201 KAR 2:230. Special limited
pharmacy - central refill pharmacy.
RELATES TO: KRS 315.010(9), 315.020,
315.035, 315.191(1)(a)
STATUTORY AUTHORITY: KRS 315.020,
315.035, 315.191(1)(a)
NECESSITY, FUNCTION, AND CONFORMITY: KRS
315.020 requires that prescription drugs, medicines, and pharmaceuticals be
dispensed or manufactured by a licensed pharmacist. KRS 315.035 requires that
all pharmacies hold a permit issued by the board. This administrative
regulation establishes, consistent with the requirements of KRS 315.191(1)(a),
minimum requirements for the permitting of those pharmacies that package, label
and distribute refill prescriptions to pharmacies in the Commonwealth.
Section 1. Definition. "Central
refill pharmacy" means a pharmacy located in the Commonwealth that
provides packaging, labeling and delivery of a refill prescription product to
another pharmacy for the purpose of the refilling of a valid prescription.
Section 2. The central refill pharmacy
shall:
(1) Either:
(a) Have a written contract with the
pharmacy which has custody of the original prescription authorization for
refill dispensing; or
(b) Be under common ownership with that
pharmacy;
(2) Prepare the label for the refill
prescription product which clearly identifies the name and address of the
pharmacy preparing the product for refill dispensing and the name and address
of the pharmacy that will receive the prepared product for dispensing to the
patient;
(3) In addition to its obligation to
maintain complete and accurate records of drug products received and otherwise
disposed of, maintain complete and accurate records of the preparation of the
refilled prescription product, including the name of the:
(a) Pharmacist who verified the accuracy
of the refilled prescription product;
(b) Pharmacy preparing the refilled
prescription product; and
(c) Pharmacy to which the prepared refill
prescription product is delivered;
(4) Provide the originating pharmacy with
written information that describes how a patient may contact the central refill
pharmacy if the patient has any questions about the preparation of the
prescription refill; and
(5) Be responsible for ensuring that the
order has been properly prepared and verified by a pharmacist.
Section 3. The pharmacy to which a
prepared prescription refill product is delivered shall:
(1) In addition to its obligation to
maintain complete and accurate records of drug products received and otherwise
disposed of, maintain complete and accurate records of the receipt and dispensing
of the centrally refilled prescription product, including the name of the:
(a) Pharmacist who verified the accuracy
of the refilled prescription product prior to its dispensing; and
(b) Pharmacy preparing the refilled
prescription product;
(2) Be responsible for ensuring that the
refill has been properly prepared, packaged and labeled;
(3) Provide the patient with written
information that described how a patient may contact either:
(a) The central refill pharmacy if the
patient has any questions about the preparation of the prescription refill; or
(b) the dispensing pharmacy if the
patient has any questions about the use of the medication; and
(4) Be responsible for adherence to the
requirements of 201 KAR 2:210. (26 Ky.R. 1735; Am. 2238; eff. 6-12-2000; 35 Ky.R.
1851; eff. 3-11-09.)