315.035 Permit required for operation of a pharmacy -- Application -- Fee --
762 words·~3 min read·
/ky/315-035A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Issuance -- Fee for failure to renew -- Premises covered by permit -- Rules and
regulations -- Requirements for in-state pharmacy doing business through the
Internet -- Board may waive permit requirements for out-of-state pharmacy --
Temporary operation of pharmacy during state of emergency.
(1)No person shall operate a pharmacy within this Commonwealth, physically or by
means of the Internet, facsimile, phone, mail, or any other means, without having
first obtained a permit as provided for in KRS Chapter 315. An application for a
permit to operate a pharmacy shall be made to the board upon forms provided by it
and shall contain such information as the board requires, which may include
affirmative evidence of ability to comply with such reasonable standards and rules
and regulations as may be prescribed by the board. Each application shall be
accompanied by a reasonable permit fee to be set by administrative regulation
promulgated by the board pursuant to KRS Chapter 13A, not to exceed two hundred
fifty dollars ($250).
(2)Upon receipt of an application of a permit to operate a pharmacy, accompanied by
the permit fee not to exceed two hundred fifty dollars ($250), the board shall issue a
permit if the pharmacy meets the standards and requirements of KRS Chapter 315
and the rules and regulations of the board. The board shall refuse to renew any
permit to operate unless the pharmacy meets the standards and requirements of KRS
Chapter 315 and the rules and regulations of the board. The board shall act upon an
application for a permit to operate within thirty
(30)days after the receipt thereof;
provided, however, that the board may issue a temporary permit to operate in any
instance where it considers additional time necessary for investigation and
consideration before taking final action upon the application. In such event, the
temporary permit shall be valid for a period of thirty
(30)days, unless extended.
(3)A separate permit to operate shall be required for each pharmacy.
(4)Each permit to operate a pharmacy, unless sooner suspended or revoked, shall
expire on June 30 following its date of issuance and be renewable annually
thereafter upon proper application accompanied by such reasonable renewal fee as
may be set by administrative regulation of the board, not to exceed two hundred
fifty dollars ($250) nor to increase more than twenty-five dollars ($25) per year. An
additional fee not to exceed the annual renewal fee may be assessed and set by
administrative regulation as a delinquent renewal penalty for failure to renew by
June 30 of each year.
(5)Permits to operate shall be issued only for the premises and persons named in the
application and shall not be transferable; provided however, that a buyer may
operate the pharmacy under the permit of the seller pending a decision by the board
of an application which shall be filed by the buyer with the board at least five
days prior to the date of sale.
(6)The board may promulgate rules and regulations to assure that proper equipment
and reference material is on hand considering the nature of the pharmaceutical
practice conducted at the particular pharmacy and to assure reasonable health and
sanitation standards for areas within pharmacies which are not subject to health and
sanitation standards promulgated by the Kentucky Cabinet for Health and Family
Services or a local health department.
(7)Each pharmacy shall comply with KRS 218A.202.
(8)Any pharmacy within the Commonwealth 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, prior to obtaining a permit, 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 program approved by the Kentucky Board of Pharmacy, accreditation shall
be maintained and remain current.
(9)Any pharmacy within the Commonwealth doing business by use of the Internet
shall certify the percentage of its annual business conducted via the Internet 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.
(10)A pharmacist may temporarily operate a pharmacy in an area not designated on the
permit as authorized in KRS 315.500.