Single Source Drug definition

Single Source Drug means a drug that is produced and distributed under an original New Drug Application approved by the federal Food and Drug Administration. This shall include a drug marketed by the innovator manufacturer and any cross-licensed producers or distributors operating under the New Drug Application, and shall also include a biological product, except for vaccines, marketed by the innovator manufacturer and any cross-licensed producers or distributors licensed by the federal Food and Drug Administration pursuant to Section 262 of Title 42 of the United States Code. A drug ceases to be a single-source drug when the same drug in the same dosage form and strength manufactured by another manufacturer is approved by the federal Food and Drug Administration under the provisions for an Abbreviated New Drug Application.

Single Source Drug will have the meaning set forth in Sectionsection 1927(k)(7)(A)(iv) of the Act. It also includes a Covered Outpatient Drug approved under a PLA, ELA or ABA.

Single Source Drug means a Covered Outpatient Drug approved under a PLA, ELA or ADA.

Examples of Single Source Drug in a sentence

• Single source drug means a drug de- scribed by section 1847A(c)(6)(D) of theAct.Timely delivery means delivery of a CAP drug within the defined routine and emergency delivery timeframes.

• Centers for Medicare & Medicaid Services, HHS § 447.505 Single source drug means a covered outpatient drug that is produced or dis- tributed under an original NDA ap- proved by the FDA, including a drug product marketed by any cross-li- censed producers or distributors oper- ating under the NDA.

• Single source drug discounts are greater than multiple source drug discounts.

• Single source drug means a covered outpatient drug that is produced or distributed under an original NDA approved by FDA and has an approved NDA number issued by FDA, including a drug product marketed by any cross- licensed producers or distributors operating under the NDA.

• Single source drug means a covered outpatient drug that is, including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under section 1927(k)(4) of the Act, which is produced or distributed under an original NDAa new drug application approved by FDA and has an approved NDA number issued bythe FDA, including a drug product marketed by any cross-licensed producers or distributors operating under the NDA.

More Definitions of Single Source Drug

Single Source Drug means a drug that is not a multi source

Single Source Drug means a drug produced or distributed under an original new drug application approved by the FDA.

Single Source Drug means a covered outpatient drug, including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug in accordance with 42 USC 1398r-8(k)(4), which is produced or distributed under a 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 unless the Secretary determines that a narrow exception applies (as described in section 447.502 of title 42, Code of Federal Regulations (or any successor regulation)). Such term also includes a covered outpatient drug that is a biological product licensed, produced, or distributed under a biologics license application approved by the Food and Drug Administration.

Single Source Drug means a drug produced or distributed under an original new drug application approved by the FDA((, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application)).

Single Source Drug means a drug other than a

Single Source Drug will have the meaning set forth in section 1927(k)(7)(A)(iv) of the Act as implemented by 42 CFR 447.502.

Single Source Drug means a prescription drug that is produced under an original new drug application (NDA) approved by FDA for which there are no generic alternatives.