Sec. 16.5. (a) A wholesale drug distributor shall designate in writing on a form prescribed by the board a designated representative for each of the wholesale drug distributor's facilities licensed under this chapter.
(b) A designated representative shall submit to the board an application prescribed by the board and provide to the board the following:
(1) The date and place of birth of the designated representative.
(2) A list of the occupations, positions of employment, and offices held by the designated representative during the immediately preceding seven (7) years, including the principal business and address of the organization with which the occupation, position, or office was associated.
(3) A statement concerning whether the designated representative, during the immediately preceding seven (7) years, has been temporarily or permanently enjoined by a court from violating a state or federal law regulating the possession, control, or distribution of legend drugs, including details of related events.
(4) A description of any involvement by the designated representative with a business that:
(A) manufactured, administered, prescribed, distributed, or stored legend drugs; and
(B) was named as a party in a lawsuit;
during the immediately preceding seven (7) years, including investments other than the ownership of stock in a publicly traded company or mutual fund.
(5) A description of any criminal offense of which the designated representative has been convicted, regardless of whether adjudication of guilt was withheld or whether the designated representative pleaded nolo contendere. If the designated representative indicates that a criminal conviction is under appeal, the designated representative shall submit to the board:
(A) a copy of the notice of appeal; and
(B) a copy of the final written order of disposition.
(6) A photograph of the designated representative taken within the immediately preceding thirty (30) days under procedures specified by the board.
(7) A list of the name, address, occupation, and date and place of birth of each member of the designated representative's immediate family, including the designated representative's spouse, children, parents, and siblings, and the spouses of the designated representative's children and siblings. Information collected under this subdivision is confidential.
(8) Any other information required by the board.
(c) A designated representative must have at least two (2) years of verifiable full-time managerial or supervisory experience in a pharmacy or with a wholesale drug distributor licensed under this chapter or in another state. The designated representative's responsibilities must have included record keeping, storage, and shipment of legend drugs.
(d) A designated representative shall not serve as the designated representative for more than one (1) wholesale drug distributor facility at any one (1) time.
(e) A designated representative shall be actively involved and aware of the actual daily operations of the wholesale drug distributor as follows:
(1) Be employed full time in a managerial position by the wholesale drug distributor.
(2) Be physically present at the wholesale drug distributor's facility during normal business hours, except when absent due to illness, family illness or death, scheduled vacation, or another authorized absence.
(3) Be aware of and knowledgeable about all policies and procedures pertaining to the operations of the wholesale drug distributor.
(f) A designated representative must complete continuing education programs specified by the board regarding state and federal law relevant to the distribution, handling, and storage of legend drugs.
(g) A third party logistics provider must comply with this subsection until the third party logistics provider has obtained accreditation. A third party logistics provider must identify to the board a designated representative who is responsible for the facility's compliance with applicable state and federal law. The designated representative:
(1) may be a corporate employee or officer, outside counsel, or an outside consulting specialist with authority to help ensure compliance;
(2) may be responsible for multiple facilities; and
(3) is not required to be physically present at the facility.
As added by P.L.212-2005, SEC.51. Amended by P.L.98-2006, SEC.19.