RULE NO: RULE TITLE
64B16-27.700: Definition of Compounding
- NOTICE OF CHANGENotice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 30 No. 50, December 10, 2004 issue of the Florida Administrative Weekly.
The change is in response to written comments submitted by the staff of the Joint Administrative Procedures Committee. The changes are as follows:
1. Subsection (3) will be added to the rule and shall read as follows:
(3) Office use compounding. Office use means the provision and administration of a compounded drug to a patient by a practitioner in the practitioners 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) The quantity of compounded drug does not exceed the amount a practitioner anticipates may be used in the practitioners office before the expiration date of the drug;
(b) The quantity of compounded drug is reasonable considering the intended use of the compounded drug and the nature of the practitioners practice;
(c) The quantity of compounded drug for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca Poston, Executive Director, Board of Pharmacy,
