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