75th OREGON LEGISLATIVE ASSEMBLY--2009 Regular Session
NOTE: Matter within { + braces and plus signs + } in an
amended section is new. Matter within { - braces and minus
signs - } is existing law to be omitted. New sections are within
{ + braces and plus signs + } .
LC 2888
House Bill 3103
Sponsored by Representative THOMPSON; Representative MAURER
SUMMARY
The following summary is not prepared by the sponsors of the
measure and is not a part of the body thereof subject to
consideration by the Legislative Assembly. It is an editor's
brief statement of the essential features of the measure as
introduced.
Updates certain statutes relating to regulation of pharmacies
and pharmacists.
Removes requirement that instruction of practitioner not to
substitute generic drug be in practitioner's or pharmacist's
handwriting.
Removes requirement that pharmacy post sign relating to
substitution of generic drugs.
Changes circumstances under which pharmacist may administer
drugs or devices.
Allows State Board of Pharmacy to approve dispensing of drugs
by vending machines.
Allows pharmacist to personally possess or store drugs under
certain conditions.
A BILL FOR AN ACT
Relating to the practice of pharmacy; creating new provisions;
amending ORS 442.580, 689.005, 689.225, 689.515, 689.655 and
689.765; and repealing ORS 689.015.
Be It Enacted by the People of the State of Oregon:
SECTION 1. ORS 689.005 is amended to read:
689.005. As 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 by:
(a) A practitioner or the { + practitioner's + } authorized
agent
{ - thereof - } ; or
(b) The patient or research subject at the direction of the
practitioner.
(2) 'Approved continuing pharmacy education program' means
those seminars, classes, meetings, workshops and other
educational programs on the subject of pharmacy approved by the
board.
(3) 'Board of pharmacy' or 'board' means the State Board of
Pharmacy.
(4) 'Continuing pharmacy education' means { + :
(a) + } Professional, pharmaceutical post-graduate education in
the general areas of socio-economic and legal aspects of health
care;
{ + (b) + } The properties and actions of drugs and dosage
forms; and
{ + (c) + } The etiology, characteristics and therapeutics of
the disease state.
(5) 'Continuing pharmacy education unit' means the unit of
measurement of credits for approved continuing education courses
and programs.
(6) 'Deliver' or 'delivery' means the actual, constructive or
attempted transfer of a drug or device other than by
administration from one person to another, whether or not for a
consideration.
(7) 'Device' means an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent or other similar
or related article, including any component part or accessory,
which is required under federal or state law to be prescribed by
a practitioner and dispensed by a pharmacist.
(8) 'Dispense' or 'dispensing' means the preparation and
delivery of a prescription drug pursuant to a lawful order of a
practitioner in a suitable container appropriately labeled for
subsequent administration to or use by a patient or other
individual entitled to receive the prescription drug.
(9) 'Distribute' means the delivery of a drug other than by
administering or dispensing.
(10) 'Drug' means:
(a) Articles recognized as drugs in the official United States
Pharmacopoeia, official National Formulary, official Homeopathic
Pharmacopoeia, other drug compendium or any supplement to any of
them;
(b) Articles intended for use in the diagnosis, cure,
mitigation, treatment or prevention of disease in a human or
other animal;
(c) Articles { - ( - } { + , + } other than food { - ) - }
{ + , + } intended to affect the structure or any function of
the body of humans or other animals; and
(d) Articles intended for use as a component of any articles
specified in paragraph (a), (b) or (c) of this subsection.
(11) 'Drug order' means a written order, in a hospital or other
inpatient care facility, for an ultimate user of any drug or
device issued and signed by a practitioner, or an order
transmitted by other means of communication from a practitioner,
that is immediately reduced to writing by a pharmacist, licensed
nurse or other practitioner.
(12) 'Drug outlet' means any pharmacy, nursing home, shelter
home, convalescent home, extended care facility, drug abuse
treatment center, penal institution, hospital, family planning
clinic, student health center, retail store, wholesaler,
manufacturer, mail-order vendor or other establishment with
facilities located within or out of this state that is engaged in
dispensing, delivery or distribution of drugs within this state.
(13) 'Drug room' means a secure and lockable location within an
inpatient care facility that does not have a licensed pharmacy.
(14) 'Electronically transmitted' or 'electronic transmission'
means a communication sent or received through technological
apparatuses, including computer terminals or other equipment or
mechanisms linked by telephone or microwave relays, or any
similar apparatus having electrical, digital, magnetic, wireless,
optical, electromagnetic or similar capabilities.
(15) 'Institutional drug outlet' means hospitals and inpatient
care facilities where medications are dispensed to another health
care professional for administration to patients served by the
hospitals or facilities.
(16) 'Intern' means { - any person who has completed the
junior or third academic year of a course of study at an approved
college of pharmacy and - } { + a person who is enrolled in or
has completed a course of study at a school or college of
pharmacy approved by the board and who + }is licensed with the
board as an intern.
(17) 'Internship' means a professional and practical experience
program approved by the board under the supervision of a licensed
pharmacist registered with the board as a preceptor.
(18) 'Itinerant vendor' means { - all persons who sell or
otherwise distribute - } { + a person who sells or
distributes + } nonprescription drugs by passing from house to
house, or by haranguing the people on the public streets or in
public places, or who { - use - } { + uses + } the customary
devices for attracting crowds { - and therewith - } { + , + }
recommending their wares and offering them for sale.
(19) 'Labeling' means the process of preparing and affixing of
a label to any drug container exclusive, however, of the labeling
by a manufacturer, packer or distributor of a nonprescription
drug or commercially packaged legend drug or device. { - Any
such label shall include all information required by federal and
state law or regulation. - }
(20) 'Manufacture' means the production, preparation,
propagation, compounding, conversion or processing of a device or
a drug, either directly or indirectly by extraction from
substances of natural origin or independently by means of
chemical synthesis or by a combination of extraction and chemical
synthesis and includes any packaging or repackaging of the
substances or labeling or relabeling of its container, except
that this term does not include the preparation or compounding of
a drug by an individual for their own use or the preparation,
compounding, packaging or labeling of a drug:
(a) By a practitioner as an incident to administering or
dispensing of a drug in the course of professional practice; or
(b) By a practitioner or by the practitioner's authorization
under supervision of the practitioner for the purpose of or as an
incident to research, teaching or chemical analysis and not for
sale.
(21) 'Manufacturer' means a person engaged in the manufacture
of drugs.
(22) 'Nonprescription drug outlet' means shopkeepers and
itinerant vendors registered under ORS 689.305.
(23) 'Nonprescription drugs' means drugs which may be sold
without a prescription and which are prepackaged for use by the
consumer and labeled in accordance with the requirements of the
statutes and regulations of this state and the federal
government.
(24) 'Person' means an individual, corporation, partnership,
association or any other legal entity.
(25) 'Pharmacist' means an individual licensed by this state to
engage in the practice of pharmacy.
(26) 'Pharmacy' means a place that meets the requirements of
rules of the board, is licensed and approved by the board where
the practice of pharmacy may lawfully occur and includes
apothecaries, drug stores, dispensaries, hospital outpatient
pharmacies, pharmacy departments and prescription laboratories
but does not include a place used by a manufacturer or
wholesaler.
(27) 'Pharmacy technician' means a person licensed by the State
Board of Pharmacy who assists the pharmacist in the practice of
pharmacy pursuant to rules of the board.
{ + (28) 'Practice of pharmacy' means:
(a) The interpretation and evaluation of prescription orders;
(b) The compounding, dispensing and labeling of drugs and
devices, except labeling by a manufacturer, packer or distributor
of nonprescription drugs and commercially packaged legend drugs
and devices;
(c) The administering of vaccines and immunizations pursuant to
ORS 689.645;
(d) The administering of drugs and devices to the extent
permitted under ORS 689.655;
(e) The participation in drug selection and drug utilization
reviews;
(f) The proper and safe storage of drugs and devices and the
maintenance of proper records therefor;
(g) The responsibility for advising, where necessary or where
regulated, of therapeutic values, content, hazards and use of
drugs and devices;
(h) The monitoring of therapeutic response or adverse effect to
drug therapy; and
(i) The offering or performing of those acts, services,
operations or transactions necessary in the conduct, operation,
management and control of pharmacy. + }
{ - (28) - } { + (29) + } 'Practitioner' means a person
licensed and operating within the scope of such license to
prescribe, dispense, conduct research with respect to or
administer drugs in the course of professional practice or
research:
(a) In this state; or
(b) In another state or territory of the United States
{ - not residing - } { + if the person does not reside + } in
Oregon and { + is + } registered under the federal Controlled
Substances Act.
{ - (29) - } { + (30) + } 'Preceptor' means a pharmacist
{ + or a person + } licensed { - and in good standing,
registered - } by the board to supervise the internship training
of a licensed intern.
{ - (30) - } { + (31) + } 'Prescription drug' or 'legend
drug' means a drug which is:
(a) Required by federal law, prior to being dispensed or
delivered, to be labeled with either of the following statements:
(A) 'Caution: Federal law prohibits dispensing without
prescription'; or
(B) 'Caution: Federal law restricts this drug to use by or on
the order of a licensed veterinarian'; or
(b) Required by any applicable federal or state law or
regulation to be dispensed on prescription only or is restricted
to use by practitioners only.
{ - (31) - } { + (32) + } 'Prescription' or 'prescription
drug order ' means a written, oral or electronically transmitted
direction, given by a practitioner authorized to prescribe drugs,
for the preparation and use of a drug. When the context requires,
' prescription' also means the drug prepared under such written,
oral or electronically transmitted direction.
{ - (32) - } { + (33) + } 'Retail drug outlet' means a
place used for the conduct of the retail sale, administering or
dispensing or compounding of drugs or chemicals or for the
administering or dispensing of prescriptions and licensed by the
board as a place wherein the practice of pharmacy may lawfully
occur.
{ - (33) - } { + (34) + } 'Shopkeeper' means a business or
other establishment, open to the general public, for the sale or
nonprofit distribution of drugs.
{ - (34) - } { + (35) + } 'Unit dose' means a sealed
single-unit container so designed that the contents are
administered to the patient as a single dose, direct from the
container. Each unit dose container must bear a separate label,
be labeled with the name and strength of the medication, the name
of the manufacturer or distributor, an identifying lot number
and, if applicable, the expiration date of the medication.
{ - (35) - } { + (36) + } 'Wholesale drug outlet' means any
person who imports, stores, distributes or sells for resale any
drugs including legend drugs and nonprescription drugs.
{ - (36) 'Class I wholesaler' means any person operating or
maintaining a wholesale distribution center, wholesale business
or any other business in which drugs, medicinal chemicals, or
poisons are sold, dispensed, stocked, exposed or offered for sale
at wholesale to a pharmacy or other legally licensed drug outlets
or persons. - }
{ - (37) 'Class II wholesaler' means any person operating or
maintaining a wholesale distribution center, wholesale business
or any other business in which nonprescription drugs are offered
for sale at wholesale to a drug outlet legally authorized to
resell. - }
SECTION 2. { + ORS 689.015 is repealed. + }
SECTION 3. ORS 689.225 is amended to read:
689.225. (1) { - It shall be unlawful for any person to - }
{ + A person may not + } engage in the practice of pharmacy
unless { + the person is + } licensed { - to so practice under
the provisions of - } { + under + } this chapter. Nothing in
this section prevents physicians, dentists, veterinarians,
osteopaths or other practitioners of the healing arts who are
licensed under the laws of this state from dispensing and
administering prescription drugs to their patients in the
practice of their respective professions where specifically
authorized to do so by law of this state.
(2) { - It shall be unlawful for any person, not legally
licensed as a pharmacist, to - } { + A person may not + } take,
use or exhibit the title of pharmacist or the title of druggist
or apothecary, or any other title or description of like import
{ + unless the person is licensed to practice pharmacy under
this chapter + }.
(3) { - In the practice of pharmacy, a pharmacist is licensed
to practice as defined in ORS 689.015, but is not authorized
to - } { + A pharmacist may not + } possess personally or
{ - to - } store drugs other than in a licensed pharmacy except
for those drugs legally prescribed for the personal use of the
pharmacist { + or when the pharmacist possesses or stores the
drugs in the usual course of business and within the pharmacist's
scope of practice + }. An employee, agent or owner of any
registered manufacturer, wholesaler or pharmacy may lawfully
possess legend drugs if the person is acting in the usual course
of the business or employment of the person.
(4) The State Board of Pharmacy shall adopt rules relating to
the use of pharmacy technicians working under the supervision,
direction and control of a { - licensed - } pharmacist. For
retail and institutional drug outlets, the board shall adopt
rules which include requirements for training, including
provisions for appropriate on-the-job training, guidelines for
adequate supervision, standards and appropriate ratios for the
use of pharmacy technicians. Improper use of pharmacy technicians
{ - shall be - } { + is + } subject to the reporting
requirements of ORS 689.455.
(5) The mixing of intravenous admixtures by pharmacy
technicians working under the supervision, direction and control
of a { - licensed - } pharmacist is authorized and does not
constitute the practice of pharmacy by the pharmacy technicians.
(6) Any person who is found to have unlawfully engaged in the
practice of pharmacy is guilty of a Class A misdemeanor.
SECTION 4. ORS 689.515 is amended to read:
689.515. (1) As used in this section unless the context
requires otherwise:
(a) 'Brand name' means the proprietary or trade name selected
by the manufacturer and placed upon a drug, its container, label
or wrapping at the time of packaging.
(b) 'Dosage form' means the physical formulation or medium in
which the product is intended, manufactured and made available
for use, including but not limited to tablets, capsules, oral
solutions, aerosols, ointments, inhalers and suppositories, and
the particular form of which utilizes a specific technology or
mechanism to control, enhance or direct the release, targeting,
systemic absorption or other delivery of a dosage regimen in the
body.
(c) 'Generic name' means the official title of a drug or drug
ingredients published in the latest edition of the official
Pharmacopoeia, Homeopathic Pharmacopoeia or Formulary.
(d) 'Substitute' means to dispense without the prescriber's
express authorization a different drug product in place of the
drug ordered or prescribed.
(e) 'Therapeutically equivalent' means drugs that are approved
by the United States Food and Drug Administration for interstate
distribution and the Food and Drug Administration has determined
that the drugs will provide essentially the same efficacy and
toxicity when administered to an individual in the same dosage
regimen.
(2) Except as limited by subsections (3) and { - (5) - }
{ + (4) + } of this section, unless the purchaser instructs
otherwise, { - the - } { + a + } pharmacist may substitute as
follows:
(a) A drug product with the same generic name in the same
strength, quantity, dose and dosage form as the prescribed drug
which is, in the pharmacist's professional opinion,
therapeutically equivalent.
(b) When the prescriber is not reasonably available for
consultation and the prescribed drug does not utilize a unique
delivery system technology, an oral tablet, capsule or liquid
form of the prescribed drug so long as the form dispensed or
administered has the same strength, dose and dose schedule and is
therapeutically equivalent to the drug prescribed.
(3) A practitioner may specify in writing, by a telephonic
communication or by electronic transmission that there
{ - shall - } { + may + } be no substitution for the specified
brand name drug in { - any - } { + a + } prescription.
{ - The phrase 'no substitution' or the notation ' N.S.' must be
in the practitioner's handwriting or, if the prohibition was
communicated by telephonic communication or electronic
transmission, in the pharmacist's handwriting and shall not be
preprinted or stamped or initialed on the prescription form. - }
{ - (4) Every pharmacy shall post a sign in a location easily
seen by patrons at the counter where prescriptions are dispensed
or administered stating that, 'This pharmacy may be able to
substitute a less expensive drug which is therapeutically
equivalent to the one prescribed by your doctor unless you do not
approve.' The printing on the sign shall be in block letters not
less than one inch in height. If the pharmacist has reasonable
cause to believe that the purchaser cannot read the sign or
comprehend its content, the pharmacist shall endeavor to explain
the meaning of the sign. - }
{ - (5) - } { + (4) + } A pharmacist { - shall - }
{ + may + } substitute a drug product under this section only
when there will be a savings in or no increase in cost to the
purchaser.
{ - (6) - } { + (5) + } If the practitioner prescribes a
drug by its generic name, the pharmacist shall, consistent with
reasonable professional judgment, dispense or administer the
lowest retail cost, effective brand which is in stock.
{ - (7) - } { + (6) + } Except as provided in subsection
{ - (8) - } { + (7) + } of this section, when a pharmacist
dispenses a substituted drug as authorized by subsection (2) of
this section, the pharmacist
{ - must - } { + shall + } label the prescription container
with the name of the dispensed drug. If the dispensed drug does
not have a brand name,
{ - the prescription label shall indicate - } { + the
pharmacist shall label the prescription container with + } the
generic name of the drug dispensed along with the name of the
drug manufacturer.
{ - (8) - } { + (7) + } A prescription dispensed by a
pharmacist { - shall - } { + must + } bear upon the label the
name of the medication in the container or shall be labeled as
intended by the prescriber.
{ - (9) - } { + (8) + } The substitution of any drug by a
{ - licensed - } pharmacist or the pharmacist's employer
pursuant to this section does not constitute the practice of
medicine.
{ - (10) - } { + (9) + } { - No - } { + A + }
substitution of drugs made by a pharmacist or the pharmacist's
employer in accordance with this section and any rules that the
State Board of Pharmacy may adopt thereunder
{ - shall - } { + does not + } constitute evidence of
negligence if the substitution was made within reasonable and
prudent practice of pharmacy or if the substituted drug was
accepted in a generally recognized formulary or government list.
{ - (11) - } { + (10) + } Failure of a practitioner to
specify that no substitution is authorized does not constitute
evidence of negligence unless the practitioner knows that the
health condition of the patient for whom the practitioner is
prescribing warrants the use of the brand name drug product and
not the substituted drug.
SECTION 5. ORS 689.655 is amended to read:
689.655. { - (1) Only as provided in this section and in
accordance with rules adopted by the State Board of Pharmacy
under ORS 689.205, a pharmacist may: - }
{ - (a) In collaboration with and under an order from a
physician, nurse practitioner or physician assistant practicing
within the scope of practice allowed by law, flush heparin or
saline through existing intravenous lines that are connected to a
person; - }
{ - (b) In collaboration with and under an order from a
physician, nurse practitioner or physician assistant practicing
within the scope of practice allowed by law, attach an infusion
pump or enteric feeding pump to existing intravenous lines or
enteric feeding lines that are connected to a person, and
activate the pump; - }
{ - (c) Administer drugs and devices in a medical emergency
within a health care facility in the presence of and under the
direction of a physician or nurse practitioner; and - }
{ - (d) Administer a drug or device to a person in the course
of teaching the person to self-administer the drug or device that
the person will be required routinely to self-administer as part
of a course of therapy ordered by a physician, nurse practitioner
or physician assistant practicing within the scope of practice
allowed by law. - }
{ - (2) Nothing in this section shall be construed to allow a
pharmacist to establish an intravenous or enteric line or to
attach or activate a pump for any intrathecal medication. - }
{ + A pharmacist may administer a drug or device if the
pharmacist is acting:
(1) Under the direction of or pursuant to a lawful prescription
or order issued by a licensed practitioner acting within the
scope of the practitioner's practice; and
(2) In accordance with the rules adopted by the State Board of
Pharmacy regarding the administration of drugs and devices. + }
SECTION 6. ORS 689.765, as amended by section 4, chapter 4,
Oregon Laws 2008, is amended to read:
689.765. (1) { - No drugs shall be dispensed - } { + Except
as approved by rule by the State Board of Pharmacy, a person may
not dispense drugs + } to the public by means of automatic
vending machines.
(2) As used in this section, 'automatic vending machine ' means
any mechanical device or contrivance whereby the purchaser is
able to secure drugs.
(3) { - No person shall - } { + A person may not + }
adulterate for the purpose of sale any drug in such manner as to
render it injurious to health, or knowingly sell or offer for
sale any adulterated drug.
(4) { - No person shall - } { + A person may not + }
manufacture, compound or sell or offer for sale or cause to be
manufactured, compounded, sold or offered for sale any drug,
compound or preparation for internal or external use under or by
a name recognized in the United States Pharmacopoeia, Homeopathic
Pharmacopoeia or National Formulary which differs from the
standard of strength and purity specified therein as official at
the time of manufacture, compounding, sale or offering for sale.
(5) { - No person shall - } { + A person may not + }
manufacture, compound, sell or offer for sale, or cause to be
manufactured, sold or offered for sale, any drug, the strength
and purity of which falls below the professed standard of
strength and purity under which it is sold.
(6) { - No person shall - } { + A person may not + } sell,
give away, barter, dispense, distribute, buy, receive or possess
any prescription drug except as authorized by law.
(7) { - No manufacturer or wholesaler shall - } { + A
manufacturer or wholesaler may not + } sell or otherwise
distribute, or offer to sell or otherwise distribute, any drug or
device except to a person legally authorized to resell, dispense
or otherwise redistribute such drug or device. The board may
grant an exemption from the requirement of this subsection in the
form of a special permit if the board finds that an exemption is
in the best interest of the public health and safety.
{ - (8) Any practitioner who receives any complimentary
samples of any controlled substance, as defined in ORS 475.005,
shall keep the samples in a securely locked, substantially
constructed cabinet and shall maintain a record of receipts and
withdrawals from each inventory of samples. The record
requirements shall be specified by rule of the licensing board
that has jurisdiction over the practitioner's license. The
licensing board may inspect the records and the inventory of
samples. - }
{ - (9)(a) - } { + (8)(a) + } { - No person may - }
{ + A person may not + } sell, purchase or trade or offer to
sell, purchase or trade any drug sample.
(b) As used in paragraph (a) of this subsection, 'drug sample'
means a unit of a drug, subject to this chapter, that is not
intended to be sold and is intended to promote the sale of the
drug, and includes a coupon or other form which may be redeemed
for a drug.
{ - (10) - } { + (9) + } For purposes of this section and
ORS 678.375, distribution of prepackaged complimentary samples of
medications by a nurse practitioner or clinical nurse specialist
with prescription writing authority shall not constitute
dispensing when the sample medication is within the prescriptive
authority granted to that nurse practitioner or clinical nurse
specialist.
SECTION 7. { + Section 8 of this 2009 Act is added to and made
a part of ORS chapter 689. + }
SECTION 8. { + A practitioner who receives a complimentary
sample of a controlled substance as defined in ORS 475.005 shall
keep the sample in a securely locked, substantially constructed
cabinet and shall maintain a record of receipts and withdrawals
from each inventory of samples. Each licensing board that has
jurisdiction over a practitioner's license shall specify the
recording requirements for complimentary samples by rule. The
licensing board may inspect the records and the inventory of
samples. + }
SECTION 9. ORS 442.580 is amended to read:
442.580. (1) There is created the Health Resources Commission,
consisting of eleven members appointed by the Governor.
(2) The commission shall include:
(a) Four physicians, one of whom engages in family practice,
and each of whom shall be licensed to practice in this state and
experienced in health research and the evaluation of medical
technologies and clinical outcomes;
(b) One representative of hospitals;
(c) One insurance industry representative;
(d) One business representative;
(e) One representative of labor organizations;
(f) One consumer representative; and
(g) Two pharmacists engaged in the practice of pharmacy, one of
whom engages in the practice of pharmacy at a retail drug outlet.
For the purposes of this paragraph:
(A) 'Pharmacist' has the meaning given that term in ORS
689.005;
(B) 'Practice of pharmacy' has the meaning given that term in
ORS { - 689.015 - } { + 689.005 + }; and
(C) 'Retail drug outlet' has the meaning given that term in ORS
689.005.
(3) The term of office of each member of the commission is
three years. Each member serves at the pleasure of the Governor.
Before the expiration of the term of a member, the Governor shall
appoint a successor whose term begins on July 1 next following. A
member is eligible for reappointment. If there is a vacancy for
any cause, the Governor shall make an appointment to become
immediately effective for the unexpired term.
(4) The consumer representative on the commission shall be
entitled to compensation and expenses as provided in ORS 292.495.
The other members shall not be entitled to compensation or
expenses.
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