Saturday, June 1, 2013

Iowa Board of Pharmacy Clarification on Compounded Preparations

Clarification on Compounded
Iowa Board of Pharmacy Subrule 657 IAC 20.3(1) allows
the compounding of a commercially available product only if
it is necessary to meet the unique medical need of a patient.
The complete text of that subrule is provided below. Pursuant
to 657 IAC 20.2, all compounding, regardless of the type
of product, is to be done pursuant to a prescription and the
prescription must be based on a valid pharmacist/patient/prescriber
relationship. Subrule 657 IAC 20.3(4) allows for the
preparation of non-patient-specific products for “office use” if
the product is administered to an individual patient by the prescribing
practitioner in a professional practice setting. Subrule
657 IAC 20.3(4) also allows a pharmacy to prepare and sell
to a hospital pharmacy a compounded drug product prepared
pursuant to a prescriber’s authorization for administration to a
specific patient. Iowa law and rules have never allowed a pharmacy
to prepare and sell to a hospital pharmacy compounded
preparations in the absence of a prescription. Such activity is
considered manufacturing. This would include the preparation
of sterile products such as outsourced compounded solutions,
IVs, or injectables.
657 Iowa Administrative Code – 20.3(1) Compounding
commercially available product. Based on the
existence of a pharmacist/patient/prescriber relationship
and the presentation of a valid prescription,
pharmacists may compound, for an individual patient,
drug products that are commercially available in the
marketplace, if the compounded product is changed
to produce for that patient a significant difference, as f
authorized by the prescriber, between the compounded
drug and the comparable commercially available drug
product, or if use of the compounded product is in the
best interest of the patient. “Significant difference”
would include the removal of a dye for a medical reason
such as an allergic reaction. When a compounded
product is to be dispensed in place of a commercially
available product, the prescriber and patient shall
be informed that the product will be compounded

quoted from Iowa Board of Pharmacy June 2013 Newsletter

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