KRS 315.0351: 315.0351 Out -of-state pharmacy -- Permit -- Requests for information --

Records -- Toll-free telephone service -- Pharmacist on duty -- Requirements

for out-of-state pharmacy doing business through the Internet -- Application

to sale or distribution of dialysate solution or devices.

(1) Except as provided in subsection (2) of this section:

(a) Every person or pharmacy located outside this Commonwealth which does

business, physically or by means of the Internet, facsimile, phone, mail, or

any other mea ns, inside this Commonwealth within the meaning of KRS

Chapter 315, shall hold a current pharmacy permit as provided in KRS

315.035(1) and (4) issued by the Kentucky Board of Pharmacy. The pharmacy

shall be designated an "out -of-state pharmacy" and the per mit shall be

designated an "out-of-state pharmacy permit." The fee for the permit shall not

exceed the current in -state pharmacy permit fee as provided under KRS

315.035;

(b) Every out-of-state pharmacy granted an out -of-state pharmacy permit by the

board shall disclose to the board the location, names, and titles of all principal

corporate officers and all pharmacists who are dispensing prescription drugs

to residents of the Commonwealth. A report containing this information shall

be made to the board on a n annual basis and within thirty (30) days after any

change of office, corporate officer, or pharmacist;

(c) Every out -of-state pharmacy granted an out -of-state pharmacy permit shall

comply with all statutorily -authorized directions and requests for inform ation

from any regulatory agency of the Commonwealth and from the board in

accordance with the provisions of this section. The out -of-state pharmacy

shall maintain at all times a valid unexpired permit, license, or registration to

conduct the pharmacy in compliance with the laws of the jurisdiction in which

it is a resident. As a prerequisite to seeking a permit from the Kentucky Board

of Pharmacy, the out-of-state pharmacy shall submit a copy of the most recent

inspection report resulting from an inspectio n conducted by the regulatory or

licensing agency of the jurisdiction in which it is located. Thereafter, the out -

of-state pharmacy granted a permit shall submit to the Kentucky Board of

Pharmacy a copy of any subsequent inspection report on the pharmacy

conducted by the regulatory or licensing body of the jurisdiction in which it is

located;

(d) Every out-of-state pharmacy granted an out -of-state pharmacy permit by the

board shall maintain records of any controlled substances or dangerous drugs

or devices dispensed to patients in the Commonwealth so that the records are

readily retrievable from the records of other drugs dispensed;

(e) Records for all prescriptions delivered into Kentucky shall be readily

retrievable from the other prescription records of the out-of-state pharmacy;

(f) Each out -of-state pharmacy shall, during its regular hours of operation, but

not less than six (6) days per week and for a minimum of forty (40) hours per

week, provide a toll-free telephone service directly to the pharmacist in charge

of the out -of-state pharmacy and available to both the patient and each

licensed and practicing in -state pharmacist for the purpose of facilitating

communication between the patient and the Kentucky pharmacist with access

to the patient's prescri ption records. A toll -free number shall be placed on a

label affixed to each container of drugs dispensed to patients within the

Commonwealth;

(g) Each out-of-state pharmacy shall have a pharmacist in charge who is licensed

to engage in the practice of pha rmacy by the Commonwealth that shall be

responsible for compliance by the pharmacy with the provisions of this

section and for the distribution and sale of dialysate solutions and devices

pursuant to subsection (2) of this section;

(h) Each out-of-state pharmacy shall comply with KRS 218A.202;

(i) Any out -of-state pharmacy that dispenses more than twenty -five percent

(25%) of its total prescription volume as a result of an original prescription

order received or solicited by use of the Internet, including b ut not limited to

electronic mail, shall receive and display in every medium in which it

advertises itself a seal of approval for the National Association of Boards of

Pharmacy certifying that it is a Verified Internet Pharmacy Practice Site

(VIPPS) or a s eal certifying approval of a substantially similar program

approved by the Kentucky Board of Pharmacy. VIPPS, or any other

substantially similar accreditation, shall be maintained and remain current;

(j) Any out-of-state pharmacy doing business in the Commonwealth of Kentucky

shall certify the percentage of its annual business conducted via the Internet

and electronic mail and submit such supporting documentation as requested

by the board, and in a form or application required by the board, when it

applies for permit or renewal;

(k) Any pharmacy doing business within the Commonwealth of Kentucky shall

use the address on file with the Kentucky Board of Pharmacy as the return

address on the labels of any pack age shipped into or within the

Commonwealth. The return address shall be placed on the package in a clear

and prominent manner; and

(l) The Kentucky Board of Pharmacy may waive the permit requirements of this

chapter for an out -of-state pharmacy that only does business within the

Commonwealth of Kentucky in limited transactions.

(2) (a) Only subsection (1)(g) of this section shall apply to the sale or distribution of

dialysate solutions or devices necessary to perform home peritoneal kidney

dialysis to patients with end-stage renal disease, if:

1. The dialysate solutions or devices are approved or cleared by the federal

Food and Drug Administration, as required by federal law;

2. The dialysate solutions or devices are lawfully held by a manufacturer

or manuf acturer's agent that is properly registered with or licensed by

the board as a manufacturer, wholesale distributer, or third -party

logistics provider under this chapter;

3. The dialysate solutions or devices are held and delivered in their

original, sealed packaging from a Food and Drug Administration -

approved manufacturing facility;

4. The dialysate solutions or devices are only delivered upon receipt of a

physician's prescription by a Kentucky licensed pharmacy and the

transmittal of an order from the Ken tucky licensed pharmacy to the

manufacturer or manufacturer's agent; and

5. The manufacturer or manufacturer's agent delivers the dialysate

solutions or devices directly to:

a. A patient with end-stage renal disease or the patient's designee for

the patient's self-administration of dialysis therapy; or

b. A health-care provider or institution for administration or delivery

of dialysis therapy to a patient with end-stage renal disease.

(b) 1. A manufacturer or manufacturer's agent who sells or distributes

dialysate solutions or devices under this subsection shall employ or

contract with a pharmacist who is licensed to engage in the practice of

pharmacy by the Commonwealth to conduct a retrospective audit on ten

percent (10%) of the orders processed by that ma nufacturer or

manufacturer's agent each month.

2. On or before February 1 of each year, an annual summary of the

monthly audits shall be prepared and submitted to the board, in the form

prescribed by the board.

3. On or before June 1 of each year, the board shall compile the summaries

of monthly audits into a single report and submit that report to the

Interim Joint Committee on Health Services.

(c) Prescriptions and records of delivery for dialysate solutions or devices sold or

distributed under this subse ction shall be maintained by the manufacturer or

manufacturer's agent for a minimum of two (2) years and shall be made

available to the board upon request.

(d) As used in this subsection, "dialysate solutions" means dextrose or icodextrin

when used to perform home peritoneal kidney dialysis.

(e) The Kentucky Board of Pharmacy will retain oversight of the distribution of

dialysate solutions and devices under this section.