Oregon Administrative Rules Chapter 855 - BOARD OF PHARMACY
Oregon Administrative Rules (OAR) Chapter 855 is the comprehensive set of regulations overseen by the Oregon Board of Pharmacy. This chapter dictates nearly every aspect of pharmacy practice in the state, ensuring public health and safety in the distribution and use of medications.
Here's a breakdown of the key areas covered in OAR Chapter 855:
I. General Administration and Definitions (Divisions 1, 6, 10, 102, 104, 110):
Procedural Rules: Outlines how the Board operates, conducts meetings, and manages its administrative functions.
Definitions: Provides clear definitions for terms used throughout the rules, such as "pharmacist," "pharmacy technician," "drug outlet," "prescription," etc.
Fees: Specifies the various fees for licenses, registrations, renewals, and other services provided by the Board.
Public Health Emergency: Includes specific provisions for how pharmacy operations might be adapted during public health emergencies.
Health Professional's Service Program: Addresses programs for licensees facing impairment or other issues.
Universal Rules: Covers general requirements applicable to all licensees and registrants, such as record and document retention, patient access to records, and criminal background checks.
II. Pharmacists (Divisions 19, 20, 21, 115):
Licensure: Details the qualifications for obtaining a pharmacist license, including education, examination requirements (NAPLEX, MPJE), and reciprocity for out-of-state pharmacists. It also addresses licensure for foreign pharmacy graduates.
General Responsibilities of a Pharmacist: Outlines the core duties and responsibilities of licensed pharmacists, emphasizing professional judgment, patient care services, supervision of other pharmacy personnel (interns, technicians), and compliance with all laws and rules. This includes:
Drug Utilization Review (DUR)
Patient counseling
Medication Therapy Management (MTM)
Collaborative Drug Therapy Management
Administration of drugs (e.g., immunizations)
Pharmacist-in-Charge (PIC): Specifies the heightened responsibilities of the PIC for overall pharmacy operations, security, record-keeping, and ensuring compliance. This includes requirements for self-inspections and controlled substance inventories.
Continuing Pharmacy Education (CPE): Sets the requirements for ongoing education for pharmacists to maintain their licenses, including specific hours for pharmacy law, patient safety/medication error prevention, cultural competency, and pain management.
Prescriptive Authority: Addresses specific areas where pharmacists may have prescriptive authority under protocol, such as for contraceptives, naloxone, and various vaccines.
Prohibited Practices: Identifies actions or behaviors that are not allowed for pharmacists and can lead to disciplinary action.
III. Pharmacy Personnel (Divisions 25, 31, 120, 125):
Pharmacy Technicians and Certified Oregon Pharmacy Technicians: Outlines the requirements for registration, certification, scope of practice, and supervision for pharmacy technicians. This includes provisions for technician checking validation programs (TCVP) allowing technicians to perform final verification under specific conditions.
Interns: Defines the role, duties, and supervision requirements for pharmacy interns.
IV. Operation of Pharmacies and Drug Outlets (Divisions 35, 41, 42, 43, 44, 139, 141, 143):
Retail and Institutional Drug Outlets: Establishes comprehensive regulations for the operation of all types of pharmacies, including:
Security of prescription areas.
Minimum equipment requirements.
Proper storage of drugs.
Policies and procedures.
Requirements for prescriptions (authenticity, refills, expiration, labeling, recordkeeping).
Patient communication, including requirements for interpretation services and labels in multiple languages for limited English proficiency patients.
Drug loss reporting and disposal.
Nonprescription and Medical Device, Equipment, and Gas (MDEG) Outlets: Rules for outlets that sell over-the-counter drugs and medical devices.
Nuclear Pharmacies and Pharmacists: Specific regulations for the handling and dispensing of radioactive pharmaceuticals.
Practitioner Dispensing: Rules for healthcare practitioners who dispense medications directly to patients.
Charitable Pharmacies: Regulations specific to the operation of charitable pharmacies.
Drug Compounding: Rules governing the compounding of sterile and non-sterile preparations.
Non-Resident Pharmacies: Requirements for out-of-state pharmacies that dispense drugs to Oregon residents.
Newer Pharmacy Models: Includes regulations for:
Remote Dispensing Site Pharmacies (RDSP): Telepharmacy models where services are provided remotely by a pharmacist to a site staffed by a technician.
Pharmacy Prescription Kiosks and Lockers: Regulations for automated dispensing and pickup systems.
V. Drug Manufacturing and Distribution (Divisions 60, 62, 65):
Pharmaceutical Manufacturers: Licensing and operational requirements for drug manufacturers in Oregon.
Drug Distribution Agents: Regulations for entities involved in the distribution of drugs.
Wholesale Drug Outlets: Rules for wholesale distributors of drugs.
VI. Controlled Substances (Division 80):
Schedule of Controlled Substances: Defines the classification of controlled substances in Oregon.
Prescribing and Dispensing: Rules related to controlled substance prescriptions, including dispensing limits, refills, and electronic prescribing.
In summary, OAR Chapter 855 is a detailed and extensive legal framework that underpins the entire practice of pharmacy in Oregon, from the qualifications of individual pharmacists to the operational standards of drug outlets and the handling of controlled substances. Its primary goal is to protect public health and safety by ensuring competent practice, secure drug handling, and appropriate patient care.
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