The Board proposes the rule amendment so that the rule does not conflict with state or federal law and to make clear that office use compounding of products intended for human use (sterile and nonsterile) shall require being registered as an ...

Notice of Proposed Rule

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.700Definition of Compounding

PURPOSE AND EFFECT: The Board proposes the rule amendment so that the rule does not conflict with state or federal law and to make clear that office use compounding of products intended for human use (sterile and nonsterile) shall require being registered as an Outsourcing Facility as defined by §465.003(19), Fla. Stat. (2016).

SUMMARY: Office use compounding of sterile and nonsterile products for human use shall comply with federal law to include being a registered Outsourcing Facility.

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 determined that any and all positive or negative economic impacts are a direct result of state and federal law to include, but not limited to, §465.016(1)(e), Fla. Stat. (2016); §465.023(1)(c), Fla. Stat. (2016); 21 U.S.C. §351(a)(2)(b) (2016); 21 U.S.C. §352(f)(1) (2016); 21 U.S.C. §353a (2016); 21 U.S.C. § 353b (Nov. 27, 2013); and 21 U.S.C. §355(a) (2016). The rule amendment does not change the economic status quo. Rather, the amendment adds clarity to what is already required when sterile and nonsterile products for human use are compounded for office or stock use. 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 FS.

LAW IMPLEMENTED: 465.003, 465.0155, 465.0265 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: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-27.700 Definition of Compounding.

“Compounding” is the professional act by a pharmacist or other practitioner authorized by law, employing the science or art of any branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for administration by a practitioner or the practitioner’s agent; and shall specifically include the professional act of preparing a unique finished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S. The term also includes the preparation of nuclear pharmaceuticals and diagnostic kits incident to use of such nuclear pharmaceuticals. The term “commercially available products,” as used in this section, means any medicinal product as defined by Sections 465.003(7) and (8), F.S., that are legally distributed in the State of Florida by a drug manufacturer or wholesaler.

(1) through (2) No change.

(3) Office use compounding, “Office use” means the provision and administration of a compounded drug to a patient by a practitioner in the practitioner’s office or by the practitioner in a health care facility or treatment setting, including a hospital, ambulatory surgical center, or pharmacy. A pharmacist may dispense and deliver a quantity of a compounded drug to a practitioner for office use by the practitioner in accordance with this section provided:

(a) through (f) No change.

(g) In the case of compounded sterile products intended for human use, the pharmacy must be in full compliance with 21 U.S.C. § 353b, including being registered as an Outsourcing Facility. 21 U.S.C. § 353b (eff. Nov. 27, 2013) is hereby adopted and incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-04180.

Rulemaking Authority 465.005 FS. Law Implemented 465.003, 465.0155, 465.0265 FS. History–New 10-1-92, Formerly 21S-27.700, 61F10-27.700, 59X-27.700, Amended 11-2-03, 10-7-08, 3-21-13, 6-22-14, _________.

 

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: June 6, 2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 21, 2017