The Board proposes the rule amendment to implement House Bill 7077 that was passed in the 2014 Legislative session. The bill created a mandatory new permit – Nonresident Sterile Compounding Permit. The House Bill is now officially codified in ...

 

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 implement House Bill 7077 that was passed in the 2014 Legislative session. The bill created a mandatory new permit – Nonresident Sterile Compounding Permit. The House Bill is now officially codified in Florida Statutes under section 465.0158. The rule amendment incorporates the application that is required to be submitted to the Board when an applicant applies for the new license.

SUMMARY: The rule is being amended to implement House Bill 7077, passed in the 2014 Legislative session. The application that is required to be submitted to the Board when an applicant applies for a new license will be incorporated.

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, 465.0158, 465.022 FS.

LAW IMPLEMENTED: 456.013, 456.025(3), 456.0635, 465.0158, 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: Allison Dudley, 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 (8) No change.

(9) Nonresident Sterile Compounding Permit: This permit is required before an Outsourcing Facility or a Nonresident Pharmacy ships, mails, delivers, or dispenses, in any manner, a compounded sterile product into Florida.

(a) Outsourcing Facility applicants for this permit shall submit an application using Form DH5004-MQA-2/15, Nonresident Sterile Compounding Permit Application for Outsourcing Facilities, that is hereby incorporated by reference. The Form is available at http://www.flrules.org/Gateway/reference.asp?No=Ref- or http://floridaspharmacy.gov. Applicants must comply with all requirements found in Section 465.0158, F.S.

(b) Nonresident Pharmacy applicants for this permit shall submit an application using Form DH5003-MQA-2/15, Nonresident Sterile Compounding Permit Application for Nonresident Pharmacies, that is hereby incorporated by reference. The Form is available at http://www.flrules.org/Gateway/reference.asp?No=Ref- or http://floridaspharmacy.gov .Applicants must comply with all requirements found in Section 465.0158, F.S

(c) Once a Nonresident Sterile Compounding Permit is issued, the permit holder must notify the board within 10 days of any change in the prescription department manager or pharmacist in charge or the supervising pharmacist on Form DH5005-MQA-2/15,_Nonresident Sterile Compounding Permit Change in Pharmacist, that is hereby incorporated by reference. The Form is available at http://www.flrules.org/Gateway/reference.asp?No=Ref- or http://floridaspharmacy.gov.

Rulemaking Authority 465.005, 465.0158, 465.022 FS. Law Implemented 456.013, 456.025(3), 456.0635, 465.0158, 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: February 10, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 31, 2014