The Board proposes the rule amendment add language regarding Special Sterile Compounding Pharmacies and to incorporate the application.

 

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 add language regarding Special Sterile Compounding Pharmacies and to incorporate the application.

SUMMARY: The proposed rule amendments are necessary to add language and incorporate the application for special sterile compounding permits.

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 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, 465.022 FS.

LAW IMPLEMENTED: 456.013, 456.025(3), 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: Mark Whitten, 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://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 (7) No change.

(8) Special Sterile Compounding Permit: Except those pharmacies which already hold an active stand alone Special Parenteral/Enteral or Special Parenteral/Enteral Extended Scope Compounding permit, any pharmacy engaged in sterile compounding must obtain a special sterile compounding permit by filing an application on form 1270, “Special Sterile Compounding Permit Application and Information,” effective May 2013, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-

(a) All applicants that hold an active pharmacy permit that are currently engaged in sterile compounding have 180 days from the effective date of this amendment to obtain a Special Sterile Compounding Permit. All pharmacies, which obtain the permit within the 180 days, are exempt from paying an additional application or license fee.

(b) Applicants for a Special Sterile Compounding Permit must:

1. Comply with all permitting requirements in subsection (1) of this rule;

2. Designate a prescription department manager or consultant pharmacist of record.

(c) The permittee and the newly designated prescription department manager of record or consultant pharmacist of record shall notify the board within 10 days of any change in the prescription department manager or consultant pharmacists of record on FORM DH-MQA PH10, “Prescription Department Manger Change,” effective December 2010 or FORM DH-MQA 1184, “Change of Consultant Pharmacist of Record,” effective December 2010, which is incorporated by reference herein and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-02299.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 456.013, 456.025(3), 465.018, 465.019, 465.0193, 465.0196, 465.0197, 465.022 FS. History–New 2-21-13,. 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 2, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 3, 2013