The Board proposes the rule development and amendment to update the rule for any identified needed changes and to amend the rule to require and make clear that the compounding of human products (sterile and nonsterile) for office use must be in full ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.700Definition of Compounding

PURPOSE AND EFFECT: The Board proposes the rule development and amendment to update the rule for any identified needed changes and to amend the rule to require and make clear that the compounding of human products (sterile and nonsterile) for office use must be in full compliance with 21 U.S.C. §353b, including being registered as an Outsourcing Facility. In addition, the purpose and effect is to ensure that the rule does not conflict with state and federal law.

SUBJECT AREA TO BE ADDRESSED: Compounding; the compounding for human use; office use compounding for human use of sterile and nonsterile products.

RULEMAKING AUTHORITY: 465.005 FS.

LAW IMPLEMENTED: 465.003, 465.0155, 465.0265 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/MQA, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3258.

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