Ohio Admin. Code 4729:5-3-23 - Mobile clinics or medication units

(A) The following may operate a mobile unit to dispense, personally furnish, or otherwise distribute or administer prescription medications and devices to individuals in this state without a fixed address or who would otherwise not have access to medication services:

(1) A nonprofit organization, corporation, or association as defined in the Ohio Revised Code; or

(2) A for-profit entity for the purpose of providing services to an individual needing treatment for a substance use disorder, a mental health condition, and any related medical issue.

(B) A mobile clinic or medication unit shall register for a no-cost, satellite license affiliated with an existing terminal distributor of dangerous drugs as specified by the board.

(C) A mobile clinic or medication unit shall comply with the following:

(1) Except as provided in paragraph (C)(2) of this rule, if distributing dangerous drugs that have already been dispensed or personally furnished in accordance with this division of the Administrative Code, the drugs must be in the full and actual charge of a licensed or registered health care professional authorized under Chapter 4715., 4723., 4729., 4730., 4731., or 4741. of the Revised Code.

(2) If transporting drugs for distribution and there is no healthcare professional present on the mobile unit, as described in paragraph (C)(1) of this rule, all dangerous drugs shall be secured using physical locks to prevent unauthorized access.

(3) If engaged in the following:

(a) Dispensing dangerous drugs: a licensed pharmacist shall be on the premises and the mobile unit shall be under the control and management of the pharmacist. All dispensing activities shall comply with the requirements of Chapter 4729:5-5 of the Administrative Code.

(b) Personally furnishing dangerous drugs: a licensed healthcare professional authorized to prescribe drugs shall be on the premises and the mobile unit shall be under the control and management of the licensed healthcare provider. All personally furnishing activities shall comply with the requirements of Chapter 4729:5-19 of the Administrative Code.

(4) Implement a record keeping system that will provide accountability for proper receipt, delivery, disposal, and return of all prescription medications in accordance with applicable record keeping provisions in division 4729:5 of the Administrative Code.

(5) Except for mobile units that are stored in a locked garage with access control, dangerous drugs shall not be left in the mobile unit during the hours that the mobile unit is not in operation. Without exception, a terminal distributor shall not maintain controlled substances in the mobile unit when the unit is not in use.

(6) All mobile units shall be dry, well lit, well ventilated, and maintained in a clean, sanitary, and orderly condition. Storage areas for dangerous drugs shall be maintained at temperatures and conditions which will ensure the integrity of the drugs as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(7) All mobile units shall be secured with suitable locks capable of preventing unauthorized access.

Notes

Ohio Admin. Code 4729:5-3-23

Effective: 1/15/2025
Five Year Review (FYR) Dates: 01/15/2030
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 3719.07, 4729.37, 4729.51, 4729.54, 4729.55