With the nationwide fungal meningitis outbreak caused by contaminated compounded products, the Florida Board of Pharmacy adopted Emergency Rule 64B16ER12-1, Florida Administrative Code. This Emergency Rule requires all Florida licensed pharmacy permit holders, including non-residents, to complete a mandatory survey to inform the Board of its compounding activities. The goal of this mandatory survey is to determine the scope of sterile and non-sterile compounding within Florida licensed pharmacies –whether physically located in or out-of-state.
Failure to timely complete the mandatory survey is grounds for disciplinary action; however the goal is not to discipline, only to obtain critical data. Your cooperation in this matter is important to the department’s public protection mission.
This Emergency Rule became effective Monday, November 26, 2012 and the survey must be completed by December 11, 2012.
In addition to completing this survey, all non-resident pharmacy permit holders are required to provide copies of their two most recent inspection reports from the state in which their pharmacy is physically located. The inspection reports must be postmarked by December 11, 2012 and mailed to:
Florida Department of Health
Board of Pharmacy
c/o Mark Whitten, Executive Director
4052 Bald Cypress Way, Bin C04
Tallahassee, Florida 32399-3254
Protecting patient safety and the integrity of the pharmacy compounding industry is critical. This survey is intended to gather data that will allow policymakers to make informed decisions, without creating undue regulatory burdens.
Florida Board of Pharmacy Compounding Survey Report.
Thank you for helping the Department of Health and the Board to protect, promote and improve the health of all people in Florida through integrated state, local and community efforts.