The OSMA Division of Regulatory Affairs actively monitors the activities of state and federal regulatory agencies. If necessary, the OSMA engages with the agency and/or submits comments to the agency that is drafting new or amended rules. Advocating the OSMA’s position on draft rules is one of the most active points of involvement in the entire regulatory process.
For more information, contact Jennifer Hayhurst, OSMA Director of Regulatory Affairs, (614) 527-6762.
OSMA Regulatory Advisory Panel (NEW!)
If you would like to assist the OSMA in reviewing new rule drafts, please consider joining the OSMA's Regulatory Advisory Panel. If interested, please contact Jennifer Hayhurst for details.
OSMA Rule Watch
The OSMA is actively monitoring the following rules:
Medical Marijuana Rules-The State Medical Board of Ohio, The Ohio State Board of Pharmacy and the Ohio Department of Commerce will be drafting rules to implement recent changes to Ohio law regarding medical marijuana. The OSMA will be actively following the regulatory process.
State Medical Board of Ohio
Ohio Department of Health
The Ohio Department of Health (ODH) has substantially amended Ohio Administrative Code (OAC) rules 3701-7-07 to 3701-7-11 pertaining to the Licensing of Maternity Units, Newborn Care Nurseries and Maternity Homes. The OSMA is working with representatives from the medical specialties that are most impacted by these rules (OBGYN, radiology) to determine whether these groups will be negatively impacted by the proposed changes. The draft rules are posted on the OSMA Regulatory Affairs web. Comments will be accepted on the draft rules until April 6, 2017.
Ohio State Board of Pharmacy
State of Ohio Board of Pharmacy Extends Licensure Deadline for Previously Exempted Prescriber Locations that Store Controlled Substances (NEW!)
The Board has granted an extension to all previously exempted prescribers that possess controlled substances in their offices from the requirement to obtain a terminal distributor of dangerous drugs license in accordance with section 4729.541 of the Revised Code. This extension is valid until June 1, 2017.
Wholesalers will still be permitted to sell to these locations during this extension period.
After June 1, 2017, a wholesaler shipping controlled substances to any prescriber office in Ohio must verify the prescriber is appropriately licensed as a Category III Terminal Distributor of Dangerous Drugs by the State of Ohio Board of Pharmacy.
For more information on this requirement, please visit: www.pharmacy.ohio.gov/TDDDcs.
- The State Pharmacy Board recently finalized rules that regulate the compounding of prescription drugs in a physician’s office. As the OSMA has reported in several previous communications and on the OSMA website, we have been expressing our concerns to the pharmacy board on a regular basis since the rules were released in May 2016. In response to the OSMA’s concerns and others, the pharmacy board retracted the rules, amended the rules, and delayed the implementation of the rules until April 2017.
- OSMA Guide to Ohio's Compounding Rules
Pharmacy Board Guidance on Compounding Rules and Recent Changes to the Terminal Distributor of Dangerous Drugs (TDDD) License (2-2-17)
Ohio Administrative Code 4729-16-11 Hazardous drugs compounded by a prescriber
Prescribers and prescriber associations are encouraged to sign up for web updates by visiting: www.pharmacy.ohio.gov/update
Ohio Bureau of Workers' Compensation