The Board proposes the rule amendment to provide additional updated requirements for an automated pharmacy system in a community pharmacy.

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO: RULE TITLE
64B16-28.141: Requirements for an Automated Pharmacy System in a Community Pharmacy
PURPOSE AND EFFECT: The Board proposes the rule amendment to provide additional updated requirements for an automated pharmacy system in a community pharmacy.
SUBJECT AREA TO BE ADDRESSED: Requirements for an Automated Pharmacy System in a Community Pharmacy.
SPECIFIC AUTHORITY: 465.005, 465.022 FS.
LAW IMPLEMENTED: 465.018, 465.022 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE WEEKLY.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Rebecca Poston, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

64B16-28.141 Automated Pharmacy System in a Community Pharmacy.

(1) Definitions. “Automated pharmacy system” means a mechanical system, located within or adjacent to the confines the prescription department, that performs operations or activities, other than compounding or administration, relative to storage, packaging, dispensing, or distribution of medication, and which collects, controls, and maintains all transaction information.

(2)(a) through (d) No change.

(3) Additional Requirements for Patient Accessed Automated Pharmacy Systems. A pharmacy may use a patient accessed automated pharmacy system, provided that:

(a) Meets the requirements in subsection (2) above.

(b) The stocking or restocking of a medicinal drug shall only be completed by a Florida licensed pharmacist, except as provided in paragraph (c) below.

(c) If the automated pharmacy system uses removable cartridges or containers to store the drug, the stocking or restocking of the cartridges or containers may occur at a licensed repackaging facility and be sent to the provider pharmacy to be loaded by personnel designated by the pharmacist if:

1. A Florida licensed pharmacist verifies the cartridge or container has been properly filled and labeled.

2. The individual cartridge or container is transported to the provider pharmacy in a secure, tamper-evident container.

3. The automated pharmacy system uses a bar code verification, electronic verification, weight verification, radio frequency identification (RFID) or similar process to ensure that the cartridge or container is accurately loaded into the automated pharmacy system.

4. The Florida licensed pharmacist verifying the filling and labeling is responsible if the cartridge or container is stocked or restocked incorrectly by the personnel designated to load the cartridges or containers.

(d) The automated pharmacy system must use at least two separate verifications, such as bar code verification, electronic verification, weight verification, radio frequency identification (RFID) or similar process to ensure that the proper medication is being dispensed from the automated system.

(e) The medication shall bear a patient specific label that complies with Rule 64B16-28.108, F.A.C.

(f) The record of transactions with the patient accessed automated pharmacy system shall be available to authorized agents of the Department of Health. The record of transactions shall include:

1. Name of the patient.

2. Name, strength, and dosage form of the drug product dispensed.

3. Quantity of drug dispensed.

4. Date and time of dispensing.

5. Name of provider pharmacy.

6. Prescription number.

7. Name of prescribing practitioner.

8. Identity of the pharmacist who approved the prescription or order.

9. Identity of the person to whom the drug was released.

(4) The Florida licensed pharmacist responsible for filling, verifying, or loading the automated pharmacy system shall be responsible for her or his individual action.

(5) A prescription dispensed pursuant to the requirements of this rule shall be deemed to have been certified by the pharmacist.

Specific Authority 465.005, 465.022 FS. Law Implemented 465.018, 465.022 FS. History–New 11-29-04, Amended________.