KRS 315.035: Permit required for operation of a pharmacy -- Application -- Fee --

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 mea ns, 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 includ e

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 reasona ble 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 howeve r, 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 (5)

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 disp enses 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 simil ar 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 busine ss 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.