Louisiana § RS 40:1046.3 - Therapeutic marijuana laboratory; licensure and renewal requirements

§ RS 40:1046.3. Therapeutic marijuana laboratory; licensure and renewal requirements

            A.(1) Prior to analyzing, testing, or handling therapeutic marijuana in Louisiana, an applicant for a therapeutic marijuana laboratory license shall submit an initial license application on a form and in a manner prescribed by the Louisiana Department of Health, referred to hereafter in this Section as the "department".

            (2) Approved laboratories may include the Department of Agriculture and Forestry agricultural chemistry laboratory; the colleges, universities, other institutions, and systems governed by the Louisiana Board of Regents; public-private partnerships involving the systems, colleges, and universities governed by the Louisiana Board of Regents and private laboratories; and private laboratories. The Department of Agriculture and Forestry agricultural chemistry laboratory shall be exempt from the application process and deemed approved but shall comply with Subparagraphs (d) and (e) of this Paragraph. All other applicants shall meet all of the following requirements:

            (a) Provide proof of accreditation through either of the following:

            (i) Be accredited by the National Institute on Drug Abuse, the National Environmental Laboratory Accreditation Conference, the International Organization for Standardization, or other accrediting entity approved by the department, which accreditation shall be maintained in active and good standing or other substantially similar status for the duration of licensure.

            (ii) Comply with both of the following criteria:

            (aa) Provide documentation that the owner has operated a state-approved, active medical marijuana laboratory in another state for at least the past twelve months.

            (bb) Be accredited by the International Organization for Standardization or other accrediting entity approved by the department or have an application pending for International Organization for Standardization accreditation. If the accreditation is not achieved within nine months of the department's inspection, the department shall not accept any additional certificates of analysis from the laboratory until the accreditation is received.

            (b) Employ or hire a laboratory director or other qualifying individual. The laboratory director or other qualifying individual and any persons involved in the testing of marijuana or marijuana products or whose involvement with the laboratory requires or authorizes access to restricted limited access areas of the laboratory shall obtain a permit in accordance with the requirements of R.S. 40:1047.

            (c) Submit to at least one on-site facility inspection conducted by the department prior to licensure.

            (d) Implement and utilize the Louisiana Medical Marijuana Tracking System (LMMTS) computerized inventory tracking system to post accurate analyses and results, which shall be subject to review by the department. Payment of any costs associated with access to or implementation or use of LMMTS shall be the responsibility of the laboratory exclusively.

            (e) Demonstrate acceptable laboratory performance standards regarding accuracy, precision, proficiency, reportable ranges, specificity, or other quality controls required by the department.

            B.(1) Each therapeutic marijuana laboratory license shall be effective for one year and shall be renewed on or before December thirty-first annually.

            (2) Each therapeutic marijuana laboratory licensee shall apply for license renewal on or before October thirty-first each year on a form and in a manner prescribed by the department.

            (3) Any therapeutic marijuana laboratory license not timely renewed as required by this Subsection shall expire on December thirty-first at midnight. Upon expiration of the license, the laboratory shall cease all operations and destroy all marijuana or marijuana products physically remaining at its location.

            (4) Prior to granting a license renewal application, the department shall ensure that the therapeutic marijuana laboratory licensee continues to meet the requirements of this Part, including but not limited to the licensee's compliance with Subsection A of this Section and its good standing with applicable requirements of the secretary of state. The department shall conduct an out-of-cycle inspection of the therapeutic marijuana laboratory licensee if necessary to ensure acceptable lab performance standards, accuracy, precision, proficiency, reportable ranges, specificity, or other quality controls and assurances necessary to protect Louisiana patients.

            Acts 2022, No. 491, §1.