{"data":{"id":"us-ky/krs-315.342","jurisdiction":"us-ky","citation":"KRS 315.342","heading":"Permit for operation of out-of-state outsourcing facility doing","body":"business in Kentucky -- Requirements -- Administrative regulations.\n(1) (a) Each  out-of-state outsourcing facility that does business physically or by\nmeans  of the Internet, facsimile, phone, mail, or any other means, inside\nthis Commonwealth, shall hold a current outsourcing facility permit issued\nby the board.\n(b) An  application for a permit to operate an out-of-state outsourcing facility\nshall be made  to the board upon forms provided by it and shall contain\nsuch information as the board requires, which may  include affirmative\nevidence of ability to comply with reasonable standards and regulations\nas may be prescribed by the board.\n(c) Each  application shall be accompanied by a permit fee to be set by\nadministrative regulation promulgated by the board. The fee shall not\nexceed:\n1. Two  hundred fifty dollars ($250); or\n2. The current in-state outsourcing facility permit.\n(2) (a) As a prerequisite to obtaining or renewing a permit from the board, the\nout-of-state outsourcing 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 out-of-state outsourcing facility has not been inspected by the\nUnited States Food and Drug Administration within the required\nperiod required under subparagraph 1. of this paragraph, the board\nmay:\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  may  charge an  inspection fee in an  amount\nsufficient to cover the costs of the inspection.\n(3) (a) Upon  receipt of an application for a permit to operate an out-of-state\noutsourcing facility, accompanied  by  the permit fee required by\nsubsection (1) of this section, the board shall:\n1. Issue a permit if the out-of-state outsourcing facility meets the\nrequirements of this chapter and the administrative regulations\npromulgated by the board; or\n2. Refuse  to renew any permit to operate unless the out-of-state\noutsourcing facility meets 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 thereof. The board may issue a temporary\npermit to operate in any instance where it considers additional time\nnecessary for investigation and consideration before taking final action\nupon the application. The temporary permit shall be valid for a period of\nthirty (30) days, unless extended.\n(4) A separate permit to operate shall be required for each out-of-state outsourcing\nfacility.\n(5) Each out-of-state outsourcing facility granted an out-of-state outsourcing facility\npermit by the board shall disclose to the board the location, names, and titles of\nall its principal corporate officers and all its pharmacists who are dispensing\nprescription drugs to entities within the Commonwealth. A report containing this\ninformation shall be made to the board on an annual basis and within thirty (30)\ndays after any change of office, corporate officer, or pharmacist.\n(6) (a) An  out-of-state outsourcing facility granted an out-of-state outsourcing\nfacility permit shall comply with all requests for information within three (3)\nbusiness days of a written request by the board or its agents.\n(b) An  out-of-state outsourcing facility shall maintain at all times a valid\nunexpired permit, license, or registration to conduct the outsourcing\nfacility in compliance with the laws of the jurisdiction in which it is a\nresident.\n(c) As  a prerequisite to seeking a permit from the board, the out-of-state\noutsourcing facility shall submit a copy of the most recent inspection\nreport resulting from an inspection conducted by the regulatory or\nlicensing agency of the jurisdiction in which it is located. Thereafter, the\nout-of-state outsourcing facility granted a permit shall submit to the board\na  copy of any subsequent inspection report of the outsourcing facility\nconducted by the regulatory or licensing body of the jurisdiction in which it\nis located.\n(7) Each out-of-state outsourcing facility granted an out-of-state outsourcing facility\npermit by the board shall maintain records of any controlled substances or\ndangerous drugs.\n(8) Each  out-of-state outsourcing facility shall, during its regular hours of\noperation, but not less than five (5) days per week and for a minimum of forty\n(40) hours per week, provide a toll-free telephone service directly to the\npharmacist in charge of the out-of-state outsourcing facility for the purpose of\nfacilitating communication. A toll-free number shall be placed on a label affixed\nto each container of drugs dispensed to an entity within the Commonwealth.\n(9) An out-of-state outsourcing facility shall comply with KRS 218A.202.\n(10) An out-of-state outsourcing facility doing business within the Commonwealth  of\nKentucky shall use the address on file with the board as the return address on\nthe labels of any package shipped into or within the Commonwealth. The return\naddress shall be placed on the package in a clear and prominent manner.\n(11)(a) A permit to operate an out-of-state outsourcing facility, unless suspended\nor revoked, shall expire on June 30 following its date of issuance and be\nrenewable annually thereafter upon proper application accompanied by\nthe nonrefundable renewal fee established by subsection (1) of this\nsection.\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(12) 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 out-of-state outsourcing facility under the permit of the seller pending a\ndecision by the board on an application which shall be filed by the buyer with\nthe board at least five (5) days prior to the date of sale.\n(13) The  board may  promulgate administrative regulations to ensure that proper\nequipment and reference material is on hand considering the nature of the\npharmaceutical practice conducted at the particular out-of-state outsourcing\nfacility.\n(14) Each  out-of-state outsourcing facility shall compound  in compliance with the\nrequirements of state and federal law and regulations, to include all applicable\nguidance documents and Current Good Manufacturing Practices published by\nthe United States Food and Drug Administration.","path":["KRS Chapter 315"],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=46696","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:58:12Z","sha256":"8a01a0192c3db75d0ffb6bd2d45a830cf1ff2249c1dbcc940d02c47e6a3c8ea6","source_id":"us-ky","stale":false,"prev":"us-ky/krs-315.340","next":"us-ky/krs-315.350"},"notice":"GroundRules: Original legal text. Not legal advice."}