The Board proposes the rule amendment to remove a subsection that has been moved to Chapter 32.

 

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 remove a subsection that has been moved to Chapter 32.

SUMMARY: A subsection has been removed due to being relocated in another rule.

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: 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 Board meeting, 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, 465.0156, 465.022 FS.

LAW IMPLEMENTED: 465.0156 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: Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.100 Pharmacy Permits – Applications and Permitting.

This section addresses the application and permitting requirements of business establishments regulated under Chapter 465, F.S. Any establishment that is required to have a permit 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/licensing/ http://www.doh.state.fl.us/mqa/pharmacy 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.com. The application must be accompanied with a $250 initial permit fee, payable to the Board. 

(1) through (6) No change.

(7) Non-Resident Pharmacy Registration as authorized by Section 465.0156, F.S., is required for those pharmacies located outside the state and which ships, mails, or delivers a dispensed medicinal drug into this state. Applicants for a Non-Resident Registration must complete an application for a registration using an original Form DH-MQA 1217, “Non-Resident Pharmacy Permit Application and Information,” effective August 2012, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-02304. Applicants for registration as a non-resident pharmacy must comply with all requirements found in Section 465.0156, F.S.

(7)(8) No change.

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

 

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: December 14, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 25, 2017