Prescription drug products that require patient package inserts; ampicillin and phenytoin--Food and Drug Administration. Final rule.
The Food and Drug Administration (FDA) amends its patient package insert regulations to list ampicillin and phenytoin as drugs that must be dispensed with patient package inserts. The ampicillin patient package insert applies to drug products containing amoxicillin, ampicillin, or hetacillin. Elsewhere in this issue of the Federal Register, FDA announces the availability of final guideline patient package inserts for ampicillin and phenytoin and applies the agency's patient package insert regulations to them.
D000667:Ampicillin / Q000008:administration & dosage*; D004348:Drug Labeling / Q000592:standards*; D006801:Humans; D010672:Phenytoin / Q000008:administration & dosage*; D014481:United States; D014486:United States Food and Drug Administration