The board proposes the rule amendment to add language and clarification to the existing rule.  

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    DEPARTMENT OF HEALTH

    Board of Pharmacy

    RULE NO.:RULE TITLE:

    64B16-28.802Special Sterile Compounding Permits

    PURPOSE AND EFFECT: The board proposes the rule amendment to add language and clarification to the existing rule.

    SUMMARY: The proposed rule amendment adds language to clarify the requirements of Special Sterile Compounding Permits.

    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, 465.022 FS.

    LAW IMPLEMENTED: 465.0196 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: Mark Whitten, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

     

    THE FULL TEXT OF THE PROPOSED RULE IS:

     

    (Substanial Rewording of Rule 64B16-28.802 follows. See Florida Administrative Code for present text.)

     

    64B16-28.802 Special Sterile Compounding Permits.

    With the exception of those pharmacies which hold an active stand alone Special Parenteral/Enteral or Special Parenteral / Enteral Extended Scope Compounding permit, a special sterile compounding permit is a type of special permit, which is required before any permitted pharmacy may engage in the preparation of compounding sterile products. This permit is an additional permit required by a licensed pharmacy and shall not be considered a modifier. The compounding of sterile products must be in strict compliance with the standards set for in Rules 64B16-27.700 and 64B16-27.797, F.AC.

    Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196 FS. History–New 6-18-13, Amended_______.

     

    NAME OF PERSON ORIGINATING PROPOSED RULE: Compounding Committee

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

    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 4, 2013

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 3, 2013

Document Information

Comments Open:
7/22/2013
Summary:
The proposed rule amendment adds language to clarify the requirements of Special Sterile Compounding Permits.
Purpose:
The board proposes the rule amendment to add language and clarification to the existing rule.
Rulemaking Authority:
465.005, 465.022 FS.
Law:
465.0196 FS.
Contact:
Mark Whitten, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.
Related Rules: (1)
64B16-28.802. Special Sterile Compounding Permits