The Board proposes the rule promulgation to create a rule regarding Nonresident Sterile Compounding Permits – Change in Location or Change in Ownership.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-32.013Nonresident Sterile Compounding Permits - Change in Location or Change in Ownership.

PURPOSE AND EFFECT: The Board proposes the rule promulgation to create a rule regarding Nonresident Sterile Compounding Permits – Change in Location or Change in Ownership.

SUMMARY: A rule will be created regarding Nonresident Sterile Compounding Permits – Change in Location or Change in Ownership.

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(8) FS.

LAW IMPLEMENTED: 465.0158 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:

 

64B16-32.013 Nonresident Sterile Compounding Permits – Change in Location or Change in Ownership.

(1) Change in Location: A change in location for a nonresident sterile compounding permit for nonresident pharmacies and a nonresident sterile compounding permit for outsourcing facilities shall require a new permit. Therefore, in the event of a change of location, the permit holder shall submit an application for a new permit. 

(2) Change of Ownership: A nonresident sterile compounding permit for nonresident pharmacies and a nonresident sterile compounding permit for outsourcing facilities are non-transferable; therefore, if the ownership changes, a new permit shall be required. To determine what constitutes a change of ownership, please review rule 64B16-28.2021, F.A.C.

Rulemaking Authority 465.005, 465.0158(8) FS. Law Implemented 465.0158 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