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.
42 CFR § 447.502
For the purpose of this subpart, the following definitions apply: