Effective October 1, 2014, s. 465.0158, Florida Statutes, requires all nonresident pharmacies to obtain a Nonresident Sterile Compounding Permit in order to ship, mail, deliver, or dispense, in any manner, a compounded sterile product into the State of Florida. Nonresident pharmacies must obtain a Florida Nonresident Sterile Compounding Permit in addition to their current Florida Nonresident Pharmacy Permit.
Nonresident pharmacies that are compounding sterile products under their current Florida pharmacy permit may continue to do so if: the product meets or exceeds the standards for sterile compounding in this state; the product is not compounded in violation of any law or rule of the state, territory, or district where the pharmacy is located; and the pharmacy is issued the new Nonresident Sterile Compounding Permit on or before February 28, 2015. Nonresident Sterile Compounding Permit applicants will also be required to demonstrate full compliance with Chapter 797 of the United States Pharmacopeia, (USP 797).
Applications must be received by January 15, 2015 to ensure a license may be issued prior to the February 28, 2015 deadline. The application is available at https://floridaspharmacy.gov/licensing/
As a reminder, effective November 27, 2013, pharmacies are now only permitted to ship patient-specific sterile compounded products, or they must be in full compliance with 21 United States Code, (U.S.C.) § 353b, which includes being registered as an Outsourcing Facility.
Thank you for collaborating with the Florida Board of Pharmacy to protect, promote and improve the health of all people in Florida. If you have any questions you may contact our office by email at info@floridaspharmacy.gov
