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The Ohio Board of Pharmacy (BOP) has rescinded certain OAC rules (OAC 4729:5-18-01 through 4729:5-18-06), removing regulations on office-based opioid treatment (OBOT) clinics. The rescissions took effect on June 3, 2024.

The BOP also published a new rule, OAC 4729:8-5-01, which sets explicit reporting guidelines for licensed dispensaries and became effective on June 7, 2024.

Below is a detailed overview of the new, rescinded, and proposed rules.

Ownership - OAC 4729:5-18-02 (Rescinded)
This rule mandated that OBOT clinics be solely owned and operated by physicians. Non-physician ownership is now permitted, eliminating the need for waivers previously required for such ownership. Additionally, the requirement to submit a new licensure application upon any change of ownership has been removed, offering greater flexibility in the ownership and operation of OBOT clinics.

Criminal Records Checks for Office-Based Opioid Treatment Clinics - OAC 4729:5-18-03 (Rescinded)
This rule required OBOT clinics to conduct both Ohio Bureau of Criminal Identification and Investigation (BCI&I) and Federal Bureau of Investigations (FBI) records checks for physician owners, officers, and specified personnel, including fingerprint submissions. Clinics also had to ensure that employees had no felony theft or drug abuse convictions within the past ten years, with new checks required for any personnel changes.

Security, Control, and Storage of Dangerous Drugs - OAC 4729:5-18-04 (Rescinded)
This rule mandated that controlled substances be stored in locked, substantially constructed cabinets or safes, with limited access to prescribers and certain licensed health care professionals.

Record Keeping - OAC 4729:5-18-05 (Rescinded)
This rule required OBOT clinics to maintain comprehensive records of all dangerous drugs received, administered, personally furnished, disposed of, sold, or transferred, including specifics about drug receipts, temperature control monitoring, patient and prescriber information, and drug disposal methods.

Compliance - OAC 4729:5-18-06 (Rescinded)
This rule outlined the compliance requirements that OBOT clinics were required to follow.

Dispensary Reporting into the Prescription Monitoring Program - OAC 4729:8-5-01 (New)
Effective June 7, 2024, this rule requires that licensed dispensaries report detailed medical marijuana dispensing information to the BOP within five (5) minutes of dispensing. Required data includes dispensary and patient details, the recommending physician’s Drug Enforcement Agency number, and comprehensive prescription information. If no dispensing occurs in a 24-hour period, the dispensary must submit a "zero report" within thirty-six (36) hours of the previous report. Dispensaries closed on certain days must inform the BOP of its hours to automate "zero reports" for non-business days. Additionally, dispensaries must notify the BOP if it ceases dispensing medical marijuana. All information must be formatted according to the American Society for Automation in Pharmacy standards and comply with confidentiality laws. This rule aims to ensure accurate, timely, and confidential reporting to enhance monitoring and compliance within the medical marijuana program.

There will be a hearing on July 16, 2024, for the proposed new and amended rules below. Public comments are due by the date of the hearing. Please reach out to BMD Member Daphne Kackloudis for help preparing comments on these rules.  

Disciplinary Actions (Pharmacists) - ORC 4729:1-4-01 (Amended)
This amended rule defines the word “reckless behavior” in the context of pharmacy personnel. Additionally, the rule narrows the scope of violations involving conspiracy, attempts, or aiding and abetting considered by the BOP, and exempts pharmacy personnel from disciplinary action related to an error in dispensing unless the individual engaged in reckless behavior.

Duty to Report (Pharmacists) - ORC 4729:1-4-02 (New)
This new rule establishes clear requirements for when and how pharmacists should notify the BOP about violations of Ohio laws. Under this proposed rule, pharmacists are obligated to report knowledge of violations, including practicing while impaired by substances, unprofessional conduct, and dispensing errors, to the Board within ten (10) days of discovery. The rule maintains the confidentiality of the reporting pharmacist, though they may be required to testify in disciplinary proceedings without disclosing their identity as the reporter. Additionally, pharmacists must report criminal convictions, entry into diversion programs, arrests for felonies, and any disciplinary actions taken by other states within ten (10) days of such events.

New rules (ORC 4729:2-4-02 and ORC 4729:3-4-02) also extend reporting obligations to pharmacy interns and pharmacy technicians for the same conduct.

Continuous Quality Improvement Programs in Pharmacy Services - ORC 4729:5-3-22 (New)
This new rule mandates that all pharmacies licensed as terminal distributors of dangerous drugs establish Continuous Quality Improvement (CQI) programs. This rule aims to enhance patient safety and the quality of pharmacy services by systematically addressing and preventing dispensing errors.

Under this new rule, pharmacies must implement or participate in a CQI program that documents, assesses, and responds to dispensing errors. Dispensing errors are broadly defined, encompassing variations from prescriber's orders, failure to exercise professional judgment in identifying and managing drug interactions, and errors in bulk repackaging or filling of automated devices. This program shall include written policies, internal reporting mechanisms, and documentation of all quality assurance activities for a minimum of three (3) years.

In the event of a dispensing error, pharmacies are required to promptly communicate the error to the patient or caregiver and, if the error could result in patient harm, to the prescriber. Documentation of these communications must be maintained for three (3) years.

Duty to Report (Pharmacies) - ORC 4729:5-4-02 (New)
The new rule mandates that pharmacies report any dispensing errors resulting from reckless behavior or errors that result in permanent patient harm, near-death events, or patient death, as categorized by the National Coordinating Council for Medication Error Reporting and Prevention Medication Error Index. Additionally, pharmacies are required to report the termination or resignation of any licensed or registered individual due to dispensing errors, unprofessional conduct, dishonesty, reckless behavior, or impairment by substances that render them unfit for professional duties.

Reports must be submitted by mail, through the Board’s online complaint form, or by telephone within ten (10) days of the quality assurance review or the employment action.

For assistance or questions regarding these regulatory updates, please contact BMD Healthcare Member Daphne Kackloudis at dlkackloudis@bmdllc.com or Attorney Jordan Burdick at jaburdick@bmdllc.com.