Oklahoma Administrative Code Title 535 - Oklahoma State Board of Pharmacy

Title 535 – Oklahoma State Board of Pharmacy

Chapter 1: General Provisions

535:1-1-1 — Purpose and Scope

Establishes the authority and duties of the Oklahoma State Board of Pharmacy.

Regulates the practice of pharmacy, including dispensing, compounding, and distribution of drugs.

Ensures public safety and compliance with federal and state pharmacy laws.

535:1-1-2 — Definitions

Key terms include:

Board – Oklahoma State Board of Pharmacy.

Pharmacy – Establishment licensed to dispense prescription drugs.

Pharmacist – Individual licensed to practice pharmacy.

Drug – Any substance intended for use in diagnosis, treatment, or prevention of disease.

Prescription – Order from a licensed practitioner for drugs to be dispensed to a patient.

Chapter 2: Licensure and Registration

535:1-2-1 — Pharmacist Licensure

Requirements include:

Graduation from an accredited pharmacy school,

Completion of internship hours approved by the Board,

Passing the North American Pharmacist Licensure Examination (NAPLEX) and Multistate Pharmacy Jurisprudence Examination (MPJE),

Submission of application and fees.

535:1-2-2 — Pharmacy Licensure

Pharmacies must be licensed by the Board before operating.

Requirements include inspection, proper facilities, recordkeeping, and compliance with regulations.

535:1-2-3 — Technician Registration

Pharmacy technicians must register with the Board.

Requirements include education, training, and compliance with scope of practice.

535:1-2-4 — Renewal

Licenses for pharmacists, pharmacies, and technicians must be renewed periodically.

Renewal requires fees, continuing education, and compliance with Board rules.

Chapter 3: Standards of Practice

535:1-3-1 — Pharmacy Operations

Pharmacies must maintain proper storage, security, sanitation, and recordkeeping.

All prescription drugs must be accurately labeled and dispensed.

535:1-3-2 — Compounding

Compounding must follow professional standards and USP guidelines.

Compounded drugs must be prepared safely and accurately.

535:1-3-3 — Dispensing

Pharmacists must ensure accuracy and appropriateness of all prescriptions.

Counseling patients on medication use is required when necessary.

535:1-3-4 — Controlled Substances

Controlled substances are subject to federal and state regulations.

Prescriptions must be properly documented, stored, and reported to the Prescription Monitoring Program (PMP).

Chapter 4: Inspections and Enforcement

535:1-4-1 — Inspections

The Board conducts routine and unannounced inspections of pharmacies, records, and operations.

Inspections verify compliance with regulations and identify violations.

535:1-4-2 — Complaints

Complaints may be filed against pharmacists, technicians, or pharmacies for alleged violations.

Complaints are investigated by Board staff.

535:1-4-3 — Disciplinary Actions

Violations may result in:

Fines

License suspension or revocation

Probation

Mandatory corrective actions

Chapter 5: Continuing Education

535:1-5-1 — Requirements

Pharmacists must complete a minimum number of continuing education (CE) hours per renewal period.

CE courses must be Board-approved and relevant to pharmacy practice.

535:1-5-2 — Recordkeeping

Licensees must maintain CE records for verification during audits or inspections.

Chapter 6: Administration and Fees

535:1-6-1 — Board Structure

The Board consists of appointed members including licensed pharmacists and public representatives.

Members serve fixed terms and oversee licensing, enforcement, and regulation.

535:1-6-2 — Fees

Fees are established for licensure, registration, inspections, and renewals.

Fees may vary based on license type and duration.

535:1-6-3 — Rules and Policies

The Board may adopt rules and policies to implement regulatory authority, including clarifications for licensing, inspections, and professional conduct.

Chapter 7: Recordkeeping and Reporting

535:1-7-1 — Prescription Records

Pharmacies must maintain accurate prescription records for all dispensed medications.

Records must be accessible for inspection and retained according to retention schedules.

535:1-7-2 — Reporting to PMP

Pharmacies must report controlled substance prescriptions to the state Prescription Monitoring Program.

Reporting ensures monitoring and prevention of misuse or diversion.

This summary covers the core structure of Title 535, including licensure, standards of practice, inspections, continuing education, enforcement, administration, and recordkeeping.

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