Fla. Admin. Code Ann. R. 64B16-27.700 - Compounding

(1) Compounding is defined by Section 465.003(9), F.S. All sterile compounding shall be done pursuant to standards of practice as stipulated under Rule 64B16-27.797, F.A.C.

(2) Compounded products shall be properly labeled meeting requirements under Rule 64B16-28.108, F.A.C., and follow recordkeeping requirements listed under subsection 64B16-28.140(4), F.A.C.

(3) Veterinary office use compounding, "Office use" means the provision and administration of a compounded drug to a patient by a veterinarian, veternarian assistant, or veternarian technician in the practitioner's office and the administration of a compounded medication by a veterinarian to a patient outside the office for veterinary use only. A pharmacist may dispense and deliver a quantity of a compounded drug to an aforementioned practitioner for veterinary 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.

(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 f in accordance with Rule 64B16-28.140, F.A.C., be readily retrievable within 72 hours 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 veterinary 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 "Compounded Drug."

(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.

Notes

Fla. Admin. Code Ann. R. 64B16-27.700

Rulemaking Authority 465.005 FS. Law Implemented 465.003, 465.0155, 465.0265, 465.0276(5) FS.

New 10-1-92, Formerly 21S-27.700, 61F10-27.700, 59X-27.700, Amended 11-2-03, 10-7-08, 3-21-13, Amended by Florida Register Volume 40, Number 112, June 10, 2014 effective 6/22/2014, Amended by Florida Register Volume 44, Number 011, January 17, 2018 effective 1/28/2018, Amended by Florida Register Volume 51, Number 058, March 25, 2025 effective 4/9/2025.

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.