Louisiana Revised Statutes 40:1046.2 – Contractors; selection; minimum standards
Terms Used In Louisiana Revised Statutes 40:1046.2
- Oversight: Committee review of the activities of a Federal agency or program.
- person: includes a body of persons, whether incorporated or not. See Louisiana Revised Statutes 1:10
A. The contractor selected by the licensed university through a competitive bid process to cultivate, extract, process, produce, and transport therapeutic marijuana shall be subject to oversight and inspections by the Louisiana Department of Health as provided in this Section.
B. Initial inspections of contractor facilities shall be conducted in accordance with the following procedures and requirements:
(1) Prior to commencement of operations, the Louisiana Department of Health shall conduct an initial inspection of the contractor’s facility, limited strictly to a determination of the following:
(a) That the contractor facility adheres to all of the following:
(i) Is within a building that has a complete roof enclosure supported by connecting walls, constructed of solid materials, that extend from the ground to the roof.
(ii) Has a foundation, slab, or equivalent base to which the floor is securely attached.
(iii) Meets performance standards ensuring that cultivation and processing activities cannot be and are not reasonably perceptible from the structure in terms of common visual observation, odors, smell, fragrances, or other olfactory stimulus, light pollution, glare, brightness, adequate ventilation to prevent mold, and noise.
(iv) Provides complete visual screening.
(v) Meets the standards of any applicable state and local electrical, fire, plumbing, and building specification codes.
(b) That the contractor possesses and maintains accurate, detailed plans and elevation drawings of all operational areas involved with the cultivation, extraction, processing, and production of therapeutic marijuana.
(c) That the contractor possesses and maintains a written operations plan, which shall be limited to standard operating procedures for the cultivation of marijuana in each facility production area, instructions for making each product produced on the premises, equipment operations manuals, procedures for conducting necessary safety checks, sanitization procedures for working surfaces and equipment, quality control procedures, and emergency preparedness procedures.
(d) That the contractor has connection and access to the Louisiana Medical Marijuana Tracking System.
(e) That the contractor has security against unauthorized entry via the presence of operational alarm and video surveillance systems, limited access areas, secure locking systems, and door controls throughout the facility.
(f) The initial inventory and accuracy of inventory reporting.
(g) The existence of current, complete, and accurate personnel records.
(2)(a) Notwithstanding Paragraph (1) of this Subsection, nothing in this Section shall be construed to obstruct or impede the lawful activity of any licensee or permittee.
(b) The provisions of this Subsection are intended to ensure a reliable, adequate, and uninterrupted supply of therapeutic marijuana to Louisiana patients.
C.(1) Inspections of contractor facilities other than initial inspections shall be conducted in accordance with the procedures and requirements provided in Paragraph (2) of this Subsection.
(2) After a contractor commences producing therapeutic marijuana in an approved facility, the Louisiana Department of Health shall inspect each contractor facility at least twice annually to verify the existence or accuracy of the following:
(a) Possession and accuracy of detailed plans and elevation drawings of all operational areas involved with the cultivation, extraction, processing, and production of medical marijuana.
(b) Existence and possession of a current written operations plan.
(c) Connection and accessibility to the Louisiana Medical Marijuana Tracking System.
(d) Operational alarm and video surveillance systems.
(e) Secure locks throughout the facility.
(f) Controls to limited access areas.
(g) Current, complete, and accurate personnel records.
(h) Biannual inventory reports.
D. All of the following standards and requirements for security shall apply with respect to contractor facilities:
(1) Any contractor facility alarm or surveillance system shall include the following:
(a) A panic device that sounds an audible alarm and notifies law enforcement.
(b) Surveillance system coverage for all points of ingress and egress to the facility, including but not limited to doorways, windows, and loading bays.
(c) “Duress” or “hold up” features to enable activation of a silent alarm.
(d) Date- and time-stamped recording of all points of ingress and egress, any limited access areas including rooms containing a safe, any room in which any part of the disposal process occurs, and any room or area used to cultivate, extract, process, produce, or store therapeutic marijuana.
(e) Capabilities including continuous recording, archiving, and at least one on-site display monitor connected to the system.
(2) Each contractor facility shall maintain on-site security personnel, at a minimum, during standard United States business hours of eight o’clock a.m. to five o’clock p.m. and shall maintain off-site, electronic security monitoring at all other times.
(3) All surveillance recordings shall be maintained for a minimum of thirty days and access to surveillance controls and monitoring shall be limited to specifically authorized personnel.
(4) Each contractor shall limit access to and post limited-access signage where marijuana is cultivated, extracted, processed, produced, or stored. Limited access areas shall remain locked and accessible only by authorized personnel.
(5) Each employee, supervisor, or agent of each contractor shall keep a current identification card, in a form approved by the department, on his person when present at a contractor facility.
E. All of the following procedures, restrictions, and authorizations shall apply relative to visitors at contractor facilities:
(1) Persons who do not possess a contractor identification card shall be issued a visitor identification badge after signing a log maintained by the contractor that properly identifies the visitor to the premises. The visitor shall wear the badge for the duration of his time on the premises, and the visitor shall not be left unaccompanied in any area where marijuana or marijuana products are present.
(2) Notwithstanding Paragraph (1) of this Subsection, if it is necessary for a visitor to enter a facility to conduct repairs, maintenance, or other specific duties on the premises, the visitor may be escorted to the work site and left unaccompanied while completing a job if that job is not within a limited access area. If it is necessary for a visitor to enter a facility’s limited access area, the visitor shall be escorted to the work area and shall remain accompanied by facility personnel while the work is being completed in the limited access area if marijuana or marijuana products are within the limited access area. The visitor may be left unaccompanied in the limited access area if no marijuana or marijuana products are within the limited access area while the visitor is present. If the visitor is left unaccompanied in the limited access area, facility personnel shall ensure that the visitor is under video surveillance for the duration of the visitor’s time spent on the premises.
F. All of the following requirements shall apply with respect to data management by contractors:
(1) Each contractor shall acquire and maintain all software, hardware, and communications infrastructure necessary to ensure connectivity to and implementation of the Louisiana Medical Marijuana Tracking System, referred to hereafter in this Subsection as the LMMTS, to track therapeutic marijuana from seed to distribution to an approved laboratory, to licensed pharmacies, to another cultivation contractor or to destruction, tagging each plant and product with a unique identification number, and entering the number into the LMMTS for tracking. The contractor shall bear the cost of all expenses related to tracking, tagging, and implementation of the LMMTS.
(2) Within twenty-four hours of the respective qualifying event, the contractor shall record the following in the LMMTS:
(a) Any purchase or acquisition of therapeutic marijuana seeds; plants, including immature plants and seedlings; or derivatives thereof.
(b) The sale, transfer, or transport of therapeutic marijuana or its derivatives to another contractor, approved laboratory, or therapeutic marijuana pharmacy.
(c) The disposal of therapeutic marijuana.
(3) Notwithstanding any other provision of this Section, each contractor shall keep all documents and information required by this Part for at least the current year and the three preceding calendar years, including but not limited to business records necessary to fully account for each business transaction conducted by the contractor.
G. All of the following standards and requirements shall apply to contractors’ inventory:
(1) Each contractor shall maintain a comprehensive inventory of all marijuana, including without limitation usable marijuana available for dispensing, mature marijuana plants, and seedlings at each authorized location. Following an initial inventory, all marijuana shall be inventoried on a weekly basis.
(2) Any therapeutic marijuana waste product shall be properly weighed and recorded in the Louisiana Medical Marijuana Tracking System and stored in a limited access area of a contractor facility until rendered unusable.
H. Material safety data sheet requirements shall include all of the following:
(1) Any pesticides or chemicals used by a contractor in the production of therapeutic marijuana shall be used and stored according to the contractor’s written operations plan.
(2) Each contractor shall maintain a material safety data sheet in each facility area where toxic cleaning compounds, sanitizing agents, solvents used in the production of therapeutic marijuana extracts and concentrates, pesticide chemicals, or other agricultural chemicals are used or stored.
(3) Each contractor shall record the following information when applying a pesticide or other agricultural chemical to therapeutic marijuana at any cultivation stage:
(a) The date and time of the pesticide or chemical application.
(b) The name of each individual who applied the pesticide or chemical.
(c) The identification number of all batches receiving the application.
(d) The amount and name of the pesticide or chemical applied, including the United States Environmental Protection Agency registration number, if any.
I. All of the following requirements shall apply to transportation of therapeutic marijuana by contractors:
(1) Prior to transporting therapeutic marijuana, a contractor shall generate an inventory manifest in the Louisiana Medical Marijuana Tracking System, referred to hereafter in this Subsection as the LMMTS, including all of the following information:
(a) The name of the contractor originating the transport.
(b) The name of the contractor, approved laboratory, or licensed pharmacy receiving the transport.
(c) The quantity by weight or unit of each type of therapeutic marijuana product contained in the transport.
(d) The date and approximate departure and arrival times for the transport.
(e) The identity of the agent or agents accompanying the transport.
(f) The make, model, and license plate number of the transport delivery vehicle.
(2) The contractor originating the transport shall provide the contractor, approved laboratory, or licensed pharmacy receiving the transport with a copy of the LMMTS inventory manifest, which shall not be altered after departing the originating contractor’s facility.
(3) The contractor, approved laboratory, or licensed pharmacy receiving the transport shall record the quantities of all therapeutic marijuana products in the LMMTS. However, any contractor, approved laboratory, or licensed pharmacy receiving a therapeutic marijuana transport shall refuse the transport if it is not accompanied by an unaltered LMMTS inventory manifest.
Acts 2022, No. 491, §1.