Multiple source drug

Multiple source drug means, for a rebate period, a covered outpatient drug for which there is at least one other drug product which meets the following criteria:
(1) Is rated as therapeutically equivalent as reported in the FDA's “Approved Drug Products with Therapeutic Equivalence Evaluations” which is available at
(2) Is pharmaceutically equivalent and bioequivalent, as determined by the FDA.
(3) Is sold or marketed in the United States during the rebate period.


42 CFR § 447.502

Scoping language

For the purpose of this subpart, the following definitions apply:

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