205.5631 Definitions for KRS 205.5631 to 205.5639.
150 words·~1 min read·
/ky/chapter-205/205-5631A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(1)As used in KRS 205.5631 to 205.5639, "commissioner" means the commissioner of
the Department for Medicaid Services.
(2)As used in KRS 205.5632, "new drug" means a drug that is approved for marketing
by the Federal Food and Drug Administration under a product licensing application,
new drug application, or a supplement to a new drug application, and that is a new
chemical or molecular entity, but shall not mean the following:
(a)Drugs, classes of drugs, or medical uses identified in 42 U.S.C. sec. 1396r-
8(d)(2), as amended;
(b)Drugs that are considered to be less than effective by the Federal Food and
Drug Administration or drugs that are considered to be identical, related, or
similar to the less than effective drugs; and
(c)Drugs that are excluded from coverage by the Kentucky Medicaid program
due to lack of compliance by the drug manufacturer with federal drug rebate
requirements.