The Board proposes the rule amendment to update form DH-MQA 1220 incorporated by reference into this rule consistent with Rule 64B16-28.810.  

  •  

    DEPARTMENT OF HEALTH

    Board of Pharmacy

    RULE NO.:RULE TITLE:

    64B16-28.100Pharmacy Permits Applications and Permitting

    PURPOSE AND EFFECT: The Board proposes the rule amendment to update form DH-MQA 1220 incorporated by reference into this rule consistent with Rule 64B16-28.810, F.A.C.

    SUMMARY: The proposed rule amendment is necessary to make form DH-MQA 1220 incorporated by reference into this rule consistent with Rule 64B16-28.810, F.A.C.

    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 because the changes to the rule text only update an incorporated form used for special permits, the changes to the incorporated form are at the request of JAPC to make the form consistent with rule 64B16-28.810, and the request of such a special permit by a pharmacy under rule 64B16-28.810 is optional. 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, 465.022 FS.

    LAW IMPLEMENTED: 456.013, 456.025(3), 465.018, 465.019, 465.0193, 465.0196, 465.0197, 465.022 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: Tammy Collins, Acting Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

     

    THE FULL TEXT OF THE PROPOSED RULE IS:

     

    64B16-28.100 Pharmacy Permits – Applications and Permitting.

    This section addresses the application and permitting requirements of business establishments regulated under Chapter 465, F.S. Any establishment that is required to have a permit shall apply to the board for the appropriate permit on forms indicated in this rule. Applications and forms referenced in this section may be accessed or downloaded from the web at http://www.doh.state.fl.us/mqa/pharmacy or may be obtained by contacting the Board the Board of Pharmacy, at 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or (850)488-0595. Inquiries regarding the status of the application or license verification may be obtained at http://www.FLHealthsource.com. The application must be accompanied with a $250 initial permit fee, payable to the Board.

    (1) through (4) No change.

    (5) Special Pharmacy Permits as authorized in Section 465.0196, F.S., is required for any location where medicinal drugs are compounded, dispensed, stored, or sold and which are not a community pharmacy, institutional pharmacy, nuclear pharmacy or internet pharmacy. Applicants for a Special-Limited Community, Special – Parenteral and Enteral, Special – Closed System Pharmacy, Special – End Stage Renal Disease (ESRD), Special – Parenteral/Enteral Extended Scope, and Special – Assisted Living Facility (ALF) permits must complete an application for a permit using an original Form DH-MQA 1220, “Special Pharmacy Permit Application and Information,” effective December 2013 August 2012, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-_____02303.

    (a) through (d) No change.

    (6) through (8) No change.

    Rulemaking Authority 465.005, 465.022 FS. Law Implemented 456.013, 456.025(3), 456.0635, 465.018, 465.019, 465.0193, 465.0196, 465.0197, 465.022 FS. History–New 2-21-13, Amended 9-23-13,__________.

     

    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: December 4, 2013

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 30, 2014

Document Information

Comments Open:
2/20/2014
Summary:
The proposed rule amendment is necessary to make form DH-MQA 1220 incorporated by reference into this rule consistent with Rule 64B16-28.810.
Purpose:
The Board proposes the rule amendment to update form DH-MQA 1220 incorporated by reference into this rule consistent with Rule 64B16-28.810.
Rulemaking Authority:
465.005, 465.022 FS.
Law:
456.013, 456.025(3), 465.018, 465.019, 465.0193, 465.0196, 465.0197, 465.022 FS.
Contact:
Tammy Collins, Acting Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.
Related Rules: (1)
64B16-28.100. Pharmacy Permits - Applications and Permitting