64816-27.700 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
fmished 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 compoundin&; "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 facil ity 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 acreement shall specifically provide:
l. That the compounded drug mav only be administered to the patient and may not be dispensed to the patient or sold to
any other person or entitv:
2. That the practitioner shall include on the patient's chart, medication order, or medication administration record the Jot
number and the bevond-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 anv 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 two (4) years and shall include:
l. The name, address and phone number of the practitioner ordering the compounded drug for office use and the date of the
2. The name, strength. and quantity of the compounded drug provided, including the number of containers and quantity in
3. The date the drug was compounded;
4. The date the compounded drug was provided to the practitioner:
5. The Jot number and bevond 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 phannacy's Jot nwnber and beyond-use-date;
4. The quantitv or amount in the container:
5. The appropriate ancillarv 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 ~Authority 465.005 FS. Law Implemented 465.003(12), 465.0155, 465.0265 FS. History-New 10-1-92, Formerly 21S-27.700,
6 1F J0-27.700, 59X-27.700, Amended 11-2-03, 10-7-08,__ ___ _
For complete PDJ with letter re: adoption click here
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