essentially a copy of a commercially available drug product

(2)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.

Source

21 USC § 353a(b)(2)


Scoping language

For purposes of paragraph
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