2012 Kentucky Revised Statutes CHAPTER 315 PHARMACISTS AND PHARMACIES 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.
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315.0351 Out-of-state pharmacy -- Permit -- Requests for information -- Records -Toll-free telephone service -- Pharmacist on duty -- Requirements for out-ofstate pharmacy doing business through the Internet.
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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-ofstate 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.
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.
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-ofstate 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.
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.
Records for all prescriptions delivered into Kentucky shall be readily retrievable
from the other prescription records of the out-of-state pharmacy.
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.
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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.
(8) Each out-of-state pharmacy shall comply with KRS 218A.202.
(9) 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.
(10) 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.
(11) 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.
(12) 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.
Effective: June 26, 2007
History: Amended 2007 Ky. Acts ch. 124, sec. 10, effective June 26, 2007. -- Amended
2005 Ky. Acts ch. 150, sec. 20, effective June 20, 2005. -- Amended 2004 Ky. Acts
ch. 107, sec. 4, effective July 13, 2004. -- Created 1990 Ky. Acts ch. 155, sec. 1,
effective July 13, 1990.
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