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 http://www.accessdata.fda.gov/scripts/cder/ob/.
(2) Is pharmaceutically equivalent and bioequivalent, as determined by the FDA.
(3) Is sold or marketed in the United States during the rebate period.

Source

42 CFR § 447.502


Scoping language

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

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