217.814 Definitions for KRS 217.815 to 217.826.

328 words·~1 min read·/ky/chapter-217/217-814

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

The following words and phrases, as used in KRS 217.815 to 217.826, shall have the following meanings, unless the context requires otherwise:

(1)"Biological product" has the same meaning as in 42 U.S.C. sec. 262;

(2)"Board" means the Kentucky Board of Pharmacy;

(3)"Brand name" means the name that a manufacturer of a drug or pharmaceutical

places on the container thereof at the time of packaging;

(4)"Dosage formulation" shall include but not be limited to those specific dosage

forms which, by the nature of their physical manufacture, are deemed to be

nonequivalent to other similar formulations such as controlled-release tablets,

aerosol-nebulizer drug delivery systems, and enteric-coated oral dosage forms;

(5)"Equivalent drug product" means a product with the same generic name, active

ingredients, strength, quantity, and dosage form as the drug product identified in a

prescription;

(6)"Generic name" means the chemical or established name of a drug or

pharmaceutical;

(7)"Interchangeable biological product" means:

(a)A biological product that the United States Food and Drug Administration has

licensed and determined meets the standards for interchangeability pursuant to

42 U.S.C. sec. 262(k)(4); or

(b)A biological product that the United States Food and Drug Administration has

determined is therapeutically equivalent as set forth in the latest edition or

supplement to the federal Food and Drug Administration's Approved Drug

Products with Therapeutic Equivalence Evaluations;

(8)"Nonequivalent drug product formulary" means a formulary of drugs, drug

products, and dosage formulations for which there are no equivalent drugs, drug

products, or dosage formulations and which have been determined to be

noninterchangeable or to have actual or potential bioequivalency problems by the

United States Food and Drug Administration and are contained in a drug

bioequivalence problems list as published in the United States Food and Drug

Administration publication entitled "Approved prescription drug products with

therapeutic equivalence evaluations" with supplements;

(9)"Pharmacist" has the same meaning as in KRS 315.010; and

(10)"Practitioner" has the same meaning as in KRS 217.015.