Sec. 178.5. “Single source drug” means an outpatient drug that is produced or distributed under an original new drug application approved by the federal Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application.

As added by P.L.76-1994, SEC.1. Amended by P.L.6-2002, SEC.2 and P.L.107-2002, SEC.7.