Multiple source drug

Multiple source drug means, for a rebate period, a covered outpatient drug, including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under section 1927(4) of the Act, for which there is at least 1 other drug product which meets all of the following criteria:
(1) Is rated as therapeutically equivalent (under the FDA's most recent publication of “Approved Drug Products with Therapeutic Equivalence Evaluations” which is available at http://www.accessdata.fda.gov/scripts/cder/ob/).
(2) Except as provided at section 1927(k)(7)(B) of the Act, is pharmaceutically equivalent and bioequivalent, as defined at section 1927(k)(7)(C) of the Act and as determined by FDA.
(3) Is sold or marketed in the United States during the period.

Source

42 CFR § 447.502

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Scoping language

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

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