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      RS 40:1046     

  

PART X-E. THERAPEUTIC USE OF MARIJUANA

§1046. Recommendation and dispensing of marijuana for therapeutic use; rules and regulations of the Louisiana Board of Pharmacy; production facility licensing; permitting by the Louisiana Department of Health

            A.(1) Notwithstanding any other provision of this Part, any clinician authorized by the provisions of Subsection B of this Section to recommend medical marijuana, referred to in this Section as an "authorized clinician", may recommend, in any form as permitted by the rules and regulations of the Louisiana Board of Pharmacy, raw or crude marijuana, tetrahydrocannabinols, or a chemical derivative of tetrahydrocannabinols for therapeutic use by any patient clinically diagnosed as suffering from a debilitating medical condition.

            (2)(a) For purposes of this Subsection, "debilitating medical condition" means any of the following:

            (i) Cancer.

            (ii) Glaucoma.

            (iii) Any of the following neurodegenerative diseases and conditions:

            (aa) Alzheimer's disease.

            (bb) Amyotrophic lateral sclerosis.

            (cc) Huntington's disease.

            (dd) Lewy body dementia.

            (ee) Motor neuron disease.

            (ff) Parkinson's disease.

            (gg) Spinal muscular atrophy.

            (iv) Positive status for human immunodeficiency virus.

            (v) Acquired immune deficiency syndrome.

            (vi) Cachexia or wasting syndrome.

            (vii) Seizure disorders.

            (viii) Epilepsy.

            (ix) Spasticity.

            (x) Severe muscle spasms.

            (xi) Intractable pain.

            (xii) Crohn's disease.

            (xiii) Muscular dystrophy.

            (xiv) Multiple sclerosis.

            (xv) Post traumatic stress disorder.

            (xvi) Any of the following conditions associated with autism spectrum disorder:

            (aa) Repetitive or self-stimulatory behavior of such severity that the physical health of the person with autism is jeopardized.

            (bb) Avoidance of others or inability to communicate of such severity that the physical health of the person with autism is jeopardized.

            (cc) Self-injuring behavior.

            (dd) Physically aggressive or destructive behavior.

            (xvii) Traumatic brain injury.

            (xviii) A concussion diagnosed by an authorized clinician.

            (xix) Chronic pain associated with fibromyalgia.

            (xx) Chronic pain associated with sickle cell disease.

            (xxi) Any condition for which a patient is receiving hospice care or palliative care.

            (xxii) Any condition not otherwise specified in this Subparagraph that an authorized clinician, in his clinical opinion, considers debilitating to an individual patient and is qualified through his clinical education and training to treat.

            (b) No authorized clinician shall recommend medical marijuana for treatment of any condition associated with autism spectrum disorder for a patient who is under the age of eighteen unless the clinician complies with the provisions of this Section and consults with a pediatric subspecialist. For purposes of this Subparagraph, a pediatric subspecialist is an individual licensed to practice medicine in any state in the United States who provides care to patients with autism spectrum disorder.

            (c) Intractable pain means a pain state in which the cause of the pain cannot be removed or otherwise treated with the consent of the patient and which, in the generally accepted course of medical practice, no relief or cure of the cause of the pain is possible, or none has been found after reasonable efforts. It is pain so chronic and severe as to otherwise warrant an opiate prescription.

            (d) Repealed by Acts 2019, No. 284, §2.

            (e) Repealed by Acts 2019, No. 284, §2.

            (3) For purposes of this Part, "recommend" or "recommended" means an opinion of any authorized clinician, provided within a bona fide clinician-patient relationship, that, in the sincere judgment of the clinician, therapeutic cannabis may be helpful to the patient's condition or symptoms and is communicated by any means allowed by the Louisiana Board of Pharmacy.

            (4) Any authorized clinician may recommend medical marijuana to any patient suffering from a debilitating medical condition with whom he shares a bona fide clinician-patient relationship.

            (5)(a) No pharmacy authorized to dispense marijuana for therapeutic use in accordance with the provisions of this Section shall dispense more than two and one-half ounces, or seventy-one grams, of raw or crude marijuana every fourteen days to any individual patient.

            (b) No pharmacy authorized to dispense marijuana for therapeutic use in accordance with the provisions of this Section shall dispense raw or crude marijuana to any person under twenty-one years of age without a recommendation from an authorized clinician specifically recommending marijuana in raw or crude form for that person.

            (6) Authorized clinicians shall report adverse events and health outcomes associated with a patient's use of medical marijuana to the data system provided for in R.S. 40:1168.1 et seq.

            (7) Nothing in this Subsection shall be construed to prevent the Louisiana Board of Pharmacy from permitting, by rule, medical marijuana in a form to be administered by metered-dose inhaler. For purposes of this Section, "metered-dose inhaler" means a device that delivers a specific amount of medication to the lungs, in the form of a short burst of medicine that is usually self-administered by the patient via inhalation.

            B. All of the following licensed health professionals are hereby authorized to recommend medical marijuana to patients and, for purposes of this Part, shall be deemed "authorized clinicians":

            (1) Any physician licensed by and in good standing with the Louisiana State Board of Medical Examiners to practice medicine in this state.

            (2) Any nurse practitioner licensed by and in good standing with the Louisiana State Board of Nursing to practice advanced practice registered nursing in this state and who has prescriptive authority conferred by the Louisiana State Board of Nursing.

            (3) Any medical psychologist licensed by and in good standing with the Louisiana State Board of Medical Examiners to practice medical psychology in this state.

            C.(1) The Louisiana Board of Pharmacy shall adopt rules relating to therapeutic marijuana.

            (2) The rules promulgated pursuant to this Subsection shall include but not be limited to:

            (a) Standards, procedures, and protocols for the effective use of recommended marijuana for therapeutic use as authorized by state law and related rules and regulations.

            (b) Standards, procedures, and protocols for the dispensing and tracking of recommended therapeutic marijuana in Louisiana.

            (c) Procedures and protocols to provide that no recommended therapeutic marijuana may be dispensed from, produced from, obtained from, sold to, or transferred to a location outside of this state.

            (d) Repealed by Acts 2022, No. 491, §2.

            (e) Repealed by Acts 2022, No. 491, §2.

            (f) The establishment of standards and procedures for the revocation, suspension, and nonrenewal of licenses.

            (g) The establishment of other licensing, renewal, and operational standards which are deemed necessary by the Louisiana Board of Pharmacy.

            (h) Repealed by Acts 2022, No. 491, §2.

            (i) The establishment of health, safety, and security requirements for dispensers of recommended therapeutic marijuana.

            (j) Licensure of dispensers of recommended therapeutic marijuana.

            (k) The establishment of financial requirements for applicants of therapeutic marijuana dispensing pharmacy license under which each applicant demonstrates the following:

            (i) The financial capacity to operate a therapeutic marijuana dispensing pharmacy.

            (ii) The ability to maintain an escrow account in a financial institution headquartered in Louisiana in an amount of two million dollars, if required by the Louisiana Board of Pharmacy.

            (l) The limitations on dispensing of raw or crude marijuana as provided in Paragraph (A)(5) of this Section.

            D. Nothing in this Section shall be construed to prohibit the Louisiana State Board of Medical Examiners or the Louisiana Board of Pharmacy from adopting emergency rules as otherwise provided for in the Administrative Procedure Act.

            E. Marijuana, tetrahydrocannabinols, or a chemical derivative of tetrahydrocannabinols recommended pursuant to this Section shall be dispensed in person from a licensed pharmacy in good standing located in Louisiana.

            F.(1) A person who recommends and a person who dispenses marijuana, tetrahydrocannabinols, or a chemical derivative of tetrahydrocannabinols pursuant to this Section shall review the patient's information in the database of the prescription monitoring program established in R.S. 40:1001 et seq. prior to the recommending and dispensing thereof.

            (2) Any person who dispenses marijuana, tetrahydrocannabinols, or a chemical derivative of tetrahydrocannabinols pursuant to this Section shall comply with the reporting requirements of the prescription monitoring program established in R.S. 40:1001 et seq.

            G.(1) The Louisiana Board of Pharmacy shall develop an annual, nontransferable specialty license for a pharmacy to dispense recommended marijuana for therapeutic use and, except as provided in Paragraph (3) of this Subsection, shall limit the number of licenses granted in the state to no more than ten licenses. The board shall award one license per region as delineated in Paragraph (2) of this Subsection and one additional license to the region with the highest population density as of August 1, 2022, and shall award each license through a competitive process. The board shall consider the status of an applicant as a minority-, woman-, or veteran-owned business as a primary factor in awarding a license.

            (2) For the purposes of this Subsection, the regions among which the Louisiana Board of Pharmacy shall allocate marijuana pharmacy licenses shall correspond to the sets of parishes comprising, respectively, the administrative regions of the Louisiana Department of Health as those regions existed on August 1, 2022. On and after October 1, 2022, at least one licensed marijuana pharmacy shall be located in each region.

            (3)(a) After three thousand five hundred active, qualified patients are identified in the prescription monitoring program in a region, the Louisiana Board of Pharmacy shall allow the marijuana pharmacy licensee in that region to open one additional marijuana pharmacy location as a satellite location in that region. For the purposes of this Paragraph, "satellite location" shall mean an additional marijuana pharmacy location operated by a marijuana pharmacy licensee within the licensee's geographic region but physically separate from the location of the originally licensed therapeutic marijuana pharmacy.

            (b) If the marijuana pharmacy licensee opens a satellite location pursuant to Subparagraph (a) of this Paragraph and the original location and the satellite location are each found to be serving three thousand five hundred active, qualified patients, then the Louisiana Board of Pharmacy shall allow the marijuana pharmacy licensee in that region to open one additional marijuana pharmacy location as a second satellite location in that region.

            (c) If a marijuana pharmacy licensee declines to open a second satellite location pursuant to Subparagraph (b) of this Paragraph, then the Louisiana Board of Pharmacy may issue, pursuant to the provisions of Paragraph (1) of this Subsection, an additional marijuana pharmacy license in that region to open one marijuana pharmacy location in lieu of the original licensee's second satellite location in that region.

            (d) The board shall consider any unserved parishes within the region when approving a satellite location or additional marijuana pharmacy for licensure pursuant to this Paragraph.

            (e) For the purposes of this Paragraph, the active, qualified patient count shall be conducted on or after August 1 of each year using the preceding twelve-month period of August 1 through July 31.

            (4)(a) The total number of marijuana pharmacy locations, including satellite locations, approved by the Louisiana Board of Pharmacy pursuant to Paragraph (3) of this Subsection shall not be greater than thirty locations.

            (b) The provisions of this Paragraph shall not be construed to authorize a marijuana pharmacy licensee to open more than two satellite locations in a single region.

            (5) The provisions of this Subsection shall not be construed to require the closure of any marijuana pharmacy location, including satellite locations, if the active, qualified patient count drops below three thousand five hundred after the location is approved by the board.

            (6)(a) No marijuana pharmacy shall locate within a fifteen-mile radius of another marijuana pharmacy.

            (b) Notwithstanding the provisions of Subparagraph (a) of this Paragraph, in a region that encompasses any parish with a population of more than three hundred fifty thousand persons according to the most recent federal decennial census, no marijuana pharmacy shall locate within a ten-mile radius of another marijuana pharmacy.

            (c) Notwithstanding the provisions of Subparagraph (a) of this Paragraph, in a region that encompasses any municipality with a population of more than three hundred fifty thousand persons according to the most recent federal decennial census, no marijuana pharmacy shall locate within a five-mile radius of another marijuana pharmacy.

            (7) Each marijuana pharmacy licensed in accordance with the provisions of this Subsection shall offer home delivery to patients in each zip code within its region at least once per month.

            (8) For purposes of this Subsection, "active, qualified patient" means a patient that has acquired a therapeutic marijuana product at least once in the preceding twelve-month period of August 1 through July 31.

            H.(1)(a) The legislature hereby recognizes and declares that both the Louisiana State University Agricultural Center and the Southern University Agricultural Center timely exercised and asserted the intent of each university to be licensed to produce recommended marijuana for therapeutic use in this state in accordance with the provisions of Act No. 261 of the 2015 Regular Session of the Legislature of Louisiana.

            (b) Each institution identified in Subparagraph (a) of this Paragraph, respectively, shall select and contract with only one contractor authorized to produce therapeutic marijuana in accordance with this Part. The selection process and contracting provided for in this Subparagraph shall be done in accordance with all applicable provisions of the Louisiana Procurement Code, R.S. 39:1551 et seq. Each contractor and the university with which it contracts shall execute an agreement for services.

            (2) The Louisiana Department of Health shall issue all of the following annually:

            (a) A nontransferable specialty license for the production of recommended marijuana for therapeutic use, which the department shall issue only to the Louisiana State University Agricultural Center and the Southern University Agricultural Center.

            (b) A permit to cultivate, extract, process, produce, and transport therapeutic marijuana, which the department shall issue only to the sole contractor selected by each university in accordance with Paragraph (1) of this Subsection.

            (c) The Louisiana State University Agricultural Center, the Southern University Agricultural Center, and the University of Louisiana at Monroe may conduct research on marijuana for therapeutic use.

            (d) On or before February first annually, the Louisiana State University Agricultural Center, the Southern University Agricultural Center, and the University of Louisiana at Monroe shall each submit to the Senate and House committees on health and welfare a report which includes data and outcomes of any research conducted pursuant to Subparagraph (c) of this Paragraph. No such report shall include any proprietary information, intellectual property, or private financial data.

            (3) Repealed by Acts 2022, No. 491, §2.

            (4) Repealed by Acts 2022, No. 491, §2.

            (5) Repealed by Acts 2022, No. 491, §2.

            (6)(a) The Louisiana Department of Health shall collect all of the following information from each licensee:

            (i) The amount of gross marijuana produced by the licensee during each calendar year.

            (ii) The details of all production costs including but not limited to seed, fertilizer, labor, advisory services, construction, and irrigation.

            (iii) The details of any items or services for which the licensee subcontracted and the costs of each subcontractor directly or indirectly working for the contractor.

            (iv) The amount of therapeutic chemicals produced resulting from the marijuana grown pursuant to this Section.

            (v) The amounts paid each year to the licensee related to the licensee's production of therapeutic marijuana pursuant to this Section.

            (vi) The amount of therapeutic marijuana distributed to each pharmacy licensed to dispense therapeutic marijuana in this state during each calendar year.

            (b) The Louisiana Department of Health shall provide the information collected as required by this Paragraph for the previous calendar year in the form of a written report to the legislature no later than February first of each year. The department shall also make a copy of the report required by this Subparagraph available to the public on the internet.

            (7) No company that has made a contribution to a candidate in a Louisiana election governed by the provisions of the Campaign Finance Disclosure Act within the five years prior to bidding for the license, or is controlled wholly or in part by a person who made such a contribution within the five years prior to the company bidding for the license, may be eligible for the license.

            (8)(a) The Louisiana Department of Health shall perform the following:

            (i) Establish and collect an annual license fee of one hundred thousand dollars from each contractor permitted to cultivate, extract, process, produce, and transport therapeutic marijuana.

            (ii) Collect a nonrefundable application fee of ten thousand dollars.

            (iii) Assess a fee of seven percent of the gross sales of therapeutic marijuana. The fee shall be reported and paid by the licensed production facility or permitted contractor that sells therapeutic marijuana to marijuana pharmacies. The fee shall be collected by the Department of Revenue and shall be subject to the provisions of Chapter 18 of Subtitle II of Title 47 of the Louisiana Revised Statutes of 1950 as amended. Notwithstanding the provisions of Subparagraph (b) of this Paragraph, the Department of Revenue shall transfer monthly to the state treasury for deposit into the Disability Services Fund, as established in R.S. 28:826, the amount of revenues collected in accordance with this Item. An amount shall be allocated to the department, pursuant to legislative appropriation, for regulatory, administrative, investigative, enforcement, legal, and other such expenses as may be necessary to carry out the provisions of this Chapter and for activities associated with the enforcement of law and regulations governing the therapeutic marijuana program.

            (b) All fees collected by the department shall be used to fund the expenses relating to the regulation and control of therapeutic marijuana.

            I. The levels of THC in any marijuana produced pursuant to this Section shall be reduced to the lowest acceptable therapeutic levels available through scientifically accepted methods.

            J. Notwithstanding any other provision of law to the contrary, employers and their worker's compensation insurers shall not be obliged or ordered to pay for medical marijuana in claims arising under Title 23 of the Louisiana Revised Statutes of 1950, the Louisiana Workers' Compensation Law.

            K. Nothing in this Part shall be construed or enforced in any manner that prevents a physician authorized by Subsection A of this Section to recommend therapeutic marijuana from recommending therapeutic marijuana through telemedicine, as defined in R.S. 37:1262, in this state.

            L. The provisions of this Section shall terminate on January 1, 2025.

            Acts 1991, No. 874, §1; Acts 2006, No. 676, §3, eff. July 1, 2006; Acts 2015, No. 261, §1, eff. June 29, 2015; Acts 2016, No. 96, §§1, 2, eff. May 19, 2016; Acts 2016, No. 567, §1; Acts 2018, No. 206, §4; Acts 2018, No. 496, §§1, 2, eff. May 23, 2018; Acts 2018, No. 708, §§1, 2; Acts 2018, No. 715, §§1, 2; Acts 2019, No. 207, §§1, 3; Acts 2019, No. 284, §§1, 2; Acts 2019, No. 331, §§2, 3, eff. July 1, 2019; Acts 2020, No. 286, §§1, 2; Acts 2021, No. 424, §1, eff. Jan. 1, 2022; Acts 2022, No. 271, §4; Acts 2022, No. 444, §1; Acts 2022, No. 491, §§1, 2; Acts 2022, No. 492, §1, eff. June 16, 2022.



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