The Board proposes the promulgation of the rule to establish responsibilities and duties of Prescription Department Managers and to establish requirements to be followed upon a change of the prescription department managers.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.: RULE TITLE:

64B16-27.450Prescription Department Managers; Registration; Responsibilities.

PURPOSE AND EFFECT: The Board proposes the promulgation of the rule to establish responsibilities and duties of Prescription Department Managers and to establish requirements to be followed upon a change of the prescription department managers.

SUMMARY: The responsibilities and duties of Prescription Department Managers and the requirements to be followed upon a change of the prescription department managers will be established.

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: 465.0135, 465.018(2), 465.0197(1), (3)(b), 465.022(2), (3), (10), (11), 465.023(1) 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: Jennifer Wenhold, Interim 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. Designation is accomplished as part of the Application for a Community Pharmacy Permit, utilizing Form DH-MQA 1214, incorporated in Rule 64B16-26.100, F.A.C., or application for an Internet Pharmacy Permit, utilizing Form DH-MQA 1216, 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, 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, 10/16, 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-    , 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.

(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, Florida Statutes. This paragraph does not apply to persons fingerprinted pursuant to these statutes on or after July 1, 2013.

(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. 

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), 465.023(1), FS. History–New                         .

 

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: October 18, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 22, 2016