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Unveiling Ohio's Pharmacy Board Updates for Distributors, Mobile Clinics, and Controlled Substances

Client Alert

The Ohio Board of Pharmacy will hold a public hearing on May 28, 2024, to discuss several proposed changes and additions to Ohio Administrative Code (OAC). These changes pertain to terminal distributors of dangerous drugs (TDDDs), mobile clinics or medication units, and the classification of controlled substances. Below is a detailed overview of the proposed rules, their purposes, and their implications. 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 or for additional information.

OAC 4729:5-2-03: Change in Description of a Terminal Distributor of Dangerous Drugs (New Rule)
This new rule provides guidelines for TDDDs when there is a change in ownership. Under the rule, any change in ownership, business or trade name, category, or address requires the TDDD to submit an application and fee within 30 days of the change. Under the rule, a change in ownership includes (1) any business entity change from its original form, as licensed, to a sole proprietorship, partnership, limited liability company, corporation, or any other business entity; (2) mergers of wholly owned subsidiaries of a parent company; and (3) purchase or operation by a different business entity than what is listed on the original application of a TDDD (even if the location maintains the original "doing business as" (DBA) and/ or responsible person).

OAC 4729:5-2-04: Procedure for Discontinuing Business as a Terminal Distributor of Dangerous Drugs (Amended Rule)
The amended rule outlines procedures for TDDDs that plan to discontinue business activities.

Under the amended rule, a TDDD that plans to discontinue business activities must file a notice with the Board of Pharmacy within 30 days of their discontinuation of business. Previously, the notice had to be filed at least 30 days in advance of the proposed date of discontinuing business.

Additionally, the amended rule adds language that the TDDD must complete a full inventory of all controlled substances being transferred or disposed of on the date business is discontinued. The inventory must list the name, strength, dosage form, and quantity of all controlled substances transferred or disposed. Further, a copy of the inventory should be included in the records of each licensee involved in the transfer.

Last, under the amended rule, TDDD pharmacies that permanently close must notify patients who have filled prescriptions within the previous six months at the pharmacy of the closing. Additionally, the pharmacy must provide new patients filling prescriptions during the fifteen-calendar day period prior to the pharmacy closing with written notification that meets the requirements outlined in the rule.

OAC 4729:5-3-23: Mobile Clinics or Medication Units (New Rule)
This new rule allows nonprofit organizations, corporations, or for-profit entities to operate mobile units to dispense, personally furnish, distribute, or administer prescription medications to patients who do not have a fixed address or who lack access to medication services. All mobile clinics and medication units must register for a no-cost, satellite license affiliated with an existing terminal distributor. Further, a licensed pharmacist or healthcare professional must be present when dangerous drugs are dispensed or personally furnished from the mobile clinic. Additionally, no controlled substances may be left in the mobile clinic when the clinic is not in use.

Last, mobile units must comply with certain record-keeping and security requirements. For instance, the mobile unit must also implement a record-keeping system that tracks the proper receipt, delivery, disposal, and return of all prescription medications; the mobile unit must be dry, well lit, well ventilated, and sanitary; the mobile unit’s storage area for dangerous drugs must be maintained at temperatures and conditions that ensure the integrity of the drugs; and the mobile unit must be secured with suitable locks capable of preventing unauthorized access.

OAC 4729:5-5-18: Dispensing of Multiple Drugs in Single-Dose or Multi-Dose Containers (Amended Rule)
Under the amended rule, outpatient pharmacists may dispense customized patient medication packages (CPMPs) in lieu of dispensing two or more dangerous drugs in separate containers. A CPMP is a package for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. Previously, the quantity of the package dispensed could not exceed a 31-day supply. Now, the quantity cannot exceed a 90-day supply.

Additionally, labels affixed to the package must be of sufficient size to clearly indicate the contents of the 90-day (or less) supply.  Previously, the labels had to show a 31-day (or less) supply.

OAC 4729:9-1-04: Schedule IV controlled substances (Amended rule)
Under the amended rule, Fenfluramine is no longer considered a Schedule IV-controlled substance.

For further details or to prepare comments on these proposed rule changes, please contact BMD Healthcare Member Daphne Kackloudis at or Attorney Jordan Burdick at

LGBTQIA+ Patients and Discrimination in Healthcare

In early April, the Kaiser Family Foundation released a study outlining the challenges that LGBT adults face in the United States related to healthcare. According to the study, LGBT patients are “twice as likely as non-LGBT adults to report negative experiences while receiving health care in the last three years, including being treated unfairly or with disrespect (33% v. 15%) or having at least one of several other negative experiences with a provider (61% v. 31%), including a provider assuming something about them without asking, suggesting they were personally to blame for a health problem, ignoring a direct request or question, or refusing to prescribe needed pain medication.”

Ohio Recovery Housing Overhaul: New Standards and Certification Requirements Reshape Sober Living Spaces

Ensuring Fair Access: SB 269 Protects Affordable Medication for Low-Income Patients

SB 269, introduced on December 19, 2023, will ensure that 340B covered entities, including Federally Qualified Health Centers, Ryan White Clinics, disproportionate share hospitals, and Title X clinics, can acquire 340B drugs without facing undue restrictions or discriminatory practices from drug manufacturers and distributors. This protection is crucial for 340B covered entities to continue to provide affordable medications and comprehensive services to low-income patients.

House Bill 249: Key Updates to Involuntary Hospitalization Law for Mental Health Providers

House Bill 249 (HB 249) proposes changes to Ohio Revised Code (ORC) Sections 5122.01 and 5122.10 to expand the conditions under which a person with a mental illness can be involuntarily hospitalized.

Starting an Advanced Practice Provider Practice

Advanced practice providers (APPs), which includes non-physician providers such as nurse practitioners, physician assistants, and nurse anesthetists, commonly start their own healthcare practices. Practices may provide, for example, service offerings such as primary care, anesthesiology, mental health, and aesthetics (medical spas). However, there are a number of considerations and steps that must be taken for APPs to compliantly function independently.