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Code 353a (b)(2): This section of the law exempts personalized compounded drugs from limitations on compounding regularly or in inordinate amounts for drug products that are essentially copies of a commercially available drug product. It does so by excluding a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product. [Other limitations on inordinate compounding are discussed below.] FDA guidance, which is not legally binding, is more restrictive in its language, limiting such prescriptions to individual patients whose medical needs cannot be met by commercially available drug products. (emphasis added) This non-binding guidance goes on to give examples that suggest that such compounding should only be used in seemingly rare cases such as a patient who has an allergy and needs a medication to be made without a certain dye, an elderly patient who cannot swallow a pill and needs a medicine in a liquid form that is not otherwise available, or a child who needs a drug in a strength that is lower than that of the commercially available product. Combined, the non-binding guidance appears to establish a higher threshold than the underlying law upon which it is based, which clearly defers to the prescribing practitioners judgment and only requires that the practitioner believe the compounded drug is necessary and produces a significant difference for the identified patient

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