99(3) 100An applicant must submit the following to the board to obtain an initial permit, or to the department to renew a permit:122(a) 123Proof 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.
164(b) 165Proof of registration as a nonresident pharmacy, pursuant to s. 175465.0156, 176unless 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. 242(c) 243Written attestation by an owner or officer of the applicant, and by the applicant’s prescription department manager or pharmacist in charge, that:2651. 266The attestor has read and understands the laws and rules governing sterile compounding in this state.
2822. 283A compounded sterile product shipped, mailed, delivered, or dispensed into this state meets or exceeds this state’s standards for sterile compounding.
3043. 305A 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.
345(d) 346The 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.
388(e) 389A 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. If the applicant is unable to submit a current inspection report conducted by the regulatory or licensing agency of the state, territory, or district in which the applicant is located, due to acceptable circumstances, as established by rule, or if an inspection has not been performed, the department shall:5111. 512Conduct, or contract with an entity to conduct, an onsite inspection for which all costs shall be borne by the applicant;
5332. 534Accept a current and satisfactory inspection report, as determined by rule, from an entity approved by the board; or
5533. 554Accept a current inspection report from the United States Food and Drug Administration conducted pursuant to the federal Drug Quality and Security Act, Pub. L. No. 113-54.
821(8) 822The board shall adopt rules as necessary to administer this section, including rules for:836(a) 837Submitting an application for the permit required by this section.
847(b) 848Determining how, when, and under what circumstances an inspection of a nonresident sterile compounding permittee must be conducted.
866(c) 867Evaluating and approving entities from which a satisfactory inspection report will be accepted in lieu of an onsite inspection by the department or an inspection by the licensing or regulatory agency of the state, territory, or district where the applicant is located.
