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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 to section 503(b) and not subject to approval in an application submitted under section 505, 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 (section 503B(d)(2)(B) of the FDCA [21 U.S.C
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However, its clinical translatability requires evaluation, particularly given the complex, context-dependent role of lactate in human UC, where its accumulation can also be pathogenic [127]