ORS Chapter 689
Chapter 689 — Pharmacists;Drug Outlets; Drug Sales
2009 EDITION
PHARMACISTS;DRUG OUTLETS; DRUG SALES
OCCUPATIONSAND PROFESSIONS
GENERALPROVISIONS
689.005 Definitions
689.025 Policy;purpose
689.035 Shorttitle
689.045 Severability
STATEBOARD OF PHARMACY
689.115 Membership;qualifications; term; vacancy; compensation
689.135 Generalpowers of board; fees
689.139 StateBoard of Pharmacy Account; disposition of receipts
689.145 Enforcementpowers of board
689.151 Boardcontrol over licensing, standards and discipline
689.153 Continuingauthority of board upon lapse, suspension, revocation or voluntary surrender oflicense or certificate
689.155 Authorityof board over medications, drugs, devices and other materials; rules
689.165 Officers;executive director
689.175 Compensationof board members and executive director
689.185 Meetings
689.195 Employees
689.205 Rulemaking
689.207 Authorityof board to require fingerprints
PRACTICEOF PHARMACY
689.225 Licenserequirement; exceptions; possession of drugs; regulation of pharmacytechnicians; rules; penalty
689.255 Qualificationsfor licensure by examination
689.265 Qualificationsfor licensure by reciprocity
689.275 Renewalof licenses; rules; fees
689.285 Continuingpharmacy education; rules; fees
REGULATIONOF DRUG OUTLETS
689.305 Registrationof drug outlets; rules
689.315 Application;rules
689.325 Requiredreports
689.335 Certificaterequired; reinstatement
DISCIPLINE
689.405 Groundsfor discipline; investigation; procedure as contested case
689.445 Penaltiesand reinstatement
689.455 Dutyto report suspected violations and prohibited conduct; liability for reporting;confidentiality of report
PHARMACYTECHNICIANS
689.486 Whenlicense required; qualifications for licensure; renewal; supervision required
689.490 Boardto establish licensing system; rules; fees
689.495 Provisionof licensing information
689.497 Reportrequired upon termination of pharmacy technician
689.499 Pharmacytechnician specialized education program; rules
REQUIREMENTSRELATING TO SALES
689.505 Labelingrequirements; rules
689.508 Prescriptionrecords
689.515 Regulationof generic drugs; substitutions; rules
689.525 Out-of-stateprescriptions
689.527 Prohibitedpractices; rules
689.532 Complimentarysamples
689.555 Agriculturaldrugs, nonprescription drugs and certain other substances
MISCELLANEOUS
689.605 Powerto dispense drugs from hospital pharmacies, drug rooms and penal institutions;rules
689.615 Displayof certificate or license
689.635 Dispensingaccording to naturopathic formulary; effect of filling prescription ofnaturopath
689.645 Powerto administer vaccines and immunizations; Immunization and Vaccination AdvisoryCommittee; rules
689.655 Powerto administer drugs and devices; rules
CHARITABLEPRESCRIPTION DRUG PROGRAM
689.770 Definitionsfor ORS 689.770 to 689.780
689.772 Establishmentof program; immunity from liability
689.774 Rules
689.776 Inspection;audit
689.778 Eligibility
689.780 Immunity
PENALTIES
689.832 Civilpenalties
689.854 Civilpenalty for violation of ORS 689.515
689.995 Criminalpenalties
GENERALPROVISIONS
689.005Definitions.As used in this chapter:
(1)“Administer” means the direct application of a drug or device whether byinjection, inhalation, ingestion, or any other means, to the body of a patientor 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 pharmacyapproved 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 ofsocio-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 creditsfor approved continuing education courses and programs.
(6)“Deliver” or “delivery” means the actual, constructive or attempted transfer ofa 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 anycomponent part or accessory, which is required under federal or state law to beprescribed by a practitioner and dispensed by a pharmacist.
(8)“Dispense” or “dispensing” means the preparation and delivery of a prescriptiondrug pursuant to a lawful order of a practitioner in a suitable containerappropriately labeled for subsequent administration to or use by a patient orother individual entitled to receive the prescription drug.
(9)“Distribute” means the delivery of a drug other than by administering ordispensing.
(10)“Drug” means:
(a)Articles recognized as drugs in the official United States Pharmacopoeia,official National Formulary, official Homeopathic Pharmacopoeia, other drugcompendium or any supplement to any of them;
(b)Articles intended for use in the diagnosis, cure, mitigation, treatment orprevention of disease in a human or other animal;
(c)Articles, other than food, intended to affect the structure or any function ofthe 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 carefacility, for an ultimate user of any drug or device issued and signed by apractitioner, or an order transmitted by other means of communication from apractitioner, that is immediately reduced to writing by a pharmacist, licensednurse or other practitioner.
(12)“Drug outlet” means any pharmacy, nursing home, shelter home, convalescenthome, 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 withfacilities 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 carefacility that does not have a licensed pharmacy.
(14)“Electronically transmitted” or “electronic transmission” means a communicationsent or received through technological apparatuses, including computerterminals or other equipment or mechanisms linked by telephone or microwaverelays, or any similar apparatus having electrical, digital, magnetic,wireless, optical, electromagnetic or similar capabilities.
(15)“Institutional drug outlet” means hospitals and inpatient care facilities wheremedications are dispensed to another health care professional for administrationto patients served by the hospitals or facilities.
(16)“Intern” means a person who is enrolled in or has completed a course of studyat a school or college of pharmacy approved by the board and who is licensedwith the board as an intern.
(17)“Internship” means a professional experiential program approved by the boardunder the supervision of a licensed pharmacist registered with the board as apreceptor.
(18)“Itinerant vendor” means a person who sells or distributes nonprescriptiondrugs by passing from house to house, or by haranguing the people on the publicstreets or in public places, or who uses the customary devices for attractingcrowds, recommending their wares and offering them for sale.
(19)“Labeling” means the process of preparing and affixing of a label to any drugcontainer exclusive, however, of the labeling by a manufacturer, packer ordistributor of a nonprescription drug or commercially packaged legend drug ordevice.
(20)“Manufacture” means the production, preparation, propagation, compounding,conversion or processing of a device or a drug, either directly or indirectlyby extraction from substances of natural origin or independently by means ofchemical synthesis or by a combination of extraction and chemical synthesis andincludes any packaging or repackaging of the substances or labeling orrelabeling of its container, except that this term does not include thepreparation or compounding of a drug by an individual for their own use or thepreparation, compounding, packaging or labeling of a drug:
(a)By a practitioner as an incident to administering or dispensing of a drug inthe course of professional practice; or
(b)By a practitioner or by the practitioner’s authorization under supervision ofthe practitioner for the purpose of or as an incident to research, teaching orchemical analysis and not for sale.
(21)“Manufacturer” means a person engaged in the manufacture of drugs.
(22)“Nonprescription drug outlet” means shopkeepers and itinerant vendorsregistered under ORS 689.305.
(23)“Nonprescription drugs” means drugs which may be sold without a prescriptionand which are prepackaged for use by the consumer and labeled in accordancewith the requirements of the statutes and regulations of this state and thefederal government.
(24)“Person” means an individual, corporation, partnership, association or anyother legal entity.
(25)“Pharmacist” means an individual licensed by this state to engage in thepractice of pharmacy.
(26)“Pharmacy” means a place that meets the requirements of rules of the board, islicensed and approved by the board where the practice of pharmacy may lawfullyoccur and includes apothecaries, drug stores, dispensaries, hospital outpatientpharmacies, pharmacy departments and prescription laboratories but does notinclude a place used by a manufacturer or wholesaler.
(27)“Pharmacy technician” means a person licensed by the State Board of Pharmacywho assists the pharmacist in the practice of pharmacy pursuant to rules of theboard.
(28)“Practice of pharmacy” means:
(a)The interpretation and evaluation of prescription orders;
(b)The compounding, dispensing and labeling of drugs and devices, except labelingby a manufacturer, packer or distributor of nonprescription drugs andcommercially packaged legend drugs and devices;
(c)The administering of vaccines and immunizations pursuant to ORS 689.645;
(d)The administering of drugs and devices to the extent permitted under ORS689.655;
(e)The participation in drug selection and drug utilization reviews;
(f)The proper and safe storage of drugs and devices and the maintenance of properrecords therefor;
(g)The responsibility for advising, where necessary or where regulated, oftherapeutic 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 transactionsnecessary in the conduct, operation, management and control of pharmacy.
(29)“Practitioner” means a person licensed and operating within the scope of suchlicense to prescribe, dispense, conduct research with respect to or administerdrugs 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 notreside in Oregon and is registered under the federal Controlled Substances Act.
(30)“Preceptor” means a pharmacist or a person licensed by the board to supervisethe 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 labeledwith either of the following statements:
(A)“Caution: Federal law prohibits dispensing without prescription”; or