The Board proposes the promulgation of the rule to set the standards for those entities seeking approval to perform sterile compounding inspections for nonresident outsourcing facilities who hold or who are seeking a nonresident sterile compounding ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.: RULE TITLE:

64B16-32.017Approved Inspection Entities - Nonresident Sterile Compounding Permit for Outsourcing Facilities.

PURPOSE AND EFFECT: The Board proposes the promulgation of the rule to set the standards for those entities seeking approval to perform sterile compounding inspections for nonresident outsourcing facilities who hold or who are seeking a nonresident sterile compounding permit.

SUBJECT AREA TO BE ADDRESSED: Approved Inspection Entities – Nonresident Sterile Compounding Permit for Outsourcing Facilities.

RULEMAKING AUTHORITY: 465.0158 FS.

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

 

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE