Fla. Admin. Code R. 64B16-32.007 (2026)
Nonresident Sterile Compounding Permit for Nonresident Pharmacies
This permit is required before a nonresident pharmacy ships, mails, delivers, or dispenses, in any manner, a patient-specific compounded sterile product into Florida.
(1) A nonresident pharmacy that obtains a nonresident sterile compounding permit may only ship, mail, deliver, or dispense a patient-specific compounded sterile product into Florida.
(2) A permit issued pursuant to this section shall be issued with the following conspicuously displayed on the front of the license: Nonresident Sterile Compounding Permit – Patient Specific Prescription Compounding Only.
(3) A nonresident pharmacy applicant seeking a nonresident sterile compounding permit shall submit an application using Form DH5003-MQA (eff. 07/16), “Nonresident Sterile Compounding Permit Application for Nonresident Pharmacies,” which is hereby incorporated by reference. The Form is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-08096, or http://floridaspharmacy.gov. An applicant for this permit must comply with all provisions of section 465.0158, F.S.
Rulemaking Authority 456.0158 FS. Law Implemented 465.0158, 456.065 (3), 456.0635, 465.0156 FS History–New 4-12-17.
Effective: 4/12/2017.