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

Client Alert
May 24, 2024

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.

Ohio State Board of PharmacyOhio Administrative CodeControlled SubstancesPharmacyHealth LawHealthcareDaphne KackloudisJordan Burdick
Client Alert

Changes to FFCRA Paid Leave: Congress’ Revisions to Employment COVID-19 Leave Benefits Signals the Light is at the End of the Tunnel

December 28, 2020Late in the evening on December 27th, President Trump signed into law the government’s $900 billion COVID-19 relief package (the “Stimulus Bill”). Among other economic stimulus benefits, the Stimulus Bill contains the $600 stimulus checks that will be issued to eligible individuals as well as, relevantly, changes to the Families First Coronavirus Response Act (“FFCRA”). The FFCRA was implemented in April 2020 and provided benefits to individuals who missed work as a result of an actual or suspected COVID-19 illness or to care for a child when their school or childcare service was closed because of COVID-19. Importantly, the Stimulus Bill extends eligibility for employer payroll tax refunds for leave payments made to employees on or before March 31, 2021 under the FFCRA, signaling to the American people that Congress believes many of the employed public will be vaccinated by this time, the light at the end of the tunnel. However, the Stimulus Bill does contain a caveat that employers are no longer required to provide FFCRA leave benefits after December 31, 2020, but if they do, they will receive the payroll tax credits, up to the maximums provided in the FFCRA, for payments made prior to April 1, 2021. Below we provide a list of questions and answers we received to date following the passage of the Stimulus Bill. We expect the U.S. Department of Labor (“DOL”) to issue additional questions and answers as the Stimulus Bill is implemented, and we will update this Client Alert as these are received.Client Alert

Healthcare Speaker Programs: New OIG Alert

December 11, 2020In a rare Special Fraud Alert issued on November 16, 2020 (the “Alert”), the Office of Inspector General (“OIG”) urged companies who host speaker programs to reassess their programs in light of the “inherent risks” associated with these activities. The Alert reports that, in the last three years, drug and device companies have reported paying nearly $2 billion to health care professionals for speaker-related services.Client Alert

Value-Based Care Advances – CMS Issues New Final Rules for Stark and Anti-Kickback Statutes

December 11, 2020The Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) issued two highly anticipated (and quite extensive) Final Rules to reform the Stark Law and Anti-Kickback Statute (“AKS”) regulations. The Final Rules generally take effect on January 19, 2021. The Final Rules include new safe harbors for the AKS and new exemptions to the Stark Law to allow for greater flexibility. According to the HHS, the goal of updating both laws is to make it easier for providers to engage in care coordination and value-based care programs without running afoul of the statutes. Please note that this client alert could not cover the full extent of the Final Rule changes so please contact your BMD Healthcare attorney with questions.Client Alert

Mandatory Filings Under CFIUS New Rules

December 11, 2020On September 15, 2020, the Committee on Foreign Investment in the United States (“CFIUS”) promulgated a final rule modifying its mandatory declaration requirements for certain foreign investment transactions involving “TID US businesses” (sensitive U.S. businesses dealing in critical technologies, critical infrastructure and sensitive personal data) dealing in “critical technologies” – i.e., U.S. businesses that produce, design, test, manufacture, fabricate, or develop one or more critical technologies. The new rule also makes amendments to the definition of the term “substantial interest” (used to determine whether a foreign government has a substantial interest in an entity). The final rule became effective on October 15, 2020.Client Alert

IRS Guidance on Employee Retention Credit

December 11, 2020The Employee Retention Credit created under Section 2302 of the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act is a refundable tax credit against certain employment taxes equal to 50 percent of the qualified wages an eligible employer pays to employees after March 12, 2020, and before January 1, 2021. Since the adoption of the CARES Act, employers have expressed concern that if one employer acquires another employer that previously received a PPP loan, the acquirer’s entire aggregated group may no longer be eligible to claim the Employee Retention Credit.
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