The Board proposes the rule amendment to clarify language 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 for Pharmacies and Outsourcing Facilities

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

SUMMARY: Language regarding special sterile compounding permits for pharmacies and outsourcing facilities will be clarified.

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 Committee meetings and Board meetings, 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: Kelly Rogers, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C08, Tallahassee, Florida 32399-3258 or by email at [e-mail].

 

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 per the applicable United States Code and Code of Federal Regulations as adopted and incorporated in Rule 64B16-27.797, F.A.C.

(a) through (c) No change.

(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.

(6) The SSCP is not required for a Type B Modified Class II Institutional Pharmacy permittee engaging in sterile compounding under the following conditions:

(a) The pharmacy only compounds immediate use low-risk level compounded sterile preparations; and

(b) The pharmacy only compounds those immediate use low-risk level compounded sterile preparations for immediate use pursuant to the applicable provisions of the United States Pharmacopeia as required adopted and incorporated in Rrule 64B16-27.797, F.A.C.

(7) This rule shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196 FS. History–New 6-18-13, Amended 10-20-13, 5-8-16, 12-18-16, 11-5-17,                                    .

 

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: June 13, 2024

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 31, 2024