64B16-27.400: Practice of Pharmacy
PURPOSE AND EFFECT: The Board proposes the rule repeal because the rule language has been moved to Rule 64B16-27.1001, F.A.C.
SUMMARY: The rule will be repealed because the rule language has been moved to another rule.
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 FS.
LAW IMPLEMENTED: 465.003(11)(b), (13), 465.014, 465.026 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:
64B16-27.400 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 licensed pharmacist or a duly registered intern in this state acting under the direct and immediate personal supervision of a licensed pharmacist. The following subjects come solely within the purview of the licensed pharmacist.
(1) A licensed pharmacist or pharmacy intern must:
(a) Supervise and be responsible for the controlled substance inventory;
(b) Receive verbal prescriptions from a licensed practitioner;
(c) Interpret and identify prescription contents;
(d) Engage in consultation with a practitioner regarding interpretation of the prescription and data in a patient profile;
(e) Engage in professional communication with licensed practitioners, nurses or other health professionals;
(f) Advise or consult with a patient, both as to the prescription and the patient profile record;
(g) Certify the finished prescription.
(2) When parenteral and bulk solutions of all sizes are prepared, regardless of the route of administration, the licensed pharmacist must:
(a) Interpret and identify all incoming orders;
(b) Mix all extemporaneous compounding or be physically present and give direction to the pharmacy technician for reconstruction, for addition of additives, or for bulk compounding of parenteral;
(c) Physically examine, certify to the accuracy of the final preparation, thereby assuming responsibility for the final preparation;
(d) Systematize all records and documentation of processing in such a manner that professional responsibility can be easily traced to a pharmacist.
(3) Only a Florida licensed pharmacist may make the final check of the completed prescription thereby assuming the complete responsibility for its preparation and accuracy.
(4) The pharmacist, as an integral aspect of dispensing, shall be directly and immediately available to the patient or the patients agent for consultation and shall not dispense to a third party. No prescription shall be deemed to be properly dispensed unless the pharmacist is personally available.
(5) The pharmacist performing in this state any of the acts defined as the practice of the profession of pharmacy in Section 465.003(12), F.S., shall be actively licensed as a pharmacist in this state, regardless of whether the practice occurs in a permitted location (licensed facility) or other location.
(6) A pharmacist may take a meal break, not to exceed thirty minutes in length, during which the pharmacy department of a permittee shall not be considered closed, under the following conditions:
(a) The pharmacist shall be considered present and on duty during any such meal break if a sign has been prominently posted in the pharmacy indicating the specific hours of the day during which meal breaks may be taken by the pharmacist and assuring patients that a pharmacist is available on premises for consultation upon request during a meal break;
(b) The pharmacist shall be considered directly and immediately available to patients during such meal breaks if patients to whom medications are delivered during the meal break are verbally informed that they may request that a pharmacist contact them at the pharmacists earliest convenience after the meal break, and if a pharmacist is available on premises during the meal break for consultation regarding emergency matters; only prescriptions with final certification by the pharmacist may be delivered;
(c) The activities of 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 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 pharmacy technicians during the meal break.
Rulemaking Specific Authority 465.005, 465.0155 FS. Law Implemented 465.003(11)(b), (13), 465.014, 465.026 FS. History New 2-14-77, Formerly 21S-4.01, 21S-4.001, Amended 7-30-91, Formerly 21S-27.400, 61F10-27.400, Amended 1-30-96, 10-1-96, Formerly 59X-27.400, Amended 4-13-00, Repealed_________.
