RULE NO.:RULE TITLE:
64B16-27.700Definition of Compounding
NOTICE OF CHANGE
Notice 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. 50 No. 154, August 7, 2024 issue of the Florida Administrative Register.
The change is in response to written comments submitted by the staff of the Joint Administrative Procedures Committee. The Board voted at the duly-noticed public board meeting held October 17, 2024, in Tallahassee, Florida, to amend the rule. The rule shall now read as follows:
64B16-27.700 Compounding.
(1) Compounding is defined by Section 465.003(9), F.S. All sterile compounding shall be done pursuant to per standards of practice as stipulated under Rule 64B16-27.797, F.A.C.
(2) No change.
(3) Veterinary office use compounding, “Office use” means the provision and administration of a compounded drug to a patient by a veterinarian, veterinarian assistant, or veterinarian technician practitioner in the practitioner’s office and the administration of a compounded medication by a veterinarian to a patient outside the office or by the practitioner for veterinary use only. A pharmacist may dispense and deliver a quantity of a compounded drug to an aforementioned a practitioner for veterinary office use by the practitioner in accordance with this section provided:
(a) through (e) No change.
(f) The pharmacy shall affix a label to any compounded drug that is provided for veterinary office use. The label shall include:
1. through 5. No change.
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.”
(g) In the case of compounded 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.
(4) Human Use Compounded Drug Products: Compounding of drug products and compounding practices such as patient-specific, anticipatory, office stock or office use, and other legally permissible forms, must strictly adhere to relevant federal regulations, including but not limited to 21 USC 353a and 21 USC 353b.
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, 1-28-18, .
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Traci Zeh, Acting Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C08, Tallahassee, Florida 32399-3258; or by email at info@Floridaspharmacy.gov.
