The Board proposes the rule amendment to revise and clarify the requirements for designation as a prescription department manager for certain permit types; to update/correct the fingerprinting requirements; and to update the incorporated form.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.450Prescription Department Managers

PURPOSE AND EFFECT: The Board proposes the rule amendment to revise and clarify the requirements for designation as a prescription department manager for certain permit types; to update/correct the fingerprinting requirements; and to update the incorporated form.

SUMMARY: The requirements for designation as a prescription department manager for certain permit types will be revised and clarified. The fingerprinting requirements will be updated/corrected. The incorporated form will be updated.

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, 465.0155, 465.022(1), (10) FS.

LAW IMPLEMENTED: 456.0135, 465.018(2), 465.0197(1), (3)(b), 465.022(2), (3), (10), (11) FS.

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:

 

64B16-27.450 Prescription Department Managers.

(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, 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 dDesignation is accomplished as part of the application process using the appropriate application form for a Community Pharmacy Permit, utilizing Form DH-MQA 1214, Community 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, or 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 12/16, Change of Prescription Department Manager, which is hereby incorporated by reference and which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-     07929, 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. This paragraph does not apply to persons fingerprinted pursuant to these statutes on or after July 1, 2013.

(2) No change.

(3) All community, and 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) No change.

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,            .

 

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