The Board proposes the rule amendment to clarify language regarding issuance of pharmacy permits after onsite inspections.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.100Pharmacy Permits - Applications and Permitting

PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify language regarding issuance of pharmacy permits after onsite inspections.

SUMMARY: Language will be clarified regarding issuance of pharmacy permits after onsite inspections.

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: 456.013, 456.025(3), 456.0635, 465.003, 465.018, 465.019, 465.0193, 465.0196, 465.0197, 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: Jessica Sapp, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254; [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.100 Pharmacy Permits – Applications and Permitting.

This rule section establishes the application and permitting requirements for pharmacies regulated under chapter 465, F.S. Any pharmacy establishment shall apply to the board for the appropriate permit on forms indicated in this rule. Applications and forms referenced in this section may be accessed or downloaded from the web at http://floridaspharmacy.gov/resources/ or may be obtained by contacting the Board the Board of Pharmacy, at 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or [phone]. Inquiries regarding the status of the application or license verification may be obtained at http://www.FLHealthsource.gov. The application must be accompanied by the appropriate fee as specified by rule 64B16-26.1022, F.A.C.

(1) All Permits:

(a) through (b) No change.

(c) An onsite inspection demonstrating full compliance with all applicable rules and statutes is a prerequisite to issuance of a new permit, whether based on an initial application, change of ownership, or change of address. Passing an onsite inspection is a prerequisite to issuance of a new permit, whether based on an initial application, change of ownership, or change of address. At the time of the onsite inspection, the board inspector will document the applicant’s compliance with all applicable rules and statutes.

(d) No change.

(2) through (7) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 456.013, 456.025(3), 456.0635, 465.003, 465.018, 465.019, 465.0193, 465.0196, 465.0197, 465.022 FS. History–New 2-21-13, Amended 9-23-13, 5-31-17, 6-5-18,                    .

 

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, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 12, 2021