essentially a copy of an approved drug

(2)The term “essentially a copy of an approved drug” means— (A)a drug that is identical or nearly identical to an approved drug, or a marketed drug not subject tosection 353(b) of this titleand not subject to approval in an application submitted undersection 355 of this title, unless, in the case of an approved drug, the drug appears on the drug shortage list in effect undersection 356e of this titleat the time of compounding, distribution, and dispensing; or (B)a drug, a component of which is a bulk drug substance that is a component of an approved drug or a marketed drug that is not subject tosection 353(b) of this titleand not subject to approval in an application submitted undersection 355 of this title, unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug.

Source

21 USC § 353b(d)(2)


Scoping language

In this section
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