RS 1046 - Recommendation and dispensing of marijuana for therapeutic use; rules and regulations of the Louisiana State Board of Medical Examiners and Louisiana Board of Pharmacy; production facility licensing by the Department of Agriculture and Forestry
NOTE: Paragraph (A)(1) eff. until Jan. 1, 2022. See Acts 2021, No. 424.
A.(1) Notwithstanding any other provision of this Part, any physician licensed by and in good standing with the Louisiana State Board of Medical Examiners to practice medicine in this state may recommend, in any form as permitted by the rules and regulations of the Louisiana Board of Pharmacy except for inhalation, and 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. Nothing in this Paragraph 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.
NOTE: Paragraph (A)(1) as amended by Acts 2021, No. 424, eff. Jan. 1, 2022.
A.(1) Notwithstanding any other provision of this Part, any physician licensed by and in good standing with the Louisiana State Board of Medical Examiners to practice medicine in this state 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. Nothing in this Paragraph 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.
(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 a physician.
(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 a physician, in his medical opinion, considers debilitating to an individual patient and is qualified through his medical education and training to treat.
(b) No physician 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 physician 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 physician licensed by and in good standing with the Louisiana State Board of Medical Examiners, provided within a bona fide doctor-patient relationship, that, in the sincere judgment of the physician, 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 physician licensed by and in good standing with the Louisiana State Board of Medical Examiners to practice medicine in Louisiana may recommend medical marijuana to any patient suffering from a debilitating medical condition with whom he shares a bona fide doctor-patient relationship.
NOTE: Paragraph (A)(5) eff. until Jan. 1, 2022. See Acts 2021, No. 424.
(5) Repealed by Acts 2019, No. 284, §2.
NOTE: Paragraph (A)(5) as enacted by Acts 2021, No. 424, eff. Jan. 1, 2022.
(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 a physician specifically recommending marijuana in raw or crude form for that person.
(6) Physicians 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.
B. Repealed by Acts 2020, No. 286, §2.
C.(1) The Louisiana Board of Pharmacy shall adopt rules relating to the dispensing of recommended marijuana for therapeutic use. Any rules published by the Louisiana Board of Pharmacy on or before January 1, 2016, that describe the pharmacist as dispensing medical marijuana based on a physician's prescription should be repromulgated to indicate that the physician is "recommending" use of therapeutic marijuana.
(2) The rules 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) The establishment of standards, procedures, and protocols for determining the amount of usable recommended therapeutic marijuana that is necessary to constitute an adequate supply to ensure uninterrupted availability for a period of one month, including amounts for topical treatments.
NOTE: Subparagraph (C)(2)(e) eff. until Jan. 1, 2022. See Acts 2021, No. 424.
(e) The establishment of standards, procedures, and protocols to ensure that all recommended therapeutic marijuana dispensed is consistently pharmaceutical grade.
NOTE: Subparagraph (C)(2)(e) as amended by Acts 2021, No. 424, eff. Jan. 1, 2022.
(e) The establishment of standards, procedures, and protocols to ensure that all recommended therapeutic marijuana dispensed, except for raw or crude marijuana, is consistently pharmaceutical grade.
(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) The establishment of standards and procedures for testing recommended therapeutic marijuana samples for levels of tetrahydrocannabinol (THC) or other testing parameters deemed appropriate by the Louisiana Board of Pharmacy.
(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.
NOTE: Subparagraph (C)(2)(1) as enacted by Acts 2021, No. 424, eff. Jan. 1, 2022.
(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. The Louisiana Board of Pharmacy shall develop an annual, nontransferable specialty license for a pharmacy to dispense recommended marijuana for therapeutic use and shall limit the number of such licenses granted in the state to no more than ten licensees. The Louisiana Board of Pharmacy shall develop rules and regulations regarding the geographical locations of dispensing pharmacies in Louisiana.
H.(1)(a) The Department of Agriculture and Forestry shall develop the rules and regulations regarding the extraction, processing, and production of recommended therapeutic marijuana and the facility producing therapeutic marijuana. The rules and regulations shall require as a minimum standard that the extraction and refining process produce a product that is food-safe and capable of producing pharmaceutical-grade products.
(b) The rules and regulations shall also include but not be limited to the procedures for application, qualifications, eligibility, background checks, and standards for suitability for a license and penalties for violations of the rules and regulations.
(2)(a) The Department of Agriculture and Forestry shall develop an annual, nontransferable specialty license for the production of recommended marijuana for therapeutic use. Other than the licenses granted pursuant to Subparagraph (b) of this Paragraph, the Department of Agriculture and Forestry shall limit the number of such licenses granted in the state to no more than one licensee. The Louisiana State University Agricultural Center and the Southern University Agricultural Center shall have the right of first refusal to be licensed as the production facility, either separately or jointly. If neither of the centers exercise this option, the license shall be awarded pursuant to the requirements provided for in Paragraphs (3) through (5) of this Subsection.
(b) Prior to September 1, 2016, the Louisiana State University Agricultural Center and the Southern University Agricultural Center shall each provide written notice to the commissioner of agriculture and forestry of their intent to be licensed as a production facility, either separately or jointly.
(c) The Louisiana State University Agricultural Center or the Southern University Agricultural Center may conduct research on marijuana for therapeutic use if the center is licensed as a production facility pursuant to this Section. Effective January 1, 2020, and annually thereafter, the Louisiana State University Agricultural Center and the Southern University Agricultural Center shall submit a report to the Senate and House committees on health and welfare, to include data and outcomes of the research conducted pursuant to this Paragraph.
(3) The license shall be limited to one geographic location as provided for in rule by the Department of Agriculture and Forestry. The geographic location shall be a public record subject to disclosure under the Public Records Law, R.S. 44:1 et seq. The licensee shall permit inspection of the production facility by any elected member of the Louisiana Legislature upon request after receipt of reasonable notice.
(4)(a) The Department of Agriculture and Forestry shall grant the license pursuant to a contract awarded through a competitive sealed bid or a competitive sealed proposal as provided for in R.S. 39:1594 and 1595. The contract for the license shall be subject to the Louisiana Procurement Code and shall not be subject to any exceptions to or other variances from the Louisiana Procurement Code. The contract shall not be awarded under the sole source procurement provisions provided for in R.S. 39:1597.
(b) Any contract for the license awarded pursuant to this Subsection shall not exceed five years.
(c) Any contract, memorandum of understanding, or cooperative endeavor agreement entered into pursuant to this Section shall be a public record subject to disclosure under the Public Records Law, R.S. 44:1 et seq.
(d) Any contract, memorandum of understanding, or cooperative endeavor agreement entered into for services for the cultivation or processing in any way of marijuana pursuant to this Section shall be a public record subject to disclosure under the Public Records Law, R.S. 44:1 et seq.
(e) No person licensed pursuant to this Subsection shall subcontract for services for the cultivation or processing in any way of marijuana if the subcontractor, or any of the service providers in the chain of subcontractors, is owned wholly or in part by any state employee or member of a state employee's immediate family, including but not limited to any legislator, statewide public official, university or community or technical college employee, Louisiana State University Agricultural Center employee, or Southern University Agricultural Center employee. For the purposes of this Paragraph, "immediate family" has the same meaning as provided in R.S. 42:1102.
(f) Any bid for the license awarded pursuant to this Subsection shall include proof of the financial capability of the bidder to operate a therapeutic marijuana production facility including but not limited to a net worth of not less than one million dollars.
(5) No person licensed pursuant to this Subsection shall give or receive anything of value in connection with any contract, memorandum of understanding, or cooperative endeavor agreement executed pursuant to this Subsection except the value that is expressed in the contract, memorandum of understanding, or cooperative endeavor agreement.
(6)(a) The Department of Agriculture and Forestry shall collect 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 Department of Agriculture and Forestry shall provide the information collected pursuant to this Paragraph for the previous calendar year in the form of a written report to the Louisiana 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 department shall perform the following:
(i) Establish and collect an annual license fee of one hundred thousand dollars and an annual permit fee of one hundred dollars for administrative and inspection costs.
(ii) Collect a nonrefundable application fee of ten thousand dollars.
(iii) Assess a fee of seven percent of the gross sales of therapeutic marijuana that 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 Community and Family Support System 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 prescribed marijuana for therapeutic use.
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. 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.