Chapter 689 — Pharmacists;
Drug Outlets; Drug Sales
ORS sections in this chapter were
amended or repealed by the Legislative Assembly during its 2012 regular
session. See the table of ORS sections amended or repealed during the 2012
regular session: 2012 A&R Tables
New sections of law were adopted by the
Legislative Assembly during its 2012 regular session and are likely to be
compiled in this ORS chapter. See
sections in the following 2012 Oregon Laws chapters: 2012
Session Laws 0043
2011 EDITION
PHARMACISTS; DRUG OUTLETS; DRUG SALES
OCCUPATIONS AND PROFESSIONS
GENERAL PROVISIONS
689.005 Definitions
689.025 Policy;
purpose
689.035 Short
title
689.045 Severability
STATE BOARD OF PHARMACY
689.115 Membership;
qualifications; term; vacancy; compensation
689.135 General
powers of board; fees
689.139 State
Board of Pharmacy Account; disposition of receipts
689.145 Enforcement
powers of board
689.151 Board
control over licensing, standards and discipline
689.153 Continuing
authority of board upon lapse, suspension, revocation or voluntary surrender of
license or certificate
689.155 Authority
of board over medications, drugs, devices and other materials; rules
689.165 Officers;
executive director
689.175 Compensation
of board members and executive director
689.185 Meetings
689.195 Employees
689.205 Rules
689.207 Authority
of board to require fingerprints
PRACTICE OF PHARMACY
689.225 License
requirement; exceptions; possession of drugs; regulation of pharmacy
technicians; rules; penalty
689.255 Qualifications
for licensure by examination
689.265 Qualifications
for licensure by reciprocity
689.275 Renewal
of licenses; rules; fees
689.285 Continuing
pharmacy education; rules; fees
REGULATION OF DRUG OUTLETS
689.305 Registration
of drug outlets; rules
689.315 Application;
rules
689.325 Required
reports
689.335 Certificate
required; reinstatement
DISCIPLINE
689.405 Grounds
for discipline; investigation; procedure as contested case
689.445 Penalties
and reinstatement
689.455 Duty
to report suspected violations and prohibited conduct; liability for reporting;
confidentiality of report
PHARMACY TECHNICIANS
689.486 When
license required; qualifications for licensure; renewal; supervision required
689.490 Board
to establish licensing system; rules; fees
689.495 Provision
of licensing information
689.497 Report
required upon termination of pharmacy technician
689.499 Pharmacy
technician specialized education program; rules
REQUIREMENTS RELATING TO SALES
689.505 Labeling
requirements; rules
689.508 Prescription
records
689.515 Regulation
of generic drugs; substitutions; rules
689.525 Out-of-state
prescriptions
689.527 Prohibited
practices; rules
689.532 Complimentary
samples
689.555 Agricultural
drugs, nonprescription drugs and certain other substances
MISCELLANEOUS
689.605 Power
to dispense drugs from hospital pharmacies, drug rooms and penal institutions;
rules
689.615 Display
of certificate or license
689.635 Dispensing
according to naturopathic formulary; effect of filling prescription of
naturopath
689.645 Power
to administer and prescribe vaccines; rules
689.655 Power
to administer drugs and devices; rules
CHARITABLE PRESCRIPTION DRUG PROGRAM
689.770 Definitions
for ORS 689.770 to 689.780
689.772 Establishment
of program; immunity from liability
689.774 Rules
689.776 Inspection;
audit
689.778 Eligibility
689.780 Immunity
PENALTIES
689.832 Civil
penalties
689.854 Civil
penalty for violation of ORS 689.515
689.995 Criminal
penalties
GENERAL PROVISIONS
689.005 Definitions.
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; 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 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 experiential program approved by the board
under the supervision of a licensed pharmacist registered with the board as a
preceptor.
(18)
“Itinerant vendor” means 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 uses the customary devices for attracting
crowds, 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.
(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 prescribing and 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.
(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 if the person does not
reside in Oregon and is registered under the federal Controlled Substances Act.
(30)
“Preceptor” means a pharmacist or a person licensed by the board to supervise
the internship training of a licensed intern.
(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.
(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.
(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.
(34)
“Shopkeeper” means a business or other establishment, open to the general
public, for the sale or nonprofit distribution of drugs.
(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.
(36)
“Wholesale drug outlet” means any person who imports, stores, distributes or
sells for resale any drugs including legend drugs and nonprescription drugs. [1979
c.777 §5; 1983 c.402 §1; 1985 c.565 §94; 1987 c.108 §1; 1989 c.608 §1; 1991
c.682 §1; 1993 c.272 §1; 1993 c.571 §1; 1997 c.729 §1; 1999 c.350 §2; 2001
c.623 §6; 2005 c.313 §11; 2009 c.326 §1; 2009 c.756 §71; 2011 c.245 §2]
689.010
[Amended by 1963 c.586 §1; 1967 c.629 §1; 1969 c.514 §1; 1973 c.743 §1; 1975
c.369 §1; 1975 c.686 §8; 1979 c.785 §7; repealed by 1977 c.842 §2 and 1979
c.777 §59]
689.015 [1979
c.777 §4; 1999 c.350 §3; repealed by 2009 c.326 §2]
689.025 Policy; purpose.
(1) The practice of pharmacy in the State of Oregon is declared a health care
professional practice affecting the public health, safety and welfare and is
subject to regulation and control in the public interest. It is further
declared to be a matter of public interest and concern that the practice of
pharmacy, as defined in this chapter, merit and receive the confidence of the
public and that only qualified persons be permitted to engage in the practice
of pharmacy in the State of Oregon. This chapter shall be liberally construed
to carry out these objects and purposes.
(2)
It is the purpose of this chapter to promote, preserve and protect the public
health, safety and welfare by and through the effective control and regulation
of the practice of pharmacy and of the registration of drug outlets engaged in
the manufacture, production, sale and distribution of drugs, medications,
devices and such other materials as may be used in the diagnosis and treatment
of injury, illness and disease. [1979 c.777 §§2,3; 1985 c.565 §95; 2007 c.438 §1]
689.035 Short title.
This chapter shall be known as the “Oregon Pharmacy Act.” [1979 c.777 §1; 1985
c.565 §96]
689.045 Severability.
If any provision of ORS 167.203, 414.325, 430.405, 435.010, 453.025, 475.005,
475.135, 475.185, 475.752, 475.906 and 616.855 and ORS chapter 689 is declared
unconstitutional or illegal, or the applicability of ORS 167.203, 414.325,
430.405, 435.010, 453.025, 475.005, 475.135, 475.185, 475.752, 475.906 and
616.855 and ORS chapter 689 to any person or circumstances is held invalid by a
court of competent jurisdiction, the constitutionality or legality of the
remaining provisions of ORS 167.203, 414.325, 430.405, 435.010, 453.025,
475.005, 475.135, 475.185, 475.752, 475.906 and 616.855 and ORS chapter 689 and
the application of ORS 167.203, 414.325, 430.405, 435.010, 453.025, 475.005,
475.135, 475.185, 475.752, 475.906 and 616.855 and ORS chapter 689 to other
persons and circumstances shall not be affected and shall remain in full force
and effect without the invalid provision or application. [1979 c.777 §63; 1999
c.605 §6; 1999 c.1051 §137]
Note:
689.045 was enacted into law by the Legislative Assembly but was not added to
or made a part of ORS chapter 689 or any series therein by legislative action.
See Preface to Oregon Revised Statutes for further explanation.
689.110
[Amended by 1963 c.586 §2; 1965 c.580 §4; 1967 c.159 §1; 1969 c.514 §2;
repealed by 1977 c.842 §45 and 1979 c.777 §59]
STATE BOARD OF PHARMACY
689.115 Membership; qualifications; term;
vacancy; compensation. (1) The State Board of Pharmacy
consists of seven members appointed by the Governor and subject to confirmation
by the Senate in the manner provided in ORS 171.562 and 171.565. All members of
the board must be residents of this state. Of the members of the board:
(a)
Five must be licensed pharmacists.
(b)
Two must be members of the public who are not licensed pharmacists or a spouse,
domestic partner, child, parent or sibling of a pharmacist.
(2)(a)
Board members required to be licensed pharmacists may be selected by the
Governor from a list of three to five nominees for each vacancy, submitted by a
task force assembled by the Oregon State Pharmacy Association to represent all
of the interested pharmacy groups.
(b)
The public members of the State Board of Pharmacy must be individuals who:
(A)
Have attained the age of majority;
(B)
Are not former members of the profession of pharmacy;
(C)
Do not have and have never had any material financial interest in the providing
of pharmacy service; and
(D)
Have not engaged in any activity directly related to the practice of pharmacy.
(c)
The licensed pharmacist members of the board must at the time of their
appointment:
(A)
Be licensed and in good standing to engage in the practice of pharmacy in this
state;
(B)
Be engaged in the practice of pharmacy in this state; and
(C)
Have five years of experience in the practice of pharmacy in this state after
licensure.
(d)
In selecting the members of the board, the Governor shall strive to balance the
representation on the board according to:
(A)
Geographic areas of this state; and
(B)
Ethnic group.
(3)(a)
The term of office of each member is four years, but a member serves at the
pleasure of the Governor. The terms must be staggered so that no more than
three terms end each year. A member is eligible for reappointment. The Governor
shall fill vacancies which occur by expiration of full terms within 90 days prior
to each date of expiration, and shall fill vacancies which occur for any other
reason within 60 days after each such vacancy occurs, for the unexpired term.
(b)
A board member shall be removed immediately from the board if, during the
member’s term, the member:
(A)
Is not a resident of this state;
(B)
Has been absent from three consecutive board meetings, unless at least one
absence is excused; or
(C)
Is not a licensed pharmacist or a retired pharmacist who was a licensed
pharmacist in good standing at the time of retirement, if the board member was
appointed to serve on the board as a pharmacist.
(4)
Members of the board are entitled to compensation and expenses as provided in
ORS 292.495. The board may provide by rule for compensation to board members
for the performance of official duties at a rate that is greater than the rate
provided in ORS 292.495. [1979 c.777 §§7,8,9,11; 1987 c.108 §2; 2009 c.535 §29]
689.120
[Amended by 1967 c.159 §2; repealed by 1969 c.514 §57]
689.125 [1979
c.777 §§10,12; 1985 c.565 §97; repealed by 2009 c.535 §30 and 2009 c.756 §73]
689.130
[Repealed by 1969 c.514 §57]
689.135 General powers of board; fees.
(1) The State Board of Pharmacy shall have such other duties, powers and
authority as may be necessary to the enforcement of this chapter and to the
enforcement of board rules made pursuant thereto, which shall include, but are
not limited to, the following:
(a)
Cause to have printed and circulated annually copies of any changes in the laws
relating to pharmacy, controlled substances, drugs and poisons and the rules
adopted to enforce such laws, and set reasonable charges therefor.
(b)
Appoint advisory committees.
(2)
The board may join such professional organizations and associations organized
exclusively to promote the improvement of the standards of the practice of
pharmacy for the protection of the health and welfare of the public and whose
activities assist and facilitate the work of the board.
(3)
In addition to any statutory requirements, the board may require such surety
bonds as it deems necessary to guarantee the performance and discharge of the
duties of any officer or employee receiving and disbursing funds.
(4)
The executive director of the board shall keep the seal of the board and shall
affix it only in such manner as may be prescribed by the board.
(5)
The board shall determine within 30 days prior to the beginning of each state
fiscal year the fees to be collected for:
(a)
Examinations and reexaminations, which fee shall not exceed $400.
(b)
Pharmacist licenses, which fee shall not exceed $250.
(c)
Pharmacist licensing by reciprocity, which fee shall not exceed $300.
(d)
Intern license, which fee shall not exceed $50.
(e)
Duplicate pharmacist certificate, which fee shall not exceed $50.
(f)
Pharmacist license, delinquent renewal fee, which fee shall not exceed $50.
(g)
Certification of approved providers of continuing education courses, which fee
shall not exceed $300.
(h)
Registration of drug outlets other than pharmacies and renewal of registration,
which fee shall not exceed $500.
(i)
Initial pharmacy or institutional drug outlet, which fee shall not exceed $300.
(j)
Annual pharmacy or institutional drug outlet, which fee shall not exceed $300.
(k)
Pharmacy or institutional drug outlet delinquent renewal fee, which fee shall
not exceed $200.
(L)
Nonprescription drug outlets, which fee shall not exceed $50.
(m)
Nonprescription drug outlet delinquent renewal fee, which fee shall not exceed
$50.
(n)
Reinspection fee, which fee shall not exceed $100.
(o)
Drug outlets, other than pharmacies or institutional drug outlets, delinquent
renewal fee, which fee shall not exceed $100.
(6)
All moneys received under ORS 435.010 to 435.130 and 453.185 and this chapter
shall be paid into the State Treasury and placed to the credit of the State
Board of Pharmacy Account to be used only for the administration and
enforcement of ORS 435.010 to 435.130 and this chapter.
(7)
The board may receive and expend funds, in addition to its biennial appropriation,
from parties other than the state, provided:
(a)
Such moneys are awarded for the pursuit of a specific objective which the board
is authorized to accomplish by this chapter, or which the board is qualified to
accomplish by reason of its jurisdiction or professional expertise;
(b)
Such moneys are expended for the pursuit of the objective for which they are
awarded;
(c)
Activities connected with or occasioned by the expenditures of such funds do
not interfere with or impair the performance of the board’s duties and
responsibilities and do not conflict with the exercise of the board’s powers as
specified by this chapter;
(d)
Such moneys are kept in a separate, special state account; and
(e)
Periodic reports are made to the Governor concerning the board’s receipt and
expenditure of such moneys.
(8)
The board may assign to each drug outlet under its jurisdiction, a uniform
state number, coordinated where possible with all other states which adopt the
same uniform numbering system.
(9)
The board or its authorized representatives shall also have power to
investigate and gather evidence concerning alleged violations of the provisions
of this chapter or of the rules of the board.
(10)
The president and vice president of the board may administer oaths in connection
with the duties of the board.
(11)
The books, registers and records of the board as made and kept by the executive
director or under the supervision of the executive director, subject to the
direction of the board, shall be prima facie evidence of the matter recorded
therein, in any court of law.
(12)
The board may administer oaths, issue notices and subpoenas in the name of the
board, enforce subpoenas in the manner authorized by ORS 183.440, hold hearings
and perform such other acts as are reasonably necessary to carry out its duties
under this chapter.
(13)(a)
Notwithstanding anything in this chapter to the contrary, whenever a duly
authorized representative of the board finds or has probable cause to believe
that any drug or device is adulterated, misbranded or a new drug, as defined in
Section 201(p) of the Federal Food, Drug and Cosmetic Act, for which there is
no approval in effect pursuant to Section 505(b) of the federal Act nor an
approved notice of claimed investigational exemption pursuant to Section 505(i)
of the federal Act, or otherwise rendered unsafe for use as a result of fire,
flood or other natural disaster, the representative shall affix to such drug or
device a tag or other appropriate marking giving notice that such article is or
is suspected of being adulterated, misbranded, or otherwise rendered unsafe and
has been detained or embargoed and warning all persons not to remove or dispose
of such article by sale or otherwise until provision for removal or disposal is
given by the board, its agent or the court. No person shall remove or dispose
of such embargoed drug or device by sale or otherwise without the permission of
the board or its agent or, after summary proceedings have been instituted,
without permission from the court.
(b)
When a drug or device detained or embargoed under paragraph (a) of this
subsection has been declared by such representative to be adulterated,
misbranded or a new drug, or rendered unsafe, the board shall, as soon as
practical thereafter, petition the judge of the circuit court in whose
jurisdiction the article is detained or embargoed for an order for condemnation
of such article. If the judge determines that the drug or device so detained or
embargoed is not adulterated or misbranded or rendered unsafe, the board shall
direct the immediate removal of the tag or other marking.
(c)
If the court finds the detained or embargoed drug or device is adulterated or
misbranded or rendered unsafe, such drug or device, after entry of the
judgment, shall be destroyed at the expense of the owner under the supervision
of a board representative and all court costs and fees, storage and other
proper expense shall be borne by the owner of such drug or device. When the
adulteration or misbranding can be corrected by proper labeling or processing
of the drug or device, the court, after entry of the judgment and after such
costs, fees and expenses have been paid and a good and sufficient bond has been
posted, may direct that such drug or device be delivered to the owner thereof
for such labeling or processing under the supervision of a board
representative. Expense of such supervision shall be paid by the owner. Such
bond shall be returned to the owner of the drug or device on representation to
the court by the board that the drug or device is no longer in violation of the
embargo and the expense of supervision has been paid.
(d)
It is the duty of the Attorney General to whom the board reports any violation
of this subsection to cause appropriate proceedings to be instituted in the
proper court without delay and to be prosecuted in the manner required by law.
Nothing in this subsection shall be construed to require the board to report
violations whenever the board believes the public’s interest will be adequately
served in the circumstances by a suitable written notice or warning.
(14)
Except as otherwise provided to the contrary, the board shall exercise all of
its duties, powers and authority in accordance with ORS chapter 183. [1979
c.777 §20; 1981 c.277 §2; 1983 c.402 §2; 1985 c.565 §98; 1987 c.108 §3; 1991
c.460 §9; 1993 c.571 §3; 2001 c.457 §1; 2003 c.576 §543; 2005 c.726 §11; 2011
c.597 §142]
689.139 State Board of Pharmacy Account;
disposition of receipts. The State Board of Pharmacy
Account is established in the State Treasury, separate and distinct from the
General Fund. All moneys received by the State Board of Pharmacy shall be
deposited into the account and are continuously appropriated to the board to
carry out the duties, functions and powers of the board. Any interest or other
income from moneys in the account shall be credited to the account. [2005 c.726
§10]
689.140
[Amended by 1963 c.586 §3; repealed by 1969 c.514 §57]
689.145 Enforcement powers of board.
The responsibility for enforcement of the provisions of this chapter is vested
in the State Board of Pharmacy. The board shall have all of the duties, powers
and authority specifically granted by and necessary and proper to the
enforcement of this chapter, as well as such other duties, powers and authority
as it may be granted from time to time by law. [1979 c.777 §6; 1985 c.565 §99]
689.150
[Amended by 1969 c.514 §46; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.151 Board control over licensing,
standards and discipline. The State Board of Pharmacy
shall be responsible for the control and regulation of the practice of pharmacy
in this state including, but not limited to, the following:
(1)
The licensing by examination or by reciprocity of applicants who are qualified
to engage in the practice of pharmacy under the provisions of this chapter;
(2)
The renewal of licenses to engage in the practice of pharmacy;
(3)
The determination and issuance of standards based on nationally recognized
standards of practice and accreditation criteria for recognition and approval
of schools and colleges of pharmacy whose graduates shall be eligible for
licensure in this state, and the specification and enforcement of requirements
for practical training, including internship;
(4)
The enforcement of those provisions of this chapter relating to the conduct or
competence of pharmacists practicing in this state, and the suspension,
revocation or restriction of licenses to engage in the practice of pharmacy;
(5)
The training, qualifications and employment of pharmacy interns; and
(6)
The licensing of pharmacy technicians. [Formerly 689.245; 2001 c.595 §1; 2005
c.313 §10]
689.153 Continuing authority of board upon
lapse, suspension, revocation or voluntary surrender of license or certificate.
The lapse, suspension or revocation of a license or certificate of registration
by the operation of law or by order of the State Board of Pharmacy or by the
decision of a court of law, or the voluntary surrender of a license by a
licensee or of a certificate of registration by the holder of the certificate,
does not deprive the board of jurisdiction to proceed with any investigation or
any action or disciplinary proceeding against the licensee or certificate
holder or revise or render null and void an order of disciplinary action
against the licensee or certificate holder. [2007 c.90 §4]
689.155 Authority of board over
medications, drugs, devices and other materials; rules.
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 ORS 689.645 and 689.655 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 chapter
183.
(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 chapter 183, 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 chapter 183, make such rules as are necessary for pharmacies,
drug manufacturers and wholesalers to sell or otherwise lawfully distribute
designated pharmaceutical agents to licensed optometrists consistent with the
provisions of ORS 683.010 to 683.340. [1979 c.777 §19; 1985 c.565 §100; 1999
c.350 §4; 2001 c.632 §5]
689.160
[Amended by 1969 c.514 §4; 1979 c.785 §8; repealed by 1977 c.842 §45 and 1979
c.777 §59]
689.165 Officers; executive director.
(1) The State Board of Pharmacy shall elect from its members a president and
vice president and such other officers as it deems appropriate and necessary to
the conduct of its business. The President of the State Board of Pharmacy shall
preside at all meetings of the board and shall be responsible for the
performance of all of the duties and functions of the board required or
permitted by this chapter. If the president is absent or unable to preside, the
vice president shall preside. Each additional officer elected by the board
shall perform those duties normally associated with their position and such
other duties assigned from time to time by the board.
(2)
Officers elected by the board shall serve terms of one year commencing with the
day of their election, and ending upon election of their successors and shall
serve no more than one consecutive full term in each office to which they are
elected.
(3)
The executive director of the board shall be responsible for the performance of
the regular administrative functions of the board and such other duties as the
board may direct. The executive director shall not perform any discretionary or
decision-making functions for which the board is solely responsible. [1979
c.777 §13; 1985 c.565 §101; 2009 c.756 §75]
689.170
[Amended by 1963 c.586 §4; 1969 c.514 §5; 1973 c.743 §2; 1979 c.514 §1; 1979 c.744
§61; 1979 c.785 §9; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.175 Compensation of board members and
executive director. (1) Each member of the State
Board of Pharmacy shall receive compensation for each day on which the member
is engaged in performance of the official duties of the board, and
reimbursement for all expenses incurred in connection with the discharge of
such official duties as provided in ORS 292.495.
(2)
The Executive Director of the State Board of Pharmacy shall receive, as compensation,
an annual salary payable monthly, the amount of which shall be determined by
the board, and reimbursement for all expenses incurred in connection with
performance of official duties, subject to applicable law and to the rules of
the Oregon Department of Administrative Services. [1979 c.777 §14]
689.180
[Amended by 1969 c.514 §3; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.185 Meetings.
(1) The State Board of Pharmacy shall meet at least once every three months to
transact its business. One such meeting held during each fiscal year of the
state shall be designated by rule as the annual meeting and shall be for the
purpose of electing officers and for the reorganization of the board. The board
shall meet at such additional times as it may determine. Such additional
meetings may be called by the president of the board or by majority of members
of the board.
(2)
The board shall meet at such place as it may from time to time determine. The
place for each meeting shall be determined prior to giving notice of such
meeting and shall not be changed after such notice is given without adequate
subsequent notice.
(3)
Notice of all meetings of the board shall be given in the manner and pursuant
to requirements prescribed by the state’s applicable rules.
(4)
A majority of the members of the board shall constitute a quorum for the
conduct of a board meeting and, except where a greater number is required by
ORS 167.203, 414.325, 430.405, 435.010, 453.025, 475.005, 475.135, 475.185,
475.752, 475.906 and 616.855 and this chapter, or by any rule of the board, all
actions of the board shall be by a majority of a quorum.
(5)
All board meetings and hearings shall be open to the public. The board may, in
its discretion and according to law, conduct any portion of its meeting in
executive session closed to the public. [1979 c.777 §15; 1999 c.605 §7; 1999
c.1051 §138]
689.195 Employees.
(1) The State Board of Pharmacy may, in its discretion, employ persons in
positions or capacities as it deems necessary to the proper conduct of board
business and to the fulfillment of the board’s responsibilities as defined by
this chapter.
(2)
The employees of the board other than the executive director shall receive, as
compensation, an annual salary payable monthly, the amount of which shall be
determined by law, and reimbursement for expenses incurred in connection with
performance of their official duties. [1979 c.777 §16; 1985 c.565 §102; 2009
c.756 §76]
689.205 Rules.
The State Board of Pharmacy shall make, adopt, amend and repeal such rules as
may be deemed necessary by the board, from time to time, for the proper
administration and enforcement of this chapter. Such rules shall be adopted in
accordance with the procedures specified in ORS chapter 183. [1979 c.777 §17;
1985 c.565 §103]
689.207 Authority of board to require
fingerprints. For the purpose of requesting a state
or nationwide criminal records check under ORS 181.534, the State Board of
Pharmacy may require the fingerprints of a person who is:
(1)
Applying for a license or certificate that is issued by the board;
(2)
Applying for renewal of a license or certificate that is issued by the board;
or
(3)
Under investigation by the board. [2005 c.730 §68]
Note:
689.207 was enacted into law by the Legislative Assembly but was not added to
or made a part of ORS chapter 689 or any series therein by legislative action.
See Preface to Oregon Revised Statutes for further explanation.
689.210
[Amended by 1961 c.216 §1; 1965 c.580 §5; 1967 c.287 §1; 1969 c.514 §6; 1973
c.743 §3a; 1973 c.827 §75; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.215 [1965
c.580 §3; repealed by 1967 c.287 §3]
689.220
[Repealed by 1969 c.514 §57]
PRACTICE OF PHARMACY
689.225 License requirement; exceptions;
possession of drugs; regulation of pharmacy technicians; rules; penalty.
(1) A person may not engage in the practice of pharmacy unless the person is
licensed 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)
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)
A pharmacist may not possess personally or 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
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 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 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. [1979 c.777 §21; 1983 c.402 §3; 1985 c.565 §104;
1989 c.608 §2; 1997 c.729 §2; 2001 c.278 §1; 2009 c.326 §3]
689.230
[Amended by 1967 c.287 §2; 1969 c.514 §7; repealed by 1977 c.842 §45 and 1979
c.777 §59]
689.235 [1969
c.514 §8; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.240
[Amended by 1963 c.96 §3; 1967 c.183 §2; 1969 c.514 §9; repealed by 1977 c.842 §45
and 1979 c.777 §59]
689.245 [1979
c.777 §18; 1985 c.565 §105; renumbered 689.151 in 1997]
689.250
[Amended by 1955 c.132 §1; 1963 c.96 §4; 1965 c.580 §6; 1967 c.183 §3; 1969
c.514 §10; 1973 c.612 §24; 1975 c.686 §9; repealed by 1979 c.777 §59]
689.255 Qualifications for licensure by
examination. (1) To obtain a license to engage in
the practice of pharmacy, an applicant for licensure by examination shall:
(a)
Have submitted a written application in the form prescribed by the State Board
of Pharmacy.
(b)
Have attained the age of 18 years.
(c)
Be of good moral character and temperate habits.
(d)
Have completed requirements for the first professional undergraduate degree as
certified by a school or college of pharmacy which has been approved by the
board.
(e)
Have completed an internship or other program which has been approved by the
board, or demonstrated to the board’s satisfaction experience in the practice
of pharmacy which meets or exceeds the minimum internship requirements of the
board.
(f)
Have successfully passed an examination approved by the board.
(g)
Have paid the fees specified by the board for examination and issuance of
license.
(2)(a)
The board shall approve the content and subject matter of each examination and
determine which persons have successfully passed the examination.
(b)
The examination shall be prepared to measure the competence of the applicant to
engage in the practice of pharmacy. The board may employ and cooperate with any
organization or consultant in the preparation and grading of an appropriate
examination, but shall retain the sole discretion and responsibility of
determining which applicants have successfully passed such an examination.
(3)(a)
All applicants for licensure by examination shall obtain professional and
practical experience in the practice of pharmacy concurrent with or after
college attendance, or both, under such terms and conditions as the board shall
determine.
(b)
The board shall establish standards for internship or any other program
necessary to qualify an applicant for the licensure examination based on
nationally recognized standards of practice and shall also determine the
necessary qualifications of any preceptors used in any internship or other
program.
(4)
Any person who has received a professional degree from a school or college of
pharmacy located outside the United States which has not been approved by the
board, but who is otherwise qualified to apply for a license to practice
pharmacy in the State of Oregon may be deemed to have satisfied the degree
requirements of subsection (1)(d) of this section by verification to the board
of the academic record and graduation of the person and by meeting such other
requirements as the board may establish. The board may require such person to
successfully pass an examination or examinations given or approved by the board
to establish proficiency in English and equivalency of education of such person
with qualified graduates of a degree program referred to in subsection (1)(d)
of this section as a prerequisite of taking the licensure examination provided
for in subsection (1)(f) of this section. [1979 c.777 §22; 1987 c.108 §4; 1999
c.59 §205; 2009 c.756 §77]
689.260
[Amended by 1969 c.514 §12; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.265 Qualifications for licensure by
reciprocity. (1) To obtain a license as a pharmacist
by reciprocity, an applicant for licensure shall:
(a)
Have submitted a written application in the form prescribed by the State Board
of Pharmacy.
(b)
Have attained the age of 18 years.
(c)
Have good moral character and temperate habits.
(d)
Have possessed at the time of initial licensure as a pharmacist such other
qualifications necessary to have been eligible for licensure at that time in
this state.
(e)
Have engaged in the practice of pharmacy for a period of at least one year or
have met the internship requirements of this state within the one-year period
immediately previous to the date of such application.
(f)
Have presented to the board proof of initial licensure by examination and proof
that such license and any other license or licenses granted to the applicant by
any other state or states have not been suspended, revoked, canceled or
otherwise restricted for any reason except nonrenewal or the failure to obtain
required continuing education credits in any state where the applicant is
licensed but not engaged in the practice of pharmacy.
(g)
Have successfully passed an examination in jurisprudence approved by the board.
(h)
Have paid the fees specified by the board for issuance of a license.
(i)
Have submitted to the board proof of a professional degree that meets the
requirements of ORS 689.255 (4), if the applicant has received a professional
degree from a school or college of pharmacy located outside the United States.
(2)
No applicant shall be eligible for licensure by reciprocity unless the state in
which the applicant was initially licensed as a pharmacist also grants
reciprocal licensure to pharmacists duly licensed by examination in this state,
under like circumstances and conditions. [1979 c.777 §23; 2001 c.585 §1; 2009
c.756 §78]
689.270
[Amended by 1963 c.586 §5; 1969 c.514 §14; repealed by 1977 c.842 §45 and 1979
c.777 §59]
689.275 Renewal of licenses; rules; fees.
(1) Each pharmacist shall apply for renewal of license annually no later than June
30 or no later than such date as may be specified by rule of the State Board of
Pharmacy. The board shall renew the license of each pharmacist who is qualified
to engage in the practice of pharmacy.
(2)
The board shall specify by rule the procedures to be followed, in addition to
those specified by ORS 689.285, and the fees to be paid for renewal of
licenses.
(3)(a)
All pharmacists in good standing who have been licensed pharmacists for at
least 20 years and who are retired from practice of pharmacy are exempt from
further payment of license fees until they again engage in the practice of
pharmacy. No retired pharmacist shall engage in the practice of pharmacy
without first paying all fees for the year in which the pharmacist resumes
practice and producing evidence satisfactory to the board of continued
professional competence.
(b)
Failure to comply with the requirements of paragraph (a) of this subsection
shall be considered the practice of pharmacy without a license. [1979 c.777 §24;
2007 c.768 §51]
689.280 [1965
c.580 §2; 1967 c.183 §4; 1969 c.514 §13; 1973 c.743 §4; repealed by 1977 c.842 §45
and 1979 c.777 §59]
689.285 Continuing pharmacy education;
rules; fees. (1) The Legislative Assembly finds and
declares that:
(a)
The continuous introduction of new medical agents and the changing concepts of
the delivery of health care services in the practice of pharmacy make it
essential that a pharmacist undertake a continuing education program in order
to maintain professional competency and improve professional skills;
(b)
The state has a basic obligation to regulate and control the profession of
pharmacy in order to protect the public health and welfare of its citizens; and
(c)
It is the purpose of this chapter to protect the health and welfare of Oregon
citizens and to ensure uniform qualifications and continued competency of
licensed pharmacists by requiring participation in a continuing pharmacy
education program as a condition for renewal of licenses to practice pharmacy.
(2)
All pharmacists licensed in the State of Oregon on and after October 3, 1979,
shall satisfactorily complete courses of study and satisfactorily continue
their education by other means as determined by the State Board of Pharmacy in
subjects relating to the practice of the profession of pharmacy in order to be
eligible for renewal of licenses.
(3)
In accordance with applicable provisions of ORS chapter 183, the board shall
make reasonable rules:
(a)
Prescribing the procedure and criteria for approval of continuing pharmacy education
programs, including the number of hours of courses of study necessary to
constitute a continuing pharmacy education unit and the number of continuing
pharmacy education units required annually for renewal of a pharmacist license.
(b)
Prescribing the scope of the examinations given by the board including grading
procedures.
(c)
Prescribing the content of the form to be submitted to the board certifying
completion of an approved continuing pharmacy education program.
(d)
Necessary to carry out the provisions of this chapter.
(e)
Prescribing the completion of:
(A)
A pain management education program approved by the board and developed in
conjunction with the Pain Management Commission established under ORS 413.570;
or
(B)
An equivalent pain management education program, as determined by the board.
(4)
In adopting rules pursuant to subsection (3) of this section, the board shall
consider:
(a)
The need for formal regularly scheduled pharmacy education programs.
(b)
Alternate methods of study including home-study courses, seminars or other such
programs for those persons who, upon written application to the board and for
good cause shown, demonstrate their inability to attend regularly scheduled
formal classroom programs.
(c)
The necessity for examinations or other evaluation methods used to ensure
satisfactory completion of the continuing pharmacy education program.
(5)
The board may contract for the providing of educational programs to fulfill the
requirements of this chapter. The board is further authorized to treat funds
set aside for the purpose of continuing education as state funds for the
purpose of accepting any funds made available under federal law on a matching
basis for the promulgation and maintenance of programs of continuing education.
In no instance shall the board require a greater number of hours of study than
it provides or approves in the State of Oregon and which are available on the
same basis to all licensed pharmacists.
(6)
The board may levy an additional fee of up to $10 for each license renewal to
carry out the provisions of this chapter. [1979 c.777 §26; 1983 c.402 §5; 1985
c.565 §106; 1993 c.571 §6; 1993 c.742 §55; 2001 c.281 §1; 2005 c.162 §3]
689.290 [1969
c.514 §56; 1971 c.92 §2; 1973 c.743 §5; 1977 c.745 §43; repealed by 1977 c.842 §45
and 1979 c.777 §59]
REGULATION OF DRUG OUTLETS
689.305 Registration of drug outlets;
rules. (1) All drug outlets shall annually
register with the State Board of Pharmacy.
(2)(a)
Each drug outlet shall apply for a certificate of registration in one or more
of the following classifications:
(A)
Retail drug outlet.
(B)
Institutional drug outlet.
(C)
Manufacturing drug outlet.
(D)
Wholesale drug outlet.
(E)
Nonprescription drug outlet.
(b)
No individual who is employed by a corporation which is registered under any
classification listed in paragraph (a) of this subsection need register under
the provisions of this section.
(3)
The board shall establish by rule under the powers granted to it under ORS
689.155 and 689.205 the criteria which each drug outlet must meet to qualify
for registration in each classification designated in subsection (2)(a) of this
section. The board may issue various types of certificates of registration with
varying restrictions to the designated outlets where the board deems it
necessary by reason of the type of drug outlet requesting a certificate.
(4)
It shall be lawful for a drug outlet registered under this section to sell and
distribute nonprescription drugs. Drug outlets engaging in the sale and distribution
of such items shall not be deemed to be improperly engaged in the practice of
pharmacy. [1979 c.777 §30; 1993 c.571 §8]
689.310
[Amended by 1953 c.126 §2; 1963 c.96 §5; 1967 c.183 §5; 1969 c.514 §15; 1979
c.336 §2; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.315 Application; rules.
(1) The State Board of Pharmacy shall specify by rule the registration
procedures to be followed, including but not limited to specification of forms
for use in applying for such certificates of registration and times, places and
fees for filing such application.
(2)
Applications for certificates of registration shall include the following
information about the proposed drug outlet:
(a)
Ownership;
(b)
Location;
(c)
Identity of pharmacist licensed to practice in the state, who shall be the
pharmacist in charge of the drug outlet, where one is required by this chapter,
and such further information as the board may deem necessary; and
(d)
The identity of any person who has incident of ownership in a pharmacy who also
has a financial interest in any long term care facility, as defined in ORS
442.015.
(3)
Manufacturers and wholesalers shall keep all records and files of their
transactions for a period of three years from the date of the inception of such
records and files.
(4)(a)
Manufacturers and wholesalers shall acquire a separate registration for each
place at which they carry on their business as a manufacturer or wholesaler
within this state.
(b)
Certificates of registration issued by the board pursuant to this chapter shall
not be transferable or assignable and shall be conspicuously displayed at each
registered place of business.
(5)
The board shall specify by rule minimum standards for the professional
responsibility in the conduct of any drug outlet that has employees or
personnel engaged in the practice of pharmacy. The board is specifically
authorized to require that the portion of the facility to which such
certificate of registration applies be operated only under the direct
supervision of no less than one pharmacist licensed to practice in this state
and not otherwise, and to provide such other special requirements as deemed
necessary. [1979 c.777 §31a; 1985 c.565 §107; 1993 c.571 §9]
689.320
[Amended by 1963 c.586 §6; 1965 c.157 §1; 1967 c.261 §1; 1969 c.514 §16;
repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.325 Required reports.
(1) All registered drug outlets shall report to the State Board of Pharmacy the
occurrence of any of the following changes within the times specified by the
board by rule:
(a)
Permanent closing;
(b)
Change of ownership, management, location or pharmacist in charge; or
(c)
Any and all other matters and occurrences as the board may require by rule.
(2)
Disasters, accidents and emergencies which may affect the strength, purity or
labeling of drugs, medications, devices or other materials used in the
diagnosis or the treatment of injury, illness and disease shall be immediately
reported to the board. [1979 c.777 §32; 1993 c.571 §10]
689.330
[Amended by 1955 c.94 §1; 1957 c.598 §1; 1963 c.96 §6; 1969 c.514 §18; repealed
by 1977 c.842 §45 and 1979 c.777 §59]
689.335 Certificate required;
reinstatement. (1) No drug outlet designated in ORS
689.305 shall be operated until a certificate of registration has been issued
to said facility by the State Board of Pharmacy. Upon the finding of a
violation of ORS 689.305 or 689.405, the board may impose one or more of the
penalties under ORS 689.445.
(2)
Reinstatement of a certificate that has been suspended, revoked or restricted
by the board may be granted in accordance with the procedures specified by ORS
689.445 (2). [1979 c.777 §33; 1981 c.277 §3]
689.340
[Amended by 1969 c.514 §19; 1973 c.612 §25; repealed by 1977 c.842 §45 and 1979
c.777 §59]
689.342 [1989
c.667 §1; 2005 c.313 §1; 2007 c.70 §313; repealed by 2009 c.697 §14]
689.344 [1989
c.667 §2; 2005 c.313 §2; 2007 c.70 §314; repealed by 2009 c.697 §14]
689.346 [1989
c.667 §3; 2007 c.70 §315; repealed by 2009 c.697 §14]
689.348 [1989
c.667 §4; 2005 c.313 §3; repealed by 2009 c.697 §14]
689.350
[Amended by 1965 c.356 §1; 1967 c.183 §6; 1969 c.514 §20; repealed by 1977
c.842 §2 and 1979 c.777 §59]
689.352 [1989
c.667 §5; 2005 c.313 §4; repealed by 2009 c.697 §14]
689.354 [1989
c.667 §6; 2005 c.313 §5; repealed by 2009 c.697 §14]
689.356 [1989
c.667 §7; 1991 c.703 §32; 2005 c.313 §6; repealed by 2009 c.697 §14]
689.360 [1965
c.580 §8; 1969 c.514 §17; repealed by 1977 c.842 §45 and 1979 c.777 §59]
DISCIPLINE
689.405 Grounds for discipline;
investigation; procedure as contested case. (1)
The State Board of Pharmacy may refuse to issue or renew, or may suspend,
revoke or restrict the license of any person or the certificate of registration
of any drug outlet upon one or more of the following grounds:
(a)
Unprofessional conduct as that term is defined by the rules of the board.
(b)
Repeated or gross negligence.
(c)
Incapacity of a nature that prevents a person from engaging in the activity for
which the person is licensed with reasonable skill, competence and safety to
the public.
(d)
Impairment as defined in ORS 676.303.
(e)
Being found guilty by the board of a violation of subparagraph (B) of this
paragraph, or by a court of competent jurisdiction of one or more of the
following:
(A)
A felony, as defined by the laws of this state; or
(B)
Violations of the pharmacy or drug laws of this state or rules pertaining
thereto, or of statutes, rules or regulations of any other state, or of the
federal government.
(f)
Fraud or intentional misrepresentation by a licensee or registrant in securing
or attempting to secure the issuance or renewal of a license.
(g)
Engaging or aiding and abetting an individual to engage in the practice of
pharmacy without a license, or falsely using the title of pharmacist.
(h)
Aiding and abetting an individual in performing the duties of a pharmacy
technician without licensing.
(i)
Being found by the board to be in violation of any of the provisions of ORS
435.010 to 435.130, 453.025, 453.045, 475.035 to 475.190, 475.744, 475.752 to
475.980 or this chapter or rules adopted pursuant to ORS 435.010 to 435.130,
453.025, 453.045, 475.035 to 475.190, 475.744, 475.752 to 475.980 and this
chapter.
(j)
Disciplinary action by another state regarding a license, based upon acts by
the licensee similar to acts described in this subsection. A certified copy of
the record of disciplinary action of the state taking the disciplinary action
is conclusive evidence thereof.
(2)
Upon receipt of a complaint under this chapter, the board shall conduct an
investigation as described under ORS 676.165.
(3)
Actions taken under subsection (1) of this section shall be considered a
contested case under ORS chapter 183. [1979 c.777 §§27,28; 1981 c.277 §4; 1985
c.131 §4; 1987 c.736 §1; 1995 c.440 §11; 1997 c.729 §3; 1997 c.791 §48; 2005
c.313 §12; 2009 c.756 §79]
689.410
[Amended by 1963 c.586 §7; 1965 c.580 §7; 1969 c.514 §25; 1977 c.745 §44;
repealed by 1979 c.777 §59]
689.413 [1969
c.514 §26; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.415 [1969
c.514 §27; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.420
[Repealed by 1969 c.514 §57]
689.423 [1971
c.734 §143; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.425 [1969
c.514 §30; repealed by 1971 c.734 §21]
689.430
[Amended by 1969 c.514 §29; repealed by 1971 c.734 §21]
689.435 [1971
c.734 §144; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.440
[Repealed by 1969 c.514 §57]
689.445 Penalties and reinstatement.
(1) Upon the finding of the existence of grounds for discipline of any person
holding a license, seeking a license or renewal of a license under the
provisions of ORS 435.010 to 435.030, 475.125 and 475.135 and this chapter, the
State Board of Pharmacy may impose one or more of the following penalties:
(a)
Suspension of the offender’s license for a term to be determined by the board;
(b)
Revocation of the offender’s license;
(c)
Restriction of the offender’s license to prohibit the offender from performing
certain acts or from engaging in the practice of pharmacy in a particular
manner for a term to be determined by the board;
(d)
A civil penalty not to exceed:
(A)
$1,000 for each offense committed by an individual; and
(B)
$10,000 for each offense committed by a drug outlet;
(e)
Refusal to renew offender’s license; or
(f)
Placement of the offender on probation and supervision by the board for a
period to be determined by the board.
(2)
Any person whose license issued pursuant to this chapter has been suspended,
revoked or restricted pursuant to this chapter, whether voluntarily or by
action of the board, shall have the right, at reasonable intervals, to petition
the board for reinstatement of such license. Such petition shall be made in
writing and in the form prescribed by the board. Upon investigation and hearing,
the board may in its discretion grant or deny such petition, or it may modify
its original finding to reflect any circumstances which have changed
sufficiently to warrant such modifications. Pardon and restoration of civil
rights to any person formerly licensed by the board does not obligate the board
to restore revoked, restricted or suspended licenses.
(3)
Nothing in this chapter shall be construed as barring criminal prosecutions for
violations of ORS 435.010 to 435.130, 453.025, 453.045, 475.035 to 475.190,
475.744, 475.752 to 475.980 and this chapter where such violations are deemed
as criminal offenses in other statutes of this state or of the United States.
(4)
Civil penalties under this section shall be imposed as provided in ORS 183.745.
(5)
All penalties recovered under ORS 435.010 to 435.130, 453.025, 453.045, 475.035
to 475.190, 475.744, 475.752 to 475.980 and this chapter shall be deposited
into the State Board of Pharmacy Account established in ORS 689.139. [1979
c.777 §29; 1985 c.131 §5; 1991 c.734 §75; 1995 c.440 §12; 1997 c.729 §4; 2005
c.726 §12; 2007 c.90 §1]
689.450
[Amended by 1969 c.514 §47; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.455 Duty to report suspected
violations and prohibited conduct; liability for reporting; confidentiality of
report. (1) Unless state or federal laws
relating to confidentiality or the protection of health information prohibit
disclosure, a pharmacist or pharmacy technician shall report:
(a)
Any suspected violations of this chapter or of ORS 475.005 to 475.285 and
475.752 to 475.980 to the State Board of Pharmacy; and
(b)
Any prohibited conduct as defined in ORS 676.150 in the manner provided in ORS
676.150.
(2)
Any pharmacist or pharmacy technician who reports to the board as required by subsection
(1) of this section in good faith shall not be subject to an action for civil
damages as a result thereof.
(3)
Any information that the board obtains pursuant to ORS 689.405 or 689.445 or
this section is confidential as provided under ORS 676.175. [1985 c.131 §3;
1995 c.440 §40; 1997 c.791 §49; 2001 c.595 §4; 2009 c.536 §18]
689.460 [1973
c.743 §11; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.475 [1967
c.636 §2; 1969 c.514 §32; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.480 [1967
c.636 §3; 1969 c.514 §33; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.485 [1967
c.636 §4; 1969 c.514 §34; repealed by 1977 c.842 §45 and 1979 c.777 §59]
PHARMACY TECHNICIANS
689.486 When license required;
qualifications for licensure; renewal; supervision required.
(1) It shall be unlawful for any person to perform the duties of a pharmacy
technician or use the title of pharmacy technician unless licensed to do so
under the provisions of this chapter.
(2)
To be licensed to perform the duties of a pharmacy technician, a person shall:
(a)
Submit a license application in the manner prescribed by the State Board of
Pharmacy; and
(b)
Pay the license fee established by the board.
(3)
The license application prescribed by the board shall include, but not be
limited to:
(a)
The name and address of the applicant;
(b)
The educational qualifications of the applicant;
(c)
The work history of the applicant; and
(d)
The applicant’s criminal offender record of any conviction or of any arrest
less than one year old on which there has been no acquittal or dismissal.
(4)
A license under this section expires annually. To renew a license to perform
the duties of a pharmacy technician, a person shall:
(a)
Submit the application for renewal of a license in the form prescribed by the
board;
(b)
Pay the license renewal fee established by the board;
(c)
Pay the fee for delinquent license renewal, if applicable;
(d)
Provide updated information regarding educational qualifications, work history
and criminal arrest and conviction history; and
(e)
Comply with all other requirements for license renewal established by the
board.
(5)
No person may employ an individual to perform the duties of a pharmacy
technician unless the individual is licensed to perform the duties of a
pharmacy technician under this chapter.
(6)
A person licensed to perform the duties of a pharmacy technician may perform
the duties of a pharmacy technician only under the supervision, direction and
control of a licensed pharmacist. [1997 c.729 §6; 2001 c.595 §2; 2005 c.313 §7]
689.490 Board to establish licensing
system; rules; fees. (1) In accordance with any
applicable provisions of ORS chapter 183, the State Board of Pharmacy, by rule,
shall establish a licensing system for persons who perform the duties of a
pharmacy technician. The licensing system shall include but not be limited to
the following provisions:
(a)
Prescribing the form and content of and the procedures for submitting an
application for the issuance or renewal of a technician license.
(b)
Prescribing the fee for the original license and for renewal of a license in an
amount not to exceed $50 and the fee for delinquent license renewal in an
amount not to exceed $50.
(2)
The board may refuse to issue or renew, or may suspend, revoke or restrict a
technician license:
(a)
For any reason listed under ORS 689.405 (1);
(b)
If the applicant is not authorized to work for hire under Oregon law; or
(c)
For any other grounds that the board, in its discretion, believes would disqualify
the applicant for a license.
(3)
Denial of a license under subsection (2) of this section shall be considered a
contested case under ORS chapter 183. [1997 c.729 §7; 2001 c.595 §3; 2005 c.313
§8]
689.495 Provision of licensing
information. (1) Upon the written request of a
pharmacist, the State Board of Pharmacy shall provide the name, address,
educational qualifications, work history, technician license history and
criminal arrest and conviction history of any pharmacy technician licensed with
the board. Information provided by the board pursuant to a request under this
section shall be in writing and may be provided to the requester by means of
facsimile or other electronic transmission or the United States Postal Service.
(2)
For purposes of this section:
(a)
“Written request” includes but is not limited to a request received by means of
facsimile or other electronic transmission.
(b)
“Work history” includes but is not limited to information reported to the board
pursuant to ORS 689.497 to the extent the information is not exempt from
disclosure under ORS 676.175. [1997 c.729 §8; 2001 c.595 §5; 2005 c.313 §9]
689.497 Report required upon termination
of pharmacy technician. (1) A pharmacy that terminates a
pharmacy technician shall report the termination to the State Board of
Pharmacy. In the sole discretion of the pharmacy, the pharmacy may report the
reason for the termination.
(2)
A pharmacy reporting the termination of a pharmacy technician under subsection
(1) of this section shall provide the pharmacy technician an opportunity to
issue a statement accompanying the report of termination. The statement of the
pharmacy technician may include any mitigating factors or other information the
pharmacy technician deems relevant to the termination.
(3)
A pharmacy, pharmacist, pharmacy technician or any other person who, in good
faith, submits a report of termination of a pharmacy technician under the
provisions of this section is not liable for any civil damages as a result of
submitting the report.
(4)
The information provided to the board pursuant to this section is:
(a)
Subject to disclosure as provided in ORS 689.495; and
(b)
Admissible as evidence for any purpose in any civil proceeding before a court,
agency, board or third-party dispute resolution tribunal.
(5)
Nothing in subsection (3) of this section shall affect the admissibility in
evidence of the records of a pharmacy or pharmacist that pertain to the work
history or termination of employment of a pharmacy technician. [2001 c.595 §7]
689.499 Pharmacy technician specialized
education program; rules. (1)(a) The State Board of
Pharmacy may by rule identify activities performed by a pharmacy technician for
which a specialized education program may be required.
(b)
If the board identifies an activity requiring specialized education under this
subsection, the board shall approve no fewer than two specialized education
programs to provide the specialized education.
(c)
Upon receipt of evidence satisfactory to the board that a pharmacy technician
has satisfactorily completed a specialized education program approved by the
board, the board shall note the specialized education on the license of the
pharmacy technician.
(2)
The board may establish standards for renewal or revocation of a notation of
specialized education under this section.
(3)
As used in this section, “specialized education program” means:
(a)
A program providing education for persons desiring licensure as pharmacy
technicians that is approved by the board and offered by an accredited college
or university that grants a two-year degree upon successful completion of the
program; or
(b)
A structured program approved by the board and designed to educate pharmacy
technicians in one or more specific issues of patient health and safety that is
offered by:
(A)
An organization recognized by the board as representing pharmacists or pharmacy
technicians;
(B)
An employer recognized by the board as representing pharmacists or pharmacy
technicians; or
(C)
A trade association recognized by the board as representing pharmacies. [2005
c.313 §16]
REQUIREMENTS RELATING TO SALES
689.505 Labeling requirements; rules.
(1)(a) Except as specifically provided by law, no person shall distribute or
dispense any drug without affixing to the authorized container a clear and
legible label, either printed or written, bearing the name of the drug and the
name and place of business of the person distributing or dispensing the drug,
and any other information required by state law or rules or federal law or
regulations under whose supervision the drug is delivered or dispensed.
(b)
Labeling requirements regarding any drug may be changed or exemption therefrom
granted by the State Board of Pharmacy in the form of a special permit if the
board determines that a change or exemption is in the best interest of public
health and safety.
(2)(a)
No manufacturer or wholesaler subject to ORS 689.305 shall sell or otherwise
distribute, or offer to sell or otherwise distribute, any drug for use in a:
(A)
Parcel, package or container not bearing a label specifying the name, active
ingredients or contents, quality and quantity of the drug.
(B)
Misbranded parcel, package or container.
(b)
A parcel, package or container is misbranded:
(A)
If its labeling is false or misleading in any particular.
(B)
Unless it bears a label containing the name and business address of the
manufacturer, packer, distributor or wholesaler, and an accurate statement of
the quantity of the drug in terms of weight, measure or numerical count,
exclusive of wrappers, cartons, containers or other materials packed with such
drug.
(C)
In case it contains controlled substances which the board finds and by rule
designates after reasonable notice and opportunity for hearing to be habit
forming, unless it bears the statement “Warning--May Be Habit Forming.”
(D)
Unless it bears a label with adequate directions for the safe use of the drug
for specified conditions, and adequate warning against use in those
pathological conditions or by children where such use may be dangerous to the
health or welfare of a user.
(E)
Unless it bears a label with true representations of the intended uses of the
drug and no false claims or representations are made of the drug in
accompanying literature or advertising.
(3)
This section does not apply to parcels, packages or containers containing:
(a)
Drugs prepared and packaged solely for use by a pharmacist in compounding
prescriptions or for dispensing in dosage unit form upon a prescription, except
that such parcels, packages or containers must bear the name and business
address of the manufacturer and, if different, the name and business address of
the distributor of the drug, and the legend “Caution: Federal Law Prohibits
Dispensing Without Prescription” or an equivalent legend.
(b)
Drugs intended solely for use in the professional diagnosis of disease, except
that such parcels, packages or containers shall bear the statement “Diagnostic
Reagent--For Professional Use Only.”
(c)
Coloring agents, emulsifiers, excipients, flavorings, lubricants, preservatives
and other like inactive ingredients used in the manufacture of drugs.
(4)
The board shall by rule exempt from any labeling or packaging requirement of
this section drugs which are, in accordance with the practice of the trade, to
be processed, labeled or repacked in substantial quantities at establishments
other than those where originally processed or packed. However, such drugs must
not be adulterated or misbranded upon removal from such processing, labeling or
repacking establishment.
(5)
A pharmacist or pharmacy intern shall not dispense, on the prescription of a
practitioner, any drug without affixing to the container thereof a clear and
legible label. The label may be printed or written. Except as provided in subsection
(6) of this section, the pharmacist or pharmacy intern shall state or cause to
be stated on the label the following:
(a)
The name of the 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 distributor or manufacturer, its quantity per unit
and the directions for its use stated in the prescription. However, if the drug
is a compound, the quantity per unit need not be stated.
(b)
The name of the practitioner prescribing the drug.
(c)
The name and place of business of the pharmacist or the name and place of
business of the pharmacy for which the pharmacist or pharmacy intern is acting.
(d)
The name of the patient, unless the drug is prescribed to a partner of a
patient as defined in ORS 676.350 in accordance with rules adopted under ORS
676.350 authorizing the practice of expedited partner therapy.
(e)
When applicable and as determined by the State Board of Pharmacy, an expiration
date after which the patient should not use the drug.
(6)
If the prescribing practitioner so directs, the prescription label shall not
state the name and quantity per unit of the drug.
(7)
The State Board of Pharmacy shall determine those drugs which must bear an
expiration date under subsection (5)(e) of this section.
(8)
As used in this section, “compound” means a drug containing two or more
medically active ingredients.
(9)
No person shall deliver or dispense any drug for use by the ultimate consumer
without labeling the drug container as required in this section.
(10)
In addition to the labeling requirements imposed by subsections (1) to (9) of
this section, the board may impose by rule requirements for drug code imprints
on solid dose legend drugs. [1979 c.777 §34a; 1993 c.571 §13; 2009 c.522 §2]
689.508 Prescription records.
The original record of every prescription filled by a pharmacy must be kept on
file for three years at the pharmacy or as specified by State Board of Pharmacy
rule. The prescription record must contain the date of the transaction and the
brand name, or if the drug has no brand name, the generic name and the name of
the manufacturer of any drug substituted pursuant to ORS 689.515. If the
prescription may be communicated to the pharmacy by oral or electronic means,
the prescription information may be recorded and stored in an electronic form
that allows for ready retrieval. Prescriptions maintained in the file required
under this section must be readily accessible to the board for inspection. [2003
c.103 §2; 2009 c.756 §80]
689.510
[Amended by 1953 c.433 §1; 1971 c.650 §39; 1973 c.792 §44; 1977 c.688 §1;
repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.515 Regulation of generic drugs;
substitutions; rules. (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, 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 may be no substitution for the specified
brand name drug in a prescription.
(4)
A 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 must 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 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)
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 shall label the prescription container with the name of the
dispensed drug. If the dispensed drug does not have a brand name, the
pharmacist shall label the prescription container with the generic name of the
drug dispensed along with the name of the drug manufacturer.
(8)
A prescription dispensed by a pharmacist must bear upon the label the name of
the medication in the container or shall be labeled as intended by the
prescriber.
(9)
The substitution of any drug by a pharmacist or the pharmacist’s employer
pursuant to this section does not constitute the practice of medicine.
(10)
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 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)
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. [1979
c.777 §35; 1983 c.402 §4; 1985 c.565 §110; 1987 c.108 §5; 1989 c.706 §22; 1991
c.734 §76; part renumbered 689.854 and 689.857 in 1991; 1993 c.534 §1; 1993
c.571 §14; 1999 c.350 §5; 2001 c.589 §1; 2001 c.623 §7a; 2009 c.326 §4]
689.520
[Amended by 1965 c.466 §2; 1967 c.291 §2; 1969 c.314 §89; 1969 c.514 §35;
repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.525 Out-of-state prescriptions.
(1) A prescription written by a practitioner licensed in a state or territory
of the United States, other than Oregon, may be filled only if the pharmacist
called upon to fill such prescription determines, in the exercise of
professional judgment:
(a)
That it was issued pursuant to a valid patient-practitioner relationship; and
(b)
That it is authentic.
(2)
However, if the practitioner writing the prescription is not known to the
pharmacist, the pharmacist shall obtain proof to a reasonable certainty of the
validity of the prescription.
(3)
The provisions of ORS 689.515 authorizing generic substitution shall not apply
to prescriptions described in this section unless authorized on the
prescription. [1979 c.777 §36; 1981 c.666 §10; 1987 c.108 §6; 1993 c.571 §15;
1997 c.153 §1]
689.527 Prohibited practices; rules.
(1) 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)
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)
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)
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)
A person may not sell, give away, barter, dispense, distribute, buy, receive or
possess any prescription drug except as authorized by law.
(7)
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)(a)
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.
(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. [Formerly 689.765]
689.530
[Amended by 1969 c.514 §36; 1977 c.688 §2; repealed by 1977 c.842 §45 and 1979
c.777 §59]
689.532 Complimentary samples.
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. [2009 c.326 §8]
689.535 [1979
c.777 §37; 1981 c.217 §1; 1985 c.565 §111; repealed by 2003 c.102 §2]
689.540
[Amended by 1969 c.514 §37; 1977 c.688 §3; repealed by 1977 c.842 §45 and 1979
c.777 §59]
689.545 [1979
c.249 §1; 1981 c.388 §2; repealed by 2003 c.102 §2]
689.550
[Amended by 1965 c.466 §1; 1967 c.291 §3; repealed by 1977 c.842 §45 and 1979
c.777 §59]
689.555 Agricultural drugs,
nonprescription drugs and certain other substances.
(1) Nothing in this chapter prohibits the sale by any person of agricultural or
garden spray, sheep dip, blue stone, copperas, squirrel poison, fly paper, ant
poison, gopher poison, insect powder, poultry vermifuge and arsenic sprays when
they are in original unbroken packages, prepared and labeled with official
poison labels and showing antidotes.
(2)
Nothing in this chapter requires or authorizes the licensing or regulation of
the sale of economic poisons, which includes any substance or mixture of
substances intended to be used for preventing, destroying, repelling or
mitigating any and all insects, fungi, weeds, parasites, or other plant or
animal pest, collectively or individually, which may infest or be detrimental
to vegetation or any domestic animal or fowl life. [1979 c.777 §40; 1985 c.565 §112]
689.560
[Amended by 1969 c.514 §42; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.565 [1999
c.874 §§1,2,3,4; repealed by 2007 c.272 §13]
689.570
[Amended by 1969 c.514 §40; 1973 c.829 §69; repealed by 1977 c.842 §45 and 1979
c.777 §59]
689.580
[Amended by 1969 c.514 §45; repealed by 1973 c.743 §9 and by 1973 c.829 §71]
689.590
[Amended by 1965 c.580 §9; 1969 c.514 §44; 1973 c.427 §35; repealed by 1977
c.842 §45 and 1979 c.777 §59]
689.595 [1969
c.514 §43; repealed by 1973 c.427 §36 (689.596 enacted in lieu of 689.595)]
689.596 [1973
c.427 §37 (enacted in lieu of 689.595); repealed by 1977 c.842 §45 and 1979
c.777 §59]
689.600
[Amended by 1969 c.514 §39; repealed by 1977 c.842 §45 and 1979 c.777 §59]
MISCELLANEOUS
689.605 Power to dispense drugs from
hospital pharmacies, drug rooms and penal institutions; rules.
(1) In a hospital or long term care facility having a pharmacy and employing a
pharmacist, the pharmacy and pharmacist are subject to the requirements of this
chapter, except that in a hospital when a pharmacist is not in attendance,
pursuant to standing orders of the pharmacist, a registered nurse supervisor on
the written order of a person authorized to prescribe a drug may withdraw such
drug in such volume or amount as needed for administration to or treatment of
an inpatient or outpatient until regular pharmacy services are available in
accordance with the rules adopted by the board. However, the State Board of
Pharmacy may grant an exception to the requirement for a written order by
issuing a special permit authorizing the registered nurse supervisor in a
hospital to dispense medication on the oral order of a person authorized to
prescribe a drug. An inpatient care facility which does not have a pharmacy
must have a drug room. In an inpatient care facility having a drug room as may
be authorized by rule of the Department of Human Services or the Oregon Health
Authority, the drug room is not subject to the requirements of this chapter
relating to pharmacies. However, a drug room must be supervised by a pharmacist
and is subject to the rules of the State Board of Pharmacy. When a pharmacist
is not in attendance, any person authorized by the prescriber or by the
pharmacist on written order may withdraw such drug in such volume or amount as
needed for administration to or treatment of a patient, entering such
withdrawal in the record of the responsible pharmacist.
(2)
In a hospital having a drug room, any drug may be withdrawn from storage in the
drug room by a registered nurse supervisor on the written order of a licensed
practitioner in such volume or amount as needed for administration to and
treatment of an inpatient or outpatient in the manner set forth in subsection
(1) of this section and within the authorized scope of practice.
(3)
A hospital having a drug room shall cause accurate and complete records to be
kept of the receipt, withdrawal from stock and use or other disposal of all
legend drugs stored in the drug room. Such record shall be open to inspection
by agents of the board and other qualified authorities.
(4)
In an inpatient care facility other than a hospital, the drug room shall
contain only prescribed drugs already prepared for patients therein and such
emergency drug supply as may be authorized by rule by the Department of Human
Services.
(5)
The requirements of this section shall not apply to facilities described in ORS
441.065.
(6)
A registered nurse who is an employee of a local health department established
under the authority of a county or district board of health and registered by
the board under ORS 689.305 may, pursuant to the order of a person authorized
to prescribe a drug or device, dispense a drug or device to a client of the
local health department for purposes of caries prevention, birth control or
prevention or treatment of a communicable disease. Such dispensing shall be
subject to rules jointly adopted by the board and the Oregon Health Authority.
(7)
The board shall adopt rules authorizing a pharmacist to delegate to a
registered nurse the authority to withdraw prescription drugs from a
manufacturer’s labeled container for administration to persons confined in
penal institutions including, but not limited to, adult and juvenile
correctional facilities. A penal institution, in consultation with a
pharmacist, shall develop policies and procedures regarding medication
management, procurement and distribution. A pharmacist shall monitor a penal
institution for compliance with the policies and procedures and shall perform
drug utilization reviews. The penal institution shall submit to the board for
approval a written agreement between the pharmacist and the penal institution
regarding medication policies and procedures. [1979 c.777 §38; 1979 c.785 §9d;
1985 c.565 §113; 1989 c.526 §1; 1993 c.272 §2; 1993 c.571 §16; 1995 c.523 §3;
2003 c.617 §2; 2009 c.595 §1103]
689.610
[Amended by 1969 c.514 §41; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.615 Display of certificate or license.
(1) The holder of any certificate or license granted under this chapter shall
display it conspicuously in the pharmacy or place of business to which it
applies.
(2)
All pharmacist certificates issued by the State Board of Pharmacy shall bear
the signatures of all members and officers of the board.
(3)
On payment by the applicant of the fee prescribed in ORS 689.135, the board may
issue a new certificate to a pharmacist if the applicant has lost the
certificate or the certificate has been destroyed. [1979 c.777 §25; 1985 c.565 §114;
1987 c.108 §7; 1993 c.571 §17]
689.620
[Amended by 1965 c.545 §4; 1969 c.514 §38; 1973 c.697 §10; 1975 c.686 §10; 1977
c.745 §45; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.625 [1975
c.686 §12; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.630
[Repealed by 1965 c.46 §1]
689.635 Dispensing according to
naturopathic formulary; effect of filling prescription of naturopath.
A drug prescribed by a naturopathic physician licensed under ORS chapter 685 in
accordance with the formulary established by ORS 685.145 may be dispensed by a
licensed pharmacist or an employee of a licensed pharmacist according to the
terms of the prescription. The filling of a prescription under this section
does not constitute evidence of negligence on the part of the pharmacist or the
employee if the prescription is dispensed within the reasonable and prudent
practices of pharmacy. [1989 c.945 §4; 1993 c.571 §18; 2009 c.420 §4]
689.640
[Repealed by 1969 c.514 §57]
689.645 Power to administer and prescribe
vaccines; rules. (1) In accordance with rules
adopted by the State Board of Pharmacy under ORS 689.205, a pharmacist may
administer vaccines to persons who are at least 11 years of age.
(2)
The board may adopt rules allowing a pharmacist to prescribe vaccines to persons
who are at least 11 years of age. The rules may only be as broad as necessary
to enable pharmacists to enroll and participate in the Vaccines for Children
Program administered by the Centers for Disease Control and Prevention.
(3)
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 prescription and
administration of vaccines to persons who are at least 11 years of age.
(4)
The board shall adopt rules relating to the reporting of the prescription and
administration of vaccines to a patient’s primary health care provider and to
the Oregon Health Authority.
(5)
The board shall adopt rules requiring pharmacists to establish protocols for
the prescription and administration of vaccines to persons who are at least 11
years of age.
(6)
The board shall convene a volunteer Immunization and Vaccination 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 Oregon Health Authority, two representatives
from the Oregon Medical Board, 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. [1999 c.350 §3b; 2005 c.312 §1; 2009 c.250 §1; 2009 c.595 §1104; 2011
c.245 §1]
689.650 [1965
c.545 §6; 1969 c.314 §90; 1969 c.514 §31; repealed by 1973 c.697 §21]
689.655 Power to administer drugs and
devices; rules. 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. [1999 c.350 §3e; 2009 c.326 §5]
Note:
Section 3f, chapter 350, Oregon Laws 1999, provides:
Sec. 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. [1999 c.350 §3f]
689.660 [1965
c.545 §7; 1971 c.650 §40; 1971 c.734 §141; 1973 c.697 §8; repealed by 1977
c.745 §54 and 1977 c.842 §45]
689.665 [1975
c.369 §§3,5; 1979 c.785 §10; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.670 [1975
c.686 §2; repealed by 1977 c.842 §43 and 1979 c.777 §59]
689.675 [1975
c.686 §3; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.680 [1975
c.686 §4; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.685 [1975
c.686 §5; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.690 [1975
c.686 §6; repealed by 1979 c.777 §59]
689.695 [1975
c.686 §7; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.705 [1955
c.326 §1; 1967 c.260 §1; repealed by 1969 c.514 §57]
689.710 [1955
c.326 §2; repealed by 1969 c.514 §57]
689.715 [1955
c.326 §3; 1967 c.345 §1; repealed by 1969 c.514 §57]
689.720 [1955
c.326 §4; 1957 c.350 §1; 1963 c.96 §7; 1967 c.183 §7; 1969 c.514 §21; repealed
by 1977 c.842 §45 and 1979 c.777 §59]
689.725 [1955
c.326 §5; 1969 c.514 §28; 1973 c.743 §7; repealed by 1977 c.842 §45 and 1979
c.777 §59]
689.730 [1955
c.326 §6; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.735 [1955
c.326 §7; 1969 c.514 §22; renumbered 689.810]
689.740 [1955
c.326 §8; 1969 c.514 §23; renumbered 689.815]
689.745 [1955
c.326 §9; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.750 [1955
c.326 §10; 1969 c.514 §24; repealed by 1977 c.842 §45 and 1979 c.777 §59]
689.755 [1955
c.326 §11; repealed by 1969 c.514 §57]
689.760 [1955
c.326 §12; repealed by 1969 c.514 §57]
689.765 [1979
c.777 §39; 1985 c.131 §6; 1987 c.108 §8; 1987 c.736 §2; 1993 c.571 §19; 2003
c.103 §3; 2005 c.462 §9; 2008 c.4 §4; 2009 c.326 §6; renumbered 689.527 in
2009]
CHARITABLE PRESCRIPTION DRUG PROGRAM
689.770 Definitions for ORS 689.770 to
689.780. As used in ORS 689.770 to 689.780, “the
Charitable Prescription Drug Program” means a drug outlet that has:
(1)
A valid certificate of registration issued by the State Board of Pharmacy;
(2)
Volunteered to participate in the Charitable Prescription Drug Program; and
(3)
Been approved by the board to accept and distribute to needy individuals
donated prescription drugs through the program. [2009 c.300 §2]
689.772 Establishment of program; immunity
from liability. (1) There is created in the
State Board of Pharmacy the Charitable Prescription Drug Program. The purpose
of the program is to distribute donated prescription drugs to needy or
uninsured individuals. Participation in the program is voluntary.
(2)
The program may accept and distribute:
(a)
Prescription drugs received in original, sealed, tamper-evident packaging that
displays the lot number and expiration date of the drug; and
(b)
Sealed single unit dose packages received in opened packages containing
multiple single unit doses.
(3)
The program may not distribute donated prescription drugs that:
(a)
Fail to meet the requirements of this section;
(b)
Bear an expiration date that is less than nine months from the date the drug is
donated;
(c)
Are adulterated or misbranded; or
(d)
Belong to a category of controlled substances that may not be distributed under
the program as adopted by the board by rule pursuant to ORS 689.774.
(4)
The program shall:
(a)
Require a donor of prescription drugs to complete and sign a donor form,
adopted by rule by the board, releasing the prescription drug to the program
for distribution under the program and certifying that the donated drug has
been properly stored and has never been opened, used, adulterated or
misbranded;
(b)
Require that the pharmacist will use professional judgment, based on a visual
inspection, to verify compliance with this section and rules adopted by the
board under ORS 689.774;
(c)
Properly dispose of all prescription drugs that do not meet the requirements of
this section and rules adopted by the board under ORS 689.774;
(d)
Maintain separate confidential files for individuals receiving donated
prescription drugs through the program;
(e)
Eliminate personal information from the labels of donated prescription drugs;
(f)
Maintain an inventory of donated prescription drugs separate from any other
inventory;
(g)
Store donated prescription drugs in a secure location to be used exclusively
for the program;
(h)
Report to the board on the activities of the program in the form and manner
required by the board; and
(i)
Require a recipient of a donated prescription drug to sign a form, as adopted
by the board by rule, attesting that the recipient has been notified by the
program that:
(A)
The prescription drug distributed to the recipient was donated to the program;
(B)
A visual inspection was conducted by a pharmacist to ensure that the drug has
not expired, been adulterated or misbranded and is in its original, sealed
packaging;
(C)
A pharmacist has determined that the drug is safe to distribute based on the
accuracy of the donor’s form and the visual inspection by the pharmacist; and
(D)
Participants in the program are immune from liability as provided in ORS
689.780.
(5)
The program may not charge a fee for accepting a donation but may charge a fee
established by the board by rule for distributing a prescription drug.
(6)
The program may not sell any prescription drugs received as a donation through
the program.
(7)
The program may refuse to accept a prescription drug that, upon visual
inspection, appears not to qualify for distribution under this section or rules
adopted by the board under ORS 689.774.
(8)
The program may distribute donated prescription drugs to:
(a)
Another charitable prescription drug program; or
(b)
An individual with a new prescription for prescription drugs who meets the
requirements of ORS 689.778. [2009 c.300 §3]
689.774 Rules.
The State Board of Pharmacy shall adopt rules to carry out ORS 689.770 to
689.780, including but not limited to:
(1)
Specifying categories of prescription drugs that the program may not distribute
under the program;
(2)
Prescribing the forms described in ORS 689.772;
(3)
Establishing the criteria for licensure and regulation under the program;
(4)
Establishing standards and procedures for accepting, storing, distributing,
shipping and disposing of donated prescription drugs under the program;
(5)
Establishing standards and procedures for inspecting donated prescription drugs
to ensure that the drugs comply with the requirements of this section and ORS
689.772; and
(6)
Establishing record keeping and reporting requirements for the program. [2009
c.300 §4]
689.776 Inspection; audit.
The State Board of Pharmacy shall ensure compliance with ORS 689.770 to 689.780
by:
(1)
Inspecting the Charitable Prescription Drug Program on a regular basis; and
(2)
Auditing records required to be maintained by a pharmacy in connection with the
program. [2009 c.300 §5]
689.778 Eligibility.
An individual is eligible to obtain donated prescription drugs through the
Charitable Prescription Drug Program created in ORS 689.772 if the individual:
(1)
Is a resident of this state; and
(2)(a)
Does not have health insurance coverage for the prescription drug requested;
(b)
Is enrolled in a program of public assistance, as defined in ORS 411.010; or
(c)
Meets other requirements adopted by rule by the State Board of Pharmacy that
identify needy individuals with barriers to accessing prescription drugs. [2009
c.300 §6]
689.780 Immunity.
(1) As used in this section, “participant” means:
(a)
A person who donates a prescription drug to the Charitable Prescription Drug
Program;
(b)
The Charitable Prescription Drug Program;
(c)
The State Board of Pharmacy;
(d)
A pharmacist;
(e)
A drug manufacturer; or
(f)
A health practitioner.
(2)
A participant who accepts or distributes donated prescription drugs through the
Charitable Prescription Drug Program is not subject to criminal prosecution or
civil liability for any injury, death or loss of or damage to person or
property that results from the acceptance or distribution of the donated
prescription drugs if the participant accepts or distributes the donated
prescription drugs in good faith. [2009 c.300 §7]
689.805 [1969
c.514 §49; repealed by 1979 c.777 §59]
689.810
[Formerly 689.735; 1979 c.744 §62; repealed by 1979 c.777 §59]
689.815
[Formerly 689.740; 1975 c.484 §1; repealed by 1979 c.777 §59]
689.825 [1973
c.533 §2; 1975 c.369 §2; 1979 c.785 §11; repealed by 1979 c.777 §59]
689.830 [1975
c.218 §2; repealed by 1979 c.777 §59]
PENALTIES
689.832 Civil penalties.
(1) In addition to any other liability or penalty provided by law, the State
Board of Pharmacy may impose a civil penalty for any violation of the
provisions of this chapter or ORS chapter 475 or any rule of the board. A civil
penalty imposed under this subsection may not exceed $1,000 for each violation
by an individual and $10,000 for each violation by a drug outlet.
(2)
All penalties recovered under this section shall be deposited into the State
Board of Pharmacy Account established in ORS 689.139.
(3)
Any civil penalty under this section shall be imposed in the manner provided in
ORS 183.745.
(4)
Notwithstanding ORS 183.745, the person to whom the notice is addressed shall
have 10 days from the date of service of the notice in which to make written
application for a hearing before the board. [1981 c.217 §3; 1991 c.734 §77;
1993 c.571 §20; 1995 c.79 §348; 2005 c.726 §13; 2007 c.90 §2]
689.835 [1975
c.218 §3; 1979 c.785 §12; repealed by 1979 c.777 §59]
689.837 [1981
c.217 §4; repealed by 1993 c.571 §30]
689.840 [1975
c.218 §4; repealed by 1979 c.777 §59]
689.842 [1981
c.217 §5; repealed by 1993 c.571 §30]
689.845 [1975
c.218 §6; 1979 c.785 §13; repealed by 1979 c.777 §59]
689.847 [1981
c.217 §6; 1989 c.706 §23; repealed by 1991 c.734 §122]
689.850 [1975
c.218 §5; repealed by 1979 c.777 §59]
689.852 [1981
c.217 §7; 1991 c.734 §78; repealed by 1993 c.571 §30]
689.854 Civil penalty for violation of ORS
689.515. (1) In addition to all other penalties
provided by law every person who violates ORS 689.515 or any rule adopted
thereunder may incur a civil penalty of up to $250 for every such violation.
(2)
The penalty imposed under this section may be remitted or mitigated upon such
terms and conditions as the State Board of Pharmacy considers proper and
consistent with the public health and safety.
(3)
Civil penalties under this section shall be imposed as provided in ORS 183.745.
(4)
Civil penalties recovered under this section shall be deposited into the State
Board of Pharmacy Account established in ORS 689.139. [Formerly part of
689.515; 2005 c.726 §14]
689.855
[Formerly 453.310; repealed by 1979 c.777 §59]
689.857 [1981
c.217 §8; 1991 c.734 §79; subsection (2) formerly part of 689.515; repealed by
1993 c.571 §30]
689.860
[Formerly 453.320; repealed by 1979 c.777 §59]
689.865
[Formerly 453.020; 1973 c.743 §8; 1975 c.218 §7; 1979 c.785 §14; repealed by
1979 c.777 §59]
689.880 [1977
c.611 §3; repealed by 1979 c.777 §59]
689.885 [1977
c.611 §2; repealed by 1979 c.777 §59]
689.890 [1977 c.611
§4; repealed by 1979 c.777 §59]
689.895 [1977
c.255 §2; 1979 c.249 §2; repealed by 1979 c.777 §59]
689.990
[Subsection (12) of 1965 Replacement Part enacted as 1955 c.326 §13; 1967 c.158
§1; 1969 c.514 §54; repealed by 1979 c.777 §59]
689.992 [Repealed
by 1967 c.158 §2]
689.995 Criminal penalties.
(1) Violation of any provision of this chapter or of any rule of the State
Board of Pharmacy is a misdemeanor.
(2)
Failure to comply with any notice, citation or subpoena issued by the board
under ORS 689.135 (12) is a misdemeanor. Each day during which the violation
continues is a separate offense.
(3)
Refusal to furnish information required under this chapter or willfully
furnishing false information, is a misdemeanor.
(4)
Any attempt to secure or the securing of registration or licensure for any
person under any certificate, license or permit authorized by this chapter by
making or causing to be made any false representations is a misdemeanor. [1979
c.777 §41; 1985 c.131 §7; 1985 c.565 §115; 1993 c.571 §22; 2011 c.597 §143]
_______________