Advocacy >> Regulatory Affairs

Regulatory Affairs

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

Telemedicine Rule

Opioid Prescribing Rules

The medical board has proposed several changes to the rules governing how physicians must treat acute pain when opioids are prescribed.  The OSMA has formed a physician work group to provide feedback about the proposed rules as they are drafted and published for comment.
Ohio State Board of Pharmacy

Proposed Changes to Controlled Substance Prescribing Rules -New

The Ohio State Board of Pharmacy is proposing a few changes to the way prescriptions for controlled substances are written. For those engaged in e-prescribing, this may mean updates to software to include both the diagnosis code and the days’ supply on the prescription. For those who are using paper prescriptions, this will mean two additional fields to handwrite or print on the prescription. For those without ICD-10 codes included in their prescribing software or electronic medical record, this will also mean locating the correct ICD-10 code, which may add to a prescriber’s overall administrative burden. This requirement may also add an administrative burden to a pharmacist who will have to obtain this information from a prescriber or the prescriber’s agent prior to dispensing a prescription if the information is missing​.
The OSMA has assembled a physcian work group to provide feedback about the proposed rules as they make their way through the rule drafting process.  Comments on the most recent draft of the rules are due 5-17-17.

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, 2017Wholesalers 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 the Pharmacy Board's page on the TDDD license


Compounding Rules

  • 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 the Pharmacy Board Website

Ohio Bureau of Workers' Compensation

Utilization of Opioids

  • O.A.C. 4123-6-21.7 Utilization of opioids in the subacute or chronic phases of pain treatment for a work-related injury or occupational disease 

Additional Resources

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