The Board proposes the rule amendment to update information regarding the incorporated rule chapter.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.120All Permits - Storage of Legend Drugs; Prepackaging

PURPOSE AND EFFECT: The Board proposes the rule amendment to update information regarding the incorporated rule chapter.

SUMMARY: The incorporated rule chapter information will be updated.

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 FS.

LAW IMPLEMENTED: 435.019(2), 465.003(7), 465.022 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: 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:

 

64B16-28.120 All Permits – Storage of Legend Drugs; Prepackaging.

(1) No change.

(2) All medicinal drugs or drug preparations as defined in Section 465.003(8), F.S., within Class I Institutional permittees as defined in Section 465.019(2)(a), F.S., and Special ALF Permit 64B16-28.870, F.A.C., shall:

(a) No change.

(b) Be prohibited within the confines of Class I Institutional pharmacies unless obtained upon a proper prescription and properly labeled in accordance with Chapter 499, F.S., and the rules and regulations contained in Chapter 59A-4, F.A.C., incorporated herein by reference and effective August 25, 2023 August 1, 2006, which may be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-            or https://www.flrules.org/gateway/ChapterHome.asp?Chapter=59A-4, pertaining to the licensure of nursing homes and related facilities.

(3) through (4) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 435.019(2), 465.003(7), 465.022 FS. History–New 9-18-84, Formerly 21S-1.44, 21S-1.044, Amended 7-31-91, Formerly 21S-28.120, 61F10-28.120, 59X-28.120, Amended 2-8-07, 8-16-10, _______________.

 

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: August 25, 2023

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 6, 2023