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Florida Administrative Code (Last Updated: April 18, 2024) |
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64. Department of Health |
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64B16. Board of Pharmacy |
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64B16-32. Nonresident Pharmacies |
1This 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.
29(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.
85(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.
121(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 160http://www.flrules.org/Gateway/reference.asp?No=Ref-08097, 162or http://floridaspharmacy.gov.
164Rulemaking Authority 456.0158 FS. Law Implemented 465.0158, 171456.065(3) FS. 173History–New 4-12-17.
