Or. Admin. Code § 855-006-0005

Current through Register Vol. 63, No. 11, November 1, 2024

Section 855-006-0005 - Definitions

As used in OAR Chapter 855:

(1) "Adulterated" has the same meaning as set forth in 21 USC 351 (v. 03/23/2024).

(2) "Alarm system" means a device or series of devices, which emit or transmit an audible or remote visual or electronic alarm signal, which is intended to summon a response.

(3) "Audiovisual communication system" means a continuously accessible, two-way audiovisual link that allows audiovisual communication in real-time and that prevents unauthorized disclosure of protected health information.

(4) "Biological product" means, with respect to the prevention, treatment or cure of a disease or condition of human beings, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component, blood derivative, allergenic product, protein other than a chemically synthesized polypeptide, analogous products or arsphenamine or any other trivalent organic arsenic compound.

(5) "Biosimilar" product means a biological product licensed by the United States Food and Drug Administration pursuant to 42 USC 262(k)(3)(A)(i) (v. 03/23/2024).

(6) "Board" means the Oregon Board of Pharmacy unless otherwise specified or required by the context.

(7) "Certified health care interpreter" has the meaning given that term in ORS 413.550.

(8) "Certified Oregon Pharmacy Technician" means a person who has taken and passed a national pharmacy technician certification examination offered by the Pharmacy Technician Certification Board (PTCB) or National Healthcareer Association (NHA) and is licensed by the State Board of Pharmacy who assists the Pharmacist in the practice of pharmacy pursuant to rules of the board.

(9) "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, or physician or naturopathic physician.

(10) "Collaborative Drug Therapy Management" means the participation by a Pharmacist in the management of drug therapy pursuant to a written protocol that includes information specific to the dosage, frequency, duration, and route of administration of the drug, authorized by a practitioner and initiated upon a prescription order for an individual patient and:

(a) Is agreed to by one Pharmacist and one practitioner; or

(b) Is agreed to by one or more Pharmacists at a single pharmacy registered by the board and one or more practitioners in a single organized medical group, such as a hospital medical staff, clinic, or group practice, including but not limited to organized medical groups using a pharmacy and therapeutics committee.

(11) "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or device:

(a) As the result of a practitioner's prescription drug order, or initiative based on the relationship between the practitioner, the Pharmacist and the patient, in the course of professional practice; or

(b) For the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing; or

(c) The preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

(12) "Confidential Information" means any patient information obtained by a Pharmacist or pharmacy.

(13) "Consulting Pharmacist" means a Pharmacist that provides a consulting service regarding a patient medication, therapy management, drug storage and management, security, education, or any other pharmaceutical service.

(14) "Counseling" or "Counsel" means communication between a pharmacist and a patient or a patient's agent in which the pharmacist provides the patient or patient's agent with advice regarding the safe and effective use of a drug or device.

(15) The "Container" is the device that holds the drug and that is or may be in direct contact with the drug.

(16) "Custodian of pharmacy records" means a board licensee or registrant who is responsible for the maintenance, care or keeping of pharmacy records based on the services provided by the pharmacy, regardless of whether the records are in that person's actual physical custody and control.

(17) "Dispensing or Dispense" 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.

(18) "Drug Regimen Review" or "DRR" means the process conducted by a Pharmacist who is consulting for a long-term-care facility or other institution, either prior to dispensing or at a later time, with the goal of ensuring that optimal patient outcomes are achieved from the drug therapy.

(19) "Drug utilization review" or "DUR" means evaluation of a prescription to identify and resolve potential problems through the review of information provided to the Pharmacist by the patient, patient's agent, prescriber and the patient's record.

(20) "Entry system" enables control of access to a secured area.

(21) "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 dosage, device, or product.

(22) "Good standing" means a license or registration that is not suspended, revoked, or otherwise restricted from the practice of pharmacy or subject to a current disciplinary order.

(23) "Health care interpreter" has the meaning given that term in ORS 413.550.

(24) "Health care interpreter registry" means the registry described in ORS 413.558 that is administered by the Oregon Health Authority.

(25) "Individual with limited English proficiency" means a person who, by reason of place of birth or culture, communicates in a language other than English and does not communicate in English with adequate ability to communicate effectively with a health care provider.

(26) "Interchangeable" means, in reference to a biological product, that the United States Food and Drug Administration has determined that a biosimilar product meets the safety standards set forth in 42 USC 262(k)(4) (v. 03/23/2024).

(27) "Intern" means a person who is enrolled in or has completed a course of study at a board approved college or school of pharmacy and who is licensed with the board as an Intern.

(28) "Interpretation and evaluation of prescription orders" means the review of the order for therapeutic and legal correctness. Therapeutic review includes identification of the prescription drug ordered, its applicability and its relationship to the other known medications used by the patient and determination of whether or not the dose and time interval of administration are within accepted limits of safety. The legal review for correctness of the prescription order includes a determination that the order is valid and has not been altered, is not a forgery, is prescribed for a legitimate medical purpose, contains all information required by federal and state law, and is within the practitioner's scope of practice.

(29) "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 non-prescription drug or commercially packaged legend drug or device.

(30) "Misbranded" has the same definition as set forth in 21 USC 352 (v. 03/23/2024).

(31) "Monitoring of therapeutic response or adverse effect of drug therapy" means the follow up of the therapeutic or adverse effect of medication upon a patient, including direct consultation with the patient or his agent and review of patient records, as to result and side effect, and the analysis of possible interactions with other medications that may be in the medication regimen of the patient. This section shall not be construed to prohibit monitoring by practitioners or their agents.

(32) "Medication Therapy Management (MTM)" means a distinct service or group of services that is intended to optimize therapeutic outcomes for individual patients. Medication Therapy Management services are independent of, but can occur in conjunction with, the provision of a medication product.

(33) "Nationally Certified Exam" means an exam that is approved by the board which demonstrates successful completion of a Specialized Education Program. The exam must be reliable, psychometrically sound, legally defensible, and valid.

(34) "Non-legend drug" means a drug which does not require dispensing by prescription and which is not restricted to use by practitioners only.

(35) "Offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of pharmacy" means, among other things:

(a) The creation and retention of accurate and complete patient records;

(b) Assuming authority and responsibility for product selection of drugs and devices;

(c) Developing and maintaining a safe practice setting for the Pharmacist, for pharmacy staff and for the general public;

(d) Maintaining confidentiality of patient information.

(36) "Official compendium" means the official United States Pharmacopeia <USP>, official National Formulary <NF> (v. USP NF 2023, Issue 3), official Homeopathic Pharmacopoeia of the United States <HPUS> (v. 2024), or any supplement to any of these.

(37) "Pharmaceutical Care" means the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life. These outcomes include:

(a) Cure of a disease;

(b) Elimination or reduction of a patient's symptomatology;

(c) Arrest or slowing of a disease process; or

(d) Prevention of a disease or symptomatology.

(38) "Pharmacist" means an individual licensed by this state to engage in the practice of pharmacy or to engage in the practice of clinical pharmacy.

(39) "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.

(40) "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.

(41) "Practice of pharmacy" is as defined in ORS 689.005.

(42) "Prescription drug" or "legend drug" is as defined in ORS 689.005 and:

(a) Required by federal law, prior to being dispensed or delivered, to be labeled with "Rx only"; 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.

(43) "Prescription released by the Pharmacist" means, a prescription which has been reviewed by the Pharmacist that does not require further Pharmacist intervention such as reconstitution or counseling.

(44) "Prohibited conduct" means conduct by a licensee that:

(a) Constitutes a criminal act against a patient or client; or

(b) Constitutes a criminal act that creates a risk of harm to a patient or client.

(45) "Proper and safe storage of drugs and devices and maintenance of proper records therefore" means housing drugs and devices under conditions and circumstances that:

(a) Assure retention of their purity and potency;

(b) Avoid confusion due to similarity of appearance, packaging, labeling or for any other reason;

(c) Assure security and minimize the risk of their loss through accident or theft;

(d) Accurately account for and record their receipt, retention, dispensing, distribution or destruction;

(e) Protect the health, safety and welfare of the Pharmacist, pharmacy staff and the general public from harmful exposure to hazardous substances.

(46) "Quality Assurance Plan" is a written set of procedures to ensure that a pharmacy has a planned and systematic process for the monitoring and evaluation of the quality and appropriateness of pharmacy services and for identifying and resolving problems.

(47) "Reasonable professional judgment" means an objectively reasonable and impartial belief, opinion or conclusion held with confidence, and founded on appropriate professional knowledge, skills, abilities, qualifications, and competencies, after careful review, analysis and consideration of the relevant subject matter and all relevant facts and circumstances that were then known by, or reasonably available to, the person or party holding such belief, opinion, or conclusion.

(48) "Reference biological product" means the biological product licensed pursuant to 42 USC 262(a) (v. 03/23/2024) against which a biological product is evaluated in an application submitted to the United States Food and Drug Administration for licensure of a biological product as a biosimilar product or for determination that a biosimilar product is interchangeable.

(49) "Repackage" means the act of taking a drug from the container in which it was distributed by the manufacturer and placing it into a different container without further manipulation of the drug.

(50) "Still image capture" means a specific image captured electronically from a video or other image capture device.

(51) "Store and forward" means a video or still image record which is saved electronically for future review.

(52) "Supervision by a Pharmacist" means being stationed within the same work area, except as authorized under OAR 855-041-3200 through OAR 855-041-3250, as the Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician being supervised, coupled with the ability to control and be responsible for the Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician's action.

(53) "Surveillance system" means a system of video cameras, monitors, recorders, and other equipment used for surveillance.

(54) "Tamper-resistant Prescription" means a form for the purpose of issuing a handwritten or typed prescription, intended to be manually delivered to a pharmacy, which has been developed, and formatted to ensure security, integrity and authenticity using currently accepted technologies. Formatted features may include but are not limited to characteristics such as:

(a) The word "void" appears when photocopies are attempted;

(b) Background ink which reveals attempted alterations;

(c) Heat sensitive ink that changes colors;

(d) Penetrating ink to prevent chemical alterations;

(e) A watermark which cannot be photocopied;

(f) Coin reactive ink that reveals word when rubbed with a coin;

(g) Sequential numbering.

(55) "Therapeutic substitution" means the act of dispensing a drug product with a different chemical structure for the drug product prescribed under circumstances where the prescriber has not given clear and conscious direction for substitution of the particular drug for the one which may later be ordered.

(56) "Verification" means the confirmation by the Pharmacist of the correctness, exactness, accuracy and completeness of the acts, tasks, or functions performed by an Intern, a Certified Oregon Pharmacy Technician, or a Pharmacy Technician.

Or. Admin. Code § 855-006-0005

1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1984, f. & ef. 4-16-84; PB 2-1988, f. & cert. ef. 5-3-88; PB 2-1989, f. & cert. ef. 1-30-89; PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1994, f. & cert. ef. 2-2-94; BP 4-1998, f. & cert. ef. 8-14-98; BP 1-2006, f. & cert. ef. 6-9-06; BP 12-2006, f. & cert. ef. 12-19-06; BP 2-2008, f. & cert. ef. 2-20-08; BP 6-2010, f. & cert. ef. 6-29-10; BP 3-2012, f. & cert. ef. 6-19-12; BP 8-2015, f. & cert. ef. 12/23/2015; BP 2-2016, f. 6-30-16, cert. ef. 7/1/2016; BP 12-2019, amend filed 12/20/2019, effective 12/20/2019; BP 1-2020, temporary amend filed 03/23/2020, effective 03/23/2020 through 09/17/2020; BP 87-2020, amend filed 09/11/2020, effective 9/11/2020; BP 15-2021, amend filed 06/15/2021, effective 6/15/2021; BP 29-2021, amend filed 12/10/2021, effective 12/10/2021; BP 32-2021, temporary amend filed 12/10/2021, effective 12/10/2021 through 06/07/2022; BP 15-2022, amend filed 04/20/2022, effective 4/20/2022; BP 25-2022, temporary amend filed 04/22/2022, effective 4/22/2022 through 10/18/2022; BP 27-2022, amend filed 06/15/2022, effective 6/16/2022; BP 57-2022, amend filed 12/20/2022, effective 12/21/2022; BP 10-2023, amend filed 06/13/2023, effective 6/13/2023; BP 12-2024, amend filed 02/15/2024, effective 3/1/2024; BP 57-2024, amend filed 06/18/2024, effective 6/20/2024

Publications: Publications referenced are available for review at the agency or from United States Pharmacopoeia.

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.005, ORS 689.151, ORS 689.155 & ORS 689.703