Florida Regulations 64B16-28.451: Pharmacy Common Database; Exceptions for Prescription Drug Processing Only Pharmacies
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(1) A pharmacy licensed under this chapter may perform prescription drug processing for other pharmacies, provided that all pharmacies are under common ownership, utilize a common database, and are properly licensed, permitted or registered in this state or another state. Nothing in this subsection shall prohibit a pharmacist employee of said pharmacies who is licensed in Florida or in another state from remotely accessing the pharmacy’s electronic database from outside the pharmacy in order to process prescriptions, provided the pharmacy establishes controls to protect the privacy and security of confidential records.
(2) Prescription drug processing shall include the following:
(a) Receiving, interpreting, or clarifying a prescription;
(b) Entering prescription data into the pharmacy’s record;
(c) Verifying or validating a prescription;
(d) Performing prospective drug review as defined by the Board;
(e) Obtaining refill and substitution authorizations;
(f) Interpreting or acting on clinical data;
(g) Performing therapeutic interventions;
(h) Providing drug information concerning a patient’s prescription; and,
(i) Providing patient counseling.
(3) Each pharmacist that performs a specific function within the prescription drug processing process via use of a common database shall be responsible for any errors or omissions committed by that pharmacist during the performance of that specific function.
(4) Each pharmacy performing prescription drug processing pursuant to this section must maintain a policy and procedure manual, which shall be made available to the Board or its agent upon request. The policy and procedures manual shall include the following information:
(a) A description for how each pharmacy will comply with federal and state laws, rules and regulations;
(b) The procedure for maintaining appropriate records to identify the pharmacies and pharmacists responsible for the prescription drug processing and dispensing of the prescription;
(c) The policy and procedure for providing adequate security to protect the confidentiality and integrity of patient information; and,
(d) The procedure to be used by the pharmacy in implementing and operating a quality assurance program designed to objectively and systematically monitor, evaluate, and improve the quality and appropriateness of patient care.
(5) The prescription drug processing of a prescription by one pharmacy for another pursuant to this section shall not be construed as the transferring of a prescription as set forth in Florida Statutes § 465.026
(6) In addition to all record requirements of Fl. Admin. Code R. 64B16-28.140, 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.
(7) Prescription drug processing only pharmacies. A pharmacy permittee which solely performs prescription drug processing for other pharmacies pursuant to this rule, and at which medicinal drugs are not compounded, dispensed, stored or sold, nor are prescriptions filled or dispensed, and which notifies the Board that its pharmacy practice is limited solely to prescription drug processing shall be exempt from the following rules:
(a) Fl. Admin. Code R. 64B16-28.102, Sink and Running Water, Sufficient Space, Refrigeration, Sanitation, Equipment;
(b) Fl. Admin. Code R. 64B16-28.1035, Patient Consultation Area;
(c) Fl. Admin. Code R. 64B16-28.1081, Regulation of Daily Operating Hours; and,
(d) Rule 64B16-28.109(1), F.A.C., relating to signage.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented Florida Statutes § 465.0266. History-New 3-24-08, Amended 1-1-10, 7-14-16.
(a) Receiving, interpreting, or clarifying a prescription;
(b) Entering prescription data into the pharmacy’s record;
(c) Verifying or validating a prescription;
(d) Performing prospective drug review as defined by the Board;
(e) Obtaining refill and substitution authorizations;
(f) Interpreting or acting on clinical data;
(g) Performing therapeutic interventions;
(h) Providing drug information concerning a patient’s prescription; and,
(i) Providing patient counseling.
(3) Each pharmacist that performs a specific function within the prescription drug processing process via use of a common database shall be responsible for any errors or omissions committed by that pharmacist during the performance of that specific function.
(4) Each pharmacy performing prescription drug processing pursuant to this section must maintain a policy and procedure manual, which shall be made available to the Board or its agent upon request. The policy and procedures manual shall include the following information:
(a) A description for how each pharmacy will comply with federal and state laws, rules and regulations;
(b) The procedure for maintaining appropriate records to identify the pharmacies and pharmacists responsible for the prescription drug processing and dispensing of the prescription;
(c) The policy and procedure for providing adequate security to protect the confidentiality and integrity of patient information; and,
(d) The procedure to be used by the pharmacy in implementing and operating a quality assurance program designed to objectively and systematically monitor, evaluate, and improve the quality and appropriateness of patient care.
(5) The prescription drug processing of a prescription by one pharmacy for another pursuant to this section shall not be construed as the transferring of a prescription as set forth in Florida Statutes § 465.026
(6) In addition to all record requirements of Fl. Admin. Code R. 64B16-28.140, 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.
(7) Prescription drug processing only pharmacies. A pharmacy permittee which solely performs prescription drug processing for other pharmacies pursuant to this rule, and at which medicinal drugs are not compounded, dispensed, stored or sold, nor are prescriptions filled or dispensed, and which notifies the Board that its pharmacy practice is limited solely to prescription drug processing shall be exempt from the following rules:
(a) Fl. Admin. Code R. 64B16-28.102, Sink and Running Water, Sufficient Space, Refrigeration, Sanitation, Equipment;
(b) Fl. Admin. Code R. 64B16-28.1035, Patient Consultation Area;
(c) Fl. Admin. Code R. 64B16-28.1081, Regulation of Daily Operating Hours; and,
(d) Rule 64B16-28.109(1), F.A.C., relating to signage.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented Florida Statutes § 465.0266. History-New 3-24-08, Amended 1-1-10, 7-14-16.