The Board proposes the rule promulgation to set the parameters for required inspections, acceptable circumstances for a current inspection; determining how, when, and under what circumstances an inspection must be conducted; and to adopt rules for ...
RULE NO.:RULE TITLE:
64B16-28.907Outsourcing Facility Inspections for Obtaining a Nonresident Sterile Compounding Permit.
PURPOSE AND EFFECT: The Board proposes the rule promulgation to set the parameters for required inspections, acceptable circumstances for a current inspection; determining how, when, and under what circumstances an inspection must be conducted; and to adopt rules for evaluating and approving entities that may perform an inspection in lieu of an onsite inspection by the department. The rule promulgation is to implement Ch. 2014-148, Laws of Florida (HB 323).
SUBJECT AREA TO BE ADDRESSED: Outsourcing Facility Inspections for Obtaining a Nonresident Sterile Compounding Permit.
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: Patrick Kennedy, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254
THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE.
Document Information
- Subject:
- Outsourcing Facility Inspections for Obtaining a Nonresident Sterile Compounding Permit.
- Purpose:
- The Board proposes the rule promulgation to set the parameters for required inspections, acceptable circumstances for a current inspection; determining how, when, and under what circumstances an inspection must be conducted; and to adopt rules for evaluating and approving entities that may perform an inspection in lieu of an onsite inspection by the department. The rule promulgation is to implement Ch. 2014-148, Laws of Florida (HB 323).
- Rulemaking Authority:
- 465.0158 FS.
- Law:
- 465.0158 FS.
- Contact:
- Patrick Kennedy, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.
- Related Rules: (1)
- 64B16-28.907. Outsourcing Facility Inspections for Obtaining a Nonresident Sterile Compounding Permit.