active pharmaceutical ingredient

(2)The term “active pharmaceutical ingredient” means— (A)a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended— (i)to be used as a component of a drug; and (ii)to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or (B)a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A).

Source

21 USC § 379j–41(2)


Scoping language

None: Default is title Scope
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