Section 64B16-32.007 - Nonresident Sterile Compounding Permit for Nonresident PharmaciesThis 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.Fla. Admin. Code Ann. R. 64B16-32.007
Rulemaking Authority 456.0158 FS. Law Implemented 465.0158, 456.065 (3), 456.0635, 465.0156 FS
Adopted by Florida Register Volume 43, Number 060, March 28, 2017 effective 4/12/2017.