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.)