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 http://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



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