§ 2068. Requirements; applicants; licenses

An applicant shall satisfy the Board that it has, and licensees shall maintain, the following:

(1) Acceptable storage and handling conditions plus facilities standards.

(2) Minimum liability and other insurance as may be required under any applicable federal or State law.

(3) A security system that includes after hours, central alarm or comparable entry detection capability, restricted premises access, adequate outside perimeter lighting, comprehensive employment applicant screening, and safeguards against employee theft.

(4) An electronic, manual, or any other reasonable system of records, describing activities governed by this subchapter for the two-year period following disposition of each product, which shall be reasonably accessible, as defined by the Board by rule, during any inspection authorized by the Board.

(5) Officers, directors, managers, and other persons in charge of wholesale drug distribution, manufacture, storage, and handling, who shall at all times demonstrate and maintain their capability to conduct business according to sound financial practices as well as State and federal law.

(6) Complete, updated information about the applicant or licensee, which shall be provided to the Board. The information shall include all pertinent ownership and other key personnel and facilities information deemed necessary, by the Board, for enforcement of this subchapter. Any changes in such information shall be submitted at the time of license renewal or within 12 months from the date of such change, whichever occurs first.

(7) Written policies and procedures that assure reasonable wholesale distributor preparation for, protection against, and handling of any facility security or operation problems, including those caused by natural disaster or government emergency, inventory inaccuracies or product shipping and receiving, outdated product or other unauthorized product control, appropriate disposition of returned goods, and product recalls.

(8) Sufficient inspection procedures for all incoming and outgoing product shipments.

(9) Operations in compliance with all federal requirements.

(10)(A) Compliance with standards and procedures that the Board shall adopt by rule concerning provisions for initial and periodic on-site inspections, criminal and financial background checks, ongoing monitoring, reciprocity for out-of-state entities inspected by a third party organization recognized by the Board or inspected and licensed by a State licensing authority with legal standards for licensure that are comparable to the standards adopted by the Board pursuant to this subdivision (10), protection of proprietary information, and any other requirements consistent with the purposes of this subdivision (10).

(B) The Board rules may recognize third party accreditation in satisfaction of some or all of the requirements of this subdivision (10). (Added 1991, No. 240 (Adj. Sess.), § 2; amended 2005, No. 139 (Adj. Sess.), § 4; 2019, No. 30, § 14.)