Current through Reg. 50, No. 187; September 24, 2024
"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.
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.
