The Board proposes the rule amendment to revise and clarify the requirements for designation as a consultant pharmacist of record for certain permit types; to update the fingerprinting requirements, to update incorporated form, and require ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.501Institutional Permit - Consultant Pharmacist of Record

PURPOSE AND EFFECT: The Board proposes the rule amendment to revise and clarify the requirements for designation as a consultant pharmacist of record for certain permit types; to update the fingerprinting requirements, to update incorporated form, and require continuous designation of the Consultant Pharmacist of Record.

SUMMARY: The amendment will revise and clarify the requirements for designation as a consultant pharmacist of record for certain permit types, update the fingerprinting requirements, and require continuous designation of the Consultant Pharmacist of Record.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 465.005, 465.0125, 465.022 FS.

LAW IMPLEMENTED: 465.0125, 465.019, 465.022, 465.0266 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.501 Institutional Permit – 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 64B16-28.901, 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), Change of Consultant Pharmacist of Record, which is hereby incorporated by reference and which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-       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.

(1) Each facility holding a Class I, a Class II, or a Modified Class II Institutional permit shall designate a consultant pharmacist of record to ensure compliance with the laws and rules governing the permit. The Board office shall be notified in writing within ten (10) days of any change in the consultant pharmacist of record.

(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)(2) Drug Regimen Reviews. The consultant pharmacist of record for a Class I, Class II, or Modified Class II 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)(3) 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,                   .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 6, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 26, 2018