deleted text begin Requirements deleted text end new text begin Generally new text end .

deleted text begin (a) All wholesale drug distributors are subject to the requirements of this subdivision. deleted text end new text begin Each manufacturer, repackager, wholesale distributor, and dispenser shall comply with the requirements set forth in United States Code, title 21, section 360eee-1, with respect to the role of such manufacturer, repackager, wholesale distributor, or dispenser in a transaction involving a product. If an entity meets the definition of more than one of the entities listed in the preceding sentence, such entity shall comply with all applicable requirements in United States Code, title 21, section 360eee-1, but shall not be required to duplicate requirements. new text end

deleted text begin (b) No person or distribution outlet shall act as a wholesale drug distributor without first obtaining a license from the board and paying any applicable fee specified in section 151.065 . deleted text end

deleted text begin (c) Application for a wholesale drug distributor license under this section shall be made in a manner specified by the board. deleted text end

deleted text begin (d) No license shall be issued or renewed for a wholesale drug distributor to operate unless the applicant agrees to operate in a manner prescribed by federal and state law and according to the rules adopted by the board. deleted text end

deleted text begin (e) No license may be issued or renewed for a drug wholesale distributor that is required to be licensed or registered by the state in which it is physically located unless the applicant supplies the board with proof of licensure or registration. The board may establish, by rule, standards for the licensure of a drug wholesale distributor that is not required to be licensed or registered by the state in which it is physically located. deleted text end

deleted text begin (f) The board shall require a separate license for each drug wholesale distributor facility located within the state and for each drug wholesale distributor facility located outside of the state from which drugs are shipped into the state or to which drugs are reverse distributed. deleted text end

deleted text begin (g) The board shall not issue an initial or renewed license for a drug wholesale distributor facility unless the facility passes an inspection conducted by an authorized representative of the board, or is accredited by an accreditation program approved by the board. In the case of a drug wholesale distributor facility located outside of the state, the board may require the applicant to pay the cost of the inspection, in addition to the license fee in section 151.065 , unless the applicant furnishes the board with a report, issued by the appropriate regulatory agency of the state in which the facility is located, of an inspection that has occurred within the 24 months immediately preceding receipt of the license application by the board, or furnishes the board with proof of current accreditation. The board may deny licensure unless the applicant submits documentation satisfactory to the board that any deficiencies noted in an inspection report have been corrected. deleted text end

deleted text begin (h) As a condition for receiving and retaining a wholesale drug distributor license issued under sections 151.42 to 151.51 , an applicant shall satisfy the board that it has and will continuously maintain: deleted text end

deleted text begin (1) adequate storage conditions and facilities; deleted text end

deleted text begin (2) minimum liability and other insurance as may be required under any applicable federal or state law; deleted text end

deleted text begin (3) a viable security system that includes an after hours central alarm, or comparable entry detection capability; restricted access to the premises; comprehensive employment applicant screening; and safeguards against all forms of employee theft; deleted text end

deleted text begin (4) a system of records describing all wholesale drug distributor activities set forth in section 151.44 for at least the most recent two-year period, which shall be reasonably accessible as defined by board regulations in any inspection authorized by the board; deleted text end

deleted text begin (5) principals and persons, including officers, directors, primary shareholders, and key management executives, who must at all times demonstrate and maintain their capability of conducting business in conformity with sound financial practices as well as state and federal law; deleted text end

deleted text begin (6) complete, updated information, to be provided to the board as a condition for obtaining and retaining a license, about each wholesale drug distributor to be licensed, including all pertinent corporate licensee information, if applicable, or other ownership, principal, key personnel, and facilities information found to be necessary by the board; deleted text end

deleted text begin (7) written policies and procedures that assure reasonable wholesale drug distributor preparation for, protection against, and handling of any facility security or operation problems, including, but not limited to, those caused by natural disaster or government emergency, inventory inaccuracies or product shipping and receiving, outdated product or other unauthorized product control, appropriate disposition of returned goods, and product recalls; deleted text end

deleted text begin (8) sufficient inspection procedures for all incoming and outgoing product shipments; and deleted text end

deleted text begin (9) operations in compliance with all federal requirements applicable to wholesale drug distribution. deleted text end

deleted text begin (i) An agent or employee of any licensed wholesale drug distributor need not seek licensure under this section. deleted text end