§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 Dep
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§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.