Chapter 350 Oregon Laws 1999
Session Law
AN ACT
HB 2690
Relating to pharmacy;
creating new provisions; amending ORS 414.025, 689.005, 689.015, 689.155 and
689.515; and declaring an emergency.
Be It Enacted by the People of the State of Oregon:
SECTION 1.
ORS 414.025 is amended to read:
414.025. As used in this chapter, unless the context or a
specially applicable statutory definition requires otherwise:
(1) "Category of aid" means old-age assistance, aid
to the blind, aid to the disabled, temporary assistance for needy families or
Supplemental Security Income payment of the Federal Government.
(2) "Categorically needy" means, insofar as funds are
available for the category, a person who is a resident of this state and who:
(a) Is receiving a category of aid.
(b) Would be eligible for, but is not receiving a category of
aid.
(c) Is in a medical facility and, if the person left such
facility, would be eligible for a category of aid.
(d) Is under the age of 21 years and would be a dependent child
under the program for temporary assistance for needy families except for age
and regular attendance in school or in a course of professional or technical
training.
(e) Is a caretaker relative named in ORS 418.035 (1)(c) who
cares for a dependent child who would be a dependent child under the program
for temporary assistance for needy families except for age and regular
attendance in school or in a course of professional or technical training; or
is the spouse of such caretaker relative and fulfills the requirements of ORS
418.035 (2).
(f) Is under the age of 21 years, is in a foster family home or
licensed child-caring agency or institution under a purchase of care agreement
and is one for whom a public agency of this state is assuming financial
responsibility, in whole or in part.
(g) Is a spouse of an individual receiving a category of aid
and who is living with the recipient of a category of aid, whose needs and
income are taken into account in determining the cash needs of the recipient of
a category of aid, and who is determined by the Department of Human Resources
to be essential to the well-being of the recipient of a category of aid.
(h) Is a caretaker relative named in ORS 418.035 (1)(c) who
cares for a dependent child receiving temporary assistance for needy families
or is the spouse of such caretaker relative and fulfills the requirements of
ORS 418.035 (2).
(i) Is under the age of 21 years, is in a youth care center and
is one for whom a public agency of this state is assuming financial
responsibility, in whole or in part.
(j) Is under the age of 21 years and is in an intermediate care
facility which includes institutions for the mentally retarded; or is under the
age of 22 years and is in a psychiatric hospital.
(k) Is under the age of 21 years and is in an independent
living situation with all or part of the maintenance cost paid by the State
Office for Services to Children and Families.
(L) Is a member of a family that received temporary assistance
for needy families in at least three of the six months immediately preceding
the month in which such family became ineligible for such assistance because of
increased hours of or increased income from employment. As long as the member
of the family is employed, such families will continue to be eligible for
medical assistance for a period of at least six calendar months beginning with
the month in which such family became ineligible for assistance because of
increased hours of employment or increased earnings.
(m) Is an adopted person under 21 years of age for whom a
public agency is assuming financial responsibility in whole or in part.
(n) Is an individual or is a member of a group who is required
by federal law to be included in the state's medical assistance program in
order for that program to qualify for federal funds.
(o) Is an individual or member of a group who, subject to the
rules of the office and within available funds, may optionally be included in
the state's medical assistance program under federal law and regulations
concerning the availability of federal funds for the expenses of that
individual or group.
(p) Is a pregnant woman who would be eligible for temporary
assistance for needy families including such aid based on the unemployment of a
parent, whether or not the woman is eligible for cash assistance.
(q) Would be eligible for temporary assistance for needy
families pursuant to 42 U.S.C. 607 based upon the unemployment of a parent,
whether or not the state provides cash assistance.
(r) Except as otherwise provided in this section and to the
extent of available funds, is a pregnant woman or child for whom federal
financial participation is available under Title XIX of the federal Social
Security Act.
(s) Is not otherwise categorically needy and is not eligible
for care under Title XVIII of the federal Social Security Act or is not a
full-time student in a post-secondary education program as defined by the
Department of Human Resources by rule, but whose family income is less than the
federal poverty level and whose family investments and savings equal less than
the investments and savings limit established by the department by rule.
(3) "Income" means income as defined in ORS 413.005
(3).
(4) "Investments and savings" means cash, securities
as defined in ORS 59.015, negotiable instruments as defined in ORS 73.0104 and
such similar investments or savings as the Department of Human Resources may
establish by rule that are available to the applicant or recipient to
contribute toward meeting the needs of the applicant or recipient.
(5) "Medical assistance" means so much of the
following medical and remedial care and services as may be prescribed by the
Department of Human Resources according to the standards established pursuant
to ORS 414.065, including payments made for services provided under an
insurance or other contractual arrangement and money paid directly to the
recipient for the purchase of medical care:
(a) Inpatient hospital services, other than services in an
institution for mental diseases;
(b) Outpatient hospital services;
(c) Other laboratory and X-ray services;
(d) Skilled nursing facility services, other than services in
an institution for mental diseases;
(e) Physicians' services, whether furnished in the office, the
patient's home, a hospital, a skilled nursing facility or elsewhere;
(f) Medical care, or any other type of remedial care recognized
under state law, furnished by licensed practitioners within the scope of their
practice as defined by state law;
(g) Home health care services;
(h) Private duty nursing services;
(i) Clinic services;
(j) Dental services;
(k) Physical therapy and related services;
(L) Prescribed drugs,
including those dispensed and administered as provided under ORS chapter 689;
(m) Dentures[,] and prosthetic devices; and eyeglasses
prescribed by a physician skilled in diseases of the eye or by an optometrist,
whichever the individual may select;
[(m)] (n) Other diagnostic, screening,
preventive and rehabilitative services;
[(n)] (o) Inpatient hospital services,
skilled nursing facility services and intermediate care facility services for
individuals 65 years of age or over in an institution for mental diseases;
[(o)] (p) Any other medical care, and any
other type of remedial care recognized under state law;
[(p)] (q) Periodic screening and diagnosis
of individuals under the age of 21 years to ascertain their physical or mental
defects, and such health care, treatment and other measures to correct or
ameliorate defects and chronic conditions discovered thereby;
[(q)] (r) Inpatient hospital services for
individuals under 22 years of age in an institution for mental diseases; and
[(r)] (s) Hospice services.
(6) "Medical assistance" includes any care or
services for any individual who is a patient in a medical institution or any
care or services for any individual who has attained 65 years of age or is
under 22 years of age, and who is a patient in a private or public institution
for mental diseases. "Medical assistance" includes "health
services" as defined in ORS 414.705. "Medical assistance" does
not include care or services for an inmate in a nonmedical public institution.
(7) "Medically needy" means a person who is a
resident of this state and who is considered eligible under federal law for
medically needy assistance.
(8) "Resources" means resources as defined in ORS
413.005 (4).
SECTION 2.
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 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
professional, pharmaceutical post-graduate education in the general areas of
socio-economic and legal aspects of health care; the properties and actions of
drugs and dosage forms; and 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 or mail order vendor 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) "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.
(15) "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 is licensed with the board as an intern.
(16) "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.
(17) "Itinerant vendor" means all persons who sell or
otherwise distribute nonprescription drugs by passing from house to house, or
by haranguing the people on the public streets or in public places, or who use
the customary devices for attracting crowds and therewith recommending their
wares and offering them for sale.
(18) "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.
(19) "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 [pharmacist or]
practitioner as an incident to administering or dispensing of a drug in the
course of professional practice; or
(b) By a [pharmacist or 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.
(20) "Manufacturer" means a person engaged in the
manufacture of drugs.
(21) "Nonprescription drug outlet" means shopkeepers
and itinerant vendors registered under ORS 689.305.
(22) "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.
(23) "Person" means an individual, corporation,
partnership, association or any other legal entity.
(24) "Pharmacist" means an individual licensed by
this state to engage in the practice of pharmacy.
(25) "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.
(26) "Pharmacy technician" means a person registered
by the State Board of Pharmacy who assists the pharmacist in the practice of
pharmacy pursuant to rules of the board.
(27) "Practitioner" means a person licensed and
operating within the scope of such license to prescribe, [and] 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 in Oregon and registered under the federal Controlled Substances Act.
(28) "Preceptor" means a pharmacist licensed and in
good standing, registered by the board to supervise the internship training of
a licensed intern.
(29) "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.
(30) "Prescription" or "prescription drug
order" means a written or oral 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 or
oral direction.
(31) "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.
(32) "Shopkeeper" means a business establishment,
open to the general public, for the sale of nonlegend drugs, in the original
and unbroken package, properly labeled according to state and federal laws, in
conformity with the rules of the board.
(33) "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.
(34) "Wholesale drug outlet" means any person who
imports, stores, distributes or sells for resale any drugs including legend
drugs and nonprescription drugs.
(35) "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.
(36) "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 3.
ORS 689.015 is amended to read:
689.015. The "practice of pharmacy" means the
interpretation and evaluation of prescription orders; the compounding,
dispensing, labeling of drugs and devices (except labeling by a manufacturer,
packer or distributor of nonprescription drugs and commercially packaged legend
drugs and devices); the administering of
vaccines and immunizations pursuant to section 3b of this 1999 Act; the
administering of drugs and devices to the extent permitted under section 3e of
this 1999 Act; the participation in drug selection and drug utilization
reviews; the proper and safe storage of drugs and devices and the maintenance
of proper records therefor; the responsibility for advising, where necessary or
where regulated, of therapeutic values, content, hazards and use of drugs and
devices; the monitoring of therapeutic response or adverse effect to drug
therapy; and the offering or performing of those acts, services, operations or
transactions necessary in the conduct, operation, management and control of
pharmacy.
SECTION 3a. Sections 3b to 3f of this 1999 Act are
added to and made a part of ORS chapter 689.
SECTION 3b. (1) In accordance with rules adopted by the
State Board of Pharmacy under ORS 689.205, a pharmacist may administer vaccines
and immunizations only to persons who are more than 18 years of age.
(2) The board is authorized
to issue, to licensed pharmacists who have completed training accredited by the
Centers for Disease Control and Prevention, the American Council on
Pharmaceutical Education or a similar health authority or professional body, certificates
of special competency in the administration of vaccines and immunizations to
persons more than 18 years of age.
(3) The board shall adopt
rules relating to the reporting of the administration of vaccines and
immunizations to a patient's primary health care provider and to the Health
Division.
(4) The board shall adopt
rules requiring pharmacists to establish protocols for the administration of
vaccines and immunizations to persons more than 18 years of age.
(5) The board shall convene
a volunteer Immunization Advisory Committee consisting of no more than nine
members for the purpose of advising the board in promulgating rules under this
section. The committee shall consist of one representative from the Health
Division, two representatives from the Board of Medical Examiners, two
representatives from the Oregon State Board of Nursing and two representatives
from the State Board of Pharmacy and no more than two pharmacists other than
the representatives from the State Board of Pharmacy.
SECTION 3c. (1) Not sooner than 90 days after the
effective date of this 1999 Act, the State Board of Pharmacy may convene a
volunteer task force on child and adolescent immunizations.
(2) The task force
established in subsection (1) of this section shall have no more than nine
members. The membership shall consist of:
(a) One representative from
and appointed by the State Board of Pharmacy;
(b) One representative from
and appointed by the Board of Medical Examiners;
(c) One representative from
and appointed by the Oregon State Board of Nursing;
(d) Two representatives from
and appointed by the Health Division;
(e) One licensed physician
specializing in pediatric or adolescent medicine appointed by the Board of
Medical Examiners after considering the recommendation of the Oregon Medical
Association;
(f) One licensed pharmacist
specializing in community pharmacy practice appointed by the State Board of
Pharmacy after considering the recommendation of the Oregon State Pharmacists
Association;
(g) One licensed pharmacist
specializing in hospital-based or in-home care, appointed by the State Board of
Pharmacy after considering the recommendation of the Oregon State Pharmacists
Association; and
(h) One licensed nurse
specializing in pediatric or adolescent care appointed by the Oregon State
Board of Nursing after considering the recommendation of the Oregon Nurses
Association.
(3) The task force shall
conduct a study of the need and appropriateness of expanding delivery of
immunization services for children and adolescents to pharmacists.
(4) The State Board of
Pharmacy shall provide staff necessary for the performance of the functions of
the task force. The task force shall use the services of permanent legislative
staff to the greatest extent practicable.
(5) All agencies,
departments and officers of this state are directed to assist the task force in
the performance of its functions and to furnish such information and advice as
the members of the task force consider necessary to perform their functions.
(6) The task force may
accept contributions of funds and assistance from the United States, its
agencies or from any other source, public or private, and agree to conditions
thereon not inconsistent with the purposes of the task force. All such funds
are to aid in financing the functions of the task force and shall be deposited
in the General Fund of the State Treasury to the credit of separate accounts
for the task force and shall be disbursed for the purpose for which
contributed.
(7) Official action by the
task force established under this section shall require the approval of six of
the members of the task force. The task force shall present its findings and
recommendations to the Seventy-first Legislative Assembly and to the Governor.
All legislation recommended by official action of the task force must indicate
that it is introduced at the request of the task force. Such legislation shall
be prepared in time for presession numbering and presession filing pursuant to
ORS 171.130 for presentation to the regular session of the Seventy-first
Legislative Assembly.
SECTION 3d. Section 3c of this 1999 Act is repealed
January 1, 2002.
SECTION 3e. (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.
SECTION 3f. Nothing in this 1999 Act shall be construed
to allow a pharmacist to prescribe drugs or to dispense or administer any drug
or device that requires a prescription without a prescription or order of a
practitioner authorized to prescribe drugs.
SECTION 4.
ORS 689.155 is amended to read:
689.155. The State Board of Pharmacy shall also have the
following responsibilities in regard to medications, drugs, devices and other
materials used in this state in the diagnosis, mitigation and treatment or
prevention of injury, illness and disease:
(1) The regulation of the sale at retail, the administering by pharmacists to the extent provided in sections
3b and 3e of this 1999 Act and the dispensing of medications, drugs,
devices and other materials including the right to seize any such drugs,
devices and other materials found to be detrimental to the public health and
welfare by the board after appropriate hearing as required under ORS 183.310 to
183.550.
(2) The specifications of minimum professional and technical
equipment, environment, supplies and procedures for the compounding, administering and dispensing of such
medications, drugs, devices and other materials within the practice of pharmacy
and any drug outlet.
(3) The control of the purity and quality of such medications,
drugs, devices and other materials within the practice of pharmacy and any drug
outlet.
(4) The issuance and renewal of certificates of registration of
drug outlets for purposes of ascertaining those persons engaged in the
manufacture and distribution of drugs, receiving and collecting annual fees
therefrom and suspending, revoking or refusing to renew such registration in
the manner provided in this chapter.
(5) In conjunction with the regularly constituted law enforcement
agencies of this state, enforce all laws of the state which pertain to the
practice of pharmacy, the manufacture, production, sale or distribution of
drugs, chemicals and poisons, and to their standard of strength and purity.
(6) Investigate all complaints of alleged violations of this
chapter and take necessary action as the board may require or direct.
(7) Pursuant to ORS 183.310 to 183.550, make such rules as are
necessary and feasible for carrying out ORS 453.175, 453.185, 475.005, 475.135
and 475.185 and this chapter and make rules relating to controlled substances,
designated as such pursuant to ORS 475.025 and 475.035.
(8) At all reasonable hours, in performance of the duties
imposed by this section, enter, or cause its authorized representatives to
enter upon, and examine the premises or records required by law of any drug
outlet under the jurisdiction of the board.
(9) Assist the regularly constituted law enforcement agencies
of this state in enforcing ORS 453.005 to 453.135, 475.005 and 475.135 and this
chapter by prosecution in the courts of this state or otherwise.
(10) Cause to have made a regular inspection of all pharmacies.
(11) Pursuant to ORS 183.310 to 183.550, make such rules as are
necessary for pharmacies, drug manufacturers and wholesalers to sell or
otherwise lawfully distribute designated, diagnostic topical pharmaceutical
agents to licensed optometrists consistent with the provisions of ORS 683.010
to 683.335.
SECTION 5.
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) of this
section, unless the purchaser instructs otherwise, the 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 or by a telephonic
communication that there shall be no substitution for the specified brand name
drug in any 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, 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) A pharmacist shall substitute a drug product under this
section only when there will be a savings in or no increase in cost to the
purchaser.
(6) 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) Except as provided in subsection (8) of this section, when
a pharmacist dispenses a substituted drug as authorized by subsection (2) of
this section, the pharmacist must 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 generic name of the drug dispensed
along with the name of the drug manufacturer.
(8) A prescription dispensed by a pharmacist shall bear upon
the label the name of the medication in the container except if the prescriber
writes "do not label," or words of similar import, on the
prescription or so designates in an oral transmission of the prescription.
(9) 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) No 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 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) 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 6. This 1999 Act being necessary for the
immediate preservation of the public peace, health and safety, an emergency is
declared to exist, and this 1999 Act takes effect on its passage.
Approved by the Governor
June 25, 1999
Filed in the office of
Secretary of State June 25, 1999
Effective date June 25, 1999
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