Florida Regulations 64B16-27.1001: Practice of Pharmacy
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Those functions within the definition of the practice of the profession of pharmacy, as defined by Florida Statutes § 465.003(13), 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) Supervise and be responsible for the controlled substance inventory.
(b) Receive verbal prescriptions from a practitioner.
(c) Interpret and identify prescription contents.
(d) Engage in consultation with a practitioner regarding interpretation of the prescription and date in patient profile.
(e) Engage in professional communication with practitioners, nurses or other health professionals.
(f) Advise or consult with a patient, both as to the prescription and the patient profile record.
(2) When parenteral and bulk solutions of all sizes are prepared, regardless of the route of administration, the pharmacist must:
(a) Interpret and identify all incoming orders.
(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) Physically examine, certify to the accuracy of the final preparation, thereby assuming responsibility for the final preparation.
(d) Systemize all records and documentation of processing in such a manner that professional responsibility can be easily traced to a pharmacist.
(3) Only a 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 patient’s 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 Florida Statutes § 465.003(13), shall be actively licensed as a pharmacist in this state, regardless of whether the practice occurs in a permitted location (facility) or other location.
(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) 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 the 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 meal breaks are verbally informed that they may request that a pharmacist contact them at the pharmacist’s earliest convenience after the meal break, and if a pharmacist is available on the premises during the meal break for consultation regarding emergency matters. Only prescriptions with the final certification by the pharmacist may be delivered.
(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 interns 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.
Rulemaking Authority 465.005, 465.0155 FS. Law Implemented 465.003(11)(b), (13), 465.014, 465.026 FS. History-New 11-18-07, Amended 1-1-10.
(a) Supervise and be responsible for the controlled substance inventory.
(b) Receive verbal prescriptions from a practitioner.
(c) Interpret and identify prescription contents.
(d) Engage in consultation with a practitioner regarding interpretation of the prescription and date in patient profile.
(e) Engage in professional communication with practitioners, nurses or other health professionals.
(f) Advise or consult with a patient, both as to the prescription and the patient profile record.
(2) When parenteral and bulk solutions of all sizes are prepared, regardless of the route of administration, the pharmacist must:
(a) Interpret and identify all incoming orders.
(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) Physically examine, certify to the accuracy of the final preparation, thereby assuming responsibility for the final preparation.
(d) Systemize all records and documentation of processing in such a manner that professional responsibility can be easily traced to a pharmacist.
(3) Only a 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 patient’s 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 Florida Statutes § 465.003(13), shall be actively licensed as a pharmacist in this state, regardless of whether the practice occurs in a permitted location (facility) or other location.
(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) 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 the 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 meal breaks are verbally informed that they may request that a pharmacist contact them at the pharmacist’s earliest convenience after the meal break, and if a pharmacist is available on the premises during the meal break for consultation regarding emergency matters. Only prescriptions with the final certification by the pharmacist may be delivered.
(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 interns 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.
Rulemaking Authority 465.005, 465.0155 FS. Law Implemented 465.003(11)(b), (13), 465.014, 465.026 FS. History-New 11-18-07, Amended 1-1-10.