(1) Designation as
Consultant Pharmacist of Record.
(a) Initial
Designation. Pursuant to sections
465.019 and
465.022, F.S., a permit for an
Institutional pharmacy may not be issued unless a licensed pharmacist is
designated as the consultant pharmacist of record. In addition, pursuant to
rule
64B16-28.870, F.A.C., an
application for a Special Assisted Living Facility pharmacy permit requires the
supervising licensed pharmacist be designated as the consultant pharmacist of
record. Finally, applications for Special Sterile Compounding Permits
associated with an Institutional pharmacy require the pharmacist-in-charge be
designated as the consultant pharmacist of record. Initial designation is
accomplished as part of the application process using the appropriate
application form incorporated in rule
64B16-28.100, F.A.C.
(b) Change of Consultant Pharmacist of
Record.
No later than ten (10) days after a change of designated
consultant pharmacist for an Institutional, Special Assisted Living Facility
pharmacy, or a Special Sterile Compounding Permitee, both the pharmacy
permittee and the newly designated consultant pharmacist of record shall notify
the Board of the change and the identity of the newly designated consultant
pharmacist. Notification shall be accomplished by completing Form DH-MQA 1184
(01/18), Consultant Pharmacist of Record (COR) 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-09437
or the Board's website at
http://floridaspharmacy.gov/Applications/app
- change - consultant - pharmacist.pdf . In addition, an outgoing consultant
pharmacist of record may choose to notify the Board they will no longer serve
as consultant pharmacist of record using this form.
(c) Submission of Fingerprints. In addition
to submission of Form DH-MQA 1184, the newly designated consultant pharmacist
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)
Continuous Designation. All Institutional, Special Assisted Living Facility,
and, if applicable, Special Sterile Compounding Pharmacy permittees shall
continuously maintain a designated consultant pharmacist of record at all times
the pharmacy is open and in operation.
(3) Drug Regimen Reviews. The consultant
pharmacist of record for a Class I, Class II, Modified Class II, or Class III
Institutional permit shall conduct Drug Regimen Reviews as required by Federal
or State law, inspect the facility and prepare a written report to be filed at
the permitted facility at least monthly. In addition, the consultant pharmacist
of record must monitor the facility system for providing medication
administration records and physician order sheets to ensure that the most
current record of medications is available for the monthly drug regimen review.
The consultant pharmacist of record may utilize additional consultant
pharmacists to assist in this review and in the monthly facility
inspection.
(4) Remote Access. A
consultant pharmacist licensed in Florida may remotely access a facility or
pharmacy's electronic database from outside the facility or pharmacy to conduct
any services additional or supplemental to regular drug regimen reviews,
subject to the pharmacy or facility establishing policies and procedures to
ensure the security and privacy of confidential patient records, including
compliance with applicable Federal HIPAA regulations.
Notes
Fla. Admin.
Code Ann. R. 64B16-28.501
Rulemaking Authority 465.005, 465.0125, 465.022 FS. Law
Implemented 465.0125, 465.019, 465.022, 465.0266
FS.
New 7-18-94, Formerly
61F10-28.501, 59X-28.501, Amended 1-2-02, 12-30-07, Amended by
Florida
Register Volume 43, Number 206, October 24, 2017 effective
11/5/2017, Amended
by
Florida
Register Volume 44, Number 100, May 22, 2018 effective
6/5/2018, Amended by
Florida
Register Volume 44, Number 177, September 11, 2018 effective
9/27/2018.
New 7-18-94, Formerly 61F10-28.501, 59X-28.501, Amended
1-2-02, 12-30-07, 11-5-17, 6-5-18,
9-27-18.
