The Board proposes the rule amendment to update the standards of practice for compounding sterile products.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.797The Standards of Practice for Compounding Sterile Products

PURPOSE AND EFFECT: The Board proposes the rule amendment to update the standards of practice for compounding sterile products.

SUMMARY: The standards of practice for compounding sterile products will be updated.

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, 465.0155, 465.022 FS.

LAW IMPLEMENTED: 465.0155, 465.022 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:

 

64B16-27.797 The Standards of Practice for Compounding Sterile Products.

The purpose of this section is to assure positive patient outcomes through the provision of standards for 1) pharmaceutical care; 2) the preparation, labeling, and distribution of sterile pharmaceuticals by pharmacies, pursuant to or in anticipation of a prescription drug order; and 3) product quality and characteristics. These standards are intended to apply to all sterile pharmaceuticals, notwithstanding the location of the patient (e.g., home, hospital, nursing home, hospice, doctor’s office, or ambulatory infusion center).

(1) through (3) No change.

(4) Registered Outsourcing facilities: For any pharmacy registered as an outsourcing facility, the minimum standards of practice for sterile compounding shall be the current good manufacturing practices as adopted in subsection (3).

(5) (4) Clarifications, Variances, or Specific Exceptions to the United States Pharmacopeia:

(a) through (c) No change.

(d) USP Chapter 797 provides in part that the compounding facility’s ceiling tiles located in the ante-area, buffer area, and clean room that consist of inlaid panels “shall be impregnated with a polymer to render them impervious and hydrophobic, and they shall be caulked around each perimeter to seal them to the support frame.” A pharmacy shall not be required to caulk the inlaid ceiling tiles to the perimeter of the support frame if the following are met:

1. The ceiling tiles are specifically manufactured to be utilized in a facility that must meet and maintain an airborne particulate cleanliness of ISO Class 7 or better.

2. The core of the ceiling tiles are sealed on the front, back, and all edges to render them impervious and hydrophobic, so they can be properly maintained and cleaned as required by this rule.

3. The ceiling tiles are inlaid or installed using a gasket grid sealing system, which is manufactured for use in facilities that must meet and maintain an airborne particulate cleanliness of ISO Class 7 or better. The sealing system must create and maintain a positive seal between the ceiling tiles and the support frame and the seal between the ceiling tiles and support frame shall be secured with retention clips.

Rulemaking Authority 465.005, 465.0155, 465.022 FS. Law Implemented 465.0155, 465.022 FS. History–New 6-18-08, Amended 1-7-10, 10-1-14,                                    .

 

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 9, 2016

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