The Board proposes the promulgation of the rules to implement new legislation.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-31.010Collaborative Practice Certification: HIV Postexposure Prophylaxis Certification

64B16-31.011Collaborative Practice Certification: HIV Postexposure Prophylaxis Certification Course

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

PURPOSE AND EFFECT: The Board proposes the promulgation of the rules to implement new legislation.

SUMMARY: The rules will be promulgated due to new legislation.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Committee meetings and Board meetings, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 465.1895 FS.

LAW IMPLEMENTED: 465.1895 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Kelly Rogers, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C08, Tallahassee, Florida 32399-3258 or by email at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-31.010 Collaborative Practice Certification: HIV Postexposure Prophylaxis Certification.

(1) Applicants for HIV Infection Prevention Certification pursuant to section 465.1861, F.S., shall submit an application using Form DH5098-MQA (eff. 06/2024), “Application for HIV Postexposure Prophylaxis Certification” that is hereby incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-xxxxx or http://floridaspharmacy.gov.

(2) All applicants for certification must meet all requirements for certification as outlined in Section 465.1861(6), F.S.

(3) Prior to registration, the applicant must complete a course approved by the Board per Rule 64B16-31.011, F.A.C., and section 465.1861(6)(e), F.S.

Rulemaking Authority 465.1895 FS. Law Implemented 465.1895 FS. History‒New            .

 

64B16-31.011 Collaborative Practice Certification: HIV Postexposure Prophylaxis Certification Course.

Any entity seeking to offer the HIV Postexposure Prophylaxis certification course must submit an application using Form DH5100-MQA (eff. 06/24), “Application for Initial HIV Postexposure Prophylaxis Certification Course” ” that is hereby incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-xxxxx or http://floridaspharmacy.gov. Courses must be at least two (2) hours in duration and shall include instruction on all areas enumerated in Section 465.1861(6)(e), F.S. The course may only be offered by a program provider who is accredited by the Accreditation Council for Pharmacy Education (ACPE), a program provider who is accredited to provide educational activities designated for the American Medical Association Physician’s Recognition Award Category I credit, or a program provider approved by the American Osteopathic Association to offer continuing medical education credits.

Rulemaking Authority 465.1895 FS. Law Implemented 465.1895 FS. History‒New               .

 

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 465.1895 FS. Law Implemented 465.1895 FS. History‒New             .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 9, 2024

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 26, 2024