As used in this chapter:

Terms Used In Oregon Statutes 689.005

  • 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. See Oregon Statutes 689.005

  • Clinical pharmacy agreement: means an agreement between a pharmacist or pharmacy and a health care organization or a physician as defined in ORS § 677. See Oregon Statutes 689.005
  • Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
  • 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. See Oregon Statutes 689.005
  • 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. See Oregon Statutes 689.005
  • 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. See Oregon Statutes 689.005
  • 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. See Oregon Statutes 689.005
  • Drug outlet: means a 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. See Oregon Statutes 689.005
  • 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. See Oregon Statutes 689.005
  • Internship: means a professional experiential program approved by the board under the supervision of a licensed pharmacist registered with the board as a preceptor. See Oregon Statutes 689.005
  • 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. See Oregon Statutes 689.005
  • legend drug: means a drug that 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. See Oregon Statutes 689.005

  • 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. See Oregon Statutes 689.005

  • Manufacturer: means a person engaged in the manufacture of drugs. See Oregon Statutes 689.005
  • Nonprescription drugs: means drugs that may be sold without a prescription and that 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. See Oregon Statutes 689.005
  • Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
  • Person: means an individual, corporation, partnership, association or other legal entity. See Oregon Statutes 689.005
  • Pharmacist: means an individual licensed by this state to engage in the practice of pharmacy or to engage in the practice of clinical pharmacy. See Oregon Statutes 689.005
  • 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. See Oregon Statutes 689.005
  • 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. See Oregon Statutes 689.005

  • Preceptor: means a pharmacist or a person licensed by the board to supervise the internship training of a licensed intern. See Oregon Statutes 689.005
  • Third-party logistics provider: means an entity that:

    (a) Provides or coordinates warehousing of, or other logistics services for, a product in interstate commerce on behalf of a manufacturer, wholesale distributor or dispenser of the product; and

    (b) Does not take ownership of, or have responsibility to direct the sale or disposition of, the product. See Oregon Statutes 689.005

  • 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. See Oregon Statutes 689.005
  • United States: includes territories, outlying possessions and the District of Columbia. See Oregon Statutes 174.100

(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 State Board of Pharmacy.

(3) ‘Clinical pharmacy agreement’ means an agreement between a pharmacist or pharmacy and a health care organization or a physician as defined in ORS § 677.010 or a naturopathic physician as defined in ORS § 685.010 that permits the pharmacist to engage in the practice of clinical pharmacy for the benefit of the patients of the health care organization, physician or naturopathic physician.

(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 a 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 similar apparatus having electrical, digital, magnetic, wireless, optical, electromagnetic or similar capabilities.

(15) ‘Injectable hormonal contraceptive’ means a drug composed of a hormone or a combination of hormones that is approved by the United States Food and Drug Administration to prevent pregnancy and that a health care practitioner administers to the patient by injection.

(16) ‘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.

(17) ‘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.

(18) ‘Internship’ means a professional experiential program approved by the board under the supervision of a licensed pharmacist registered with the board as a preceptor.

(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 a business or other establishment that is open to the general public for the sale or nonprofit distribution of nonprescription drugs and is registered under ORS § 689.305.

(23) ‘Nonprescription drugs’ means drugs that may be sold without a prescription and that 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 other legal entity.

(25) ‘Pharmacist’ means an individual licensed by this state to engage in the practice of pharmacy or to engage in the practice of clinical 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 board who assists in the practice of pharmacy pursuant to rules of the board.

(28) ‘Practice of clinical pharmacy’ means:

(a) The health science discipline in which, in conjunction with the patient’s other practitioners, a pharmacist provides patient care to optimize medication therapy and to promote disease prevention and the patient’s health and wellness;

(b) The provision of patient care services, including but not limited to post-diagnostic disease state management services; and

(c) The practice of pharmacy by a pharmacist pursuant to a clinical pharmacy agreement.

(29) ‘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 and the providing of patient care services 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 regarding the safe storage of drugs and devices;

(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;

(i) The optimizing of drug therapy through the practice of clinical pharmacy;

(j) Patient care services, including medication therapy management and comprehensive medication review;

(k) The offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of pharmacy;

(L) The prescribing and administering of injectable hormonal contraceptives and the prescribing and dispensing of self-administered hormonal contraceptives pursuant to ORS § 689.689;

(m) The prescribing and dispensing of emergency refills of insulin and associated insulin-related devices and supplies pursuant to ORS § 689.696;

(n) The prescribing, dispensing and administering of preexposure prophylactic antiretroviral therapies and post-exposure prophylactic antiretroviral therapies, pursuant to ORS § 689.704 and rules adopted by the board under ORS § 689.645 and 689.704; and

(o) The delegation of tasks to other health care providers who are appropriately trained and authorized to perform the delegated tasks.

(30) ‘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.

(31) ‘Preceptor’ means a pharmacist or a person licensed by the board to supervise the internship training of a licensed intern.

(32) ‘Prescription drug’ or ‘legend drug’ means a drug that 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.

(33) ‘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.

(34) ‘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 where the practice of pharmacy may lawfully occur.

(35) ‘Self-administered hormonal contraceptive’ means a drug composed of a hormone or a combination of hormones that is approved by the United States Food and Drug Administration to prevent pregnancy and that the patient to whom the drug is prescribed may administer to oneself. ‘Self-administered hormonal contraceptive’ includes, but is not limited to, hormonal contraceptive patches and hormonal contraceptive pills.

(36) ‘Third-party logistics provider’ means an entity that:

(a) Provides or coordinates warehousing of, or other logistics services for, a product in interstate commerce on behalf of a manufacturer, wholesale distributor or dispenser of the product; and

(b) Does not take ownership of, or have responsibility to direct the sale or disposition of, the product.

(37) ‘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.

(38) ‘Wholesale distributor drug outlet’ means a person, other than a manufacturer, manufacturer’s colicensed partner, third-party logistics provider or repackager, as defined in 21 U.S.C. § 360eee(16), that is engaged in wholesale distribution, as defined in 21 U.S.C. § 353(e)(4). [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; 2015 c.362 § 3; 2015 c.649 § 4; 2017 c.289 § 1; 2017 c.356 § 93; 2019 c.95 § 4; 2021 c.365 § 3; 2022 c.45 § 25; 2023 c.93 § 1]

 

[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]

 

[1979 c.777 § 4; 1999 c.350 § 3; repealed by 2009 c.326 § 2]