The Ohio Board of Pharmacy has announced plans to revise certain pharmacy regulations, initiating a process that includes both the adoption of new rules and the repeal of outdated ones. A recent public hearing offered insight into these proposed regulatory adjustments, which have the potential to affect pharmacists, pharmacies, and home medical equipment providers throughout the state.
It is important for pharmacies and pharmacists to stay informed about these developments and assess the impact any rule changes may have on their operations and compliance obligations.
Key Proposed Rule Changes: What Licensees Should Know About the Proposed Rules & Regulations
A. Update to Schedule I Controlled Substances Classification
The Ohio Board has proposed a revision to the state’s Schedule I Controlled Substances list to include compounds that meet the structural requirements of the 2- benzyl benzimidazole “nitazene” opioid pharmacophores. While the Board acknowledged potential concerns from stakeholders – particularly related to criminal penalties and implications for manufacturers and distributors – it emphasized that public safety remains the primary goal. The proposal responds to the DEA’s emergency scheduling of seven nitazene-related opioids in April 2022 due to rising health risks.
B. Revisions to Disciplinary Action Rules
The Board also proposed an amendment to its rules on disciplinary actions by eliminating references to “moral turpitude” – a now-unlawful licensing criterion in Ohio – and incorporating clearer language around disqualifying offenses. This change reflects an effort to align disciplinary protocols with updated statutory standards.
C. Amendments Related to Home Medical Equipment Providers
Proposed amendments will increase regulatory oversight of home medical equipment providers. These providers may experience increased costs by having to respond with a corrective action for issues found during an inspection. If violations are identified during an inspection, providers may be required to submit a corrective action plan within 30 days. This added layer of compliance could lead to increased operational costs and heightened scrutiny.
How Frier Levitt Can Help
Pharmacists and pharmacies should be cognizant of any changes to their Board of Pharmacy’s rules and regulations. Frier Levitt has extensive experience representing pharmacies, pharmacists, pharmacy suppliers and distributors and healthcare providers in matters involving licensing boards and state and federal regulatory enforcement. Our attorneys help clients navigate complex rule changes, prepare for public hearings, and implement compliance strategies that mitigate risk.
If your pharmacy or business is affected by these proposed updates – or if you operate in another state considering similar action – our team is here to help.
Contact us today to speak with an experienced member of our pharmacy law team.
