Notice to FDA Registered Outsourcing Facilities

Posted in Latest News on September 24, 2014.

Effective October 1, 2014, s. 465.0158, Florida Statutes, requires all nonresident outsourcing facilities 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.

In addition to holding a Florida Nonresident Sterile Compounding Permit, nonresident outsourcing facilities must be duly registered with the Food and Drug Administration. Applicants will also be required to demonstrate full compliance with current Good Manufacturing Practices. Outsourcing facilities intending to ship, mail, deliver, or dispense a compounded sterile product into Florida must apply on an application located at https://floridaspharmacy.gov/licensing/.

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



More Latest News

Notification of Renewal Deadline Extension
April 1, 2021

State Surgeon General Scott A. Rivkees issued Emergency Order 21-001 granting licensure renewal extensions Continue reading


NTSB Study on Drug Use Trends in Aviation
March 8, 2021

National Transportation Safety Board issues recommendations to states on prescribing controlled substances for pain and the dangers of operating a vehicle in any mode of transportation Continue reading