315.0351 Out-of-state pharmacy -- Permit -- Requests for information --
1,244 words·~6 min read·
/ky/315-0351A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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 means, 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 permit 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 an 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 information
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 inspection 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 prescription 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 pharmacy 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 but 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 seal 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 package 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.
(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 manufacturer'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 Kentucky 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 manufacturer 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 subsection 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.