A compounded product that is contaminated or adulterated or a compounding pharmacy which lacks proper sterile and sanitary environments, presents an immediate, clear, present danger to the welfare, health, and safety of the citizens of the state of Florida as manifested by the recent outbreak of infections and resulting deaths. Moreover, The State Surgeon General recently issued the emergency suspension of two Florida compounding pharmacies for improper sanitary and environmental controls. For the protection of the citizens’ health, welfare and safety from continued proliferation of unsanitary or contamination compounding environments and distribution of contaminated products into this state, the board is in immediate need of comprehensive data: the specific compounding activities taking place at all permitted pharmacies and non-resident pharmacies. The rule is specifically designed to target, through inspection reporting requirements of non-resident pharmacies, to identify and minimize the immediate threat of contaminated products. The rule is also critical for identifying the high risk compounding activities in Florida pharmacies, so the department and board can prioritize inspections to minimize the immediate health and safety risks associated with unsanitary and unsterile compounding facilities in Florida.
REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES:
On November 14, the Board provided a public notice that the board would be holding a public meeting on November 20, 2012, to address compounding pharmacies. The board published the notice in the Florida Administrative Register. The Florida Administrative Register is available worldwide on the web. The agenda included the topic of requiring mandatory compounding reporting. The board placed the notice on the department website and provided a public notice of the agenda on the same website. On November 20, 2012, the board held a publicly noticed meeting for the purposes of addressing pharmacy compounding that included the necessity of this emergency rule. The board gave all interested parties the opportunity to provide input on pharmacy compounding and the rule. The parties present included counsels for pharmacy companies; state and national pharmacy associations; and individual pharmacy company representatives. Accordingly, the board provided all impacted parties sufficient notice of the intended action and provided a fair procedural opportunity for participation. Additionally, the board has directed that all pharmacies impacted by this emergency rule must be given direct notice of the rule through electronic mail or via correspondence at the the address of record on file with the department.
