Fla. Admin. Code R. 64B16-32.009

Current through Reg. 50, No. 119; June 18, 2024

Section 64B16-32.009 - Nonresident Sterile Compounding Permit for an Outsourcing Facility

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.

(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 http://www.flrules.org/Gateway/reference.asp?No=Ref-08097, or http://floridaspharmacy.gov.

Fla. Admin. Code Ann. R. 64B16-32.009

Rulemaking Authority 456.0158 FS. Law Implemented 465.0158, 456.065(3) FS.

Adopted by Florida Register Volume 43, Number 060, March 28, 2017 effective 4/12/2017.

New 4-12-17.