Compounding is the preparation of components into a drug
product either as the result of a practitioner's prescription
drug order based on a valid practitioner/patient/pharmacist
relationship in the course of professional practice, or for
the purpose of, or as an incident to, research, teaching,
or chemical analysis that are not for sale or dispensing.
Compounding is a part of the practice of pharmacy subject
to regulation and oversight from the state boards of pharmacy.
Compounded medication may be dispensed to prescribers for
office use, where applicable state law permits. Office use
does not include prescribers reselling compounded medications.
Compounding may be conducted in anticipation of receiving
prescription orders when based on routine, regularly observed
prescribing patterns. Anticipatory compounding is limited
to reasonable quantities, based on such patterns.
Compounding does not include the preparation of copies of
commercially available drug products. Compounded preparations
that produce, for the patient, a significant difference between
the compounded drug and the comparable commercially available
drug product or are determined, by the prescriber, as necessary
for the medical best interest of the patient are not copies
of commercially available products. "Significant"
differences may include, for example, the removal of a dye
for a medical reason (such as an allergic reaction), changes
in strength, and changes in dosage form or delivery mechanism.
Price differences are not a "significant" difference
to justify compounding.
Both the prescriber (via the prescription) and the patient
(via the label) should be aware that a compounded preparation
is dispensed.
The pharmacy may advertise or otherwise promote that it provides
prescription drug compounding services. Such advertising should
include only those claims, assertions, or inference of professional
superiority in the compounding of drug products that can be
independently and scientifically substantiated.
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