The Board proposes the rule amendment to clarify the requirements for compounding for office use.

 

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO.:RULE TITLE:
64B16-27.700Definition of Compounding
PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify the requirements for compounding for office use.
SUMMARY: Requirements for compounding for office use 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 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 FS.
LAW IMPLEMENTED: 465.003(12), 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: Mark Whitten, 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 (c) No change.

(d) The pharmacy and the practitioner enter into a written agreement. The agreement shall specifically provide:

1.  That the compounded drug may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity;

2.  That the practitioner shall include on the patient’s chart, medication order, or medication administration record the lot number and the beyond-use-date of any compounded drug administered to the patient that was provided by the pharmacy;

3.  That the practitioner will provide notification to the patient for the reporting of any adverse reaction or complaint in order to facilitate any recall of batches of compounded drugs.

(e) The pharmacy shall maintain readily retrievable records of all compounded drugs ordered by practitioners for office use.  The records must be maintained for a minimum of four (4) years and shall include:

1.  The name, address and phone number of the practitioner ordering the compounded drug for office use and the date of the order;

2.  The name, strength, and quantity of the compounded drug provided, including the number of containers and quantity in each;

3.  The date the drug was compounded;

4.  The date the  compounded drug was provided to the practitioner;

5.  The lot number and beyond use date.

(f) The pharmacy shall affix a label to any compounded drug that is provided for office use.  The label shall include:

1.  The name, address, and phone number of the compounding pharmacy;

2.  The name and strength of the preparation of a list of active ingredients and strengths;

3.  The pharmacy’s lot number and beyond-use-date;

4.  The quantity or amount in the container;

5.  The appropriate ancillary instructions such as storage instructions, cautionary statements, or hazardous drug warning labels were appropriate; and

6.  The statement “For Institutional or Office Use Only – Not for Resale,” or if the drug is provided to a veterinarian the statement “Compounded Drug.”

Rulemaking Specific Authority 465.005 FS. Law Implemented 465.003(12), 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,                           .

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: October 9, 2012
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 27, 2012