To access a copy of the PDF application for Nonresident Sterile Compounding Permit Application For Nonresident Pharmacies please click here.
To access a copy of the PDF application for Nonresident Sterile Compounding Permit Application For Outsourcing Facilities please click here.
An applicant must submit the following to the board to obtain an initial permit, or to the department to renew a permit:
(a) Proof of registration as an outsourcing facility with the Secretary of the United States Department of Health and Human Services if the applicant is eligible for such registration pursuant to the federal Drug Quality and Security Act, Pub. L. No. 113-54.
(b) Proof of registration as a nonresident pharmacy, pursuant to s. 465.0156, unless the applicant is an outsourcing facility and not a pharmacy, in which case the application must include proof of an active and unencumbered license, permit, or registration issued by the state, territory, or district in which the outsourcing facility is physically located which allows the outsourcing facility to engage in compounding and to ship, mail, deliver, or dispense a compounded sterile product into this state.
The requirements are as follows and can be found in Chapter 465.0158, Florida Statutes:
1. In order to ship, mail, deliver, or dispense, in any manner, a compounded sterile product into this state, a nonresident pharmacy registered under s. 465.0156, or an outsourcing facility, must hold a nonresident sterile compounding permit.
2. An applicant must submit the following to the board to obtain an initial permit, or to the department to renew a permit:
(a) Proof of registration as an outsourcing facility with the Secretary of the United States Department of Health and Human Services if the applicant is eligible for such registration pursuant to the federal Drug Quality and Security Act, Pub. L. No. 113-54.
(b) Proof of registration as a nonresident pharmacy, pursuant to s. 465.0156, unless the applicant is an outsourcing facility and not a pharmacy, in which case the application must include proof of an active and unencumbered license, permit, or registration issued by the state, territory, or district in which the outsourcing facility is physically located which allows the outsourcing facility to engage in compounding and to ship, mail, deliver, or dispense a compounded sterile product into this state.
(c)Written attestation by an owner or officer of the applicant, and by the applicant’s prescription department manager or pharmacist in charge, that:
1. The attestor has read and understands the laws and rules governing sterile compounding in this state.
2. The attestor has read and understands the laws and rules governing sterile compounding in this state.
3. A compounded sterile product shipped, mailed, delivered, or dispensed into this state must not have been, and may not be, compounded in violation of the laws and rules of the state, territory, or district in which the applicant is located.
(d) The applicant’s existing policies and procedures for sterile compounding, which must comply with pharmaceutical standards in chapter 797 of the United States Pharmacopoeia and any standards for sterile compounding required by board rule or current good manufacturing practices for an outsourcing facility.
(e) A current inspection report from an inspection conducted by the regulatory or licensing agency of the state, territory, or district in which the applicant is located. The inspection report must reflect compliance with this section. An inspection report is current if the inspection was conducted within 6 months before the date of submitting the application for the initial permit or within 1 year before the date of submitting an application for permit renewal.