{"data":{"id":"us-ky/krs-315.340","jurisdiction":"us-ky","citation":"KRS 315.340","heading":"Permit for operation of in-state outsourcing facility doing business in","body":"Kentucky  -- Requirements -- Administrative regulations.\n(1) (a) A  person  shall not  operate an  outsourcing facility within this\nCommonwealth,  physically or by means of the Internet, facsimile, phone,\nmail, or any other means, without first obtaining a permit from the board.\n(b) An  application for a permit to operate an outsourcing facility shall be\nmade  to the board upon forms provided by the board and shall contain\nsuch information as the board requires, which may  include affirmative\nevidence of the ability to comply with the requirements of this chapter and\nthe administrative regulations promulgated by the board.\n(c) Each  application shall be accompanied by a nonrefundable permit fee to\nbe  set by administrative regulation promulgated by the board, not to\nexceed five hundred dollars ($500).\n(2) (a) As a prerequisite to obtaining or renewing a permit from the board, the\noutsourcing facility shall:\n1. Register as an outsourcing facility with the United States Secretary\nof Health and Human  Services in accordance with 21 U.S.C. sec.\n353b; and\n2. Submit  a copy of a current inspection report resulting from an\ninspection conducted  by  the United States Food  and  Drug\nAdministration that indicates compliance with the requirements of\nstate and  federal law and  regulations, including all applicable\nguidance documents  and Current Good  Manufacturing Practices\npublished by the United States Food and Drug Administration.\n(b) 1. The  inspection report required pursuant to paragraph (a)2. of this\nsubsection shall be deemed  current for the purposes of this section\nif the inspection was conducted no more than:\na. One  (1) year prior to the date of submission of an application\nfor a permit to the board; or\nb. Two  (2) years prior to the date of submission of an application\nfor renewal of a permit to the board.\n2. If the outsourcing facility has not been inspected by the United\nStates Food  and Drug Administration within the period required\nunder subparagraph 1. of this paragraph, the board may:\na. Accept  an inspection report or other documentation from\nanother entity that is satisfactory to the board; or\nb. Cause  an inspection to be conducted by its duly authorized\nagent and charge an inspection fee in an amount sufficient to\ncover the costs of the inspection.\n(3) (a) Upon  receipt of an application for a permit to operate an outsourcing\nfacility accompanied  by the permit fee prescribed by administrative\nregulation, the board shall:\n1. Issue a permit if the outsourcing facility meets the requirements of\nthis chapter and the administrative regulations promulgated by the\nboard; or\n2. Refuse to issue or renew any permit to operate if the outsourcing\nfacility fails to meet  the requirements of this chapter and the\nadministrative regulations promulgated by the board.\n(b) The  board shall act upon an application for a permit to operate within\nthirty (30) days after the receipt of the application. The board may issue a\ntemporary permit to operate in any instance where it considers additional\ntime necessary for investigation and consideration before taking final\naction upon the application. The temporary permit shall be valid for a\nperiod of thirty (30) days, unless extended.\n(4) A separate permit to operate shall be required for each outsourcing facility.\n(5) (a) Each  permit to operate an outsourcing facility, unless suspended  or\nrevoked, shall expire on June 30 following its date of issuance and be\nrenewable annually thereafter upon proper application accompanied by\nthe renewal fee as established by administrative regulations promulgated\nby  the board. The renewal fee shall not exceed five hundred dollars\n($500).\n(b) An  additional nonrefundable fee not to exceed the annual renewal fee\nmay  be assessed and set by administrative regulation as a delinquent\nrenewal penalty for failure to renew by June 30 of each year.\n(6) Permits to operate shall be issued only for the premises and persons named in\nthe application and shall not be transferable, except that a buyer may operate\nthe outsourcing facility under the permit of the seller pending a decision by the\nboard on an application, which shall be filed by the buyer with the board at\nleast five (5) days prior to the date of sale.\n(7) The board may promulgate administrative regulations to ensure:\n(a) That proper equipment and reference material is on hand considering the\nnature of the pharmaceutical practice conducted at the particular\noutsourcing facility; and\n(b) Health and sanitation standards for areas within outsourcing facilities that\nadhere to Current Good Manufacturing Practices published by the United\nStates Food and Drug Administration.\n(8) Each outsourcing facility shall comply with KRS 218A.202.\n(9) Each  outsourcing facility shall compound  in compliance with the requirements\nof state and federal law and regulations, including all applicable guidance\ndocuments and Current Good Manufacturing Practices published by the United\nStates Food and Drug Administration.\n(10) A  pharmacist may temporarily operate an outsourcing facility in an area not\ndesignated on the permit as authorized in KRS 315.500.","path":["KRS Chapter 315"],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=46695","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:58:12Z","sha256":"fed2a894b595713c138cccca35596d27f0fb1a1e7b9c7c99d5d9a939ddc89642","source_id":"us-ky","stale":false,"prev":"us-ky/krs-315.335","next":"us-ky/krs-315.342"},"notice":"GroundRules: Original legal text. Not legal advice."}