Current through Reg. 50, No. 187; September 24, 2024
(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 rule
64B16-28.100, F.A.C., or as part
of the application for an Internet Pharmacy Permit, utilizing Form DH-MQA 1220,
Special Pharmacy Permit Application and Information, incorporated in rule
64B16-28.100, F.A.C.
(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 permittee, 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.
New 3-9-17, Amended
6-5-18.
