adverse event

(1) Adverse event The term “adverse event” means any health-related event associated with the use of a nonprescription drug that is adverse, including— (A) an event occurring from an overdose of the drug, whether accidental or intentional; (B) an event occurring from abuse of the drug; (C) an event occurring from withdrawal from the drug; and (D) any failure of expected pharmacological action of the drug.


21 USC § 379aa(a)(1)

Scoping language

In this section
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