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.

(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 for a minimum of four (4) years 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 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 “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.

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.