Knowledge base

Single Source Drug

relevant to both Medicaid and Medicare Outpatient prescription drug coverage, this term is defined as a covered outpatient drug which is produced or distributed under an original new drug application approved by the Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributors operating under the New Drug Application (NDA).” It also includes a Covered Outpatient Drug approved under a BLA, ELA or ADA.

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