RELATES TO:

KRS 217.814, 315.191

STATUTORY AUTHORITY:

KRS 315.191(1)(a), (f)

NECESSITY, FUNCTION, AND CONFORMITY:

KRS 315.191(1)(a) authorizes the board to promulgate administrative regulations necessary to regulate and control all matters set forth in KRS Chapter 315 relating to pharmacists. KRS 315.191(1)(f) authorizes the board to promulgate administrative regulations to control the storage, retrieval, dispensing, refilling, and transfer of prescription drug orders within and between qualifying pharmacists and pharmacies. This administrative regulation establishes procedural and substantive requirements for dispensing an equivalent drug product pursuant to a practitioner declaration of formulary compliance approval.

1. Section 1. Dispensing.

   1. (1) A pharmacist may dispense a therapeutic equivalent drug product under the following conditions:

      1. (a) The ordering practitioner has indicated "formulary compliance approval" on the prescription, in one of the following ways:

         1. 1. In the practitioner's own handwriting; or
         2. 2. By checking a "formulary compliance approval" box on a preprinted form;
      2. (b) The pharmacist receives a formulary change as a consequence of the patient's third-party plan; and
      3. (c) The product designated as "preferred" by the third-party formulary is in the same therapeutic class as the prescribed drug.

   2. (2) The pharmacist, within twenty-four (24) hours of the formulary compliance substitution, shall notify the ordering practitioner, in an original writing or by facsimile:

      1. (a) That the pharmacist engaged in formulary compliance; and
      2. (b) The therapeutic equivalent drug product that was dispensed.
2. Section 2. The pharmacist may make adjustments in the quantity and directions to provide for an equivalent dose of the preferred formulary therapeutic alternative.

History

(29 Ky.R. 2197; 2447; eff. 4-11-2003; Crt eff. 4-17-2019.)