The Board proposes the rule amendment for the specific purpose of determining the necessity of incorporating and setting as the minimum standards to follow when compounding sterile products, the following chapters of the United States Pharmacopeia: ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.797Standards of Practice for Compounding Sterile Preparations (CSPs)

PURPOSE AND EFFECT: The Board proposes the rule amendment for the specific purpose of determining the necessity of incorporating and setting as the minimum standards to follow when compounding sterile products, the following chapters of the United States Pharmacopeia: 797; 1160; 71; 85; 731; and 1231.

SUMMARY: The following chapters of the United States Pharmacopeia will be incorporated into the rule as the minimum standards to follow when compounding sterile products: 797; 1160; 71; 85; 731; and 1231.

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. Specifically, the Board considered that 21 U.S.C. §353a, as amended by Public Law Number 113-54 (November 27, 2013), requires compounding to comply with the applicable chapters of the United States Pharmacopeia (USP) on compounding. Therefore, any economic impact is a direct result of federal mandates. Further, the Board considered that all institutional pharmacies are already mandated to comply with the compounding provisions that are being incorporated. Finally, the Board considered that since approximately 2008, Board rule requirements essentially required compliance with the provisions of the USP which are being incorporated. The Board considered that having to come into compliance with laws and rules that are already effective is not an economic impact that is applicable for consideration for this proposed rule amendment. 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: Tammy Collins, Acting 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 64B16-27.797 follows. See Florida Administrative Code for present text.)

 

64B16-27.797 The Standards of Practice for Compounding Sterile Products Preparations (CSPs).

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) Adoption of the United States Pharmacopiea: Beginning on October 1, 2014, all sterile compounding shall be performed in accordance with the minimum practice and quality standards of the following chapters of the United States Pharmacopeia (USP):

(a) Chapter 797, Pharmaceutical Compounding-Sterile Preparations;

(b) Chapter 1160, Pharmaceutical Calculations in Prescription Compounding;

(c) Chapter 71, Sterility Tests;

(d) Chapter 85, Bacterial Endotoxins Test;

(e) Chapter 731, Loss on Drying; and

(f) Chapter 1231, Water for Pharmaceutical Purposes.

All referenced chapters of the USP, in subsection (1) are specifically referring to the United States Pharmacopeia, 36th revision, Second Supplement, which is hereby incorporated and adopted by reference with the effective chapter dates of December 1, 2013. A copy of the USP chapters referenced in this rule may be examined and inspected, but not copied, at the office of the Board of Pharmacy in Tallahassee, Florida. A subscription to all relevant chapters is available for purchase at www.uspnf.com.

(2) Minimum Standards: The minimum practice and quality standards of the USP are adopted as the minimum standards to be followed when sterile products are compounded. However, nothing in this rule shall be construed to prevent the compounding of sterile products in accordance with standards that exceed the USP.

(3) Current Good Manufacturing Practices: The Board deems that this rule is complied with for any sterile products that are compounded in strict accordance with Federal Current Good Manufacturing Practices per 21 C.F.R. §§ 210.1 - 211.3.

(4) Specific Exceptions to the United States Pharmacopeia:

(a) Although the USP requires the donning of gloves prior to entry into the clean-room, all required donning of gloves can be performed after entry into the clean-room to avoid contamination of the gloves from the door handle or access device leading into the clean-room.

(b) USP Chapter 797 requires that: “When closed-system vial-transfer devices (CSTDs) (i.e., vial-transfer systems that allow no venting or exposure of hazardous substance to the environment) are used, they shall be used within an ISO Class 5 (see Table 1) environment of a BSC or CACI. The use of the CSTD is preferred because of their inherent closed system process. In facilities that prepare a low volume of hazardous drugs, the use of two tiers of containment (e.g., CSTD within a BSC or CACI that is located in a non-negative pressure room) is acceptable.” For purpose of said provision, a “low volume of hazardous drugs” is defined as less than 40 doses per month.

(5) Additional Exceptions: The Board encourages the use of a Petition for Rulemaking to inform the Board of a request to add an additional exception to subsection (5) of this rule. A Petition for Rulemaking is controlled by Section 120.54(7) of the Florida Statutes.

(6) Rule Conflicts: On October 1, 2014 this rule shall control notwithstanding any rule to the contrary located throughout the provision of Chapter 64B16, F.A.C. Upon the effective date of this rule, the board will begin the process of repealing all rules that conflict with this rule.

THIS RULE SHALL TAKE EFFECT OCTOBER 1, 2014.

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.

 

The Board has determined that posting the material on the Internet would constitute a violation of the federal copyright law. At the time of adoption, the copyrighted incorporated material will be available for public inspection and examination at the Department of Health, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254 and at the Department of State, Administrative Code and Register Unit, R.A. Gray Building, 500 South Bronough Street, Tallahassee, Florida 32399-0250.

 

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: February 11, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 20, 2013