Oregon Revised Statutes
Chapter 689 — Pharmacists; Drug Outlets; Drug Sales
204 sections
As used in this chapter:
“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 practitioner or the practitioner’s authorized agent; or
The patient or research subject at the direction of the practitioner.
“Approved continuing pharma…
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 c…
This chapter shall be known as the “Oregon Pharmacy Act.”
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 circumst…
STATE BOARD OF PHARMACY
The State Board of Pharmacy consists of nine 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:
Five must be licensed pharmacists.
Two must be licensed pharmacy technicians.
Two must be members …
The State Board of Pharmacy shall exercise the duties, powers and authority necessary to enforce this chapter and to enforce board rules adopted pursuant to this chapter, including but not limited to the following:
Annual printing and circulation of copies of any changes in the laws relating to pharmacy, controlled substances, drugs and poisons and the rule…
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…
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.
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:
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;
The renewal of licenses to engage i…
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 proce…
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:
The regulation of the sale at retail, the administering by pharmacists to the extent provided in ORS 689.645 and 68…
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 boa…
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.
The Executive Director of the State Board of Pharmacy shall rece…
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 determ…
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.
The employees of the board other than the executive director shall receive, as compensation, an annual salary payable mo…
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.
For the purpose of requesting a state or nationwide criminal records check under ORS 181A.195, the State Board of Pharmacy may require the fingerprints of a person who is:
Applying for a license or certificate that is issued by the board;
Applying for renewal of a license or certificate that is issued by the board; or
Under investigation by the board.
No…
PRACTICE OF PHARMACY
A person may not engage in the practice of pharmacy unless the person is licensed under this chapter or authorized in another state or United States territory and is practicing under ORS 676.347. Nothing in this section prevents physicians, dentists, veterinarians or other practitioners of the healing arts who are licensed under the laws of this state from d…
To obtain a license to engage in the practice of pharmacy, an applicant for licensure by examination shall:
Have submitted a written application in the form prescribed by the State Board of Pharmacy.
Have attained the age of 18 years.
Be of good moral character and temperate habits.
Have completed requirements for the first professional undergraduate deg…
To obtain a license as a pharmacist by reciprocity, an applicant for licensure shall:
Have submitted a written application in the form prescribed by the State Board of Pharmacy.
Have attained the age of 18 years.
Have good moral character and temperate habits.
Have possessed at the time of initial licensure as a pharmacist such other qualifications neces…
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.
The board shall specify by rule the procedures to be followed, in addition to tho…
The Legislative Assembly finds and declares that:
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;
The state…
In accordance with rules adopted by the State Board of Pharmacy under ORS 689.205, a pharmacist may engage in the practice of clinical pharmacy.
REGULATION OF DRUG OUTLETS
All drug outlets shall annually register with the State Board of Pharmacy.
Each drug outlet shall apply for a certificate of registration in one or more of the following classifications:
Retail drug outlet.
Institutional drug outlet.
Manufacturer drug outlet.
Wholesale distributor drug outlet.
Nonprescription drug outlet.
Third-party logistics provide…
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.
Applications for certificates of registration shall include the following information about the pro…
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:
Permanent closing;
Change of ownership, management, location or pharmacist in charge; or
Any and all other matters and occurrences as the board may require by rule.
Disasters, accidents an…
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.
Reinstatement of a certificate that has been suspended, revoked or rest…
As used in this section, “pharmacy prescription locker” means a mechanical device that serves as an extension of a retail drug outlet’s will call or point of sale area in which completed patient-specific prescription drugs, devices and related supplies and nonprescription drugs, devices and related supplies are stored for pickup.
A retail drug outlet may op…
DISCIPLINE
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:
Unprofessional conduct as that term is defined by the rules of the board.
Repeated or gross negligence.
Incapacity of a nature that prevents …
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:
Suspension of the offender’s license for a term to be deter…
Unless state or federal laws relating to confidentiality or the protection of health information prohibit disclosure, a pharmacist or pharmacy technician shall report:
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
Any prohibited conduct as defined in ORS 676.150 in the manne…
PHARMACY TECHNICIANS
It is unlawful for any person to perform the duties of a pharmacy technician or use the title of pharmacy technician unless licensed to perform the duties of a pharmacy technician.
To be licensed to perform the duties of a pharmacy technician, a person shall:
Submit a license application in the manner prescribed by the State Board of Pharmacy; and
Pay the…
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:
Prescribing the form and content of and the procedures for submitting an appl…
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 writin…
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.
A pharmacy reporting the termination of a pharmacy technician under subsection (1) of this section shall provide the pharmacy technician an opportunity t…
The State Board of Pharmacy may by rule identify activities performed by a pharmacy technician for which a specialized education program may be required.
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.
Up…
As used in this section:
“Health care provider” means a person that is licensed, certified or otherwise authorized under the laws of this state to prescribe, provide or dispense pharmaceutical products to patients for the purposes of diagnosis, treatment or care of disease, injury or congenital conditions including, but not limited to, a person who is:
A p…
Except as specifically provided by law and in compliance with ORS 689.564, a person may not 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 informat…
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 pu…
As used in this section unless the context requires otherwise:
“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.
“Dosage form” means the physical formulation or medium in which the product is intended, manufactured and made available for use, incl…
A pharmacy or pharmacist filling a prescription order for a biological product may not substitute a biological product for the prescribed biological product unless:
The substitute biological product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biological product;
The prescribing practitione…
ORS 689.522 does not prohibit an insurer or other health care payer from requiring prior authorization or imposing other appropriate utilization controls in approving coverage for any biological product.
Note: 689.524 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 …
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:
That it was issued pursuant to a valid patient-practitioner relationship; and
That it is authentic.
However, if t…
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.
As used in this section, “automatic vending machine” means any mechanical device or contrivance whereby the purchaser is able to secure drugs.
A person may not adulterate for the purpose of sale any drug in such m…
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 …
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.
Nothing in t…
The State Board of Pharmacy shall establish by rule instructions for the disposal of a marijuana item as defined in ORS 475C.009 left behind by individuals visiting retail drug outlets.
At a minimum, the instructions established under subsection (1) of this section must:
Require an employee or supervisor of the retail drug outlet to notify law enforcement …
As used in this section:
“Person who is blind” means a person who is:
Visually impaired;
Print disabled; or
A person who is blind as that term is defined in ORS 346.510.
“Prescription reader” means a device that is designed to audibly convey the information contained on the label of a prescription drug.
Except as provided in subsection (4) of this sect…
The State Board of Pharmacy shall adopt rules to require that, if a patient is of limited English proficiency and the prescribing practitioner, patient or an authorized representative of the patient so requests, a prescription drug dispensed by a pharmacy bear a label in both English and in the language requested and, if authorized by the board by rule, incl…
MISCELLANEOUS
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 prescr…
The addition of flavoring to a drug intended for dispensation may not be considered compounding if the flavoring:
Is inert, nonallergenic and has no effect other than imparting a flavor to the drug or modifying the flavor of the drug; and
Does not constitute more than five percent of the total volume of the drug.
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.
All pharmacist certificates issued by the State Board of Pharmacy shall bear the signatures of all members and officers of the board.
On payment by the applicant of the fee established by the board by …
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 th…
In accordance with rules adopted by the State Board of Pharmacy under ORS 689.205:
A pharmacist, or a pharmacy technician under the supervision of a pharmacist, may administer vaccines:
To persons who are seven years of age or older;
If authorized by the Governor or the Director of the Oregon Department of Emergency Management under ORS 433.441 or the Pub…
The State Board of Pharmacy shall convene a Public Health and Pharmacy Formulary Advisory Committee consisting of seven members, appointed by the Governor, for the purpose of advising the board in promulgating rules under ORS 689.645. The committee shall consist of:
Two physicians licensed to practice medicine under ORS 677.100 to 677.228;
Two advanced pra…
A pharmacist may administer a drug or device if the pharmacist is acting:
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
In accordance with the rules adopted by the State Board of Pharmacy regarding the administration of drugs and devices. [1…
A pharmacy may perform the tests and examinations described in subsection (2) of this section if the pharmacy obtains a waiver from the United States Department of Health and Human Services pursuant to 42 C.F.R. 493.35 and complies with the requirements of 42 C.F.R. 493.35, 493.37 and 493.39.
Tests and examinations authorized under this section include any …
Consistent with the protocols adopted by the State Board of Pharmacy by rule, as recommended by the Public Health and Pharmacy Formulary Advisory Committee, a pharmacist may test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and prescribe, dispense and administer treatment, including drug therapy, for SARS-CoV-2.
When testing for SARS-CoV…
In accordance with rules adopted by the State Board of Pharmacy under ORS 689.205, a pharmacist may prescribe and administer injectable hormonal contraceptives and prescribe and dispense self-administered hormonal contraceptives.
The board shall adopt rules to establish, in consultation with the Oregon Medical Board, the Oregon State Board of Nursing and th…
A pharmacist may dispense to a patient, pursuant to a prescription from a practitioner, a prescription drug that is approved by the United States Food and Drug Administration and that contains one or more cannabinoids.
The State Board of Pharmacy may adopt rules to carry out this section.
As used in this section:
“Insulin” includes various types of insulin analogs and insulin-like medications, regardless of activation period or whether the solution is mixed before or after dispensation.
“Insulin-related devices and supplies”:
Includes needles, syringes, cartridge systems, prefilled pen systems, glucose meters and test strips.
Does not inc…
A pharmacist may prescribe, dispense and administer to a patient medication for the treatment of opioid use disorder in accordance with:
A statewide drug therapy management protocol developed, in consultation with a physician with a background in addiction medicine, by the Public Health and Pharmacy Formulary Advisory Committee convened under ORS 689.649 an…
As used in this section, “telepharmacy” means the delivery of pharmacy services by a pharmacist, through the use of a variety of electronic and telecommunications technologies, to a patient at a remote location staffed by a pharmacy technician.
The pharmacy services for which a pharmacist may use telepharmacy include the supervision of the dispensation of p…
A pharmacist, pharmacy technician or intern, or an individual similarly licensed or otherwise authorized by another state, who is contracted or employed by a pharmacy may access the pharmacy’s electronic database regardless of whether the pharmacist, pharmacy technician or intern or other individual described in this subsection is physically located inside t…
As used in this section, “final verification” means, after prescription information is entered into a pharmacy’s electronic system and reviewed by a pharmacist for accuracy, a physical verification that the drug and drug dosage, device or product selected from a pharmacy’s inventory pursuant to the electronic system entry is the prescribed drug and drug dosa…
As used in this section:
“HIV test” has the meaning given that term in ORS 433.045.
“Post-exposure prophylactic antiretroviral therapy” means a drug or other therapy intended to reduce the likelihood of the acquisition of human immunodeficiency virus following a possible exposure to human immunodeficiency virus.
“Preexposure prophylactic antiretroviral th…
CHARITABLE PRESCRIPTION DRUG PROGRAM
As used in ORS 689.770 to 689.780, “the Charitable Prescription Drug Program” means a drug outlet that has:
A valid certificate of registration issued by the State Board of Pharmacy;
Volunteered to participate in the Charitable Prescription Drug Program; and
Been approved by the board to accept and distribute to needy individuals donated prescription drug…
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.
The program may accept and distribute within this state:
Prescription drugs received as donations in original, sealed, …
The State Board of Pharmacy shall adopt rules to carry out ORS 689.770 to 689.780, including but not limited to:
Specifying categories of prescription drugs that the Charitable Prescription Drug Program may not distribute under the program;
Prescribing the forms described in ORS 689.772;
Establishing the criteria for licensure and regulation under the pro…
The State Board of Pharmacy shall ensure compliance with ORS 689.770 to 689.780 by:
Inspecting the Charitable Prescription Drug Program on a regular basis; and
Auditing records required to be maintained by a pharmacy in connection with the program.
An individual is eligible to obtain donated prescription drugs through the Charitable Prescription Drug Program created in ORS 689.772 if the individual:
Is a resident of this state; and
Does not have health insurance coverage for the prescription drug requested;
Is enrolled in a program of public assistance, as defined in ORS 411.010, or medical assistan…
As used in this section, “participant” means:
A person who donates a prescription drug to the Charitable Prescription Drug Program;
The Charitable Prescription Drug Program;
The State Board of Pharmacy;
A pharmacist;
A drug manufacturer; or
A health practitioner.
A participant who accepts or distributes donated prescription drugs through the Charitabl…
As used in this section:
“Kit” means a package of one or more doses of a short-acting opioid antagonist and the necessary medical supplies to administer the short-acting opioid antagonist.
“Opioid” means a natural, synthetic or semisynthetic chemical that interacts with opioid receptors on nerve cells in the body and brain to reduce the intensity of pain s…
As used in this section:
“Opioid” means a natural, synthetic or semisynthetic chemical that interacts with opioid receptors on nerve cells in the body and brain to reduce the intensity of pain signals and feelings of pain.
“Opioid overdose” means a medical condition that causes depressed consciousness, depressed respiratory function or the impairment of vi…
For purposes of this section, “social services agency” includes, but is not limited to, homeless shelters and crisis centers.
A person may administer to an individual a short-acting opioid antagonist, as defined in ORS 689.800, that was not distributed to the person if:
The individual to whom the short-acting opioid antagonist is being administered appears…
A retail or hospital outpatient pharmacy shall provide written notice in a conspicuous manner that a short-acting opioid antagonist, as defined in ORS 689.800, and the necessary medical supplies to administer the short-acting opioid antagonist are available at the pharmacy.
The State Board of Pharmacy may adopt rules to carry out this section.
As used in this section, “opioid,” “opioid overdose” and “short-acting opioid antagonist” have the meanings given those terms in ORS 689.800.
The Public Health Officer appointed under ORS 431.045, or a physician licensed under ORS chapter 677 who is employed by the Oregon Health Authority, may issue a standing order to prescribe a short-acting opioid antago…
As used in this section, “kit,” “opioid,” “opioid overdose” and “short-acting opioid antagonist” have the meanings given those terms in ORS 689.800.
The owner of any building or facility to which the public has legal access may have in the building or facility one or more kits stored in a location in the building or facility easily accessible by members of …
A requirement that a health care provider who is authorized to prescribe drugs in this state label a drug dispensed by the health care provider with the information described in subsection (2) of this section does not apply to a drug approved by the United States Food and Drug Administration for the reversal of an opioid overdose if the drug is:
In the form…
PROHIBITIONS RELATED TO 340B DRUGS
As used in this section:
“Covered entity” has the meaning given that term in 42 U.S.C. 256b(a)(4).
“Manufacturer” has the meaning given that term in ORS 646A.689.
“340B drug” means a drug that has been subject to an offer of a reduced price by a manufacturer pursuant to 42 U.S.C. 256b and is purchased by a covered entity.
“Utilization review” has the mea…
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 ORS 689.818. A civil penalty imposed under this section may not exceed $5,000 per day on a manufacturer for each violation.
All penalties recovered under this section shall be deposited into the State Board of Pharmacy A…
PENALTIES
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 …
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.
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 pu…
Violation of any provision of this chapter or of any rule of the State Board of Pharmacy is a misdemeanor.
Failure to comply with any notice, citation or subpoena issued by the board under ORS 689.135 is a misdemeanor. Each day during which the violation continues is a separate offense.
Refusal to furnish information required under this chapter or willfull…