Good News for Florida Physicians Prescribing Compounded Drugs!
November 14, 2008
The Florida Board of Pharmacy has made a major reversal from its previous position forbidding purchasing compounded drugs for “office use”. Florida has modified Section 64B16-27.700 in Florida Administrative Code to specifically include a practitioner’s right to purchase compounded drugs for office administration without a patient specific prescription. The final ruling became effective on October 7, 2008.
The pharmacists at McGuff Compounding Pharmacy Services applaud the Florida Board of Pharmacy for their willingness to change the rules of pharmacy to allow practitioners greater flexibility in the treatment of their patients.
Below is the final, effective rule with new wording added in Red and wording that Florida practitioners should know, understand and implement in Blue.
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) Compounding includes:
(a) The preparation of drugs or devices in anticipation of prescriptions based on routine, regularly observed prescribing patterns.
(b) The preparation pursuant to a prescription of drugs or devices which are not commercially available.
(c) The preparation of commercially available products from bulk when the prescribing practitioner has prescribed the compounded product on a per prescription basis and the patient has been made aware that the compounded product will be prepared by the pharmacist.The reconstitution of commercially available products pursuant to the manufacturer’s guidelines is permissible without notice to the practitioner.
(2) The preparation of drugs or devices for sale or transfer to pharmacies, practitioners, or entities for purposes of dispensing or distribution is not compounding and is not within the practice of the profession of pharmacy. Except that the supply of patient specific compounded prescriptions to another pharmacy under the provisions of Section 465.0265, F.S., and Rule 64B16-28.450, F.A.C., is authorized.
(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) The quantity of compounded drug does not exceed the amount a practitioner anticipates may be used in the practitioner’s 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 practitioner’s 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.
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