Fla. Admin. Code R. 64B16-32.009 (2026)
Nonresident Sterile Compounding Permit for an Outsourcing Facility
This permit is required before an outsourcing facility that is located outside of Florida, ships, mails, delivers, or dispenses, in any manner a compounded sterile product into Florida.
(1) An outsourcing facility that obtains a nonresident sterile compounding permit may ship, mail, or deliver a sterile compounded product into Florida for office-use and may ship, mail, deliver, or dispense a patient-specific compounded sterile product into Florida. This permit does not authorize the shipping, mailing, delivering, or dispensing of a non-compounded medicinal drug into Florida.
(2) A permit issued pursuant to this section shall be issued with the following conspicuously displayed on the front of the license: Outsourcing Facility Nonresident Sterile Compounding Permit – Patient Specific Prescription Compounding and Office-Use Compounding.
(3) An outsourcing facility applicant seeking a nonresident sterile compounding permit shall submit an application using Form DH5004-MQA (eff. 07/16), “Nonresident Sterile Compounding Permit Application for Outsourcing Facilities” which is hereby incorporated by reference. This Form is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-08097, or http://floridaspharmacy.gov.
Rulemaking Authority 456.0158 FS. Law Implemented 465.0158, 456.065(3) FS. History–New 4-12-17.
Effective: 4/12/2017.