KRS 205.5631: Definitions for KRS 205.5631 to 205.5639.

(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.