The Board proposes the rule amendment to update the rule regarding special sterile compounding permits for pharmacies and outsourcing facilities.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.802Special Sterile Compounding Permits

PURPOSE AND EFFECT: The Board proposes the rule amendment to update the rule regarding special sterile compounding permits for pharmacies and outsourcing facilities.

SUMMARY: The rule will be updated regarding special sterile compounding permits for pharmacies and 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: 465.005, 465.022 FS.

LAW IMPLEMENTED: 465.0968 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:

 

64B16-28.802 Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities.

(1) through (3) No change.

(4) An outsourcing facility shall comply with current good manufacturing practices as adopted and incorporated in Rule 64B16-27.797, F.A.C.

(a) No change.

(b) If a pharmacy is issued an SSCP and later becomes registered as an outsourcing facility, the pharmacy will not be required to obtain a new or additional SSCP. However, the pharmacy applicant shall comply with current good manufacturing practices to be eligible to retain the issued SSCP and the pharmacy shall notify the department in writing within 7 business days of becoming a registered outsourcing facility.

(c) An outsourcing facility that does not engage in patient specific sterile compounding and dispensing pursuant to such prescription shall only be required to obtain the SSCP. However, if the outsourcing facility engages in patient-specific sterile compounding, in addition to the SSCP, the outsourcing facility shall be required to obtain a pharmacy permit specific to the type of patient dispensing that the pharmacy will be engaged in (i.e., community pharmacy permit or institutional pharmacy permit).

(5) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196 FS. History–New 6-18-13, Amended 10-20-13,

5-8-16,                                           .

 

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: August 10, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 14, 2016