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If CMS determines that FDA has approved such a therapeutically equivalent drug under a 505(j) ANDA, CMS will then use the NDC Directory, including historical information from NDC Directory files such as discontinued, delisted, and expired listings provided by FDA or published on the FDA website to determine the marketing status of such therapeutically equivalent drug and to determine whether, during the applicable period, the therapeutically equivalent drug was marketed

General Instructions ME 12 Injection should be administered by a qualified healthcare professional in the clinical or hospital setting

Janesz notes