64B16-28.141: Requirements for an Automated Pharmacy System in a Community Pharmacy
64B16-28.451: Pharmacy Common Database
64B16-28.605: Class II Institutional Pharmacies Automated Distribution and Packaging
64B16-28.607: Automated Pharmacy System Long-Term Care, Hospice or Prison
64B16-28.830: Special - Closed System Pharmacy
64B16-28.901: Nuclear Pharmacy - General Requirements
PURPOSE AND EFFECT: The Board proposes the rule amendment to update the references to pharmacy technicians.
SUMMARY: References to pharmacy technicians will be updated.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board determined the proposed rule will not have an impact on small business.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 465.005, 465.022, 465.0155 FS.
LAW IMPLEMENTED: 465.003(14), 465.0126, 465.014, 465.018, 465.019, 465.0196, 465.022, 465.0235, 465.026, 465.0266 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3253
THE FULL TEXT OF THE PROPOSED RULE IS:
64B16-28.141 Requirements for an Automated Pharmacy System in a Community Pharmacy.
(1) No change.
(2) General Requirements. A pharmacy may use an automated pharmacy system provided that:
(a) The pharmacy develops and maintains a policy and procedure manual that includes:
1. The type or name of the system including a serial number or other identifying nomenclature.
2. A method to ensure security of the system to prevent unauthorized access. Such method may include the use of electronic passwords, biometric identification (optic scanning or fingerprint) or other coded identification.
3. A process of filling and stocking the system with drugs; an electronic or hard copy record of medication filled into the system including the product identification, lot number, and expiration date.
4. A method of identifying all the registered pharmacy interns pharmacists or registered pharmacy technicians involved in the dispensing process.
5. Compliance with a Continuous Quality Improvement Program.
6. A method to ensure that patient confidentiality is maintained.
7. A process to enable the prescription department manager or designee to revoke, add, or change access at any time.
(b) No change.
(c) The system shall maintain a readily retrievable electronic record to identify all pharmacists, registered pharmacy technicians, or other personnel involved in the dispensing of a prescription.
(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) No change.
(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 container 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) through (e) No change.
(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) No change.
Rulemaking Specific Authority 465.005, 465.022 FS. Law Implemented 465.018, 465.022 FS. HistoryNew 11-29-04, Amended 12-30-07,________.
64B16-28.451 Pharmacy Common Database.
(1) through (5) No change.
(6) In addition to all record requirements of Rule 64B16-28.140, F.A.C., all pharmacies participating in prescription drug processing, shall maintain appropriate records which identify, by prescription, the name(s), initials, or identification code(s) of each pharmacist or registered pharmacy technician who performs a processing function for a prescription. Such records shall be maintained:
(a) Separately by each pharmacy and pharmacist; or
(b) In a common electronic file, as long as the records are maintained in such a manner that the data processing system can produce a printout which lists the functions performed by each pharmacy, pharmacist, registered pharmacy intern and registered pharmacy technician.
Rulemaking Specific Authority 465.005, 465.022 FS. Law Implemented 465.0266 FS. HistoryNew 3-24-08, Amended ________.
64B16-28.605 Class II Institutional Pharmacies Automated Distribution and Packaging.
(1) through (3) No change.
(4) Stocking or Restocking of a Decentralized Automated Medication System.
(a) Medications in a decentralized Automated Medication System shall be stocked or restocked by a pharmacist, registered pharmacy intern, or by a registered pharmacy technician supervised by a pharmacist.
(b) No change.
(5) through (9) No change.
Rulemaking Specific Authority 465.005, 465.0155, 465.022 FS. Law Implemented 465.019, 465.022, 465.0235, 465.026 FS. HistoryNew 4-22-07, Amended________.
64B16-28.607 Automated Pharmacy System Long Term Care, Hospice, and Prison.
(1) No change.
(2) Provider Pharmacy Requirements.
(a) through (b) No change.
(c) Supervision of the automated pharmacy system shall be the responsibility of a Florida licensed pharmacist employed by the provider pharmacy.
(d) through (f) No change.
(3) through (4) No change.
(5) Security Requirements.
(a) through (b) No change.
(c) Access to the drugs shall be limited to a pharmacist or a registered pharmacy technician employed by the provider pharmacy or licensed personnel in the facility or institution who are authorized to administer medication.
(d) No change.
(6) through (7) No change.
Rulemaking Specific Authority 465.005, 465.0155, 465.022 FS. Law Implemented 465.019, 465.022, 465.0235 FS. HistoryNew 4-22-07, Amended________.
64B16-28.830 Special Closed System Pharmacy.
(1) through (5) No change.
(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 Specific Authority 465.005, 465.022 FS. Law Implemented 465.0196, 465.022 FS. HistoryNew 7-31-91, Amended 10-1-92, Formerly 21S-28.830, 61F10-28.830, 59X-28.830, Amended ________.
64B16-28.901 Nuclear Pharmacy General Requirements.
The process employed by any permit holder in this state concerning the handling of radioactive materials must involve appropriate procedures for the purchase, receipt, storage, manipulation, compounding, distribution and disposal of radioactive materials. In order to insure the public health and safety in this respect, a nuclear pharmacy in this state shall meet the following general requirements:
(1) through (7) No change.
(8) A nuclear pharmacist upon receiving an oral prescription order for a radiopharmaceutical shall immediately have the prescription order reduced to writing. The pharmacist may delegate this duty to a registered pharmacy technician only as authorized by Rule 64B16-27.410, F.A.C. The prescription order shall contain at least the following:
(a) through (i) No change.
(9) through (10) No change.
Rulemaking Specific Authority 465.005, 465.022 FS. Law Implemented 465.003(14), 465.0126, 465.014 FS. HistoryNew 1-7-76, Formerly 21S-3.03, Amended 12-11-86, 4-4-88, Formerly 21S-3.003, 21S-28.901, 61F10-28.901, Amended 2-26-95, Formerly 59X-28.901, Amended 4-5-05,________.
