(1) A Special – Closed System Pharmacy permit is a type of special pharmacy as provided for by Section 465.0196, F.S., which dispenses medicinal drugs, utilizing closed delivery systems, to facilities where prescriptions are individually prepared for the ultimate consumer, including nursing homes, jails, ALF’s (Adult Congregate Living Facilities), ICF-MR’s (Intermediate Care Facility/Mentally Retarded) or other custodial care facilities when defined by AHCA rules which the Board may approve.

    (2) A special – closed system pharmacy permittee shall maintain a policy and procedure manual including drug procurement, storage, handling, compounding, dispensing, record keeping and disposition.

    (3) A special – closed system pharmacy permittee shall provide twenty-four hour emergency and on-call service.

    (4) A special – closed system pharmacy permittee may dispense parenteral and enteral medications as provided by rule.

    (5) A special – closed system pharmacy permittee shall be under the supervision of a prescription department manager who is responsible for maintaining all drug records, providing security of the prescription department and following other rules as relate to the practice of pharmacy. The prescription department manager of a closed system pharmacy shall not be the prescription department manager of any other pharmacy permit except when the permit is within the premises of a community pharmacy permit.

    (6) The utilization of registered pharmacy interns and registered pharmacy technicians is subject to the rules as provided by Rule 64B16-26.400, F.A.C.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196, 465.022 FS. History-New 7-31-91, Amended 10-1-92, Formerly 21S-28.830, 61F10-28.830, 59X-28.830, Amended 1-1-10.

Laws implemented by this Rule: Florida Statutes § 465.0196, 465.022