c 122 s 2 are each amended
to read as follows:
No hospital or health facility may interfere with the
physician/patient relationship by restricting or forbidding the use of
amygdalin (Laetrile) when prescribed or administered by a physician
licensed pursuant to chapter 18.57 or 18.71 RCW and requested by a
patient under his/her care who has requested the substance after having
been given sufficient information in writing to make an informed
decision.
For the purposes of RCW 70.54.130 through 70.54.150, the ((state
board of pharmacy)) pharmacy quality assurance commission shall provide
for the certification as to the identity of amygdalin (Laetrile) by
random sample testing or other testing procedures, and shall promulgate
rules and regulations necessary to implement and enforce its authority
under this section.
Sec. 124 RCW 70.106.150 and 1987 c 236 s 1 are each amended to
read as follows:
The authority to promulgate regulations for the efficient
enforcement of this chapter is hereby vested in the director. However,
the director shall designate the ((Washington state board of pharmacy))
pharmacy quality assurance commission to carry out all the provisions
of this chapter pertaining to drugs and cosmetics, with authority to
promulgate regulations for the efficient enforcement thereof.
Sec. 125 RCW 70.127.130 and 1993 c 42 s 9 are each amended to
read as follows:
Licensees shall conform to the standards of RCW 69.41.030 and
69.50.308. Rules adopted by the department concerning the use of
legend drugs or controlled substances shall reference and be consistent
with ((board of pharmacy)) pharmacy quality assurance commission rules.
Sec. 126 RCW 70.225.020 and 2012 c 192 s 1 are each amended to
read as follows:
(1) When sufficient funding is provided for such purpose through
federal or private grants, or is appropriated by the legislature, the
department shall establish and maintain a prescription monitoring
program to monitor the prescribing and dispensing of all Schedules II,
III, IV, and V controlled substances and any additional drugs
identified by the ((board of pharmacy)) pharmacy quality assurance
commission as demonstrating a potential for abuse by all professionals
licensed to prescribe or dispense such substances in this state. The
program shall be designed to improve health care quality and
effectiveness by reducing abuse of controlled substances, reducing
duplicative prescribing and overprescribing of controlled substances,
and improving controlled substance prescribing practices with the
intent of eventually establishing an electronic database available in
real time to dispensers and prescribers of controlled substances. As
much as possible, the department should establish a common database
with other states.
(2) Except as provided in subsection (4) of this section, each
dispenser shall submit to the department by electronic means
information regarding each prescription dispensed for a drug included
under subsection (1) of this section. Drug prescriptions for more than
one day use should be reported. The information submitted for each
prescription shall include, but not be limited to:
(a) Patient identifier;
(b) Drug dispensed;
(c) Date of dispensing;
(d) Quantity dispensed;
(e) Prescriber; and
(f) Dispenser.
(3) Each dispenser shall submit the information in accordance with
transmission methods established by the department.
(4) The data submission requirements of subsections (1) through (3)
of this section do not apply to:
(a) Medications provided to patients receiving inpatient services
provided at hospitals licensed under chapter 70.41 RCW; or patients of
such hospitals receiving services at the clinics, day surgery areas, or
other settings within the hospital's license where the medications are
administered in single doses;
(b) Pharmacies operated by the department of corrections for the
purpose of providing medications to offenders in department of
corrections institutions who are receiving pharmaceutical services from
a department of corrections pharmacy, except that the department of
corrections must submit data related to each offender's current
prescriptions for controlled substances upon the offender's release
from a department of corrections institution; or
(c) Veterinarians licensed under chapter 18.92 RCW. The
department, in collaboration with the veterinary board of governors,
shall establish alternative data reporting requirements for
veterinarians that allow veterinarians to report:
(i) By either electronic or nonelectronic methods;
(ii) Only those data elements that are relevant to veterinary
practices and necessary to accomplish the public protection goals of
this chapter; and
(iii) No more frequently than once every three months and no less
frequently than once every six months.
(5) The department shall seek federal grants to support the
activities described in chapter 259, Laws of 2007. The department may
not require a practitioner or a pharmacist to pay a fee or tax
specifically dedicated to the operation of the system.
Sec. 127 RCW 82.04.272 and 2003 c 168 s 401 are each amended to
read as follows:
(1) Upon every person engaging within this state in the business of
warehousing and reselling drugs for human use pursuant to a
prescription; as to such persons, the amount of the tax shall be equal
to the gross income of the business multiplied by the rate of 0.138
percent.
(2) For the purposes of this section:
(a) "Prescription" and "drug" have the same meaning as in RCW
82.08.0281; and
(b) "Warehousing and reselling drugs for human use pursuant to a
prescription" means the buying of drugs for human use pursuant to a
prescription from a manufacturer or another wholesaler, and reselling
of the drugs to persons selling at retail or to hospitals, clinics,
health care providers, or other providers of health care services, by
a wholesaler or retailer who is registered with the federal drug
enforcement administration and licensed by the ((state board of
pharmacy)) pharmacy quality assurance commission.
NEW SECTION. Sec. 128 Section 44 of this act expires July 1,
2016.
NEW SECTION. Sec. 129 Section 45 of this act takes effect July
1, 2016.