Section 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 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 (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 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.Effective:7/15/2010
Amended 2010, Ky. Acts ch. 22, sec. 6, effective7/15/2010. -- Amended 2007, Ky. Acts ch. 124, sec. 9, effective 6/26/2007. -- Amended 2005, Ky. Acts ch. 150, sec. 19, effective 6/20/2005; ch. 61, sec. 1, effective 6/20/2005; and ch. 99, sec. 597, effective 6/20/2005. -- Amended 1998, Ky. Acts ch. 426, sec. 548, effective 7/15/1998. -- Amended 1996, Ky. Acts ch. 257, sec. 5, effective 7/15/1996. -- Amended 1982 Ky. Acts ch. 191, sec. 4, effective 7/15/1982. --Amended 1974 Ky. Acts ch. 310, sec. 1. -- Created 1966 Ky. Acts ch. 260, sec. 6.