The Board proposes the rule promulgation to create a rule regarding nonresident sterile compounding permit for an outsourcing facility and to incorporate the Nonresident Sterile Compounding Permit Application for Outsourcing Facilities.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-32.009Nonresident Sterile Compounding Permit for an Outsourcing Facility.

PURPOSE AND EFFECT: The Board proposes the rule promulgation to create a rule regarding nonresident sterile compounding permit for an outsourcing facility and to incorporate the Nonresident Sterile Compounding Permit Application for Outsourcing Facilities.

SUMMARY: A rule will be created regarding nonresident sterile compounding permit for an outsourcing facility and to incorporate the Nonresident Sterile Compounding Permit Application for Outsourcing Facilities.

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: 465.0158 FS.

LAW IMPLEMENTED: 465.0158, 456.065(3) 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:

 

64B5-32.009  Nonresident Sterile Compounding Permit for an  Outsourcing Facility.

This permit is required before an outsourcing facility that is located outside of Florida, ships, mails, delivers, or dispenses, in any manner a compounded sterile product into Florida.

(1) An outsourcing facility that obtains a nonresident sterile compounding permit may ship, mail, or deliver a sterile compounded product into Florida for office-use and may ship, mail, deliver, or dispense a patient-specific compounded sterile product into Florida.  This permit does not authorize the shipping, mailing, delivering, or dispensing of a non-compounded medicinal drug into Florida. 

(2) A permit issued pursuant to this section shall be issued with the following conspicuously displayed on the front of the license:  Outsourcing Facility Nonresident Sterile Compounding Permit – Patient Specific Prescription Compounding and Office-Use Compounding. 

(3) An outsourcing facility applicant seeking a nonresident sterile compounding permit shall submit an application using Form DH5004-MQA (eff. 04/16), “Nonresident Sterile Compounding Permit Application for Outsourcing Facilities” which is hereby incorporated by reference.  This Form is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-    or http://floridaspharmacy.gov.

Rulemaking Authority 456.0158, FS.  Law Implemented 465.0158, 456.065(3) FS  History New __________.

 

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 5, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 9, 2016