Florida Regulations 64B16-27.450: Prescription Department Managers
Current as of: 2024 | Check for updates
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(1) Designation as Prescription Department Manager.
(a) Initial Designation. Pursuant to sections 465.018, 465.0197, and 465.022, F.S., a permit for a community or internet pharmacy may not be issued unless a licensed pharmacist is designated as the prescription department manager. Pursuant to rules 64B16-28.820, 64B16-28.830, and 64B16-28.901, F.A.C., applications for permits for a Special Parenteral and Enteral, Special Closed System, or Nuclear pharmacy require the supervising licensed pharmacist be designated as the prescription department manager. Finally, applications for a Special Sterile Compounding Permit require the supervising licensed pharmacist or consultant pharmacist be designated as either the prescription department manager or the consultant pharmacist of record, as applicable to the underlying permit type. Initial designation is accomplished as part of the application process using the appropriate application form incorporated in Fl. Admin. Code R. 64B16-28.100, or as part of the application for an Internet Pharmacy Permit, utilizing Form DH-MQA 1220, Special Pharmacy Permit Application and Information, incorporated in Fl. Admin. Code R. 64B16-28.100
(b) Change of prescription department manager. No later than ten (10) days after a change of designated prescription department manager for a community pharmacy, a Special Parenteral and Enteral pharmacy, a Special Closed System pharmacy, a Nuclear pharmacy, or a Special Sterile Compounding permitee, or thirty (30) days for an internet pharmacy, both the pharmacy permittee and the newly designated prescription department manager shall notify the Board of the change and the identity of the newly designated prescription department manager. Notification shall be accomplished by completing Form DOH/MQA/PH10, 01/18, Prescription Department Manager (PDM) Designation and Privacy Statement Acknowledgement, which is hereby incorporated by reference and which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-09439, the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or the Board’s website at http://floridaspharmacy.gov/Applications/app-change-perscription-dept-manager.pdf. In addition, an outgoing prescription department manager may choose to notify the Board they will no longer serve as prescription department manager using this form.
(c) Submission of Fingerprints. In addition to submission of Form DOH/MQA/PH10, the newly designated prescription department manager shall comply with the fingerprinting requirements of sections 456.0135 and 465.022, F.S. Electronic fingerprint information (“”EFI””) that has been submitted to the Florida Agency for Health Care Administration may be accessible by the Florida Department of Health for a period of sixty (60) months. If the Department is able to access EFI from AHCA, applicants will not be required to resubmit EFI for additional or new applications submitted during this time period. After sixty (60) months, new electronic fingerprint information must be submitted as part of all applications.
(2) Responsibilities of Prescription Department Managers. Prescription department managers are responsible for ensuring the pharmacy permittee’s compliance with all statutes and rules governing the practice of the profession of pharmacy, including maintenance of all drug records and ensuring the security of the prescription department, and shall competently and diligently exercise their responsibilities as a prescription department manager.
(3) All community, internet, Special Parenteral and Enteral, Special Closed System, Nuclear and, if applicable, Special Sterile Compounding pharmacy permittees shall continuously maintain a designated prescription department manager at all times the pharmacy is open and in operation.
(4) Pursuant to section 465.022(11)(c), F.S., a registered pharmacist may not serve as prescription department manager at more than one pharmacy location unless otherwise approved by the Board.
Rulemaking Authority 465.005, 465.0155, 465.022(1), (10) FS. Law Implemented 456.0135, 465.018(2), 465.0197(1), (3)(b), 465.022(2), (3), (10), (11) FS. History-New 3-9-17, Amended 6-5-18.
(b) Change of prescription department manager. No later than ten (10) days after a change of designated prescription department manager for a community pharmacy, a Special Parenteral and Enteral pharmacy, a Special Closed System pharmacy, a Nuclear pharmacy, or a Special Sterile Compounding permitee, or thirty (30) days for an internet pharmacy, both the pharmacy permittee and the newly designated prescription department manager shall notify the Board of the change and the identity of the newly designated prescription department manager. Notification shall be accomplished by completing Form DOH/MQA/PH10, 01/18, Prescription Department Manager (PDM) Designation and Privacy Statement Acknowledgement, which is hereby incorporated by reference and which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-09439, the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or the Board’s website at http://floridaspharmacy.gov/Applications/app-change-perscription-dept-manager.pdf. In addition, an outgoing prescription department manager may choose to notify the Board they will no longer serve as prescription department manager using this form.
(c) Submission of Fingerprints. In addition to submission of Form DOH/MQA/PH10, the newly designated prescription department manager shall comply with the fingerprinting requirements of sections 456.0135 and 465.022, F.S. Electronic fingerprint information (“”EFI””) that has been submitted to the Florida Agency for Health Care Administration may be accessible by the Florida Department of Health for a period of sixty (60) months. If the Department is able to access EFI from AHCA, applicants will not be required to resubmit EFI for additional or new applications submitted during this time period. After sixty (60) months, new electronic fingerprint information must be submitted as part of all applications.
(2) Responsibilities of Prescription Department Managers. Prescription department managers are responsible for ensuring the pharmacy permittee’s compliance with all statutes and rules governing the practice of the profession of pharmacy, including maintenance of all drug records and ensuring the security of the prescription department, and shall competently and diligently exercise their responsibilities as a prescription department manager.
(3) All community, internet, Special Parenteral and Enteral, Special Closed System, Nuclear and, if applicable, Special Sterile Compounding pharmacy permittees shall continuously maintain a designated prescription department manager at all times the pharmacy is open and in operation.
(4) Pursuant to section 465.022(11)(c), F.S., a registered pharmacist may not serve as prescription department manager at more than one pharmacy location unless otherwise approved by the Board.
Rulemaking Authority 465.005, 465.0155, 465.022(1), (10) FS. Law Implemented 456.0135, 465.018(2), 465.0197(1), (3)(b), 465.022(2), (3), (10), (11) FS. History-New 3-9-17, Amended 6-5-18.