The Board proposes the rule amendment to provide the standards of practice for compounded products prepared utilizing a process that includes lyophilization.  

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    DEPARTMENT OF HEALTH

    Board of Pharmacy

    RULE NO.:RULE TITLE:

    64B16-27.797The Standards of Practice for Compounding Sterile Products

    PURPOSE AND EFFECT: The Board proposes the rule amendment to provide the standards of practice for compounded products prepared utilizing a process that includes lyophilization.

    SUBJECT AREA TO BE ADDRESSED: Standards of Practice for Compounding Sterile Products.

    RULEMAKING AUTHORITY: 465.005, 465.0155, 465.022 FS.

    LAW IMPLEMENTED: 465.0155, 465.022 FS.

    IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE REGISTER.

    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

    THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS AVAILABLE AT NO CHARGE FROM THE CONTACT PERSON LISTED ABOVE.

Document Information

Subject:
Standards of Practice for Compounding Sterile Products.
Purpose:
The Board proposes the rule amendment to provide the standards of practice for compounded products prepared utilizing a process that includes lyophilization.
Rulemaking Authority:
465.005, 465.0155, 465.022 FS.
Law:
465.0155, 465.022 FS.
Contact:
C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.
Related Rules: (1)
64B16-27.797. Standards of Practice for Compounding Sterile Preparations (CSPs)