Fla. Admin. Code Ann. R. 64B16-32.007 - Nonresident Sterile Compounding Permit for Nonresident Pharmacies

Current through Reg. 47, No. 188; September 28, 2021

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.

Notes

Fla. Admin. Code Ann. R. 64B16-32.007

Rulemaking Authority 465.0158 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 4-12-17.

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