Pharmacy Law Update — Oklahoma State Board of Pharmacy Requirements
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Summarizes Oklahoma State Board of Pharmacy regulatory updates affecting pharmacy operations, compounding, immunizations, sterile practices, technician duties, and prescription monitoring for providers and pharmacies in Oklahoma.
No material clinical or coverage changes in this revision.
Coverage Criteria
Sterile office-use compounding is not permitted. Oklahoma-licensed pharmacies performing sterile compounding must hold a sterile compounding permit and comply with applicable USP standards, maintain required cleaning and equipment logs, and keep records of FDA-approved drug sourcing; compounding "for office use" may no longer be performed.
Prescribers are required to check the Prescription Monitoring Program (PMP) for new patients and for existing patients every 180 days when prescribing opiates, carisoprodol, or benzodiazepines; this requirement does not apply to hospice or long‑term care facility (LTCF) patients and must be documented in the patient’s chart.
Out‑of‑state physician assistants (PAs) and advanced registered nurse practitioners (ARNPs) are not authorized to practice in Oklahoma for controlled substance prescribing purposes; mid‑level practitioners must be licensed in Oklahoma and supervised by an Oklahoma‑licensed physician. Controlled substance (CDS III–V) supplies are limited to less than a 30‑day supply, with PAs authorized for up to 30 days (no refills) and APRNs allowed an original plus refills in any combination totaling up to 30 days.
Required Provider Actions & Documentation
Sterile compounding requires OK permit and USP compliance
Sterile compounding must be performed only by entities with an Oklahoma sterile compounding permit and in compliance with applicable USP standards (e.g., USP <797>); sterile office‑use compounding is not permitted. Outsourcing facilities producing non‑patient‑specific sterile products must meet appropriate outsourcing/503(b) and CGMP expectations.
- Sterile compounding permit required (Oklahoma).
- Must comply with applicable USP standards (e.g., USP <797>).
- Sterile office‑use compounding is not permitted; non‑sterile office use permitted; outsourcing facilities subject to 503(b)/CGMP.
Naloxone distribution: protocol or patient‑specific Rx only
Naloxone may be provided only via a physician protocol or a patient‑specific prescription; it is not available over‑the‑counter. Providers may use a local physician or contact the State Medical Director for protocol support and should provide patient/family education about seeking medical attention after use.
- Distribution permitted by physician protocol or patient‑specific Rx (NOT OTC).
- Sample protocols and educational tools available via provided resources.
Technician vs. pharmacist refill authorization rules
Technicians may accept refill authorizations from a prescriber’s office only when there are no changes to a non‑controlled (non‑CDS) prescription; pharmacists must take refill authorizations when changes are requested or for any controlled substance.
- Technician may take refill authorization for non‑CDS Rx when no changes are made.
- Pharmacist must take refill authorization if changes are made to a non‑CDS Rx or for any CDS Rx.
Mid‑level practitioner licensing, supervision, and CDS limits
Physician assistants and ARNPs must be licensed in Oklahoma and supervised by an Oklahoma‑licensed physician; out‑of‑state PAs/ARNPs are not authorized. Controlled‑substance prescribing for CDS III–V is limited to supplies under 30 days — PAs: up to 30 days with no refills; APRNs: original plus refills in any combination up to 30 days.
- No out‑of‑state PAs or ARNPs; must be licensed in OK and supervised by an OK‑licensed physician.
- CDS III–V supply limits: PA up to 30 days (no refills); APRN original + refills up to 30 days total.
Maintain temperature logs and immunization documentation
Maintain refrigerator/freezer temperature logs twice daily and keep immunization records and related documentation (including current CPR certification); date multi‑dose vials when opened and apply BUD per manufacturer or 28 days if unspecified.
- Logs for refrigerators/freezers must be maintained (twice daily).
- Immunizations require documentation; technicians may not administer immunizations; maintain current CPR.
- Date MDV when opened; default BUD 28 days unless manufacturer states otherwise.
Document PMP checks in the patient chart every 180 days as required
Prescribers must document in the patient’s chart that the Prescription Monitoring Program (PMP) was checked for new patients and for existing patients every 180 days when prescribing opiates, carisoprodol, or benzodiazepines.
- PMP review must be documented in the patient chart for new patients and every 180 days for existing patients on the listed drugs.
- PMP checks cannot be delegated to pharmacy and are enforceable by the prescriber’s licensing board.
Use DEA‑106 and send copies to OBNDD and OSBP; retain copy
When reporting thefts or losses of controlled substances, submit the DEA Form 106 electronically, send copies to the Oklahoma Bureau of Narcotics and Dangerous Drugs (OBNDD) and the Oklahoma State Board of Pharmacy (OSBP), and retain a personal copy for your records.
- Submit DEA 106 (electronic).
- Send copy to OBNDD (419 NE 38th Terrace OKC, OK 73105) and OSBP (2920 Lincoln Blvd, Ste A OKC, OK 73105).
- Keep a copy for your records.
Deliver patient‑specific fills to administration site and follow special handling
Patient‑specific filled prescriptions must be delivered to the location where they will be administered and require special handling when there is no permanent/secure mailing address or for certain categories (e.g., radiopharmaceuticals, ESRD, compounded medications); failure to deliver appropriately or follow special handling requirements may result in enforcement action.
- Deliver patient‑specific filled prescriptions to the site of administration.
- Special handling required for radiopharmaceuticals, ESRD medications, compounded medications, or when no permanent/secure mailing address exists.
- Failure to deliver to the appropriate location or follow handling requirements is actionable.
PMP check noncompliance may lead to disciplinary enforcement
Failure of a prescriber to check the PMP every 180 days for patients prescribed opiates, carisoprodol, or benzodiazepines may be enforced by the prescriber’s licensing board and could result in disciplinary action.
- PMP checks required for new patients and every 180 days for ongoing patients on specified drugs.
- Noncompliance is enforceable by the licensing board.
Background & Scope
This document summarizes regulatory and operational requirements from the Oklahoma State Board of Pharmacy relevant to pharmacies and prescribers, including standards and permit requirements for sterile compounding, obligations for PMP review and documentation, technician and immunization operational practices, recordkeeping (for example, cleaning and equipment logs), and restrictions on compounding for office use.
Key Definitions
Quantity Limits & Special Prescribing
Site of Care Requirements
Deliver patient‑specific prescriptions to site of administration
Patient‑specific filled prescriptions must be delivered to the location where they will be administered and require special handling when no permanent/secure mailing address exists or when the medication category requires it (e.g., ESRD, radiopharmaceuticals, compounded medications).
- Deliver to site of administration
- Require special handling when applicable or when no permanent/secure mailing address
Epinephrine may be prescribed to entities (schools/businesses) — up to 24 units
Prescribers may write epinephrine prescriptions to an entity (for example, a school or YMCA) and the pharmacy may fill the prescription to the entity name; prescribers are responsible for ensuring the entity has policies and procedures for proper usage and may provide up to 24 units.
- Prescribe epinephrine for an entity (e.g., school, YMCA) under the entity name
- Pharmacy may dispense and refill as directed by prescriber
- Quantity: up to 24 units
Step Therapy / Prescribing Limits
| Prescriber / Practitioner | Controlled Drugs (CDS) III–V Supply Limits |
|---|---|
| Physician Assistant (PA) | Covered: up to 30 days supply (no refills) |
| Advanced Practice Registered Nurse (APRN) | Covered: original plus refills in any combination up to 30 days total |
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