64B16-28.501. Consultant Pharmacist of Record; Initial Designation; Change

(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, or 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.

Rulemaking Authority 465.005, 465.0125, 465.022 FS. Law Implemented 465.0125, 465.019, 465.022, 465.0266 FS. History–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.