64B16-32.007. Nonresident Sterile Compounding Permit for Nonresident Pharmacies  


Effective on Wednesday, April 12, 2017
  • 1This permit is required before a nonresident pharmacy ships, mails, delivers, or dispenses, in any manner, a patient-specific compounded sterile product into Florida.

    24(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.

    49(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.

    81(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 121http://www.flrules.org/Gateway/reference.asp?No=Ref-08096, 123or http://floridaspharmacy.gov. An applicant for this permit must comply with all provisions of Section 465.0158, F.S.

    139Rulemaking Authority 456.0158 FS. Law Implemented 465.0158, 146456.065 147(3), 148456.0635, 149465.0156 FS 151History–New 4-12-17.

     

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