2018 Florida Statutes
Nonresident sterile compounding permit.
Nonresident sterile compounding permit.
465.0158 Nonresident sterile compounding permit.—
(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 application for a nonresident sterile compounding permit shall be submitted on a form furnished by the board. The board may require such information as it deems reasonably necessary to carry out the purposes of this section. The fee for an initial permit and biennial renewal of the permit shall be set by the board pursuant to s. 465.022(14).
(3) 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. A compounded sterile product shipped, mailed, delivered, or dispensed into this state meets or exceeds this state’s standards for sterile compounding.
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. 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:
1. Conduct, or contract with an entity to conduct, an onsite inspection for which all costs shall be borne by the applicant;
2. Accept a current and satisfactory inspection report, as determined by rule, from an entity approved by the board; or
3. Accept 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.
(4) A permittee may not ship, mail, deliver, or dispense a compounded sterile product into this state if the product was compounded in violation of the laws or rules of the state, territory, or district in which the permittee is located or does not meet or exceed this state’s sterile compounding standards.
(5) In accordance with this chapter, the board may deny, revoke, or suspend the permit of; fine; or reprimand a permittee for:
(a) Failure to comply with this section;
(b) A violation listed under s. 456.0635, s. 456.065, or s. 456.072, except s. 456.072(1)(s) or (1)(u);
(c) A violation under s. 465.0156(5); or
(d) A violation listed under s. 465.016.
(6) A nonresident pharmacy registered under s. 465.0156 which ships, mails, delivers, or dispenses a compounded sterile product into this state may continue to do so if the product meets or exceeds the standards for sterile compounding in this state; the product is not compounded in violation of any law or rule of the state, territory, or district where the pharmacy is located; and the pharmacy is issued a permit under this section on or before February 28, 2015.
(7) An applicant registering on or after October 1, 2014, as a nonresident pharmacy under s. 465.0156 may not ship, mail, deliver, or dispense a compounded sterile product into this state until the applicant is registered as a nonresident pharmacy and is issued a permit under this section.
(8) The board shall adopt rules as necessary to administer this section, including rules for:
(a) Submitting an application for the permit required by this section.
(b) Determining how, when, and under what circumstances an inspection of a nonresident sterile compounding permittee must be conducted.
(c) Evaluating 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.
History.—s. 3, ch. 2014-148; s. 22, ch. 2016-224.