The Board proposes the rule development to comprehensively review any needed updates to the Standards of Practice for Compounding Sterile Products. The review will include, but not be limited to, specifically reviewing the ....
RULE NO.:RULE TITLE:
64B16-27.797The Standards of Practice for Compounding Sterile Products
PURPOSE AND EFFECT: The Board proposes the rule development to comprehensively review any needed updates to the Standards of Practice for Compounding Sterile Products. The review will include, but not be limited to, specifically reviewing the need to address and incorporate updated Chapters of the United States Pharmacopeia and to review the standards related to Outsourcing Facilities (aka 503b facilities) and the incorporated and adopted current good manufacturing practices found in 21 C.F.R. Parts 210 and 211.
SUBJECT AREA TO BE ADDRESSED: The 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: Traci Zeh, Acting Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C08, Tallahassee, Florida 32399-3258 or at info@Floridaspharmacy.gov.
THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE.
Document Information
- Purpose:
- The Board proposes the rule development to comprehensively review any needed updates to the Standards of Practice for Compounding Sterile Products. The review will include, but not be limited to, specifically reviewing the need to address and incorporate updated Chapters of the United States Pharmacopeia and to review the standards related to Outsourcing Facilities (aka 503b facilities) and the incorporated and adopted current good manufacturing practices found in 21 C.F.R. Parts 210 and 211.
- Rulemaking Authority:
- 465.005, 465.0155, 465.022 FS.
- Law:
- 465.0155, 465.022 FS.
- Related Rules: (1)
- 64B16-27.797. Standards of Practice for Compounding Sterile Preparations (CSPs)