The Board proposes the rule amendment to provide a more comprehensive rule for special sterile compounding permits.

 

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 provide a more comprehensive rule for special sterile compounding permits.

SUMMARY: Rule language will be added to provide a more comprehensive explanation of 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: 465.0196 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:

 

(Substantial rewording of Rule 64B16-28.802, F.A.C. follows. See Florida Administrative Code for present text.)

64B16-28.802 Special Sterile Compounding Permits

(1) A Special Sterile Compounding Permit (SSCP) is required before any pharmacy may engage in the preparation of compounded sterile products. For purposes of this rule, an Outsourcing Facility shall be deemed a pharmacy.

(2) An SSCP shall be issued by the department as an additional permit with a separate permit number that differs from the permit number of the pharmacy obtaining the SSCP.

(3) All sterile compounding shall be done in strict compliance with the standards set forth in Rules 64B16-27.700 and 64B16-27.797, F.A.C.

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

(a) If a pharmacy is not registered as an Outsourcing Facility at the time the pharmacy applies for an SSCP, the applicant shall amend the application, within 7 business days, if the pharmacy becomes a registered Outsourcing Facility before the SSCP is issued.

(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 applicant shall comply with current good manufacturing practices to be eligible to retain the issued SSCP.

(5)  The SSCP is not required for a Special Parenteral/Enteral or Special Parenteral/Enteral Extended Scope pharmacy if that pharmacy holds no other pharmacy permit and is not registered as an Outsourcing Facility.

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

 

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: December 11, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: February 18, 2016