medically accepted indication

(6) Medically accepted indication The term “medically accepted indication” means any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.] or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(i).


42 USC § 1396r-8(k)(6)

Scoping language

In this section
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