Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
315.010(9),
315.020,
315.035,
315.191(1)(a)
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 and
pharmacies.
KRS
315.020 requires that prescription drugs,
medicines, and pharmaceuticals be dispensed or manufactured by a licensed
pharmacist.
KRS
315.035 and
315.0351
require 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 central fill prescriptions to pharmacies in the Commonwealth.
Section 1. Definition. "Central fill
pharmacy" means a pharmacy that provides packaging, labeling, and delivery of a
prescription product to another pharmacy for the purpose of the dispensing of a
valid prescription.
Section 2. The
central fill pharmacy shall:
(1) Either:
(a) Have a written contract with the pharmacy
which has custody of the original prescription authorization for dispensing;
or
(b) Be under common ownership
with that pharmacy;
(2)
Prepare the label for the prescription product which clearly identifies the
name and address of the pharmacy preparing the product for 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 prescription product, including the name of
the:
(a) Pharmacist who verified the accuracy
of the prescription product;
(b)
Pharmacy preparing the prescription product; and
(c) Pharmacy to which the prepared
prescription product is delivered;
(4) Provide the originating pharmacy with
written information that describes how a patient may contact the central fill
pharmacy if the patient has any questions about the preparation of the
prescription; 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 centrally filled prescription
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 filled prescription product,
including the name of the:
(a) Pharmacist who
verified the accuracy of the prescription product prior to its dispensing;
and
(b) Pharmacy preparing the
prescription product;
(2) Be responsible for ensuring that the
centrally filled prescription product 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 fill pharmacy if the patient
has any questions about the preparation of the prescription; 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.
Section 4. Effective January 1, 2020, a
pharmacist who provides a pharmacy service on a prescription dispensed in
Kentucky shall be licensed in Kentucky.
STATUTORY AUTHORITY:
KRS
315.020,
315.035,
315.0351,
315.191(1)(a)
