Current through Reg. 47, No. 188; September 28, 2021
This 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.
(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.
(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.
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
Fla. Admin. Code Ann. R.
FS. Law Implemented
Register Volume 43, Number 060, March 28, 2017 effective