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Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, et al

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The first (in 353a(b)(1)(D)) limits such compounding to a licensed pharmacist or licensed physician that does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product. This limit is essentially voided for personalized compounding, however, in the very next paragraph of the law: For purposes of paragraph (1)(D), the term essentially a copy of a commercially available drug product does not include 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