(A) All automated drug delivery systems intended for use by a terminal distributor of dangerous drugs to assist in the dispensing of a drug pursuant to rules 4729-5-01 and 4729-17-01 of the Administrative Code must meet the following requirements:
(1) Each automated drug delivery system must be approved via the procedure established in paragraph (B) of this rule by the board of pharmacy prior to its implementation by the terminal distributor of dangerous drugs;
(2) The automated drug delivery system shall have a documented and ongoing quality assurance program that monitors total system performance and includes security measures to ensure the safe and effective distribution of drugs;
(3) The automated drug delivery system shall have adequate security to prevent unauthorized individuals from accessing or obtaining dangerous drugs and includes safeguards to detect diversion of dangerous drugs;
(4) The records kept by the automated drug delivery system shall comply with all board requirements.
(B) Prior to the approval of an automated drug delivery system, the board shall receive a request from the responsible person on the terminal distributor of dangerous drugs license. Upon notification, the board shall conduct an inspection of the system to determine if it meets the requirements in paragraph (A) of this rule.
(C) If an inspection does not result in the approval of an automated drug delivery system, the responsible person named on the terminal distributor of dangerous drugs may request an in-person meeting with the board to appeal the denial.
Five Year Review (FYR) Dates: 10/22/2015 and 10/01/2020
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.05, 3719.07, 3719.09, 4729.28, 4729.37, 4729.51
Prior Effective Dates: 3/13/95, 1/1/01, 2/1/05, 08/22/2014