The Board proposes the rule amendment to revise incorporated form DH5032-MQA.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.750Class III Institutional Pharmacies.

PURPOSE AND EFFECT: The Board proposes the rule amendment to revise incorporated form DH5032-MQA.

SUMMARY: Incorporated form DH5032-MQA will be revised

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: 465.005, 465.022

LAW IMPLEMENTED: 456.0635, 465.019(2)(d), 465.022

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: Allison Dudley, 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:

64B16-28.750 Class III Institutional Pharmacies.

(1) through (2) No change.

(3)(a) New Class III Permits. Applicants for a new Class III Institutional Pharmacy permit must complete an application for a permit using an original Form DH5032-MQA, 04/2023 08/2018, “Class III Institutional Pharmacy Permit Application and Information,” which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-_________09948. Applicants for an Institutional Pharmacy Permit must designate a consultant pharmacist of record as required by section 465.019, F.S. and rule 64B16-28.501, F.A.C.

(b) No change.

(5) through (7) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 456.0635, 465.019(2)(d), 465.022 FS. History–New 10-10-18, Amended                .

 

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: April 13, 2023

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 2, 2023