The Board proposes the rule promulgation to create a rule regarding nonresident sterile compounding permit for nonresident pharmacies and to incorporate the nonresident sterile compounding permit application for nonresident pharmacies.  

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    DEPARTMENT OF HEALTH

    Board of Pharmacy

    RULE NO.:RULE TITLE:

    64B16-32.007Nonresident Sterile Compounding Permit for Nonresident Pharmacies.

    PURPOSE AND EFFECT: The Board proposes the rule promulgation to create a rule regarding nonresident sterile compounding permit for nonresident pharmacies and to incorporate the nonresident sterile compounding permit application for nonresident pharmacies.

    SUMMARY: A rule will be created regarding nonresident sterile compounding permit for nonresident pharmacies and to incorporate the nonresident sterile compounding permit application for nonresident pharmacies.

    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: 465.0158 FS.

    LAW IMPLEMENTED: 465.0158, 456.065(3) 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: Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

     

    THE FULL TEXT OF THE PROPOSED RULE IS:

     

    64B16-32.007 Nonresident Sterile Compounding Permit for Nonresident Pharmacies  

    This permit is required before a nonresident pharmacy ships, mails, delivers, or dispenses, in any manner, a patient-specific compounded sterile product into Florida. 

    (1) A nonresident pharmacy that obtains a nonresident sterile compounding permit may only ship, mail, deliver, or dispense a patient-specific compounded sterile product into Florida. 

    (2) A permit issued pursuant to this section shall be issued with the following conspicuously displayed on the front of the license: Nonresident Sterile Compounding Permit – Patient Specific Prescription Compounding Only.

    (3) A nonresident pharmacy applicant seeking a nonresident sterile compounding permit shall submit an application using Form DH5003-MQA (eff. 04/16), “Nonresident Sterile Compounding Permit Application for Nonresident Pharmacies,” which is hereby incorporated by reference. The Form is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-     or http://floridaspharmacy.gov.  An applicant for this permit must comply with all provisions of section 465.0158, F.S.

    Rulemaking Authority 456.0158, FS.  Law Implemented 465.0158, 456.065(3) 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: April 5, 2016

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 9, 2016

     

Document Information

Comments Open:
5/27/2016
Summary:
A rule will be created regarding nonresident sterile compounding permit for nonresident pharmacies and to incorporate the nonresident sterile compounding permit application for nonresident pharmacies.
Purpose:
The Board proposes the rule promulgation to create a rule regarding nonresident sterile compounding permit for nonresident pharmacies and to incorporate the nonresident sterile compounding permit application for nonresident pharmacies.
Rulemaking Authority:
465.0158 FS.
Law:
465.0158, 456.065(3) FS.
Contact:
Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.
Related Rules: (1)
64B16-32.007. Nonresident Sterile Compounding Permit for Nonresident Pharmacies