64B16-27.100: Display of Current License; Pharmacist and Intern Identification
64B16-27.1001: Practice of Pharmacy
64B16-27.300: Standards of Practice - Continuous Quality Improvement Program
64B16-27.430: Responsibilities of the Pharmacist
64B16-27.440: Policies and Procedures
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, 465.0155, 465.022 FS.
LAW IMPLEMENTED: 465.022, 465.003(11)(b), (13), 465.014, 465.026. 465.0155 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:
64B16-27.100 Display of Current License; Pharmacist, Registered
and Intern, and Registered Pharmacy Technician Identification.
(1) through (2) No change.
(3) A pharmacist and registered pharmacy intern must be clearly identified by a means such as an identification badge or monogrammed smock showing their name and if they are a pharmacist or a registered pharmacy
(4) The current registration of each registered pharmacy technician shall be displayed, when applicable, in a conspicuous place in or near the prescription department, and in such a manner that can be easily read by patrons of said establishment. Registered pharmacy technicians employed in a secondary practice site shall present a valid wallet registration as evidence of registration upon request.
Specific Authority 465.005, 465.0155, 465.022 FS. Law Implemented 465.022 FS. History–Amended 5-19-72, Repromulgated 12-18-74, Formerly 21S-1.06, 21S-1.006, Amended 7-30-91, Formerly 21S-27.100, 61F10-27.100, Amended 1-30-96, Formerly 59X-27.100, Amended 11-18-07, ________ .
64B16-27.1001 Practice of Pharmacy.
Those functions within the definition of the practice of the profession of pharmacy, as defined by Section 465.003(13), F.S., are specifically reserved to a pharmacist or a duly registered pharmacy intern in this state acting under the direct and immediate personal supervision of a pharmacist. The following subjects come solely within the purview of the pharmacist.
(1) A pharmacist or registered pharmacy intern must:
(a) through (f) No change.
(2) When parenteral and bulk solutions of all sizes are prepared, regardless of the route of administration, the pharmacist must:
(a) No change.
(b) Mix all extemporaneous compounding or be physically present and give direction to the registered pharmacy technician for reconstitution, for addition of additives, or for bulk compounding of the parenteral solution.
(c) through (d) No change.
(3) through (5) No change.
(6) The pharmacist may take a meal break, not to exceed 30 minutes in length, during which the pharmacy department of a permittee shall not be considered closed, under the following conditions:
(a) through (b) No change.
(c) The activities of registered pharmacy technicians during such a meal break shall be considered to be under the direct and immediate personal supervision of a pharmacist if the pharmacist is available on the premises during the meal break to respond to questions by the technicians, and if at the end of the meal break the pharmacist certifies all prescriptions prepared by the registered pharmacy technicians during the meal break.
(7) The delegation of any duties, tasks or functions to registered pharmacy intern and registered pharmacy technicians must be performed subject to a continuing review and ultimate supervision of the pharmacist who instigated the specific task, so that a continuity of supervised activity is present between one pharmacist and one registered pharmacy technician. In every pharmacy, the pharmacist shall retain the professional and personal responsibility for any delegated act performed by registered pharmacy interns and registered pharmacy technicians in the licensee’s employ or under the licensee’s supervision.
Specific Authority 465.005, 465.0155 FS. Law Implemented 465.003(11)(b), (13), 465.014, 465.026 FS. History– New 11-18-07, Amended________.
64B16-27.300 Standards of Practice – Continuous Quality Improvement Program.
(1) through (2) No change.
(3)(a) Each pharmacy shall establish a Continuous Quality Improvement Program which program shall be described in the pharmacy’s policy and procedure manual and, at a minimum shall contain:
1. Provisions for a Continuous Quality Improvement Committee that may be comprised of staff members of the pharmacy, including pharmacists, registered pharmacy interns, registered pharmacy technicians, clerical staff, and other personnel deemed necessary by the prescription department manager or the consultant pharmacist of record;
2. Provisions for the prescription department manager or the consultant pharmacist of record to ensure that the committee conducts a review of Quality Related Events at least every three months.
3. A planned process to record, measure, assess, and improve the quality of patient care; and
4. The procedure for reviewing Quality Related Events.
(b) through (c) No change.
(4) through (5) No change.
Specific Authority 465.0155 FS. Law Implemented 465.0155 FS. History–New 7-15-99, Amended 1-2-02, 6-16-03, 11-18-07,________.
64B16-27.430 Responsibilities of the Pharmacist.
The delegation of any duties, tasks or functions to registered pharmacy
licensed interns and registered pharmacy technicians must be performed subject to a continuing review and ultimate supervision of the Florida licensed pharmacist who instigated the specific task, so that a continuity of supervised activity is present between one (1) pharmacist and one (1) registered pharmacy technician. In every pharmacy, the licensed pharmacist shall retain the professional and personal responsibility for any delegated act performed by registered pharmacy licensed interns and registered pharmacy technicians in his employ and under his supervision.
Specific Authority 465.005 FS. Law Implemented 465.014 FS. History–New 2-14-77, Formerly 21S-4.03, Amended 9-1-87, Formerly 21S-4.003, 21S-27.430, 61F10-27.430, 59X-27.430, Amended________.
64B16-27.440 Policies and Procedures.
Any pharmacy utilizing registered pharmacy technicians shall be required to have written policies and procedures regarding the number of positions and their utilization, including the specific scope of responsibilities of technicians, available for inspection by the Florida Board of Pharmacy or its authorized agents and representatives.
Specific Authority 465.005 FS. Law Implemented 465.014 FS. History–New 2-14-77, Formerly 21S-4.04, 21S-4.004, Amended 9-9-92, Formerly 21S-27.440, 61F10-27.440, 59X.27-440, Amended ________.