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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 dlkackloudis@bmdllc.com or Attorney Jordan Burdick at jaburdick@bmdllc.com.