Important Information for Terminal Distributors of Dangerous Drugs: New Responsible Person Requirements for Licensure Effective February 1, 2027

Attention Terminal Distributors of Dangerous Drugs:

Effective February 1, 2027, OAC 4729:5-2-01 will require a responsible person (RP) for a terminal distributor of dangerous drugs (TDDD) to meet specific hourly on-site requirements or conduct regular site visits to ensure compliance with all applicable state and federal laws, regulations, and rules governing the distribution of dangerous drugs.

Licensees are strongly encouraged to utilize the current implementation window to ensure they can comply with the new requirements effective February 1, 2027. For the current requirements, please review the version of the rule in effect until February 1, 2027.

The Board of Pharmacy has created a guidance document outlining the new requirements for each TDDD license type, which can be accessed at www.pharmacy.ohio.gov/RPGuide.

What is a Responsible Person (RP)?

Every license issued to a terminal distributor or drug distributor (hospital, pharmacy, wholesaler, clinic, manufacturer, EMS, lab, etc.) by the Ohio Board of Pharmacy requires there to be a responsible person (RP). The RP ensures the licensee is compliant with all applicable state and federal laws, regulations, and rules governing the distribution of dangerous drugs. This includes supervision and control of dangerous drugs, security and control of dangerous drugs, and maintaining all drug records otherwise required. Home Medical Equipment Service Providers have similar requirements for designated representatives.

A terminal distributor or drug distributor must have an RP at all times. When there is a change of RP, the Board must be notified within ten days of the effective date of the appointment of the new RP. This requires the submission of a Change of Responsible Person Request in eLicense Ohio and the payment of a $15.00 processing fee.

Additional Guidance and Questions

For more information regarding these requirements, please review the Board’s guidance document at www.pharmacy.ohio.gov/RPGuide.

If you need additional information, the most expedient way to have your questions answered will be to e-mail the Board office by visiting: http://www.pharmacy.ohio.gov/contact.aspx.

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Ohio Board of Pharmacy

Mike DeWine, Governor | Steven W. Schierholt, Executive Director