ENROLLED
ACT No. 491
2022 Regular Session
HOUSE BILL NO. 697
BY REPRESENTATIVE MAGEE
1 AN ACT
2 To amend and reenact R.S. 40:1046(A)(1), (C)(1) and (2)(introductory paragraph), (G), and
3 (H)(1), (2), (6)(a)(introductory paragraph) and (b), and (8)(a)(introductory
4 paragraph) and (iii), to enact R.S. 40:1046(A)(7), (B), and 1046.1 through 1046.3,
5 and to repeal R.S. 40:1046(C)(2)(d), (e), and (h) and (H)(3) through (5), relative to
6 production of marijuana for therapeutic use; to provide for regulation of medical
7 marijuana production by the state; to transfer certain duties with respect to such
8 regulation from the Department of Agriculture and Forestry to the Louisiana
9 Department of Health; to provide for remittance to the Louisiana Department of
10 Revenue of the proceeds of certain fees; to provide relative to permitting and
11 regulation of marijuana pharmacies by the Louisiana Board of Pharmacy; to require
12 the Louisiana Department of Health to license and regulate laboratories that conduct
13 testing of medical marijuana products; to provide for selection of marijuana
14 production contractors by licensed producers of medical marijuana; to provide for
15 oversight and regulation of such contractors; to provide requirements and standards
16 for the business operations of such contractors; to require the continuation of certain
17 laboratory testing services provided by the Department of Agriculture and Forestry;
18 to authorize certain institutions to conduct research on marijuana for therapeutic use;
19 and to provide for related matters.
20 Be it enacted by the Legislature of Louisiana:
21 Section 1. R.S. 40:1046(A)(1), (C)(1) and (2)(introductory paragraph), (G), and
22 (H)(1), (2), (6)(a)(introductory paragraph) and (b), and (8)(a)(introductory paragraph) and
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1 (iii) are hereby amended and reenacted and R.S. 40:1046(A)(7), (B), and 1046.1 through
2 1046.3 are hereby enacted to read as follows:
3 §1046. Recommendation and dispensing of marijuana for therapeutic use; rules and
4 regulations of the Louisiana State Board of Medical Examiners and
5 Louisiana Board of Pharmacy; production facility licensing; by the
6 Department of Agriculture and Forestry permitting by the Louisiana
7 Department of Health
8 A.(1) Notwithstanding any other provision of this Part, any physician
9 licensed by and in good standing with the Louisiana State Board of Medical
10 Examiners to practice medicine in this state may recommend, in any form as
11 permitted by the rules and regulations of the Louisiana Board of Pharmacy, raw or
12 crude marijuana, tetrahydrocannabinols, or a chemical derivative of
13 tetrahydrocannabinols for therapeutic use by any patient clinically diagnosed as
14 suffering from a debilitating medical condition. Nothing in this Paragraph shall be
15 construed to prevent the Louisiana Board of Pharmacy from permitting, by rule,
16 medical marijuana in a form to be administered by metered-dose inhaler. For
17 purposes of this Section, "metered-dose inhaler" means a device that delivers a
18 specific amount of medication to the lungs, in the form of a short burst of medicine
19 that is usually self-administered by the patient via inhalation.
20 * * *
21 (7) Nothing in this Paragraph shall be construed to prevent the Louisiana
22 Board of Pharmacy from permitting, by rule, medical marijuana in a form to be
23 administered by metered-dose inhaler. For purposes of this Section, "metered-dose
24 inhaler" means a device that delivers a specific amount of medication to the lungs,
25 in the form of a short burst of medicine that is usually self-administered by the
26 patient via inhalation.
27 B. Nothing in this Part shall be construed or enforced in any manner that
28 prevents a physician authorized by Subsection A of this Section to recommend
29 therapeutic marijuana from recommending therapeutic marijuana through
30 telemedicine, as defined in R.S. 37:1262, in this state.
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1 C.(1) The Louisiana Board of Pharmacy shall adopt rules relating to the
2 dispensing of recommended marijuana for therapeutic use therapeutic marijuana.
3 Any rules published by the Louisiana Board of Pharmacy on or before January 1,
4 2016, that describe the pharmacist as dispensing medical marijuana based on a
5 physician's prescription should be repromulgated to indicate that the physician is
6 "recommending" use of therapeutic marijuana.
7 (2) The rules promulgated pursuant to this Subsection shall include but not
8 be limited to:
9 * * *
10 G.(1) The Louisiana Board of Pharmacy shall develop an annual,
11 nontransferable specialty license for a pharmacy to dispense recommended
12 marijuana for therapeutic use and, except as provided in Paragraph (3) of this
13 Subsection, shall limit the number of such licenses granted in the state to no more
14 than ten licenses. The Louisiana Board of Pharmacy shall develop rules and
15 regulations regarding the geographical locations of dispensing pharmacies in
16 Louisiana. The board shall award one license per region, as delineated in Paragraph
17 (2) of this Subsection and one additional license to the region with the highest
18 population density as of August 1, 2022, and shall award each license through a
19 competitive process. The board shall consider the status of an applicant as a
20 minority-, woman-, or veteran-owned business as a primary factor in awarding a
21 license.
22 (2) For the purposes of this Subsection, the regions among which the
23 Louisiana Board of Pharmacy shall allocate marijuana pharmacy licenses shall
24 correspond to the sets of parishes comprising, respectively, the administrative
25 regions of the Louisiana Department of Health as those regions existed on August
26 1, 2022. On and after October 1, 2022, at least one licensed marijuana pharmacy
27 shall be located in each region.
28 (3)(a) After three thousand five hundred active, qualified patients are
29 identified in the prescription monitoring program in a region, the Louisiana Board
30 of Pharmacy shall allow the marijuana pharmacy licensee in that region to open one
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1 additional marijuana pharmacy location as a satellite location in that region. For the
2 purposes of this Paragraph, "satellite location" shall mean an additional marijuana
3 pharmacy location operated by a marijuana pharmacy licensee within the licensee's
4 geographic region but physically separate from the location of the originally licensed
5 therapeutic marijuana pharmacy.
6 (b) If the marijuana pharmacy licensee opens a satellite location pursuant to
7 Subparagraph (a) of this Paragraph and the original location and the satellite location
8 are each found to be serving three thousand five hundred active, qualified patients,
9 then the Louisiana Board of Pharmacy shall allow the marijuana pharmacy licensee
10 in that region to open one additional marijuana pharmacy location as a second
11 satellite location in that region.
12 (c) If a marijuana pharmacy licensee declines to open a second satellite
13 location pursuant to Subparagraph (b) of this Paragraph, then the Louisiana Board
14 of Pharmacy may issue, pursuant to the provisions of Paragraph (1) of this
15 Subsection, an additional marijuana pharmacy license in that region to open one
16 marijuana pharmacy location in lieu of the original licensee's second satellite
17 location in that region.
18 (d) The board shall consider any unserved parishes within the region when
19 approving a satellite location or additional marijuana pharmacy for licensure
20 pursuant to this Paragraph.
21 (e) For the purposes of this Paragraph, the active, qualified patient count
22 shall be conducted on or after August 1 of each year using the preceding twelve-
23 month period of August 1 through July 31.
24 (4)(a) The total number of marijuana pharmacy locations, including satellite
25 locations, approved by the Louisiana Board of Pharmacy pursuant to Paragraph (3)
26 of this Subsection shall not be greater than thirty locations.
27 (b) The provisions of this Paragraph shall not be construed to authorize a
28 marijuana pharmacy licensee to open more than two satellite locations in a single
29 region.
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1 (5) The provisions of this Subsection shall not be construed to require the
2 closure of any marijuana pharmacy location, including satellite locations, if the
3 active, qualified patient count drops below three thousand five hundred after the
4 location is approved by the board.
5 (6)(a) No marijuana pharmacy shall locate within a fifteen-mile radius of
6 another marijuana pharmacy.
7 (b) Notwithstanding the provisions of Subparagraph (a) of this Paragraph,
8 in a region that encompasses any parish with a population of more than three
9 hundred fifty thousand persons according to the most recent federal decennial
10 census, no marijuana pharmacy shall locate within a ten-mile radius of another
11 marijuana pharmacy.
12 (c) Notwithstanding the provisions of Subparagraph (a) of this Paragraph,
13 in a region that encompasses any municipality with a population of more than three
14 hundred fifty thousand persons according to the most recent federal decennial
15 census, no marijuana pharmacy shall locate within a five-mile radius of another
16 marijuana pharmacy.
17 (7) Each marijuana pharmacy licensed in accordance with the provisions of
18 this Subsection shall offer home delivery to patients in each zip code within its
19 region at least once per month.
20 (8) For purposes of this Subsection, "active, qualified patient" means a
21 patient that has acquired a therapeutic marijuana product at least once in the
22 preceding twelve-month period of August 1 through July 31.
23 H.(1)(a) The Department of Agriculture and Forestry shall develop the rules
24 and regulations regarding the extraction, processing, and production of
25 recommended therapeutic marijuana and the facility producing therapeutic
26 marijuana. The rules and regulations shall require as a minimum standard that the
27 extraction and refining process produce a product that is food-safe and capable of
28 producing pharmaceutical-grade products. The legislature hereby recognizes and
29 declares that both the Louisiana State University Agricultural Center and the
30 Southern University Agricultural Center timely exercised and asserted the intent of
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1 each university to be licensed to produce recommended marijuana for therapeutic use
2 in this state in accordance with the provisions of Act No. 261 of the 2015 Regular
3 Session of the Legislature of Louisiana.
4 (b) The rules and regulations shall also include but not be limited to the
5 procedures for application, qualifications, eligibility, background checks, and
6 standards for suitability for a license and penalties for violations of the rules and
7 regulations. Each institution identified in Subparagraph (a) of this Paragraph,
8 respectively, shall select and contract with only one contractor authorized to produce
9 therapeutic marijuana in accordance with this Part. The selection process and
10 contracting provided for in the Subparagraph shall be done in accordance with all
11 applicable provisions of the Louisiana Procurement Code, R.S. 39:1551 et seq. Each
12 contractor and the university with which it contracts shall execute an agreement for
13 services.
14 (2)(a) The Department of Agriculture and Forestry shall develop an annual,
15 The Louisiana Department of Health shall issue all of the following annually:
16 (a) A nontransferable specialty license for the production of recommended
17 marijuana for therapeutic use, which the department shall issue only to the Louisiana
18 State University Agricultural Center and the Southern University Agricultural
19 Center. Other than the licenses granted pursuant to Subparagraph (b) of this
20 Paragraph, the Department of Agriculture and Forestry shall limit the number of such
21 licenses granted in the state to no more than one licensee. The Louisiana State
22 University Agricultural Center and the Southern University Agricultural Center shall
23 have the right of first refusal to be licensed as the production facility, either
24 separately or jointly. If neither of the centers exercise this option, the license shall
25 be awarded pursuant to the requirements provided for in Paragraphs (3) through (5)
26 of this Subsection.
27 (b) Prior to September 1, 2016, the Louisiana State University Agricultural
28 Center and the Southern University Agricultural Center shall each provide written
29 notice to the commissioner of agriculture and forestry of their intent to be licensed
30 as a production facility, either separately or jointly. A permit to cultivate, extract,
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1 process, produce, and transport therapeutic marijuana, which the department shall
2 issue only to the sole contractor selected by each university in accordance with
3 Paragraph (1) of this Subsection.
4 (c) The Louisiana State University Agricultural Center or, the Southern
5 University Agricultural Center, and the University of Louisiana at Monroe may
6 conduct research on marijuana for therapeutic use if the center is licensed as a
7 production facility pursuant to this Section.
8 (d) Effective January 1, 2020, and annually thereafter On or before February
9 first annually, the Louisiana State University Agricultural Center, and the Southern
10 University Agricultural Center, and the University of Louisiana at Monroe shall each
11 submit a report to the Senate and House committees on health and welfare, to include
12 a report which includes data and outcomes of the any research conducted pursuant
13 to Subparagraph (c) of this Paragraph. No such report shall include any proprietary
14 information, intellectual property, or private financial data.
15 (6)(a) The Department of Agriculture and Forestry Louisiana Department of
16 Health shall collect all of the following information from each licensee:
17 * * *
18 (b) The Department of Agriculture and Forestry Louisiana Department of
19 Health shall provide the information collected pursuant to as required by this
20 Paragraph for the previous calendar year in the form of a written report to the
21 Louisiana Legislature legislature no later than February first of each year. The
22 department shall also make a copy of the report required by this Subparagraph
23 available to the public on the Internet internet.
24 * * *
25 (8)(a) The department Louisiana Department of Health shall perform the
26 following:
27 * * *
28 (iii) Assess a fee of seven percent of the gross sales of therapeutic marijuana.
29 The fee shall be reported and paid by the licensed production facility or permitted
30 contractor that sells therapeutic marijuana to marijuana pharmacies. The fee that
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1 shall be collected by the Department of Revenue and shall be subject to the
2 provisions of Chapter 18 of Subtitle II of Title 47 of the Louisiana Revised Statutes
3 of 1950 as amended. Notwithstanding the provisions of Subparagraph (b) of this
4 Paragraph, the Department of Revenue shall transfer monthly to the state treasury for
5 deposit into the Community and Family Support System Fund, as established in R.S.
6 28:826, the amount of revenues collected in accordance with this Item. An amount
7 shall be allocated to the department, pursuant to legislative appropriation, for
8 regulatory, administrative, investigative, enforcement, legal, and other such expenses
9 as may be necessary to carry out the provisions of this Chapter and for activities
10 associated with the enforcement of law and regulations governing the therapeutic
11 marijuana program.
12 * * *
13 §1046.1. Contractors; selection; minimum standards
14 A. The contractor selected by the licensed university through a competitive
15 bid process to cultivate, extract, process, produce, and transport therapeutic
16 marijuana shall be subject to oversight and inspections by the Louisiana Department
17 of Health as provided in this Section.
18 B. Initial inspections of contractor facilities shall be conducted in accordance
19 with the following procedures and requirements:
20 (1) Prior to commencement of operations, the Louisiana Department of
21 Health shall conduct an initial inspection of the contractor's facility, limited strictly
22 to a determination of the following:
23 (a) That the contractor facility adheres to all of the following:
24 (i) Is within a building that has a complete roof enclosure supported by
25 connecting walls, constructed of solid materials, that extend from the ground to the
26 roof.
27 (ii) Has a foundation, slab, or equivalent base to which the floor is securely
28 attached.
29 (iii) Meets performance standards ensuring that cultivation and processing
30 activities cannot be and are not reasonably perceptible from the structure in terms of
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1 common visual observation, odors, smell, fragrances, or other olfactory stimulus,
2 light pollution, glare, brightness, adequate ventilation to prevent mold, and noise.
3 (iv) Provides complete visual screening.
4 (v) Meets the standards of any applicable state and local electrical, fire,
5 plumbing, and building specification codes.
6 (b) That the contractor possesses and maintains accurate, detailed plans and
7 elevation drawings of all operational areas involved with the cultivation, extraction,
8 processing, and production of therapeutic marijuana.
9 (c) That the contractor possesses and maintains a written operations plan,
10 which plan shall be limited to standard operating procedures for the cultivation of
11 marijuana in each facility production area, instructions for making each product
12 produced on the premises, equipment operations manuals, procedures for conducting
13 necessary safety checks, sanitization procedures for working surfaces and equipment,
14 quality control procedures, and emergency preparedness procedures.
15 (d) That the contractor has connection and access to the Louisiana Medical
16 Marijuana Tracking System.
17 (e) That the contractor has security against unauthorized entry via the
18 presence of operational alarm and video surveillance systems, limited access areas,
19 secure locking systems, and door controls throughout the facility.
20 (f) The initial inventory and accuracy of inventory reporting.
21 (g) The existence of current, complete, and accurate personnel records.
22 (2)(a) Notwithstanding Paragraph (1) of this Subsection, nothing in this
23 Section shall be construed to obstruct or impede the lawful activity of any licensee
24 or permittee.
25 (b) The provisions of this Subsection are intended to ensure a reliable,
26 adequate, and uninterrupted supply of therapeutic marijuana to Louisiana patients.
27 C.(1) Inspections of contractor facilities other than initial inspections shall
28 be conducted in accordance with the procedures and requirements provided in
29 Paragraph (2) of this Subsection.
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1 (2) After a contractor commences producing therapeutic marijuana in an
2 approved facility, the Louisiana Department of Health shall inspect each contractor
3 facility at least twice annually to verify the existence or accuracy of the following:
4 (a) Possession and accuracy of detailed plans and elevation drawings of all
5 operational areas involved with the cultivation, extraction, processing, and
6 production of medical marijuana.
7 (b) Existence and possession of a current written operations plan.
8 (c) Connection and accessibility to Louisiana Medical Marijuana Tracking
9 System.
10 (d) Operational alarm and video surveillance systems.
11 (e) Secure locks throughout the facility.
12 (f) Controls to limited access areas.
13 (g) Current, complete, and accurate personnel records.
14 (h) Biannual inventory reports.
15 D. All of the following standards and requirements for security shall apply
16 with respect to contractor facilities:
17 (1) Any contractor facility alarm or surveillance system shall include the
18 following:
19 (a) A panic device that sounds an audible alarm and notifies law
20 enforcement.
21 (b) Surveillance system coverage for all points of ingress and egress to the
22 facility, including but not limited to doorways, windows, and loading bays.
23 (c) "Duress" or "hold up" features to enable activation of a silent alarm.
24 (d) Date- and time-stamped recording of all points of ingress and egress, any
25 limited access areas including rooms containing a safe, any room in which any part
26 of the disposal process occurs, and any room or area used to cultivate, extract,
27 process, produce, or store therapeutic marijuana.
28 (e) Capabilities including continuous recording, archiving, and at least one
29 on-site display monitor connected to the system.
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1 (2) Each contractor facility shall maintain on-site security personnel, at a
2 minimum, during standard United States business hours of eight o'clock a.m. to five
3 o'clock p.m. and shall maintain off-site, electronic security monitoring at all other
4 times.
5 (3) All surveillance recordings shall be maintained for a minimum of thirty
6 days and access to surveillance controls and monitoring shall be limited to
7 specifically-authorized personnel.
8 (4) Each contractor shall limit access to and post limited-access signage
9 where marijuana is cultivated, extracted, processed, produced, or stored. Limited
10 access areas shall remain locked and accessible only by authorized personnel.
11 (5) Each employee, supervisor, or agent of each contractor shall keep a
12 current identification card, in a form approved by the department, on his person
13 when present at a contractor facility.
14 E. All of the following procedures, restrictions, and authorizations shall
15 apply relative to visitors at contractor facilities:
16 (1) Persons who do not possess a contractor identification card shall be
17 issued a visitor identification badge after signing a log maintained by the contractor
18 that properly identifies the visitor to the premises. The visitor shall wear the badge
19 for the duration of his time on the premises, and the visitor shall not be left
20 unaccompanied in any area where marijuana or marijuana products are present.
21 (2) Notwithstanding Paragraph (1) of this Subsection, if it is necessary for
22 a visitor to enter a facility to conduct repairs, maintenance, or other specific duties
23 on the premises, the visitor may be escorted to the work site and left unaccompanied
24 while completing a job if that job is not within a limited access area. If it is
25 necessary for a visitor to enter a facility's limited access area, the visitor shall be
26 escorted to the work area and shall remain accompanied by facility personnel while
27 the work is being completed in the limited access area if marijuana or marijuana
28 products are within the limited access area. The visitor may be left unaccompanied
29 in the limited access area if no marijuana or marijuana products are within the
30 limited access area while the visitor is present. If the visitor is left unaccompanied
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1 in the limited access area, facility personnel shall ensure that the visitor is under
2 video surveillance for the duration of the visitor's time spent on the premises.
3 F. All of the following requirements shall apply with respect to data
4 management by contractors:
5 (1) Each contractor shall acquire and maintain all software, hardware, and
6 communications infrastructure necessary to ensure connectivity to and
7 implementation of the Louisiana Medical Marijuana Tracking System, referred to
8 hereafter in this Subsection as the LMMTS, to track therapeutic marijuana from seed
9 to distribution to an approved laboratory, to licensed pharmacies, to another
10 cultivation contractor or to destruction, tagging each plant and product with a unique
11 identification number, and entering the number into LMMTS for tracking. The
12 contractor shall bear the cost of all expenses related to tracking, tagging, and
13 implementation of the LMMTS.
14 (2) Within twenty-four hours of the respective qualifying event, the
15 contractor shall record the following in the LMMTS:
16 (a) Any purchase or acquisition of therapeutic marijuana seeds; plants,
17 including immature plants and seedlings; or derivatives thereof.
18 (b) The sale, transfer, or transport of therapeutic marijuana or its derivatives
19 to another contractor, approved laboratory, or therapeutic marijuana pharmacy.
20 (c) The disposal of therapeutic marijuana.
21 (3) Notwithstanding any other provision of this Section, each contractor shall
22 keep all documents and information required by this Part for at least the current year
23 and the three preceding calendar years, including but not limited to business records
24 necessary to fully account for each business transaction conducted by contractor.
25 G. All of the following standards and requirements shall apply to contractors'
26 inventory:
27 (1) Each contractor shall maintain a comprehensive inventory of all
28 marijuana, including without limitation usable marijuana available for dispensing,
29 mature marijuana plants, and seedlings at each authorized location. Following an
30 initial inventory, all marijuana shall be inventoried on a weekly basis.
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1 (2) Any therapeutic marijuana waste product shall be properly weighed and
2 recorded in the Louisiana Medical Marijuana Tracking System and stored in a
3 limited-access area of a contractor facility until rendered unusable.
4 H. Material safety data sheet requirements shall include all of the following:
5 (1) Any pesticides or chemicals used by a contractor in the production of
6 therapeutic marijuana shall be used and stored according to the contractor's written
7 operations plan.
8 (2) Each contractor shall maintain a material safety data sheet in each facility
9 area where toxic cleaning compounds, sanitizing agents, solvents used in the
10 production of therapeutic marijuana extracts and concentrates, pesticide chemicals,
11 or other agricultural chemicals are used or stored.
12 (3) Each contractor shall record the following information when applying a
13 pesticide or other agricultural chemical to therapeutic marijuana at any cultivation
14 stage:
15 (a) The date and time of the pesticide or chemical application.
16 (b) The name of each individual who applied the pesticide or chemical.
17 (c) The identification number of all batches receiving the application.
18 (d) The amount and name of the pesticide or chemical applied, including the
19 United States Environmental Protection Agency registration number, if any.
20 I. All of the following requirements shall apply to transportation of
21 therapeutic marijuana by contractors:
22 (1) Prior to transporting therapeutic marijuana, a contractor shall generate
23 an inventory manifest in the Louisiana Medical Marijuana Tracking System, referred
24 to hereafter in this Subsection as the LMMTS, including all of the following
25 information:
26 (a) The name of the contractor originating the transport.
27 (b) The name of the contractor, approved laboratory, or licensed pharmacy
28 receiving the transport.
29 (c) The quantity by weight or unit of each type of therapeutic marijuana
30 product contained in the transport.
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1 (d) The date and approximate departure and arrival times for the transport.
2 (e) The identity of the agent or agents accompanying the transport.
3 (f) The make, model, and license plate number of the transport delivery
4 vehicle.
5 (2) The contractor originating the transport shall provide the contractor,
6 approved laboratory, or licensed pharmacy receiving the transport with a copy of the
7 LMMTS inventory manifest, which shall not be altered after departing the
8 originating contractor's facility.
9 (3) The contractor, approved laboratory, or licensed pharmacy receiving the
10 transport shall record the quantities of all therapeutic marijuana products in the
11 LMMTS. However, any contractor, approved laboratory, or licensed pharmacy
12 receiving a therapeutic marijuana transport shall refuse the transport if it is not
13 accompanied by an unaltered LMMTS inventory manifest.
14 §1046.2. Therapeutic marijuana laboratory; licensure and renewal requirements
15 A.(1) Prior to analyzing, testing, or handling therapeutic marijuana in
16 Louisiana, an applicant for a therapeutic marijuana laboratory license shall submit
17 an initial license application on a form and in a manner prescribed by the Louisiana
18 Department of Health, referred to hereafter in this Section as the "department".
19 (2) Approved laboratories may include the Department of Agriculture and
20 Forestry agricultural chemistry laboratory; the colleges, universities, other
21 institutions, and systems governed by the Louisiana Board of Regents; public-private
22 partnerships involving the systems, colleges and universities governed by the
23 Louisiana Board of Regents and private laboratories; and private laboratories. The
24 Department of Agriculture Forestry agricultural chemistry laboratory shall be exempt
25 from the application process and deemed approved but shall comply with
26 Subparagraphs (d) and (e) of this Paragraph. All other applicants shall meet all of
27 the following requirements:
28 (a) Provide proof of accreditation through either of the following:
29 (i) Be accredited by the National Institute on Drug Abuse, the National
30 Environmental Laboratory Accreditation Conference, the International Organization
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1 for Standardization, or other accrediting entity approved by the department, which
2 accreditation shall be maintained in active and good standing or other substantially
3 similar status for the duration of licensure.
4 (ii) Comply with both of the following criteria:
5 (aa) Provide documentation that the owner has operated a state-approved,
6 active medical marijuana laboratory in another state for at least the past twelve
7 months.
8 (bb) Be accredited by the International Organization for Standardization or
9 other accrediting entity approved by the department or have an application pending
10 for International Organization for Standardization accreditation. If the accreditation
11 is not achieved within nine months of the department's inspection, the department
12 shall not accept any additional certificates of analysis from the laboratory until the
13 accreditation is received.
14 (b) Employ or hire a laboratory director or other qualifying individual. The
15 laboratory director or other qualifying individual and any persons involved in the
16 testing of marijuana or marijuana products or whose involvement with the laboratory
17 requires or authorizes access to restricted limited access areas of the laboratory shall
18 obtain a permit in accordance with the requirements of R.S. 40:1047.
19 (c) Submit to at least one on-site facility inspection conducted by the
20 department prior to licensure.
21 (d) Implement and utilize the Louisiana Medical Marijuana Tracking System
22 (LMMTS) computerized inventory tracking system to post accurate analyses and
23 results, which shall be subject to review by the department. Payment of any costs
24 associated with access to or implementation or use of LMMTS shall be the
25 responsibility of the laboratory exclusively.
26 (e) Demonstrate acceptable laboratory performance standards regarding
27 accuracy, precision, proficiency, reportable ranges, specificity, or other quality
28 controls required by the department.
29 B.(1) Each therapeutic marijuana laboratory license shall be effective for one
30 year and shall be renewed on or before December thirty-first annually.
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1 (2) Each therapeutic marijuana laboratory licensee shall apply for license
2 renewal on or before October thirty-first each year on a form and in a manner
3 prescribed by the department.
4 (3) Any therapeutic marijuana laboratory license not timely renewed as
5 required by this Subsection shall expire on December thirty-first at midnight. Upon
6 expiration of the license, the laboratory shall cease all operations and destroy all
7 marijuana or marijuana products physically remaining at its location.
8 (4) Prior to granting a license renewal application, the department shall
9 ensure that the therapeutic marijuana laboratory licensee continues to meet the
10 requirements of this Part, including but not limited to the licensee's compliance with
11 Subsection A of this Section and its good standing with applicable requirements of
12 the secretary of state. The department shall conduct an out-of-cycle inspection of the
13 therapeutic marijuana laboratory licensee if necessary to ensure acceptable lab
14 performance standards, accuracy, precision, proficiency, reportable ranges,
15 specificity, or other quality controls and assurances necessary to protect Louisiana
16 patients.
17 §1046.3. Testing; sample collection; minimum standards; reporting; remediation
18 A.(1) Each contractor permitted to cultivate, extract, process, produce, and
19 transport therapeutic marijuana pursuant to this Part shall comply with approved
20 minimum standards by making each batch of therapeutic marijuana subject to
21 random selection, sampling, and analysis conducted by an independent approved
22 laboratory collector in a volume sufficient to ensure compliance.
23 (2) Each therapeutic marijuana laboratory licensed according to this Part
24 shall maintain test results for no less than three years.
25 (3) The laboratory shall record test results in the Louisiana Medical
26 Marijuana Tracking System and produce a certificate of analysis to be delivered to
27 the Louisiana Department of Health and contractor permitted to cultivate, extract,
28 process, produce, and transport therapeutic marijuana within twenty-four hours of
29 test completion.
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1 B. Each batch of medical marijuana finished product shall pass all applicable
2 testing standards, including appropriate microbial and fungal limits, acceptable
3 standards for pesticide chemical residues, appropriate residual solvent and heavy
4 metals limits, homogeneity for concentrates and extracts, and complete active
5 ingredient analysis or potency analysis prior to transportation to a medical marijuana
6 pharmacy. The administrative rules of the Louisiana Department of Health shall
7 allow for a variance of no greater than plus fifteen percent or minus fifteen percent
8 from the labeled amount of active ingredients in the ingredient analysis or potency
9 analysis.
10 C.(1) Neither a contractor nor an approved laboratory authorized pursuant
11 to this Part shall release or approve a therapeutic marijuana product for delivery or
12 sale until a sample from the applicable product batch has complied with all required
13 testing standards.
14 (2) A contractor may resubmit to an approved laboratory any sample that
15 fails one or more initial tests required by this Part. The sample may be released for
16 delivery and sale only if it passes all tests conducted by an approved laboratory in
17 duplicate. The sample may be remediated according to any reasonably acceptable
18 industry methods if it fails one or more tests conducted by an approved laboratory.
19 (3) Any remediated sample shall pass remediation testing in duplicate prior
20 to approval for delivery and sale.
21 (4) A product may be remediated only once, and any product failing
22 remediation testing shall be destroyed within sixty days of the failed test, in addition
23 to the timely destruction of the entire batch from which the sample was collected.
24 Section 2. R.S. 40:1046(C)(2)(d), (e), and (h) and (H)(3) through (5) are hereby
25 repealed in their entirety.
26 Section 3. The Department of Agriculture and Forestry, through its agricultural
27 chemistry laboratory, shall continue performing required testing of marijuana produced for
28 therapeutic use according to applicable rules and regulations in effect on the effective date
29 of this Act, subject to any overriding emergency or permanent testing rules and regulations
30 promulgated by the Louisiana Department of Health, until at least two additional laboratories
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1 are approved by the Louisiana Department of Health and have both been operational for a
2 minimum of six months to ensure a reliable, adequate, and uninterrupted supply of
3 therapeutic marijuana to Louisiana patients.
4 Section 4. To prevent any disruption to the supply chain and to ensure uninterrupted
5 availability of products for patients, if not otherwise provided in this Act, the Louisiana
6 Department of Health shall temporarily follow the applicable rules relative to marijuana for
7 therapeutic use promulgated by the Department of Agriculture and Forestry until such time
8 as it adopts all necessary emergency rules and permanent rules relating to cultivation,
9 extraction, processing, production, and transportation of marijuana for therapeutic use
10 including but not limited to the approval of product labels and packaging.
SPEAKER OF THE HOUSE OF REPRESENTATIVES
PRESIDENT OF THE SENATE
GOVERNOR OF THE STATE OF LOUISIANA
APPROVED:
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are additions.