64B16-31.012. Collaborative Practice Certification: HIV Postexposure Prophylaxis Certification Required Submissions

(1) Prior to ordering and dispensing any HIV postexposure prophylaxis drugs under section 465.1861, F.S., a certified pharmacist shall submit a copy of the collaborative practice agreement to the Board pursuant to 465.1861(4), F.S. The Pharmacist shall submit the completed agreement to the Board Office through the pharmacist’s online licensure account at http://flhealthsource.gov or via U.S. Mail to 4052 Bald Cypress Way, Bin C-04, Tallahassee, FL 32399. In the event of an addendum to the material terms of an existing collaborative pharmacy practice agreement, the pharmacist shall maintain a copy of the addendum and the initial agreement. Material terms shall be defined as those terms enumerated in Section 465.1861(4)(a), F.S.

(2) Any pharmacy in which a pharmacist is ordering and dispensing any HIV postexposure prophylaxis drugs pursuant to section 468.1861, F.S., must submit an access-to-care plan complying with section 465.1861(7), F.S., to the Board and Department prior to any pharmacist providing services at that location. The pharmacy shall submit the access-to-care plan to the Board and Department through the pharmacy’s online licensure account at http://flhealthsource.gov or via U.S. Mail to 4052 Bald Cypress Way, Bin C-04, Tallahassee, FL 32399. Each access-to-care plan shall contain the enumerated requirements of section 465.1861(7)(b), the name of pharmacy, the pharmacy’s physical location, and the pharmacy’s permit number. All pharmacies in which a pharmacist is providing services pursuant to section 465.1861, F.S., shall submit an access-to-care-plan on February 28, 2025, and each February 28 thereafter in the same manner as outlined for the initial submission.

(3) If a pharmacy fails to submit its annual access-to-care plan the matter shall be immediately referred to the Department of Health, Consumer Services Unit as a complaint for consideration of disciplinary action pursuant to section 456.073, F.S. and 465.1861(7)(a), F.S. In the event a pharmacy submits a non-compliant access-to-care plan, the Board shall issue a notice of non-compliance outlining the alleged deficiencies and provide it to the prescription department manager or consultant pharmacist of record. The pharmacy shall then be given thirty (30) days from receipt of the Notice to submit a corrected access-to-care-plan. If the corrected access-to-care plan is determined to be deficient, or if the pharmacy fails to submit a corrected access-to-care plan, the matter shall be referred to the Department of Health, Consumer Services Unit as a complaint for consideration of disciplinary action pursuant to section 456.073, F.S. and 465.1861(7)(a), F.S.

Rulemaking Authority 465.1861 FS. Law Implemented 465.1861 FS. History‒New 9-11-24.