Indicates Matter Stricken

Indicates New Matter

 

Amended

02/07/24

S. 423

Introduced by Senators Davis, Hutto, Grooms, Kimpson, Malloy, McLeod, Verdin, Fanning, Goldfinch, Gustafson and Shealy

 

S. Printed 02/07/24--S.

Read the first time January 19, 2023

 

________

 

 

 

 

 

 

 

 

 

 

A bill

 

TO AMEND THE SOUTH CAROLINA CODE OF LAWS SO AS TO ENACT THE "SOUTH CAROLINA COMPASSIONATE CARE ACT"; BY AMENDING CHAPTER 53, TITLE 44 OF THE S.C. CODE, RELATING TO POISONS, DRUGS, AND OTHER CONTROLLED SUBSTANCES, BY ADDING ARTICLE 20 so as TO PROVIDE FOR THE SALE OF MEDICAL CANNABIS PRODUCTS AND THE CONDITIONS UNDER WHICH A SALE CAN OCCUR; by adding SECTION 56-5-3910 so as to provide that It is unlawful for a driver of a motor vehicle to vaporize cannabis products as defined in Section 44-53-2010 while operating the motor vehicle and to provide penalties; BY REPEALING ARTICLE 4, CHAPTER 53, TITLE 44, RELATING TO CONTROLLED SUBSTANCES THERAPEUTIC RESEARCH; AND TO DEFINE NECESSARY TERMS.

    Amend Title To Conform

 

Be it enacted by the General Assembly of the State of South Carolina:

 

SECTION 1.  This act may be cited as the "South Carolina Compassionate Care Act".

 

SECTION 2.  The General Assembly finds that:

    (1)   as of January 1, 2023, thirty-seven states and the District of Columbia have removed state-level criminal penalties from the medical use, cultivation, and distribution of cannabis, and South Carolina now joins in this effort for the health and welfare of its citizens;

    (2)   the United States Congress has signaled support for allowing states to set their own medical cannabis policies by approving budgets that include a proviso that restricts the Department of Justice from using any appropriated funds to interfere with the implementation of those laws;

    (3)   on January 12, 2017, the National Academies of Sciences, Engineering, and Medicine issued a report presenting nearly one hundred conclusions related to the health effects of cannabis and cannabinoid use. Among other things, this report concluded that there is evidence that cannabis or cannabinoids are effective for the treatment of several medical conditions and symptoms, including chronic pain, chemotherapy-induced nausea and vomiting, and the improvement of multiple sclerosis spasticity symptoms;

    (4)   clinical studies continue to show the therapeutic value of cannabis in treating a wide array of debilitating medical conditions, including relief of neuropathic pain that often fails to respond to conventional treatments, reduced reliance on opiate-based painkillers, and symptoms of autism; and

    (5)   cannabis has many accepted medical uses in the United States, having been recommended by thousands of licensed physicians to more than four million patients in the states that have medical cannabis laws, and a wide range of medical and public health organizations have recognized the medical utility of cannabis, including the American Academy of HIV Medicine, the American College of Physicians, the American Nurses Association, the American Public Health Association, the Leukemia & Lymphoma Society, the National Multiple Sclerosis Society, the U.S. Pain Foundation, and the Epilepsy Foundation.

 

SECTION 3.  Nothing in this act shall be construed or interpreted as an effort by the South Carolina General Assembly to legalize cannabis for any reason except for therapeutic benefit to patients, upon the certification and with the supervision of a physician, under the circumstances and subject to the guidelines contained herein.

 

SECTION 4.  Chapter 53, Title 44 of the S.C. Code is amended by adding:

 

    Article 20

 

    The South Carolina Compassionate Care Act

 

    Section 44-53-2010.  As used in this article:

       (1)(a)  "Allowable amount of medical cannabis" or "allowable amount of cannabis products" means, for a fourteen-day period:

               (i)    cannabis products for topical administration including, but not limited to, patches for transdermal administration or lotions, creams, or ointments, that contain a total of no more than four thousand milligrams of tetrahydrocannabinol;

               (ii)   cannabis products for oral administration including, but not limited to, oils, tinctures, capsules, or edible forms, that contain a total of no more than one thousand six hundred milligrams of tetrahydrocannabinol;

               (iii)  cannabis products that consist of oils for vaporization that contain a total of no more than eight thousand two hundred milligrams of tetrahydrocannabinol; or

               (iv)  for any other modes of delivery, an equivalent amount as determined by the department.

           (b)(i)   In any case in which a physician has specified a certain amount of cannabis products pursuant to Section 44-53-2050(B), an allowable amount of cannabis products is the amount of cannabis products specified for a fourteen-day period.

               (ii)   In any case in which a physician has not specified a certain amount of cannabis products, an allowable amount of cannabis products is the amount of cannabis products specified for a fourteen-day period as provided in subitems (a)(i), (ii), (iii), or (iv).

           (c)   The allowable amount of medical cannabis does not include industrial hemp for human consumption.

       (2)   "Bona fide physician patient relationship" has the same meaning as in Section 40-47-113(A).

       (3)(a)  "Cannabis" means:

               (i)    all parts of any plant of the cannabis genus of plants, whether growing or not;

               (ii)   the seeds of the plant;

               (iii)  the resin extracted from any part of the plant; and

               (iv)  every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or resin.

           (b)   "Cannabis" does not mean:

               (i)    the mature stalks of the plant;

               (ii)   fiber produced from the stalks;

               (iii)  oil or cake made from the seeds of the plant;

               (iv)  a product approved as a prescription medication by the United States Food and Drug Administration; or

               (v)   the sterilized seeds of the plant that are incapable of germination.

       (4)   "Cannabis product" means a product that is infused with or otherwise contains cannabis or an extract thereof and that is intended for use, ingestion, absorption, or any method of consumption by humans cultivated and produced by a licensed facility in South Carolina. The term includes, but is not limited to, an edible cannabis product, beverage, topical, ointment, oil, patch, rosin, spray, suppository, syrup, or tincture.

       (5)   "Cardholder" means a qualifying patient or a designated caregiver who has been issued and possesses a valid registry identification card from the department.

       (6)   "Child resistant packaging" means packaging that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly, substantially similar to those defined by 16 C.F.R. 1700.20 (1995), opaque so that the packaging does not allow the product to be seen without opening the packaging material, and resealable for any product intended for more than a single use or containing multiple servings.

       (7)   "Cultivation center" means a secure indoor facility located in South Carolina operated by an organization or business that is licensed by the department pursuant to this article to cultivate, possess, transport, and distribute cannabis products to processing facilities, therapeutic cannabis pharmacies, qualifying research facilities, and independent testing laboratories. Land used for cultivation may not exceed a total of two acres or 87,120 square feet per license, and provided that if a vertically tiered or shelving system is included in the cultivation area, the surface area of each tier or shelf must be included in calculating the grow canopy area.

        (8)   "Debilitating medical condition" means:

           (a)   a diagnosis of one or more of the following that also results in a debilitating condition to the individual patient:

               (i)    cancer;

               (ii)   multiple sclerosis;

               (iii)  a neurological disease or disorder, including epilepsy;

               (iv)  post traumatic stress disorder, subject, however, to the evidentiary requirements in Section 44-53-2090(A)(2) to confirm that the applicant has experienced one or more traumatic events;

               (v)   Crohn's disease;

               (vi)  sickle cell anemia;

               (vii) ulcerative colitis;

               (viii) cachexia or wasting syndrome;

               (ix)  autism;

               (x)   severe or persistent nausea in a person who is not pregnant that is related to end-of-life or hospice care, or who is bedridden or homebound because of a condition;

               (xi)  a chronic medical condition causing severe and persistent muscle spasms; or

               (xii) any chronic or debilitating disease or medical condition for which an opioid is currently or could be prescribed by a physician based on generally accepted standards of care, subject, however, to the requirements of Section 44-53-2050(A)(3)(h)(i) and (ii) as to a physician's attestation regarding objective proof of the etiology of the patient's pain or regarding the patient having been diagnosed with a specific medical condition or disease that causes the patient severe pain;

           (b)   a terminal illness with a life expectancy of less than one year in the opinion of the person's treating physician; or

           (c)   any other serious medical condition or its treatment added by the Medical Cannabis Advisory Board, as provided for in Section 44-53-2030.

       (9)   "Department" means the South Carolina Department of Health and Environmental Control.

       (10) "Designated caregiver" or "caregiver" means a person who possesses a valid registry identification card issued by the department authorizing the person to assist a qualifying patient with the medical use of cannabis. A designated caregiver must be at least twenty-one years of age unless the person is the parent or legal guardian of each qualifying patient the person assists.

       (11) "Diversion" means the obtaining or transferring of cannabis products from a legal possession or use to an illegal use.

       (12) "Edible cannabis product" means an individually packaged food or potable liquid into which has been incorporated a cannabinoid concentrate or extract or the dried leaves or flowers of cannabis with a tetrahydrocannabinol concentration of not more than ten milligrams per serving and may include a gelatin-based chewable product; however, an edible cannabis product cannot resemble or taste like commercially sold candies or other food that is typically marketed to children. An edible cannabis product cannot be in the shape of cartoons, toys, animals, or people. An edible cannabis product cannot include baked goods that would be attractive to children.

       (13) "Exit packaging" means a sealed, child resistant packaging receptacle into which prepackaged cannabis products are placed at the retail point of sale at a therapeutic cannabis pharmacy.

       (14) "Human consumption" means absorption, ingestion, inhalation, topical application, or any other method of introduction in the human body.

       (15) "Independent testing laboratory" means a facility licensed by the department pursuant to this article to offer or perform testing related to cannabis or cannabis products that is independent of cultivation centers, processing facilities, therapeutic cannabis pharmacies, and physicians who issue written certifications for the use of medical cannabis.

       (16) "Industrial hemp" has the same meaning as "hemp" or "industrial hemp" in Section 46-55-10 (8).

       (17) "Integrated operator" means an operation licensed by the department pursuant to this article to cultivate cannabis, process cannabis products, including proper packaging and labeling, possess, transport, and operate one or more therapeutic cannabis pharmacies that sell medical cannabis.

       (18) "Medical cannabis establishment" means a cultivation center, therapeutic cannabis pharmacy, transporter, independent testing laboratory, integrated operator facilities, processing facility, or qualifying research facility licensed by the department pursuant to this article.

       (19) "Medical cannabis establishment agent" means a board member, owner, officer, pharmacist, employee, or volunteer of a medical cannabis establishment.

       (20) "Medical cannabis establishment principal" means a person who is designated as having responsibility over the actions of a board member, owner, officer, pharmacist, employee, volunteer, or agent of a medical cannabis establishment and who also has responsibility and control over any liability for any financial accounts.

       (21) "Medical use" means the acquisition, administration, possession, preparation, storage, transportation, or use of cannabis products, or paraphernalia used to administer cannabis products, to treat or alleviate a qualifying patient's debilitating medical condition or symptoms associated with the qualifying patient's debilitating medical condition and includes the transfer of cannabis products from a designated caregiver to a qualifying patient whom the designated caregiver is authorized to assist.

       (22) "Opioid" means a narcotic drug or substance that is a Schedule II controlled substance defined in Section 44-53-210(b) or (c).

       (23) "Paraphernalia" means paraphernalia as defined in Section 44-53-110 or other devices used for the human consumption of cannabis, if its sole intended purpose is for use with cannabis products, except that it shall not include bongs, pipes, rolling papers, blowtorches, or any other paraphernalia that is used to smoke cannabis.

       (24) "Pharmacist" means a person who is a pharmacist as defined in Section 40-43-30(65).

       (25) "Physician" means a person who:

           (a) is a physician as defined in Section 40-47-20, is authorized to prescribe medication under state law and by the South Carolina Board of Medical Examiners, and has a controlled substances registration pursuant to Section 44-53-290 and a controlled substances registration issued by the federal Drug Enforcement Administration; and

       (b)   specifically treats a debilitating medical condition.

       (26) "Processing facility" means a facility located in South Carolina and operated by an organization or business that is licensed by the department pursuant to this article that acquires, possesses, manufactures, delivers, transfers, transports, supplies, or sells cannabis products for human consumption to a therapeutic cannabis pharmacy and/or to an independent testing laboratory and/or a qualifying research facility.

       (27) "Qualifying patient" or "patient" means a person with a debilitating medical condition who possesses a valid registry identification card issued by the department.

       (28) "Qualifying research facility" means an organization permitted by the department to receive and possess cannabis and cannabis products for research purposes. It may include, but is not limited to, the University of South Carolina's College of Pharmacy and School of Medicine, the Medical University of South Carolina, a professor, or student working on an advanced degree who is conducting Institutional Review Board approved research. Each qualifying research facility shall be issued a registration and registry identification number by the department;

       (29) "Registry identification card" means a document issued by the department that identifies a person as a qualifying patient or designated caregiver, or documentation that is deemed a registry identification card pursuant to Section 44-53-2090.

       (30) "SLED" means the South Carolina Law Enforcement Division.

       (31) "Smoking" or "smoke" means the inhalation of smoke caused by the combustion of raw cannabis or cannabis products that causes burning, except for the vaporization of an oil or concentrate product in conformance regulation issued by the department as provided in Section 44-53-2380(C).

       (32) "Standard of care for dispensing cannabis products or certifying a patient for medical cannabis" means the level and type of care that a reasonably competent and skilled health care professional with a similar background and in the same medical community would provide, which must include whether the physician exercised a standard of care in connection with the issuance of a written certification for the medical use of  a cannabis product, to a qualifying patient, pursuant to Section 44-53-2050.

       (33) "Tamper resistant paper" means paper that possesses an industry recognized feature that prevents the copying of the paper, erasure, or modification of information on the paper, or use of counterfeit documentation.

       (34) "Therapeutic cannabis pharmacy" means a location for which a pharmacy permit has been issued by the Board of Pharmacy and in which cannabis products, industrial hemp for human consumption, and paraphernalia are maintained and dispensed to cardholders. Each therapeutic cannabis pharmacy shall be issued a registration and a registry identification number by the department.    (35) "Transporter" means an entity licensed by the department pursuant to this article that acquires, possesses, and/or stores cannabis and cannabis products for human consumption and delivers, transfers, and transports cannabis products between medical cannabis establishments.

       (36) "Verification system" means a secure, confidential, and web based system established and maintained by the department that is available to authorized department personnel, law enforcement personnel, and medical cannabis establishment agents for the verification of registry identification cards.

       (37) "Written certification" means a document dated, signed, and submitted by a physician to the department, on a form developed by the department, stating that a person has been diagnosed with a debilitating medical condition and that the potential benefits of using cannabis products outweigh any risks. The certification may be made only in the course of a bona fide physician patient relationship; must specify the person's debilitating medical condition or conditions; must indicate the date of the person's follow up appointment, not to exceed six months from the original date of issuance; and must be updated annually for each person by the certifying physician. If the person with a debilitating medical condition is expected to recover from the debilitating medical condition within a year of the written certification, not including remission due to medical cannabis treatment, or if the person is not expected to benefit from cannabis products for an entire year, then the written certification must specify that fact.

 

    Section 44-53-2020.  (A)  Subject to Chapter 35, Title 11, the South Carolina Consolidated Procurement Code, the department is authorized to procure the services of qualified contractors or other state agencies to assist the department in implementing this article, including licensure, testing, audits, inspections, registry identification card and electronic patient registry management, verification system management, seed-to-sale tracking system management, diversion control, and other compliance services.

    (B)  Subject to Chapter 35, Title 11, the South Carolina Consolidated Procurement Code, the Board of Pharmacy may procure the services of qualified contractors or other state agencies to assist the Board of Pharmacy with the implementation of this article.

 

    Section 44-53-2030.  (A)  There is created a Medical Cannabis Advisory Board, which must be comprised of:

       (1)   one member appointed by the director of the department, or his designee;

       (2)   the following members appointed by the Governor, upon the advice and consent of the Senate:

           (a)   one licensed medical doctor authorized by the State to practice medicine who does not issue written certifications for the use of medical cannabis;

           (b)   one licensed medical doctor authorized by the State to practice medicine who issues written certifications for the use of medical cannabis;

           (c)   one licensed doctor of osteopathic medicine who does not issue written certifications for the use of medical cannabis;

           (d)   one licensed doctor of osteopathic medicine who issues written certifications for the use of medical cannabis;

           (e)   one licensed medical doctor who is board certified to practice addiction medicine in South Carolina;

           (f)   one research scientist with expertise in the field of cannabinoid medicine;

           (g)   one licensed pharmacist who does not dispense a cannabis product;

           (h)   one licensed pharmacist who dispenses a cannabis product; and

           (i)     one qualifying patient and one parent of a minor qualifying patient. For an appointment made before registry identification cards are issued, this provision applies to one patient or one parent of a minor with a debilitating medical condition who intends to use medical cannabis.

       (3)   two members appointed by the President of the Senate who meet any of the qualifications provided in item (2); and

       (4)   two members appointed by the Speaker of the House of Representatives who meet any of the qualifications provided in item (2).

    (B)  The advisory board shall meet at least once per year for the purpose of reviewing petitions to add or remove debilitating medical conditions. The advisory board may consult with experts in South Carolina and other states with medical cannabis programs, as well as review any available research.  The advisory board may hold public hearings before voting on whether to add or remove a certain condition as a debilitating medical condition.

    (C)  The advisory board shall have a chairman who is appointed by the Governor. The chairman shall be responsible for scheduling advisory board meetings, presiding over all advisory board meetings, and determining whether a public hearing should be held in conjunction with an advisory board meeting.

    (D)  Members of the advisory board serve up to two terms of four years or until their successors are appointed and qualify. A vacancy on the advisory board must be filled in the manner of the original appointment for the remainder of the unexpired term.

    (E)   Members of the advisory board may not receive compensation but are entitled to mileage, subsistence, and per diem as allowed by law for members of state boards, commissions, and committees.

    (F)   Except as designated in subsection (A)(2)(i), members of the advisory board may not also be a qualifying patient and in possession of a registration identification card. Prior to being appointed to the advisory board, the department shall certify that the appointee does not have a current registration identification card. The department shall advise the Governor of any appointee who has previously had a registration identification card and the circumstances under which the card is no longer valid. If a member of the advisory board becomes a qualifying patient, then he shall resign from the advisory board and notify the department and the Governor.

 

    Section 44-53-2040.  Nothing in this article may be construed to require a health insurance provider, health care plan, property and casualty insurer, or medical assistance program to be liable for or reimburse a claim for the medical use of cannabis. Consultations in which physicians diagnose debilitating medical conditions and complete written certifications shall be reimbursed consistent with a qualifying patient's health plan design.

 

    Section 44-53-2050.  (A)  The department shall develop a written certification form to be annually completed and submitted electronically to the department by a physician. The written certification must include:

       (1)   the physician's name, mailing address, email address, telephone number, medical license number, federal-controlled substances registration number, and state-controlled substances registration number;

       (2)   an acknowledgement to be signed by the physician that sets forth the penalties for providing false information, including the department's right to notify the South Carolina Board of Medical Examiners or other similar authority established pursuant to Chapter 47, Title 40;

       (3)   a statement for the physician to attest to and sign with the following provisions:

           (a)   that the physician and patient have a bona fide physician-patient relationship as a prerequisite to any certification;

           (b)   that the physician has consulted the prescription drug monitoring program, established pursuant to Article 15, Chapter 53, Title 44, to review the patient's controlled-substance prescription history and has documented such consultation in the patient's medical record;

           (c)   that the physician has conducted an in-person evaluation and collected relevant clinical history commensurate with the presentation of the patient prior to issuing a written certification. At a minimum, the evaluation should include the patient's:

               (i)    history of present illness;

               (ii)   social history;

               (iii)  past medical and surgical history;

               (iv)  alcohol and substance use history;

               (v)   family history with an emphasis on addiction, mental illness, or psychotic disorders;

               (vi)  physical exam; and

               (vii) documentation of therapies with inadequate response;

           (d)   that the patient has a debilitating medical condition; that the treatment of the debilitating medical condition, or one or more symptoms of the debilitating medical condition or side effects of its treatment, falls within the physician's area of practice, identifying the patient's condition; and that the symptoms or side effects of the condition or its treatment could benefit from a certification for the medical use of cannabis;

           (e)   that the physician has developed a written treatment plan that includes:

               (i) a review of other measures attempted to ease the suffering caused by the debilitating medical condition that do not involve cannabis products for medical use, including chiropractic interventions;

               (ii)   advice about other options for managing the debilitating medical condition;

               (iii)  advice about the potential risks of the use of cannabis products, to include:

                  (A)  the risk of cannabis use disorder;

                  (B)  adverse events, potential exacerbation of psychotic disorders, adverse cognitive effects for children and young adults, and other risks, including falls or fractures;

                  (C)  the risks of using cannabis products during pregnancy or breast feeding; and

                  (D)  the need to safeguard all cannabis products from children and pets or other domestic animals;

               (iv)  additional diagnostic evaluations or other planned treatments; and

               (v)   an ongoing treatment plan as medically appropriate;

           (f)   notification of the patient or caregiver that cannabis products are for the qualifying patient's use only and that cannabis products must not be donated or otherwise supplied to another individual;

           (g)   that the physician has discussed the risks and benefits of the use of cannabis products with the patient or caregiver, including an admonition that qualifying patients must not drive or operate heavy machinery while under the influence of medical cannabis; and

           (h)   in the case of a patient whose debilitating medical condition is a chronic or debilitating disease or medical condition for which an opioid is currently or could be prescribed:

               (i)    an attestation that the physician has reviewed objective proof of the etiology of the patient's pain, such as a diagnostic test, which may include, but is not limited to, the results of an x-ray, computerized tomography scan, or magnetic resonance imaging; or

               (ii)   an attestation that the patient has been diagnosed with a specific medical condition or disease that causes the patient severe pain, which includes, but is not limited to, complex regional pain syndrome, residual limb pain, rheumatoid arthritis, spinal cord disease, spinal cord injury, fibromyalgia, shingles, or trigeminal neuralgia;

           (i)    that the physician has either objectively diagnosed the debilitating disease himself or has verified the diagnosis with the treating physician;

           (j)    that the physician has independently verified evidence provided under Section 44-53-2050(A)(3)(h);

       (4)   a statement that the physician maintains documentation in the patient's medical record if the patient's debilitating medical condition is one for which opioid medications could be or have been prescribed;

       (5)   a statement that the patient's debilitating medical condition is expected to last either for one year, or until a date when the patient is no longer expected to benefit from cannabis products;

       (6)   the date of the patient's follow-up appointment to assess whether the patient has found relief from his debilitating medical condition and the patient's overall health and level of function. The follow-up appointment shall not exceed six months after the initial consultation or renewal appointment; and

       (7)   an acknowledgement that the physician has considered that any patient who has a history of substance use disorder or a co-occurring mental health disorder shall require specialized assessment and treatment; in those instances, the physician must seek a consultation with or refer the patient to a pain management, psychiatric, addiction, or mental health specialist as needed.

    (B)  A physician may also choose to include a specific amount of cannabis products certified every fourteen days and the reason for the dosage, in which case the qualifying patient shall be limited to those amounts in the verification system.

    (C)  Nothing in this article may be construed to require a physician to issue a written certification to any person for the use of medical cannabis.

    (D)  A physician in a bona fide physician-patient relationship with a patient may review the patient's medical cannabis certification and dispensing history as provided by the department in regulation.

 

    Section 44-53-2060.  (A)  Any physician who issues written certifications must:

       (1)   be licensed and in good standing as a physician;

       (2)   be currently practicing medicine;

       (3)   register with the department to issue written certifications in a manner and on a format determined by the department;

       (4)   attest that he has an active, unrestricted medical license, unrestricted federal controlled substances registration, and unrestricted state-controlled substances registration; and

       (5)(a)  complete a three-hour continuing medical education course on medical cannabis on a yearly basis, including an online course, that is approved by the South Carolina Board of Medical Examiners; and

           (b)   attest to the completion of the course electronically or as otherwise specified by the department prior to writing any certifications.

    (B)  A physician is not subject to arrest by state or local law enforcement, prosecution or penalty under state or local law, or the denial of a right or privilege including, but not limited to, disciplinary action by the South Carolina Board of Medical Examiners or any other occupational or professional licensing entity, for providing a written certification as authorized by state law. A physician may not be sued for medical malpractice solely as a result of certifying a qualifying patient's medical use of cannabis products in accordance with this article, but this section shall not be construed to prevent a physician from being disciplined or sued for violating the standard of care or for any violations of this article, including certifying a person for cannabis products who does not have a debilitating medical condition.

    (C)(1)  A physician shall not:

           (a)   accept, solicit, or offer any form of pecuniary remuneration, including a salary or other monetary compensation, from or to a therapeutic cannabis pharmacy;

           (b)   offer a discount or any other thing of value to a cardholder who uses or agrees to use a particular therapeutic cannabis pharmacy;

           (c)   examine a person for the purpose of diagnosing a debilitating medical condition at a location where cannabis products are sold;

           (d)   refer a patient to a particular therapeutic cannabis pharmacy or display or distribute therapeutic cannabis pharmacy marketing materials within his office if he certifies debilitating medical conditions for patients for participation in the medical cannabis program;

           (e)   certify the use of cannabis products for himself or for a family member; or

           (f)   have a full or partial ownership interest in a therapeutic cannabis pharmacy.

       (2)   If the South Carolina Board of Medical Examiners finds that a physician engaged in unprofessional conduct by violating this article, then the South Carolina Board of Medical Examiners shall notify the department as specified in department regulations that the physician's authority to certify patients for the medical use of cannabis, or his prescriptive authority, has been restricted, which may be in addition to any other sanction imposed by the South Carolina Board of Medical Examiners, including any disciplinary action up to the suspension or revocation of the physician's medical license.

 

    Section 44-53-2070.  (A)  A pharmacist who dispenses a cannabis product pursuant to this article must:

       (1)   be in good standing with the South Carolina Board of Pharmacy;

       (2)   register with the department to dispense a cannabis product;

       (3)   attest that he has an active, unrestricted pharmaceutical license; and

       (4)(a)  complete a three-hour continuing education course on medical cannabis on a yearly basis that is approved by the South Carolina Board of Pharmacy, which must include best practices regarding dosage, based upon medical conditions or symptoms, modes of administration, and cannabinoid profiles; and

           (b)   attest to the completion of the course electronically or as specified by the department prior to dispensing cannabis products.

    (B)  A pharmacist is not subject to arrest by state or local law enforcement, prosecution, or penalty under state or local law, or the denial of a right or privilege including, but not limited to, disciplinary action by the South Carolina Board of Pharmacy of any other occupational or professional licensing entity, for dispensing cannabis products as authorized by state law. A pharmacist may not be sued for malpractice solely as a result of dispensing cannabis products to a qualifying patient in accordance with this article, but this section shall not be construed to prevent a pharmacist from being disciplined or sued for violating the standard of care or for any violations of this article including, but not limited to, dispensing cannabis products to a person who does not have a registry identification card.

    (C)(1) A pharmacist shall not:

           (a)   accept, solicit, or offer any form of pecuniary remuneration from or to a physician;

           (b)   offer a discount or any other thing of value to a cardholder who uses or agrees to use a particular therapeutic cannabis pharmacy; or

           (c)   refer a patient to a particular physician or display or distribute marketing materials for a physician within therapeutic cannabis pharmacies.

       (2)   If the South Carolina Board of Pharmacy finds that a pharmacist engaged in unprofessional conduct by violating this article or a provision of Chapter 43, Title 40, then the South Carolina Board of Pharmacy shall notify the department as specified in department regulations that the pharmacist's authority to dispense cannabis products has been restricted, which may be in addition to any other sanction imposed by the South Carolina Board of Pharmacists, including any disciplinary action up to the suspension or revocation of the pharmacist's license.

       (3)   The continuing education requirements included in subsection (A)(4)(a) are applicable to all therapeutic cannabis pharmacy employees who assist the pharmacist in the preparation or dispensing of cannabis products or who interact with qualifying patients or designated caregivers.

 

    Section 44-53-2080.  (A)  The South Carolina Board of Pharmacy shall promulgate regulations relating to the dispensing of cannabis products for therapeutic use. In considering appropriate regulations, the Board of Pharmacy shall seek input from relevant stakeholders including, but not limited to, the Office of the Attorney General, and professional law enforcements organizations and associations.

    (B)  Regulations for dispensing of cannabis products for therapeutic use must include, but not be limited to:

       (1)   standards, procedures, and protocols for cannabis products for therapeutic use as provided by law;

       (2)   standards, procedures, and protocols for consulting the verification system to verify a written certification and for entering information into the medical cannabis monitoring program to follow dispensing and tracking information of medical cannabis;

       (3)   procedures and protocols to explicitly provide that no cannabis product may be dispensed from, produced from, obtained from, sold to, or transferred to a location outside of this State;

       (4)   standards, procedures, and protocols for determining the amount of usable cannabis products necessary to constitute an adequate supply to ensure uninterrupted availability for an allowable amount of medical cannabis;

       (5)   standards, testing procedures, and protocols to ensure that all dispensed cannabis products are pharmaceutical grade;

       (6)   provisions for other licensing, renewal, and operational standards deemed necessary by the Board of Pharmacy;

       (7)   requirements for the health, safety, and security for therapeutic cannabis pharmacies;

       (8)   requirements for a pharmacist-in-charge, who accepts responsibility for the operation of a therapeutic cannabis pharmacy; and

       (9)   requirements for consultations between a pharmacist and a  cardholder, including when a cannabis product has not previously been dispensed to a patient.

    (C)  The Board of Pharmacy shall develop a process and promulgate regulations for issuing a permit to a therapeutic cannabis pharmacy. The Board of Pharmacy shall not prohibit a pharmacist who owns a non-therapeutic cannabis pharmacy from obtaining a permit to own and operate a therapeutic cannabis pharmacy, provided that the pharmacies must be located in independent structures that are at least one quarter mile apart from the other.

    (D)  A therapeutic cannabis pharmacy shall not dispense any controlled substances other than cannabis products.

 

    Section 44-53-2090.  (A)  The department shall promulgate regulations:

       (1)   developing and establishing registry identification card application forms and the process for the issuance of registry identification cards for qualifying patients and designated caregivers, including a state and national fingerprint based criminal records check for designated caregivers, and for the issuance, denial, suspension, and revocation of registry identification cards;

       (2)   providing guidelines for the types of evidence accepted to confirm that an applicant experienced one or more traumatic events. Acceptable evidence must include, but is not limited to, proof of military service in an active combat zone, that the person was the victim of a violent or sexual crime, or that the person was a first responder.

    (B)  The department shall either create the necessary software for an electronic patient registry or engage a company that can do so. The registry must be able to accept and store all necessary information pursuant to this article and department regulations.

    (C)  No later than ninety days after the effective date of the regulations promulgated pursuant to subsection (A), the department shall begin accepting applications for registry identification cards.

 

    Section 44-53-2100.  (A)  A registry identification card issued pursuant to this section must be printed with tamper resistant technology and contain, at a minimum, the following information:

       (1)   the name of the cardholder;

       (2)   the address of the cardholder;

       (3)   the cardholder's date of birth;

       (4)   a designation of whether the cardholder is a designated caregiver or qualifying patient;

       (5)   the date of issuance and expiration date of the registry identification card;

       (6)   a random alphanumeric identification number that is unique to the cardholder;

       (7)   if the cardholder is a designated caregiver, the random alphanumeric identification number of the qualifying patients that the designated caregiver is authorized to assist; and

       (8)   a photograph of the cardholder.

    (B)  Except as provided in this section or department regulations, a registry identification card shall expire one year after the date the written certification is signed by a physician.

    (C)  If a physician stated in the written certification that the qualifying patient is expected to recover from the debilitating medical condition in less than one year or that the qualifying patient is expected to benefit from cannabis products for less than one year, then the registry identification card shall expire on the date specified by the physician on the written certification.

    (D)  The department shall issue a registry identification card pursuant to Section 44-53-2110 within twenty-five days of receiving a valid, complete electronic application and any other required materials from a qualifying patient applicant or designated caregiver applicant in accordance with this article.

 

    Section 44-53-2110.  (A)  The department shall issue a registry identification card to a qualifying patient applicant who submits a valid, complete electronic application and, at a minimum, the following, in accordance with the department's regulations:

       (1)   the application or annual renewal fee set by the department pursuant to Section 44-53-2530;

       (2)   the name, residential and mailing address, email address, telephone number, and date of birth of the qualifying patient applicant, except that if the applicant is homeless, then no residential address is required;

       (3)   a recent passport sized photograph of the qualifying patient applicant's face;

       (4)   the name, mailing address, and telephone number of the qualifying patient applicant's physician authorized by this article to certify the medical use of cannabis products;

       (5)   a written certification dated, signed, and submitted to the department by the physician. For a first-time qualifying patient applicant between the ages of eighteen and twenty-three, the qualifying patient must have written certifications dated, signed, and submitted to the department by two physicians;

       (6)   the name, address, date of birth, and any other contact information required by department regulations for each proposed designated caregiver. If more than one designated caregiver is designated at any given time, then the qualifying patient applicant must submit documentation demonstrating that the additional designated caregiver is needed due to the qualifying patient applicant's age, medical condition, or place of residence;

       (7)(a)  a statement signed by the qualifying patient applicant agreeing not to divert cannabis products to anyone and acknowledging that the diversion of cannabis products is a felony that, upon conviction, results in the revocation of a registry identification card and subjects the qualifying patient to a fine of not more than five thousand dollars, imprisonment of not more than five years, or both;

           (b)   an attestation that the individual is not employed in, or contracted to perform, any job:

               (i)    in which the person will carry a weapon, including a firearm;

               (ii)   requiring a law enforcement credential;

               (iii)  requiring a commercial driver's license, charter boat license, or a pilot's license;

               (iv)  involving the operation of trains, buses, or any form of public transportation; or

               (v)   involving the operation of heavy machinery;

       (8)   a questionnaire that asks if the qualifying patient applicant would like to be notified by the department of any clinical studies needing human subjects for research on the medical use of cannabis. The department shall notify interested patients of studies that will be conducted in the United States;

       (9)   the date of a prescheduled follow up appointment with the qualifying patient applicant's physician, which shall be no later than six months after the date of the written certification. A follow up appointment may be conducted in person or through telemedicine;

       (10) for a patient whose debilitating medical condition is post-traumatic stress disorder, evidence that the person experienced trauma pursuant to Section 44-53-2090(A)(2); and

       (11) an applicant's job title and description of the applicant's job, provided that an applicant may not receive or keep a registry identification card if the applicant is employed in public safety, commercial transportation, or commercial machinery. A false representation of an applicant's job title or description is a felony and, upon conviction, the applicant's registry identification card shall be revoked. The offense is punishable by a fine of not more than five thousand dollars, imprisonment of not more than five years, or both. The department must include a notice on the application that employment in public safety, commercial transportation, or commercial machinery is a prohibition on receiving a registry identification card, and that a false representation is a felony.

    (B)  After a qualifying patient applicant has been approved for a registry identification card by the department, the department shall issue registry identification cards to associated designated caregiver applicants who submit a valid, complete electronic application and, at a minimum, the following, in accordance with department regulations:

       (1)   An associated designated caregiver applicant who is a natural person must submit:

           (a)   the application or annual renewal fee set by the department;

           (b)   the name, residential mailing address, email address, telephone number, date of birth, and any other contact information for the designated caregiver applicant as specified in department regulations;

           (c)   a recent passport sized photograph of the designated caregiver applicant's face;

           (d)   a complete set of fingerprints for a state criminal records check and national criminal records check for which the applicant must pay the costs;

           (e)   a statement signed by the designated caregiver applicant agreeing not to divert cannabis products to anyone other than the qualifying patients to whom the designated caregiver is associated and acknowledging that the diversion of cannabis products is a felony that, upon conviction, results in the revocation of a registry identification card and subjects the designated caregiver to a fine of not more than five thousand dollars, imprisonment of not more than five years, or both; and

           (f)   a statement signed by the designated caregiver applicant agreeing to not consume cannabis products intended for a qualifying patient.

       (2)(a)  An associated designated caregiver applicant that is a facility licensed by the department that provides care to qualifying patients must submit:

               (i)    the application or annual renewal fee set by the department;

               (ii)   the facility's full name, business and mailing address, license number issued by the department, email address, and telephone number; the name, title, and signature of an authorized facility representative; and any other contact information for the designated caregiver applicant as specified in department regulations;

               (iii)  a statement signed by an authorized facility representative of the designated caregiver applicant agreeing not to divert cannabis products to anyone who is not allowed to possess cannabis products pursuant to this article and acknowledging that the diversion of cannabis products is a felony that, upon conviction, results in the revocation of a registry identification card and subjects the designated caregiver to a fine of not more than five thousand dollars, imprisonment of not more than five years, or both; and

               (iv)  a statement signed by an authorized facility representative of the designated caregiver applicant agreeing to secure and ensure the proper handling of cannabis products intended for a qualifying patient.

           (b)   A staff member of a designated caregiver facility licensed by the department that provides care to qualifying patients must submit a designated caregiver application as a natural person in accordance with subsection (B) and may be required to provide additional proof of employment or contract with the designated caregiver facility.

    (C)  The department shall deny, suspend, or revoke a registry identification card for a designated caregiver applicant or a designated caregiver if he has been convicted of, or pled guilty or nolo contendere to, a felony drug related offense, unless the designated caregiver applicant completed the sentence, including any term of probation or supervised release, at least fifteen years prior.

    (D)  Each patient applicant or, in the case of a minor, the parent or guardian of each minor patient applicant who applies for a registry identification card must be asked if he wants to participate voluntarily in observational studies and other data collection on medical cannabis including those funded pursuant to Section 44-53-2540(A).

    (E)   Each designated caregiver applicant must undergo a state criminal record check, supported by fingerprints, by the State Law Enforcement Division (SLED), and a national criminal record check, supported by fingerprints, by the Federal Bureau of Investigation (FBI). The results of these criminal record checks must be reported to the department and cannot be further disseminated. SLED and the FBI are authorized to provide the department with current and future information regarding that individual,  including arrest, convictions, dispositions, warrants, and other information available to the FBI, including civil and criminal information. The department shall keep all information pursuant to this section privileged, in accordance with applicable state and federal guidelines.

 

    Section 44-53-2120.  (A)  The department may not issue a registry identification card to a person under eighteen years of age who is a qualifying patient applicant unless:

       (1)   a physician electronically submits a written certification to the department that certifies the minor's medical use of cannabis products and lists the designated custodial parent or legal guardian with the legal authority to make health care decisions on behalf of the minor;

       (2)   the physician attests to explaining the potential risks and benefits of the medical use of cannabis products to the custodial parent or legal guardian with the legal authority to make health care decisions on behalf of the minor;

       (3)   the custodial parent or legal guardian with the legal authority to make health care decisions on behalf of the minor consents in writing to:

           (a)   allow the minor's medical use of cannabis products; and

           (b)(i)   serve as one of the minor's designated caregivers and determine the frequency and route of administration of cannabis products to the patient; or

               (ii)   designate another appropriate individual as caregiver for the patient; and

       (4)   the custodial parent or legal guardian with the legal authority to make health care decisions on behalf of the minor completes applications in accordance with the requirements of Section 44-53-2110(B) on behalf of the minor and as a caregiver to the minor.

    (B)  The department may not issue a registry identification card to an incapacitated person who is a qualifying patient applicant unless:

       (1)   a physician electronically submits a written certification to the department that certifies the incapacitated person's medical use of cannabis products and lists the designated person with the legal authority to make health care decisions on behalf of the incapacitated person;

       (2)   the physician attests to explaining the potential risks and benefits of the medical use of cannabis products to the person with the legal authority to make health care decisions on behalf of the incapacitated person;

       (3)   the person with the legal authority to make health care decisions on behalf of the incapacitated person consents in writing to:

           (a)   allow the incapacitated person's medical use of cannabis products;

           (b)   serve as one of the incapacitated person's designated caregivers; and

           (c)   determine the frequency and route of administration of cannabis products to the incapacitated person;

       (4)   the person with the legal authority to make health care decisions for the incapacitated person completes applications in accordance with the requirements of Section 44-53-2110 and Section 44-53-2120 on behalf of the incapacitated person and as a caregiver to the incapacitated person; and

       (5)   the person submitting an application on the incapacitated person's behalf submits a signed statement agreeing not to consume cannabis products intended for a qualifying patient.

    (C)  For a new patient applicant, not to include a renewal, the department may not issue a registry identification card to a patient applicant who is between the ages of eighteen and twenty-three years unless two physicians who have performed in person exams and verified the patient applicant's debilitating medical condition submit a written certification to the department on behalf of the patient applicant.

    (D)(1) The department may not issue a registry identification card to a person who is employed in or contracted for any job:

           (a)   in which the individual will carry a weapon, including a firearm;

           (b)   requiring a law enforcement credential;

           (c)   requiring a commercial driver's license, a charter boat license, or a pilot's license;

           (d)   involving the operation of trains, buses, or any form of public transportation; or

           (e)   involving the operation of heavy machinery.

       (2)   The department may compare applicants for registry identification cards to any professional, licensing, or other relevant database to ensure compliance with this section.

 

    Section 44-53-2130.  (A)  A designated caregiver may serve only one patient, unless the caregiver:

       (1)   is a facility licensed by the department that provides care to qualifying patients; or

       (2)   is the spouse, parent, sibling, grandparent, child, or grandchild, whether related by whole or half blood, by marriage, or by adoption, of each qualifying patient.

    (B)  In no event may a natural person who is a designated caregiver serve more than two patients.

    (C)  A designated caregiver must be a natural person unless it is a facility licensed by the department that provides care to qualifying patients.

 

    Section 44-53-2140.  The department shall promulgate regulations governing facilities licensed by the department that provide care to qualifying patients and that serve as designated caregivers.

 

    Section 44-53-2150.  (A)  Until ninety days after the department begins accepting applications for registry identification cards, a copy of a patient's valid, written certification issued and printed by the physician on tamper-resistant paper within the previous year must be deemed a registry identification card for the qualifying patient.

    (B)  Until ninety days after the department begins accepting applications for registry identification cards, the following must be deemed a registry identification card for a designated caregiver:

       (1)   a copy of a qualifying patient's valid, written certification issued and printed by a physician on tamper-resistant paper within the previous year; and

       (2)   a notarized affidavit attesting that the person has significant responsibility for managing the well-being of the qualifying patient and that the person has been chosen by the qualifying patient.

 

    Section 44-53-2160.  (A)(1) A qualifying patient shall notify the department of any change in his name, address, telephone number, or email address, or if he ceases to have a debilitating medical condition, not including if his debilitating medical condition or the underlying cause of the debilitating medical condition goes into remission due to medical cannabis, within thirty days of the change.

       (2)   A designated caregiver shall notify the department of any change in his name, address, telephone number, or email address, or if he becomes aware that the qualifying patient is deceased, within ten days of the change.

       (3)   Before a qualifying patient changes his designated caregiver, the qualifying patient shall notify the department.

       (4)   If a cardholder loses his registry identification card, then the cardholder shall notify the department within ten days of becoming aware that the card has been lost.

       (5)   A qualifying patient shall notify the department and surrender his registry identification card before starting any job or contract:

           (a)   in which he will carry a weapon, including a firearm;

           (b)   requiring a law enforcement credential;

           (c)   requiring a commercial driver's license, a charter boat license, or a pilot's license;

           (d)   involving operation of trains, buses, or any forms of public transportation; or

           (e)   involving the operation of heavy machinery.

    (B)  If a cardholder notifies the department of an occurrence identified in subsection (A) and remains eligible for a registry identification card pursuant to this article, then the department shall issue the cardholder a new registry identification card with a new random alphanumeric identification number within a reasonable time period, not to exceed fourteen business days, of receiving the updated information and a replacement card fee set by the department. If the person notifying the department is a qualifying patient, then the department shall also issue the qualifying patient's designated caregiver, if any, a new registry identification card within a reasonable time period, not to exceed thirty business days, of receiving the updated information and a replacement card fee set by the department.

    (C)  A cardholder who fails to notify the department as required by this section is subject to a civil penalty, punishable by a fine of not more than five hundred dollars per occurrence.

    (D)  If a qualifying patient's physician notifies the department in writing either that the qualifying patient has ceased to suffer from a debilitating medical condition, not including if the qualifying patient's debilitating medical condition goes into remission due to cannabis products, or that the physician no longer believes that the qualifying patient could benefit from the medical use of cannabis products, then the patient's and designated caregiver's registry identification cards shall become null and void; however, the qualifying patient shall have fifteen days to destroy all remaining cannabis products by returning it to a therapeutic cannabis pharmacy for destruction.

 

    Section 44-53-2170.  (A)(1) The Department of Health and Environmental Control, Bureau of Drug Control, shall establish and maintain a program to monitor the dispensing of all cannabis products, which shall be recorded in a secure web-based verification system.

       (2)   For each cardholder, the department shall include in the secure web-based verification system the:

           (a)   cardholder's name;

           (b)   cardholder's registration number;

           (c)   whether the cardholder is a qualifying patient or a designated caregiver;

           (d)   in the case of a designated caregiver, the associated patient's name, address, date of birth, and registry identification number;

           (e)   expiration date of the registry identification card;

           (f)   photograph;

           (g)   the allowable amount of cannabis product if the physician specified an amount; and

           (h)   the name, address, and phone number of the certifying physician.

    (B)(1)  Before dispensing cannabis products, a therapeutic cannabis pharmacy shall:

           (a)   confirm the registry identification card presented at the therapeutic cannabis pharmacy is valid using the secure web-based verification system;

           (b)   verify each person presenting a registry identification card is the person identified on the registry identification card;

           (c)   determine the amount of cannabis dispensed to the qualifying patient directly or via the designated caregiver in the previous fourteen days; and

           (d)   ensure that the amount to be dispensed does not exceed the qualifying patient's limit.

       (2)   A therapeutic cannabis pharmacy shall electronically submit to the Bureau of Drug Control information regarding each dispensing of cannabis product. The following information must be submitted for authorization:

           (a)   the date and time that the cannabis product was dispensed;

           (b)   the qualifying patient or designated caregiver's registry identification card number;

           (c)   NDC code for the drug dispensed, if there is one;

           (d)   quantity of cannabis product dispensed;

           (e)   whether the cannabis product was dispensed directly to the qualifying patient or to the qualifying patient's designated caregiver;

           (f)   the approximate number of days supplied;

           (g)   the qualifying patient's name, address, and date of birth;

           (h)   the registry identification card number of the therapeutic cannabis pharmacy that dispensed the cannabis product; and

           (i)    the expiration date of the registry identification card.

    (C)  In developing the requirements for the secure web-based verification system, the department shall consider transmission methods and protocols provided in the latest edition of the "ASAP Telecommunications Format for Controlled Substances," developed by the American Society for Automation in Pharmacy.

    (D)  Information submitted to the Bureau of Drug Control and the secure web-based verification system is confidential and not subject to public disclosure under the Freedom of Information Act or any other provision of law, except as provided in subsections (F) and (G).

    (E)   The Bureau of Drug Control shall maintain procedures to ensure that the privacy and confidentiality of patients and patient information collected, recorded, transmitted, and maintained is not disclosed, except as provided in subsections (F) and (G).

    (F)   If there is reasonable cause to believe that a violation of law or breach of professional standards may have occurred, then the Bureau of Drug Control shall notify the appropriate law enforcement agency or professional licensure, certification, or regulatory agency or entity and shall provide prescription information required for an investigation.

    (G)  The Bureau of Drug Control may provide data in the cannabis monitoring program to the following persons:

       (1)   a physician, pharmacist, or authorized delegate who requests information and certifies that the requested information is for the purpose of providing medical or pharmaceutical treatment to a bona fide patient;

       (2)   a qualifying patient or designated caregiver who requests the individual's own cannabis monitoring information in accordance with procedures established by law;

       (3)   a designated representative of the South Carolina Department of Labor, Licensing and Regulation responsible for licensure, regulation, or discipline of physicians, pharmacists, or other persons authorized to prescribe, administer, or dispense controlled substances, and who is involved in a bona fide specific investigation involving a designated person;

       (4)   a local or state law enforcement or prosecutorial official pursuant to a court-ordered search warrant issued in connection with a criminal investigation involving a designated person;

       (5)   a properly convened grand jury pursuant to a properly issued subpoena for the records;

       (6)   personnel of the department and the Board of Pharmacy for purposes of administration and enforcement of this article;

       (7)   qualified personnel for the purpose of bona fide research or education; however, data elements that would reasonably identify a specific patient or dispenser must be deleted or redacted from such information prior to disclosure. Further, release of the information may only be made pursuant a written agreement between qualified personnel and the department in order to ensure compliance with this subsection;

       (8)   a coroner, deputy coroner, medical examiner, or deputy medical examiner who is involved in a specific inquiry into the cause and manner of death of a designated person pursuant to Chapter 5, Title 17;

       (9)   a physician who requests the physician's own written certification history; and

       (10) the presiding judge of a court pertaining to a specific case involving a designated person.

    (H)(1) A pharmacist or other therapeutic cannabis pharmacy staffer dispensing cannabis who knowingly fails to submit medical cannabis monitoring information to the Bureau of Drug Control, or to submit the information required in the verification system, as required by this article, or who knowingly submits incorrect information, is guilty of a misdemeanor and, upon conviction, must be fined not more than two thousand dollars or imprisoned not more than two years, or both.

        (2)   A person who knowingly discloses medical cannabis authorization monitoring information in violation of this article is guilty of a felony and, upon conviction, must be fined not more than ten thousand dollars or imprisoned not more than ten years, or both.

        (3)   A person who knowingly uses medical cannabis authorization monitoring information in a manner or for a purpose in violation of this article is guilty of a felony and, upon conviction, must be fined not more than ten thousand dollars or imprisoned not more than ten years, or both.

        (4)   A pharmacist or therapeutic cannabis pharmacy staffer who knowingly discloses medical cannabis monitoring information in a manner or for a purpose in violation of this article shall be reported to his respective board for disciplinary action.

    (I)    Nothing in this chapter requires a pharmacist to obtain information about a patient from the medical cannabis authorization monitoring program.

    (J)   For the purposes of this subsection, the system may only disclose to state and local law enforcement personnel the following, if the law enforcement personnel inputs a registry identification card number:

       (1)   whether the registry identification card is valid;

       (2)   the name, address, and date of birth of the cardholder;

       (3)   a photograph of the cardholder;

       (4)   whether the cardholder is a qualifying patient or a designated caregiver; and

       (5)   the registry identification card number of any associated qualifying patients or designated caregivers.

    (K)  An authorized employee of the department may access the secure web-based verification system in the course of his official duties.

 

    Section 44-53-2180.  (A)  Cannabis product information received and maintained by the department pursuant to this article is confidential and not subject to public disclosure under the Freedom of Information Act or any other provision of law, except as provided in subsections (D) and (E) and Section 44-53-2180.

    (B)  The department shall maintain procedures to ensure that the privacy and confidentiality of qualifying patients and qualifying patient information collected, recorded, transmitted, and maintained is not disclosed, except as provided for in subsections (D) and (E) and Section 44-53-2180.

    (C)  The department shall maintain a confidential list of the persons to whom the department has issued registry identification cards and all of their information required in Section 44-53-2110. The department shall maintain a confidential list of any person who submitted a registry identification card application. The lists maintained pursuant to this subsection may not be combined or linked in any manner with any other list with the exception of the medical cannabis dispensing database created pursuant to 44-53-2170. The department may provide the names and contact information for patients who volunteer to participate in research to qualified personnel for the purpose of bona fide research or education pursuant to a written agreement between qualified personnel and the department.

    (D)  If there is reasonable cause to believe a violation of law or breach of professional standards may have occurred, then the department shall notify the appropriate law enforcement or professional licensure, certification, or regulatory agency or entity and shall provide cannabis product information required for an investigation.

    (E)   The department must provide cannabis product information to the following persons:

       (1)   a physician who requests information and certifies that the requested cannabis product information is for the purpose of providing medical or pharmaceutical treatment in the course of a bona fide physician-patient relationship;

       (2)   a qualifying patient or designated caregiver who requests his own cannabis product information;

       (3)   a designated representative of the South Carolina Department of Labor, Licensing and Regulation responsible for the licensure, regulation, or discipline of any person authorized to prescribe, administer, or dispense controlled substances and who is involved in a bona fide specific investigation involving a designated person;

       (4)   a local or state law enforcement or prosecutorial official pursuant to a court-ordered search warrant issued in connection with a crime or civil investigation involving a designated person;

       (5)   a properly convened grand jury pursuant to a subpoena properly issued for the records;

       (6)   personnel of the department for the purposes of the administration and enforcement of this article;

       (7)   qualified personnel for the purpose of bona fide research, except that the department may only provide the names and contact information for qualifying patients who volunteer to participate in bona fide research, including observational studies or other data collection on cannabis product pursuant to Section 44-53-2110 (D). Release of the information may only be made pursuant to a written agreement between qualified personnel and the department in order to ensure compliance with this subsection;

       (8)   a coroner, deputy coroner, medical examiner, or deputy medical examiner who is involved in a specific inquiry into the cause and manner of death of a designated person pursuant to Chapter 5, Title 17;

       (9)   a physician who requests the physician's own written certification history; or

       (10) the presiding judge of a court pertaining to a specific case involving a designated person.

    (F)   The department shall establish by regulation reporting requirements for emergency room treatment facilities for medical cannabis incidents involving qualifying patients to be listed on the web-based verification system.

 

    Section 44-53-2190.  (A)  A qualifying patient may purchase cannabis products, industrial hemp for human consumption, or paraphernalia for medical use pursuant to this article from a therapeutic cannabis pharmacy, provided that a qualifying patient may not obtain more than an allowable amount of cannabis products in a fourteen-day period.

    (B)  A designated caregiver may purchase cannabis products or paraphernalia to assist a qualifying patient with the medical use of cannabis products pursuant to this article from a therapeutic cannabis pharmacy, provided that the designated caregiver and the designated caregiver's associated qualifying patient may not obtain more than an allowable amount of cannabis products for a fourteen-day period for each qualifying patient.

 

    Section 44-53-2200.  (A)  A qualifying patient is not subject to arrest by state or local law enforcement, prosecution, or penalty under state or local law, or the denial of a right or privilege for the medical use of cannabis products pursuant to this article if the qualifying patient does not possess more than the allowable amount of cannabis products and is lawfully using cannabis products under this article.

    (B)  A designated caregiver is not subject to arrest by state or local law enforcement, prosecution, or penalty under state or local law, or the denial of a right or privilege for assisting a qualifying patient with the medical use of cannabis products pursuant to this article if the designated caregiver does not possess more than the allowable amount of cannabis products for each associated qualifying patient.

    (C)  A designated caregiver is not subject to arrest by state or local law enforcement, prosecution, or penalty under state or local law, or the denial of a right or privilege for transporting cannabis products or administering cannabis products to a qualifying patient, provided that the caregiver does so in compliance with regulations promulgated pursuant to this article.

    (D)  A cardholder is not subject to arrest by state or local law enforcement, prosecution, or penalty under state or local law, or the denial of a right or privilege for delivering or transporting an allowable amount of cannabis products to an independent testing laboratory.

    (E)   A cardholder is presumed to be lawfully in possession of cannabis products if the cardholder possesses an amount of cannabis products that does not exceed an allowable amount of cannabis products.

    (F)   If a cardholder is found to be in possession of cannabis products in an amount or type that exceeds an allowable amount of cannabis products, then the excess amount or type of cannabis products is subject to seizure by law enforcement and may not be returned. The cardholder is also subject to criminal charges for possession of the amount in excess of the allowable amount of cannabis products as provided in this article.

    (G)  The presumption provided for in subsection (E) may be rebutted by evidence that conduct related to the use of cannabis products was not for the purpose of treating or alleviating a qualifying patient's debilitating medical condition or symptoms associated with the qualifying patient's debilitating medical condition pursuant to this article.

 

    Section 44-53-2210.  (A)  It is unlawful for a physician to certify cannabis products to any person for the purposes of smoking or burning.

    (B)  It is unlawful for a cardholder to possess cannabis in plant form or to smoke cannabis or use a device to facilitate the smoking of cannabis. A person in violation of this subsection is subject to the applicable provisions of law for unlawful possession of marijuana.

    (C)  A qualifying patient who violates this section a second or subsequent time may have his registry identification card suspended or revoked.

 

    Section 44-53-2220.  (A)  This article does not authorize any person to engage in, and does not prevent the imposition of, any civil, criminal, or other penalties for engaging in the following conduct:

       (1)   undertaking any task under the influence of cannabis, if doing so would constitute negligence or professional malpractice;

       (2)   possessing cannabis or cannabis products or otherwise engaging in the medical use of cannabis products in any correctional facility, any local or county jail, or any Department of Juvenile Justice facility;

       (3)   operating, navigating, or being in actual physical control of any motor vehicle, aircraft, train, or motorboat while under the influence of cannabis;

       (4)   using cannabis products if the person does not have a debilitating medical condition or possessing cannabis products if the person is not a qualifying patient, designated caregiver, medical cannabis establishment agent, or someone who is authorized to assist a qualifying patient;

       (5)   allowing any person who is not authorized to use cannabis products under this article to use cannabis products that a cardholder is allowed to possess under this article; or

       (6)   transferring cannabis products for medical use to any person contrary to the provisions of this article.

    (B)  Nothing in this article may be construed to prevent the arrest or prosecution of a qualifying patient for reckless driving or driving under the influence of cannabis products if probable cause exists. The mere presence of cannabis metabolites shall not automatically deem a person under the influence. If a qualifying patient refuses to submit to a blood sample test, as provided in Section 56-5-2950, then the qualifying patient's privilege to drive is suspended for at least six months and his registry identification card is suspended for six months. The qualifying patient has the right to request a contested case hearing within thirty days of the issuance of the notice of suspension. If the person does not request a contested case hearing for all issues including, but not limited to, probable cause, the refusal of, or compliance with Section 56-5-2950, or if the qualifying patient's suspension is upheld at the contested case hearing, then the qualifying patient shall enroll in an Alcohol and Drug Safety Action Program. Upon completion of the suspension period and the Alcohol and Drug Safety Action Program, the qualifying patient may reapply for a registry identification card.

    (C)  Notwithstanding any other criminal penalties related to the unlawful possession of cannabis products for medical use, knowingly making a misrepresentation to a law enforcement official of any fact or circumstance relating to the medical use of cannabis products to avoid arrest or prosecution is a misdemeanor and, upon conviction, is punishable by a fine of up to one thousand dollars per offense, in addition to any other penalties that may apply for making a false statement or for the use of cannabis products other than use undertaken pursuant to this article.

    (D)  Notwithstanding any other criminal penalties related to the unlawful possession of cannabis products for medical use, knowingly making a misrepresentation of a medical condition to a physician or fraudulently providing material misinformation to a physician in order to obtain a written certification is a misdemeanor and, upon conviction, is punishable by a fine of up to one thousand dollars per offense.

    (E)   Any cardholder who sells cannabis products or is convicted of a criminal violation of this article shall have his registry identification card permanently revoked and is subject to other penalties for the unauthorized sale of cannabis. An individual who has had his registry identification card revoked for a criminal violation of this article may never be issued another registry identification card.

    (F)   Any qualifying patient who commits a violation of subsection (A)(3) or refuses a properly requested test related to operating any mode of transportation while under the influence of cannabis products shall have his registry identification card revoked for a period of one year.

    (G)  The diversion of cannabis products to any individual who is not allowed to possess cannabis products pursuant to this article is a felony that, upon conviction, results in the revocation of a registry identification card and subjects the relevant cardholder to a fine of not more than five thousand dollars, imprisonment of not more than five years, or both.

 

    Section 44-53-2230.  It is unlawful for a qualifying patient to vaporize a cannabis product in a motor vehicle of any kind that is being operated on the public highways or highway rights-of-way of this State. A person who violates the provisions of this section shall have his registry identification card suspended and is guilty of a misdemeanor. Upon conviction, the qualifying patient must be fined not more than one hundred dollars or imprisoned not more than thirty days. Upon the satisfaction of the fine, or imprisonment, or both, the qualifying patient may reapply for a registry identification card.

 

    Section 44-53-2240.  (A)  The department may deny, revoke, or suspend the registry identification card of a qualifying patient or designated caregiver for a violation of this article or of department regulations. The qualifying patient or designated caregiver is also subject to other penalties established by law.

    (B)  A person whose registry identification card is denied, revoked, or suspended may request a hearing in the Administrative Law Court within thirty days of the receipt of written notification of the denial, revocation, or suspension and is not subject to the requirements set forth in Section 44-1-60.

 

    Section 44-53-2250.  (A)  If a state or local law enforcement officer has probable cause to believe that cannabis products are possessed at a specific address in violation of South Carolina law, then the officer may verify whether the address is associated with a qualifying patient, designated caregiver, or medical cannabis establishment through the department's verification system.

    (B)  The department shall notify a law enforcement officer about falsified or fraudulent information submitted to the department.

 

    Section 44-53-2260.  (A)  Except as provided in this article, a qualifying patient who uses cannabis products for medical use must be afforded the same rights under state and local law, including those guaranteed pursuant to Section 1-13-10, et seq., as the person would be afforded if the person was solely prescribed pharmaceutical medications, as pertaining to drug testing required by any state or local law, agency, governmental official, or state or local governmental employer.

    (B)  The rights provided by this section do not apply to the extent that they conflict with an entity's obligations under federal law or regulations, or to the extent that the rights would disqualify a state or local agency from a monetary or licensing related benefit under federal law or regulations.

    (C)  Nothing in this article requires an employer to make any accommodation for the use of cannabis products on the property or premises of any place of employment, to allow the ingestion of cannabis products in any workplace, or to allow any employee to work while under the influence of cannabis products. This article in no way limits an employer's ability to discipline or terminate an employee for being under the influence of cannabis products in the workplace or for working while under the influence of cannabis products.

    (D)  No employer may be penalized or denied any benefit under state law for employing a cardholder.

    (E)   Except as otherwise provided by this section, the provisions of this article do not require any person, corporation, landlord, or other entity that occupies, owns, or controls a property to allow the vaporization of cannabis products on that property.

    (F)   Nothing in this article requires a motor carrier or private carrier, as defined in Section 58-23-1110, to make any accommodation for the use of cannabis products by any employee whose duties affect the safety of operation of motor vehicles in transportation on public roads.

 

    Section 44-53-2270.  (A)  Nothing in this article shall require an employer to permit or accommodate any applicant's or employee's use, consumption, or possession of, or impairment by, cannabis products in any form on its premises or during work-related activities. This article also does not affect the ability of a private employer to enforce a drug-free workplace policy or zero tolerance drug testing policy prohibiting any applicant or employee from having a detectable amount of marijuana metabolites in the applicant's or employee's system.

    (B)  No employer may be penalized or denied any benefit under state law for employing a cardholder.

    (C)  This article does not create a private cause of action against a private employer for wrongful discharge, discrimination, or any other adverse employment action.

 

    Section 44-53-2280.  A person who is employed by, contracting with, or an agent of the State of South Carolina is not subject to arrest by state or local law enforcement, prosecution, or penalty under state or local law, or the denial of any right or privilege for engaging in conduct authorized by this article, if the conduct is within the scope of the person's employment.

 

    Section 44-53-2290.  (A) Nothing in this act shall be interpreted to require or allow any person or entity to infringe on another person's right to own or possess a firearm, ammunition, or to receive any related firearms certification.

    (B) No state or local agency, and no employee or agent of any state or local agency, may:

       (1) restrict, revoke, suspend, or otherwise infringe upon a person's right to own or possess a firearm, ammunition, or any related firearms certification based solely on the person's status as qualifying patient or for using medical cannabis consistent with the act; or

       (2) directly or indirectly inform a federal agency or federal official that a person owns, possesses, purchases, or may attempt to own, possess, or purchase a firearm or ammunition while possessing or using medical cannabis or while being a qualifying patient, designated caregiver, or agent of a medical cannabis establishment.

 

    Section 44-53-2300.  (A)  No school or landlord may refuse to enroll, lease to, or otherwise penalize a person solely for the person's status as a cardholder, unless:

       (1)   failing to do so would violate federal law or regulations or would cause the school or landlord to lose a monetary or licensing related benefit under federal law or regulations; or

       (2)   the landlord, manager, or school, is required to deny or terminate Section 8 housing or educational opportunities to a cardholder for cannabis-related conduct due to federal law. Denials or terminations on the basis of cannabis related conduct must be reported to the Attorney General's Office for assessment for racially discriminatory conduct or disparate racial impact.

    (B)  No school or landlord may be penalized or denied any benefit under state law for enrolling or leasing to a cardholder.

 

    Section 44-53-2310.  (A)  A physician is not subject to arrest by state or local law enforcement, prosecution, or penalty under state or local law, or the denial of a right or privilege including, but not limited to, disciplinary action by the South Carolina Board of Medical Examiners or any other occupational or professional licensing entity, for providing a written certification as authorized by state law. A physician may not be sued for medical malpractice solely as a result of certifying a qualifying patient's medical use of cannabis products in accordance with this article, but this section shall not be construed to prevent a physician from being disciplined or sued for violating the standard of care or for any violations of this article, including certifying a person for cannabis products who does not have a debilitating medical condition.

    (B)  A pharmacist or other individual authorized to dispense medical cannabis by the Board of Pharmacy is not subject to arrest by state or local law enforcement, prosecution, or penalty under state or local law, or the denial of a right or privilege including, but not limited to, disciplinary action by the South Carolina Board of Pharmacy of any other occupational or professional licensing entity, for dispensing cannabis products as authorized by state law. A pharmacist or other individual authorized to dispense medical cannabis by the Board of Pharmacy may not be sued for malpractice solely as a result of dispensing cannabis products to a qualifying patient in accordance with this article, but this section shall not be construed to prevent him from being disciplined or sued for violating the standard of care or for any violations of this article including, but not limited to, dispensing cannabis products to a person who does not have a registry identification card.

 

    Section 44-53-2320.  (A)  For the purposes of this section:

       (1)   "Financial institution" means a bank, savings and loan association, credit union, banking association, land bank, intermediate credit bank, bank for cooperatives, production credit association, land bank association, mortgage association, trust company, savings bank, or other banking or financial institution organized or operating under the laws of the United States or South Carolina.

       (2)   "Financial services" includes receiving deposits, extending credit, conducting fund transfers, and transporting cash or financial instruments.

    (B)  A bank, savings and loan association, or credit union, licensed attorney, or certified public accountant, and all associated employees, are not subject to arrest by state or local law enforcement, prosecution or penalty under state or local law, the denial of a right or privilege for engaging in conduct authorized by this article, or professional discipline for providing advice or services related to medical cannabis establishments or applications to operate medical cannabis establishments on the basis that cannabis is illegal under federal law.

    (C)  A licensed attorney, a certified public accountant, or another holder of a professional or occupational license may not be subject to professional discipline for providing advice or services related to medical cannabis establishments or applications to operate medical cannabis establishments on the basis that cannabis is illegal under federal law.

    (D)  An applicant for a professional or occupational license may not be denied a license based on previous employment related to cannabis products establishments operating in accordance with state law.

    (E)   A financial institution and agents operating on its behalf are not subject to arrest by state or local law enforcement, prosecution or penalty under state or local law, or the denial of a right or privilege for providing financial services to medical cannabis establishments and applicants for medical cannabis establishments.

    (F)(1)  A medical cannabis establishment or its principal may request in writing that the department share a person's application, license, and other regulatory and financial information with a financial institution of the person's designation. The written request shall include a waiver authorizing the transfer of that information and any confidentiality or privilege that applies to that information.

       (2)   Notwithstanding any law that might proscribe the disclosure of application, license, and other regulatory and financial information, upon receipt of a written request and waiver pursuant to item (1), the department may share an application, license, and other regulatory and financial information with the financial institution designated by the licensee in the request for the purpose of facilitating the provision of financial services for that licensee.

       (3)   A person who provides a waiver may withdraw the waiver at any time. Upon receipt of the withdrawal of a waiver, the department shall cease to share application, license, or other regulatory or financial information with a financial institution.

 

    Section 44-53-2330.  A person is not subject to arrest by state or local law enforcement, prosecution, or penalty under state or local law, or the denial of a right or privilege for:

       (1)   being in the presence or vicinity of a qualifying patient engaged in the medical use of cannabis products or a designated caregiver assisting a qualifying patient with the medical use of cannabis products;

       (2)   being in the presence of a medical cannabis establishment principal or agent engaged in conduct authorized pursuant to this article;

       (3)   assisting a qualifying patient with the act of using or administering cannabis products for medical use; or

       (4)   storing or otherwise possessing a registered qualifying patient's cannabis products on the patient's behalf at the patient's residence, a residential facility, a school, a daycare or health care facility, or a similar location that is caring for the qualifying patient.

 

    Section 44-53-2340.  (A)  The lawful use of cannabis products pursuant to this article shall not be used as a relevant factor or evidence in proceedings regarding parental rights, child welfare, guardianship, decision making, or probate matters.

    (B)  A person entitled to the custody of, or visitation or parenting time with, a child must not be denied these rights for conduct allowed pursuant to this article unless the person's behavior is such that it creates an unreasonable danger to the safety of the child as established by clear and convincing evidence.

    (C)  This section shall not be construed to allow a person to engage in any conduct that would be negligent to undertake while impaired by cannabis.

 

    Section 44-53-2350.  For the purposes of medical care, including organ and tissue transplants, a qualifying patient's use of cannabis products according to this article is considered the equivalent of the authorized use of any other medication used at the discretion of a physician and does not constitute the use of an illicit substance or otherwise disqualify the qualifying patient from needed medical care.

 

    Section 44-53-2360.  (A)  The department shall create a commission to assist in promulgating regulations. At a minimum, members of the commission must include:

       (1)   the director of the department, or his designee;

       (2)   the Director of the South Carolina Department of Labor, Licensing and Regulation, or his designee;

       (3)   the President of the South Carolina Board of Medical Examiners, or his designee;

       (4)   the Chief of SLED, or his designee, unless they decline participation;

       (5)   a sheriff designated by the South Carolina Sheriffs' Association, unless they decline participation;

       (6)   the Commissioner of the South Carolina Department of Agriculture, or his designee;

       (7)   a patient representative, appointed by the Governor;

       (8)   an industry representative, appointed by the Governor;

       (9)   an individual selected by South Carolina Advocates for Epilepsy;

       (10) a certified public accountant or an attorney with expertise in contract law, appointed by the Governor;

       (11) a representative of the African American community, appointed by the Governor in consultation with the South Carolina Commission for Minority Affairs;

       (12) the Dean or Acting Dean, or his designee, from the University of South Carolina School of Medicine; and

       (13) the President, or his designee, of the Medical University of South Carolina.

    (B)  Members of the commission may not receive compensation but are entitled to mileage, subsistence, and per diem as allowed by law for members of state boards, commissions, and committees.

    (C)  Upon the issuance of all of the cannabis establishment licenses pursuant to Section 44-53-2420, the commission shall dissolve.

 

    Section 44-53-2370.  (A)  The department shall promulgate regulations to:

       (1)   establish the form and content of medical cannabis establishment license and renewal applications;

       (2)(a)  license medical cannabis establishments utilizing a variety of business models including, but not limited to, applicants that intend to operate only a single business and integrated operators that intend to operate a cultivation center, processing facility, and one or more therapeutic cannabis pharmacies, while imposing a reasonable cap on the number of medical cannabis establishments a person or entity may hold more than five percent ownership interest in, both in any region and statewide, to avoid undue market concentration;

           (b)   establish a system to numerically score competing medical cannabis establishment applicants, which must include separate application types for independent licenses and integrated operators, and which must include the award of additional points for medical cannabis establishment applicants that meet any of the following:

               (i)    an existing agricultural business in operation for over two years in the State of South Carolina;

               (ii)   an existing production or manufacturing business in operation for over two years in the State of South Carolina;

               (iii)  an existing company working in the hemp industry for over two years in the State of South Carolina; or

               (iv)  an applicant of whom more than fifty percent of the principals are residents of the State of South Carolina;

           (c)   In cases in which more applicants apply than are allowed by the local government, the system must include an analysis of:

               (i)    in the case of therapeutic cannabis pharmacies, the suitability of the proposed location and its accessibility to patients;

               (ii)   the character, veracity, diversity, residency, background, qualifications, and relevant experience of medical cannabis establishment principals and agents; and

               (iii)  the business plan proposed by the medical cannabis establishment applicant, which in the case of cultivation centers and therapeutic cannabis pharmacies shall include the ability to maintain an adequate supply of cannabis products, plans to ensure the safety and security of patrons and the community, procedures to be used to prevent diversion, and any plan for making cannabis products available to low income qualifying patients;

       (3)   in coordination with the Division of Small and Minority Business Contracting and Certification, implement policies to:

           (a)   engage in outreach to encourage racial, ethnic, and gender diversity in the South Carolina medical cannabis industry; and

           (b)   ensure that diverse groups are afforded equal opportunity in licensing;

       (4)   govern medical cannabis establishments, with the goals of ensuring the health and safety of qualifying patients and preventing diversion and theft, without creating an undue burden or compromising the confidentiality of cardholders, including:

           (a)   oversight requirements;

           (b)   recordkeeping and inventory management requirements;

           (c)   security requirements, which must be developed in consultation with a private security expert in good standing, including lighting, physical security, and alarm requirements and, in the case of a cultivation center, access controls, perimeter intrusion detection systems, personnel identification systems, and a twenty four hour surveillance system to monitor the interior and exterior of the cultivation center, which are accessible to authorized law enforcement personnel and the department;

           (d)   health and safety regulations, including:

               (i)    restrictions on the use of pesticides that are injurious to human health; and

               (ii)   standards for testing cannabis and cannabis products, including specifying prohibited concentrations of heavy metals, pesticides, microbes, and other contaminants that are injurious to human health; and

               (iii)  requirements that any oils intended for vaporization may be sold as either pre-filled, tamper-resistant, non-refillable cartridges that are not capable of use with nicotine vaporization devices, or as disposable "all-in-one" systems that are tamper-resistant, non-fillable, and do not contain nicotine;

           (e)   standards for the manufacture of cannabis products and both the secure, indoor cultivation of cannabis by cultivation centers, including environmental impact regulations;

           (f)   requirements for the secure transportation and storage of cannabis and cannabis products by medical cannabis establishments, which must be developed in consultation with a private security expert in good standing;

           (g)   employment and training requirements, including requiring medical cannabis establishments to create, administer, and track an identification badge for each medical cannabis establishment agent and principal;

           (h)   standards for the safe manufacture of cannabis products, including extracts and concentrates;

           (i)    restrictions on the advertising, signage, and display of cannabis products, provided that the restrictions may not prevent appropriate signs on the property of a therapeutic cannabis pharmacy; listings in business directories, including phone books; listings in cannabis related or medical publications; and the sponsorship of health or not-for-profit charity or advocacy events, provided that the restrictions must include:

               (i)    requirements that the medical cannabis establishment's logo, advertising, and signage be tasteful, respectful, and medically focused and must not appeal to minors or contain cartoon-like figures or attempts at humor;

               (ii)   requirements that medical cannabis establishments submit any logo or sign for review to the department in accordance with department regulations;

               (iii)  prohibitions on medical cannabis establishments from using marijuana leaves or slang for cannabis or cannabis products in or on their signs, logos, packaging, or structures;

               (iv)  limitations on the size or location of signs; and

               (v)   prohibitions against using neon-colored signage, logos, or packaging, or neon-colored signage or logos on structures;

           (j)    requirements and procedures for the safe and accurate packaging and labeling of medical cannabis, cannabis products, and industrial hemp for human consumption;

           (k)   standards for independent testing laboratories, including requirements for equipment and qualifications for personnel;

           (l)    protocol for the safe delivery of cannabis products from therapeutic cannabis pharmacies to cardholders, which must be developed after consulting with a private security expert in good standing;

           (m)  requirements and procedures to maintain sanitary conditions for facilities and equipment;

           (n)   odor mitigation measures to ensure cannabis or cannabis products cannot be smelled outside of the property of a medical cannabis establishment; and

           (o)   requirements for medical cannabis establishments to maintain a discreet, professional appearance that is compatible with existing commercial structures or land uses within the immediate area, including requirements to maintain the medical cannabis establishment in a manner to prevent blight, deterioration, diminishment, or impairment of property values within the vicinity of the medical cannabis establishment;

       (5)   establish procedures for suspending or revoking the licenses of medical cannabis establishments that commit multiple or serious violations of the provisions of this article or the regulations promulgated pursuant to this section;

       (6)   establish labeling requirements for cannabis, cannabis products, and industrial hemp for human consumption, which must require cannabis product labels to include the following:

           (a)   the length of time it typically takes for the product to take effect;

           (b)   the disclosure of ingredients, including an indication of whether the cannabis is Sativa, Indica, or a hybrid, and possible allergens;

           (c)   a nutritional fact panel; and

           (d)   the clear identification of edible cannabis products, if practicable, with a standard symbol indicating that the product contains cannabis;

       (7)   establish requirements and procedures for the safe, appropriate, and accurate packaging and labeling of cannabis products and industrial hemp for human consumption, including prohibiting the use of any images designed or likely to appeal to minors, including cartoons, toys, animals, or children; any other likeness to images, characters, or phrases that are popularly used to advertise to children; or any imitation of candy packaging or labeling;

       (8)   establish requirements to ensure that cannabis products and industrial hemp for human consumption are designed, marketed, and packaged in a manner that is appropriate for a medicinal product and that does not resemble commercially sold candies or other food that is typically marketed to children;

       (9)   establish restrictions on the forms, appearance, and flavor of edible cannabis products and syrups in order to reduce their appeal to minors, including prohibiting edible cannabis products in the shapes of cartoons, toys, animals, or people;

       (10) establish the standards and requirements necessary for an independent testing laboratory to be licensed;

       (11) establish the standards of care and required testing to be carried out by an independent testing laboratory consistent with the guidelines promulgated by the American Herbal Pharmacopoeia;

       (12) establish minimum capital requirements for each type of medical cannabis establishment that reasonably ensure medical cannabis establishment principal applicants have sufficient resources to open and operate a medical cannabis establishment without requiring more than reasonably necessary and allowing for some of the capital requirements to be satisfied by ownership of the real property and for resources to be pooled among multiple medical cannabis establishment principals; and

       (13) establish standards and requirements necessary for the destruction of cannabis, cannabis products, and cannabis waste.

    (B)  The department shall, no less frequently than every two years, reevaluate and at its discretion:

       (1)   determine the appropriate number and geographical density of licenses for cultivation centers, processing facilities, therapeutic cannabis pharmacies, and independent testing laboratories; and

       (2)   evaluate the effectiveness of integrated operators and independent business types at providing patients a variety of product choices at reasonable prices; and

       (3)   evaluate whether caps to market concentration are meeting goals of a competitive marketplace, or whether the limits should be revised.

    (C)  After consulting with public health experts, medical professionals, and analysts who conduct health and safety research on vaporizers; reviewing federal regulations governing electronic nicotine delivery systems; and reviewing other states' regulations on medical cannabis vaporization, the department shall promulgate regulations to foster the health and safety of patients using medical cannabis vaporization products. The regulations may include:

       (1)   mandating that all models of vaporization devices sold by therapeutic cannabis pharmacies be subject to laboratory testing, including stress tests and shelf-life tests;

       (2)   requiring laboratory testing of medical cannabis cartridges that are allowed to be used with vaporization devices, including testing of the aerosolized products;

       (3)   banning all additives, cutting agents, and flavorings that are known to be harmful;

       (4)   creating a list of any non-cannabis ingredients that are permitted to be included in medical cannabis cartridges, which have been identified as safe for inhalation, and specifying the proportion of those ingredients that are allowed in each cartridge;

       (5)   issuing standards for heavy metals included in hardware;

       (6)   developing warning labels that must be included on vaporization devices, detailing any known risks;

       (7)   requiring that any vaporization device is not able to be used with cartridges containing nicotine; and

       (8)   requiring that any disposable "all-in-one" vaporization device is tamper-resistant, non-refillable, and does not contain nicotine.

    (D)  The department may waive some requirements that apply to other medical cannabis establishments in the case of some or all qualifying research facilities.

 

    Section 44-53-2380.  (A)  The department shall establish standards for and shall license up to five independent testing laboratories to test cannabis products that are to be sold in the State. An independent testing laboratory must analyze a representative sample of all cannabis products pursuant before the sale or transfer to a therapeutic cannabis pharmacy and/or a qualifying research facility by a processing facility.

    (B)  An independent testing laboratory must be responsible for selecting, picking up, and testing product samples and must be able to determine accurately:

       (1)   the concentration of tetrahydrocannabinol, cannabidiol, and other cannabinoids, if applicable;

       (2)   whether the testing material is organic or nonorganic;

       (3)   moisture content;

       (4)   allergens;

       (5)   potency;

       (6)   foreign matter, including heavy metals;

       (7)   microbiological screening results;

       (8)   residual solvent testing results;

       (9)   the presence and identification of fungi, including molds;

       (10) the presence and concentration of fertilizers and other nutrients; and

       (11) any other determinations required by the department.

    (C)  An independent testing laboratory shall report the results of all testing required by the department to the department's seed-to-sale tracking system.

    (D)  No principal, manager, employee, or agent of an independent testing laboratory may work for, contract with, receive compensation from, or have an equity interest in any other medical cannabis establishment.

 

    Section 44-53-2390.  (A)  To prevent diversion and protect public safety, the department shall require the use of a single, real-time, seed-to-sale tracking system used by all medical cannabis establishments and by the department that complies with Health Insurance Portability and Accountability Act guidelines, is hosted on a platform that allows for the dynamic allocation of resources, provides data redundancy, and is capable of recovering from natural disasters within hours.

    (B)  The department shall require that the system be capable of:

       (1)   tracking and uniquely identifying each plant, product, package, waste, transfer, conversion, sale, and returns. A unique identifier shall be issued for each cannabis plant, and shall be attached at the base of each plant;

       (2)   tracking plant and package information throughout the entire chain of custody until the point of sale to a cardholder;

       (3)   tracking each product, conversion, and derivative throughout the entire seed-to-sale chain of custody in real-time;

       (4)   tracking plant and product destruction;

       (5)   tracking the transportation of products;

       (6)   performing complete product and package recall tracking capabilities that must be able to clearly identify all of the following details relating to a specific product and package subject to recall:

           (a)   all sold products;

           (b)   products available for sale that are in finished inventory but have not been sold;

           (c)   products that are in the transfer process;

           (d)   work-in-progress products, which are in the process of being converted; and

           (e)   raw material products, which are in the post harvest stage of the process, such as drying, trimming, or curing;

       (7)   reporting and tracking loss, theft, or the diversion of products containing cannabis to the department;

       (8)   reporting and tracking all inventory discrepancies to the department;

       (9)   reporting and tracking all sales and refunds to the department;

       (10) notifying the department in real-time regarding when propagation sources are planted, when plants are harvested and destroyed, and when cannabis products are transported, sold, or destroyed;

       (11) tracking each plant and product using a tagging methodology that optimizes reporting efficiencies for cultivation centers, medical cannabis establishments, and the department;

       (12) receiving testing results electronically from independent testing laboratories via a secure application program interface into the seed-to-sale tracking system and directly attaching the testing results to the source package or sample;

       (13) restricting the altering of test results and allowing for the collection of detailed test results and uploading of a certificate of analysis;

       (14) providing the department with real time access to the database;

       (15) providing real-time analytics to the department regarding key performance indicators including, but not limited to:

           (a)   total daily sales;

           (b)   total plants in production;

           (c)   total plants destroyed; and

           (d)   total inventory adjustments;

       (16) providing the department with the ability to determine the amount of medical cannabis that a registered qualifying patient or registered designated caregiver has purchased that day in real-time by searching a patient registration number; and

       (17) providing other information specified by the department.

    (C)  The department shall require the provider of the seed-to-sale system to:

       (1)   have a current security audit that is no more than twelve months old and that was performed by a third party certified to perform such audits, demonstrating the use of sound security measures and practices by the provider hosting the data or application processing the data, as defined by a nationally recognized security framework;

       (2)   submit an annual update on any open corrective action plans associated with the most recent audit's noted deficiencies;

       (3)   produce a new or updated audit every three years; and

       (4)   have experience implementing and maintaining a seed-to-sale tracking system of a similar size and nature for at least two other state governmental agencies within the last two years without interruptions of service or security breaches, or otherwise demonstrate the ability to implement and maintain such systems.

    (D)  Upon the request of a state or local law enforcement agency, licensing authorities shall allow access to or provide information contained within the database for the seed-to-sale tracking system to assist law enforcement in their duties and responsibilities.

    (E)   Banks and other financial institutions may be allowed access to specific limited information from the seed-to-sale tracking system. The information that may be available to these institutions shall be limited to financial data of individuals and business entities that have a business relationship with these institutions. This information shall be limited to the information needed for banks to comply with applicable federal regulations and shall not disclose any medical or personal information about registered cardholders or designated caregivers.

 

    Section 44-53-2400.  (A)  It is not unlawful for a cultivation center to:

       (1)   possess, plant, propagate, cultivate, grow, harvest, produce, process, manufacture, compound, convert, prepare, pack, repack, transport, or store cannabis;

       (2)   possess, use, or manufacture cannabis paraphernalia;

       (3)   deliver, sell, supply, transfer, or transport cannabis, cannabis paraphernalia, or educational materials to processing facilities; or

       (4)   deliver, transfer, or transport cannabis to independent testing laboratories.

    (B)  It is not unlawful for a processing facility to:

       (1)   obtain, possess, process, manufacture, compound, convert, prepare, pack, repack, transport, or store cannabis or cannabis products;

       (2)   possess, use, or manufacture cannabis paraphernalia;

       (3)   deliver, sell, supply, transfer, or transport cannabis, cannabis products, industrial hemp for human consumption, or educational materials to therapeutic cannabis pharmacies or universities in South Carolina engaged in conducting Institutional Review Board-approved medical cannabis or cannabinoid research; or

       (4)   deliver, transfer, or transport cannabis or cannabis products to independent testing laboratories.

    (C)  It is not unlawful for a therapeutic cannabis pharmacy to obtain, possess, transport, or dispense cannabis products, industrial hemp for human consumption that has passed independent laboratory testing, cannabis paraphernalia, or educational materials to a cardholder in accordance with the requirements of this article or to universities in South Carolina engaged in conducting Institutional Review Board-approved medical cannabis or cannabinoid research.

    (D)  It is not unlawful for an independent testing laboratory to possess or transport cannabis, cannabis products, or cannabis paraphernalia in accordance with the requirements of this article.

    (E)   It is not unlawful for a transporter to possess or transport cannabis, cannabis products, or cannabis paraphernalia in accordance with the requirements of this article.

    (F)   It is not unlawful for a grower of industrial hemp who is permitted pursuant to Chapter 55, Title 46 to sell or transport industrial hemp for human consumption to a therapeutic cannabis pharmacy, provided that the industrial hemp products for human consumption are compliant with all regulations regarding laboratory testing, packaging, and labeling as determined by the department.

    (G)  It is not unlawful for a qualifying research facility, to possess, store, or administer medical cannabis or cannabinoids to human or animal subjects in accordance with any department rules.

    (H)  Industrial hemp operations and individuals who have been issued permits pursuant to Section 46-55-20, relating to the cultivation of industrial hemp, are authorized to provide industrial hemp for human consumption to processing facilities or therapeutic cannabis pharmacies licensed pursuant to this article.

    (I)    A medical cannabis establishment is not subject to prosecution, search, seizure, or penalty in any manner and may not be denied any right or privilege, including civil penalty or disciplinary action by a court, or business-licensing board or entity, for engaging in activities related to cannabis that are not unlawful under South Carolina law pursuant to this article.

    (J)   A medical cannabis establishment principal and medical cannabis establishment agent are not subject to arrest by state or local law enforcement, prosecution, or penalty under state or local law, or the denial of a right or privilege for engaging in activities related to cannabis that are not unlawful under South Carolina law pursuant to this article.

    (K)  Nothing in this article may be construed to prohibit medical cannabis establishments from processing, producing, or selling products for human consumption from industrial hemp.

 

    Section 44-53-2410.  (A)  The department shall issue licenses to the following numbers of qualified medical cannabis establishment applicants:

       (1)   fifteen cultivation center licenses;

       (2)   thirty processing facility licenses;

       (3)   four transporter licenses;

       (4)   one therapeutic cannabis pharmacy license for every twenty pharmacies with a state issued permit in the State;

       (5)   five independent testing laboratory licenses;

       (6)   the number integrated operator licenses recommended by the commission as being sufficient to enable the department to analyze, assess, and compare the various business models in the written reports required by Section 44-53-2380(B) and SECTION 12; and

       (7)   any number of qualifying research facilities that meet requirements established by the department.

The department shall, pursuant to the regulations promulgated in Section 44-53-2380(B)(2)(a) and (b), issue these licenses in a manner that promotes a variety of business models including, but not limited to, applicants that intend to operate only a single business and integrated operator applicants that intend to operate a cultivation center, processing facility, and one or more therapeutic cannabis pharmacies, and that enables the department to analyze, assess, and compare the various business models in the written reports required by Section 44-53-2380(B) and SECTION 12.

    (B)  In order to be licensed as a medical cannabis establishment, a medical cannabis establishment principal applicant shall submit to the department a completed electronic application signed by each medical cannabis establishment principal that, at a minimum, includes the following:

       (1)   a nonrefundable application fee to be determined by the department pursuant to Section 44-53-2530;

       (2)   proof that the applicant has sufficient liquid and non-liquid assets to open and operate the medical cannabis establishment, as determined by the department through regulation;

       (3)   on renewal, a financial statement reviewed by a licensed certified public accountant or a licensed public accountant in accordance with generally accepted accounting principles, including all disclosures required by generally accepted accounting principles;

       (4)   the legal name of the proposed medical cannabis establishment;

       (5)   the physical address of the proposed medical cannabis establishment, which:

           (a)   except in the case of a qualifying research facility located in a college or university, shall not be within one thousand feet of a public or private school existing before the date the medical cannabis establishment application is received by the department, except as provided in Section 44-53-2450(B);

           (b)   if a therapeutic cannabis pharmacy applicant, shall be located in an area zoned for commercial use; and

           (c)   if a processing facility or cultivation center applicant, shall be located in an area zoned for manufacturing or agricultural use;

       (6)   a sworn statement certifying that the proposed medical cannabis establishment is in compliance with local governmental zoning restrictions, if applicable;

       (7)   a copy of any local registration, license, or permit required by local government for the proposed medical cannabis establishment;

       (8)   the name, date of birth, and contact information for each principal of the proposed medical cannabis establishment, with a copy of a SLED and an FBI criminal records check for each principal, paid for by the principal;

       (9)   operating procedures for the proposed medical cannabis establishment to ensure accurate recordkeeping and adequate security measures;

       (10) a security plan that meets all requirements promulgated by the department, which, in connection therewith, shall consult with and receive input from a private security expert in good standing;

       (11) for a cultivation center applicant, documentation demonstrating that the applicant has appropriate expertise in agriculture and is qualified to process cannabis to sell, deliver, transport, or distribute solely for use pursuant to this article;

       (12) for a processing facility applicant, documentation demonstrating that the applicant is qualified to process medical cannabis into cannabis products, utilizing industry standards for the safe handling of food products and consistency in production;

       (13) for an independent testing laboratory applicant, documentation demonstrating that the applicant meets the standards and requirements for accreditation, inspection, and testing established through regulation by the department;

       (14) a medical cannabis establishment applicant's plan to hire employees from within the community in which it will be operating; and

       (15) for a medical cannabis establishment applicant who is applying for more than one license, a notation on the application regarding the additional licenses for which the applicant has applied.

    (C)(1)  Except as provided in items (2) and (3) and in the case of a qualifying research facility, if a licensee is not operable within twelve months of the issuance of a license, then the license is void, and the department shall within thirty days issue a license to the most qualified applicant in accordance with this article.

       (2)   A licensee may request and shall be granted one or more three month extensions of the deadline if it is able to show a cause of delay that was out of the licensee's control, despite exhibiting concerted efforts to begin operation in time to meet the deadline.

       (3)   A licensee shall not be considered "not operational" for the purposes of this subsection if it is a processing facility or therapeutic cannabis pharmacy and is not operational solely because sufficient cultivation facilities have not begun harvesting and distributing cannabis to supply it with cannabis.

    (D)  No license issued to a medical cannabis establishment is transferable until the expiration of thirty-six months from the date of issuance by the department, and until at least twenty-four months have passed since the medical establishment began operations. The license shall not be transferrable to any person who has been convicted of, or pled guilty or nolo contendere to, a felony drug-related offense. Qualifying research facility licenses are not transferrable.

    (E)   If a smaller number of qualified applicants applies for any type of medical cannabis establishment license than the department is required to issue, then the department shall issue licenses to all qualified applicants for that type of license.

    (F)   Prior to operating, a medical cannabis establishment shall pay a nonrefundable license fee in an amount determined by the department pursuant to Section 44-53-2530. If a license renewal application is not submitted by the license expiration date, the license may be renewed within 90 days after its expiration date upon application, payment of the annual license fee, and satisfaction of any renewal requirement. The licensee may continue to operate during the 90 days after the license expiration date.

    (G)  The department shall issue a renewal license within thirty days of receiving, prior to the expiration of the license, a completed electronic license renewal application signed by each medical cannabis establishment principal and the renewal fee from a medical cannabis establishment if the license is not under suspension or has not been revoked.

    (H)  Medical cannabis establishments must notify the department of any changes in medical cannabis establishment principals and must include their name, date of birth, contact information, a copy of a SLED and an FBI criminal records check, and any other information required by department regulations.

    (I)    The department shall deny, suspend, or revoke a medical cannabis establishment license if any medical cannabis establishment principal applicant or medical cannabis establishment principal has been convicted of, or pled guilty or nolo contendere to, a felony drug-related offense.

    (J)   In addition to any requirements established by the department, in order to be eligible for a therapeutic cannabis pharmacy license, the applicant must possess a therapeutic cannabis pharmacy permit issued by the Board of Pharmacy pursuant to Section 44-53-2070 and Section 44-53-2080.

 

    Section 44-53-2420.  (A)  Except in the case of qualifying research facilities, prior to any medical cannabis establishment agent beginning work at a medical cannabis establishment, the medical cannabis establishment principal shall request a license from the department for each agent and principal.  The request must be accompanied by a complete set of fingerprints for a state criminal records check and a national criminal records check for which the applicant or establishment must pay the costs.

    (B)  Each applicant to become a medical cannabis establishment agent or principal must undergo a state criminal record check, supported by fingerprints, by the State Law Enforcement Division (SLED), and a national criminal record check, supported by fingerprints, by the Federal Bureau of Investigation (FBI). The results of these criminal record checks must be reported to the department and cannot be further disseminated.  SLED and the FBI are authorized to provide the department with current and future information regarding that individual including arrest, convictions, dispositions, warrants, and other information available to the FBI, including civil and criminal information.  The department shall keep all information pursuant to this section privileged, in accordance with applicable state and federal guidelines.

    (C)  The department shall issue identification cards to a medical cannabis establishment agent or principal and allow them to work for the medical cannabis establishment if:

       (1)   the person is twenty-one years of age or older;

       (2)   the person has not been convicted of, or pled guilty or nolo contendere to, a felony drug related offense, or if the person completed the sentence, including any term of probation or supervised release, at least ten years prior;

       (3)   the person is not included in the list of individuals who are not allowed to serve as medical cannabis establishment agents or principals; and

       (4)   the person has completed, or indicated in writing that he will complete within ninety days of being hired, an educational requirement approved by the department.

    (D)  Each medical cannabis establishment shall retain all records documenting compliance with this article with regard to medical cannabis establishment agents and medical cannabis establishment principals for at least five years after the end of their employment.

    (E)   The department may require qualifying research facility staff who handle medical cannabis to register with the department, undergo a criminal records check, and/or receive a badge.

 

    Section 44-53-2430.  (A)  The department is responsible for performing inspections of medical cannabis establishments and investigating suspected violations of this article and of department regulations and is primarily responsible for other duties with respect to regulating cannabis and cannabis products for medical use, as are specifically delegated to the department by the General Assembly.

    (B)  A medical cannabis establishment is subject to inspection by the department.

    (C)  During an inspection, the department may review the medical cannabis establishment's records required pursuant to this article and department regulations. Medical cannabis establishment records must track qualifying patient specific and designated caregiver specific information, if applicable, by registry identification card number to protect confidentiality.

    (D)  The department may contract with state occupational or professional licensing entities and the law enforcement division of other state agencies to enforce the provisions of this article with respect to inspections and audits that apply to cultivation centers, processing facilities, therapeutic cannabis pharmacies, transporters, and independent testing laboratories.

    (E)   Authorized employees of state or local law enforcement agencies shall immediately notify the department if any person in possession of a registry identification card has been determined by a court of law to have willfully violated the provisions of this article or has pled guilty to an offense.

    (F)   A therapeutic cannabis pharmacy is also subject to inspections by the Board of Pharmacy.

 

    Section 44-53-2440.  (A)  Except as provided in this section, a medical cannabis establishment may not be located within one thousand feet of a school. This distance must be computed by following the shortest route of ordinary pedestrian or vehicular travel along the public thoroughfare from the nearest point of the grounds of the school.

    (B)  The department has the discretion to allow an exception to the prohibition in subsection (A) if it is shown by the applicant that the exception is necessary to provide adequate access to patients. The department may require as part of granting an exception that the medical cannabis establishment undertake additional security or other restrictions to protect children as determined by the department.

    (C)  This restriction does not apply to a qualifying research facility located in a college or university, unless otherwise provided by department regulation.

 

    Section 44-53-2450.  (A)  A local government may enact ordinances or regulations not in conflict with this article or with regulations enacted pursuant to this article, governing the time, place, manner, and number of medical cannabis establishment operations in the locality. A local government may establish penalties for the violation of an ordinance or regulation governing the time, place, and manner of a medical cannabis establishment that may operate in the locality.

    (B)  A local government may prohibit medical cannabis establishments from operating in the jurisdiction. 

    (C)  The burden for compliance with zoning or land use regulations and the requirements for seeking a variance should be no greater for a cannabis related business than for any other similar business.

 

    Section 44-53-2460.  (A)  Medical cannabis establishments shall employ a former or retired law enforcement officer in good standing, former or retired military personnel, or a security service agency with the ability to provide security to deter and prevent the theft of cannabis and cannabis products and unauthorized entrance into areas containing cannabis or cannabis products. The department shall consult with SLED to promulgate regulations regarding the qualifications for former or retired law enforcement officers in good standing, including requirements that the officer must have experience in securing and protecting controlled substances or similar products.

    (B)  All cultivation centers and processing facilities must conduct cultivation, harvesting, processing, and packaging of cannabis and cannabis products in a secure facility at a physical address provided to the department and SLED during their license application process. A processing facility or cultivation center may only be accessed by medical cannabis establishment agents, medical cannabis establishment principals, authorized department personnel, law enforcement personnel, emergency personnel, and adults who are twenty-one years of age and older who are accompanied by medical cannabis establishment agents or principals.

    (C)  All medical cannabis establishments are subject to random inspection by the department and SLED in accordance with regulations promulgated by the department, which shall be developed by the department after consulting with and receiving input from SLED.

 

    Section 44-53-2470.  (A)  The department shall require each cultivation center and processing facility to conduct routine testing, at a minimum, of cannabis and cannabis products at an independent testing facility in accordance with department regulations.

    (B)  A cultivation center shall test each strain's cannabinoid profile at least once per harvest.

    (C)  A processing facility shall test each extraction batch and each batch of ingestible products manufactured.

 

    Section 44-53-2480.  (A)  All cultivation center cannabis by product, cannabis scrap, and harvested cannabis not intended for distribution to a processing facility or independent testing laboratory must be destroyed and disposed of in accordance with department regulations. Documentation of destruction and disposal must be retained by the cultivation center for a period of not less than one year. The cultivation center shall maintain a record of the date of destruction and the amount destroyed.

    (B)  A therapeutic cannabis pharmacy shall destroy all cannabis products that are not sold to qualifying patients or designated caregivers in accordance with department regulations or transported to a qualified research facility or another therapeutic cannabis pharmacy. The therapeutic cannabis pharmacy shall retain documentation of the destruction and disposal for a period of not less than one year. The therapeutic cannabis pharmacy shall maintain a record of the date of destruction and the amount destroyed.

    (C)  A therapeutic cannabis pharmacy shall destroy all unused cannabis products that are returned to the therapeutic cannabis pharmacy by a former qualifying patient who no longer qualifies for the use of medical cannabis or his caregiver.

 

    Section 44-53-2490.  (A)  Each therapeutic cannabis pharmacy must employ a pharmacist-in-charge who is licensed by the State as a pharmacist and who completed a medical cannabis continuing education course approved by the South Carolina Board of Pharmacy as provided by Section 44-53-2070(4)(a). A pharmacist must be reasonably available during business hours to advise and educate patients in person and, in connection with providing such advice and education, shall be subject to being sued by a patient for negligence in the event that the pharmacist violates the applicable standard of care. A pharmacist must be physically on premises during dispensing hours.

    (B)  Each pharmacist and other therapeutic cannabis pharmacy staffer authorized by the Board of Pharmacy who dispenses cannabis products to qualifying patients must complete a medical cannabis continuing education course approved by the South Carolina Board of Pharmacy prior to dispensing cannabis products. The continuing education course must include best practices regarding dosage, based upon medical conditions or symptoms, modes of administration, side effects, therapeutic contraindications, potential interactions, and cannabinoid profiles.

    (C)(1)  All cannabis products and industrial hemp for human consumption sold at a therapeutic cannabis pharmacy must be properly labeled and contained in child resistant packaging. Each label must comply with state laws and regulations and, at a minimum, must include:

           (a)   the name of the therapeutic cannabis pharmacy;

           (b)   the percentage of tetrahydrocannabinol and the percentage of cannabidiol within a profile tolerance range of ten percent. For edible cannabis products, the cannabinoid profile should be listed by milligrams per serving;

           (c)   the name of the cultivation center and processing facility; and

           (d)   a conspicuous statement printed in all capital letters and in a color that provides a clear contrast to the background that reads, "NOT FOR RESALE. FOR MEDICAL USE ONLY. KEEP OUT OF THE REACH OF CHILDREN AND ANIMALS".

       (2)   Labels shall indicate whether the cannabis is Sativa, Indica, or hybrid and may include cannabinoid and terpene profiles for identification.

       (3)   All cannabis products purchased in therapeutic cannabis pharmacies should be placed in child resistant exit packaging before leaving the therapeutic cannabis pharmacy.

    (D)  A therapeutic cannabis pharmacy shall not allow a person under the age of eighteen to enter a therapeutic cannabis pharmacy unless the minor is accompanied by his parent, legal guardian, or designated caregiver.

 

    Section 44-53-2500.  (A)  After consulting with medical professionals who are knowledgeable about the risks and benefits of cannabis and cannabis products, the department shall develop a scientifically accurate safety information flyer, which shall be provided to each person applying for a registry identification card. The flyer must be offered at every therapeutic cannabis pharmacy when a cannabis product is dispensed. It must include:

       (1)   advice about the potential risks of the use of cannabis products, including:

           (a)   the variability of quality and concentration of cannabis products;

           (b)   the risk of cannabis and cannabis product use disorder and resources to reach out to for help;

           (c)   any potential exacerbation of psychotic disorders and any adverse cognitive effects for children and young adults;

           (d)   potential adverse events and other risks, including falls or fractures;

           (e)   the risks of using cannabis products during pregnancy or breast feeding; and

           (f)   the need to safeguard all cannabis and cannabis products from children and pets or other domestic animals;

       (2)   a notification that cannabis products are for a qualifying patient's use only and that cannabis products should not be donated or otherwise supplied to another individual;

       (3)   a warning that qualifying patients should not drive or operate heavy machinery while under the influence of medical cannabis; and

       (4)   unless federal statutory law or case law has changed and such a warning is no longer accurate, a disclosure that under the United States government's 1986 Gun Control Act, any "unlawful" user of a controlled substance is prohibited from purchasing or owning a gun, that federally licensed gun dealers must ask prospective customers about drug use habits before approving a purchase, and that because cannabis is a Schedule I substance under federal law, the United States government maintains that there is no way to use cannabis products lawfully.

    (B)  The department shall make the information identified in subsection (A) available online with a link to the information conspicuously located on the department's website.

 

    Section 44-53-2510.  (A)  The department may deny, suspend, or revoke the license of a medical cannabis establishment as a result of a violation of this article or department regulations.

    (B)  The department may require medical cannabis establishments to ban an individual from serving as a medical cannabis establishment agent or principal at any medical cannabis establishment for a violation of this article or department regulations. The department may maintain and disseminate to each medical cannabis establishment a list of individuals who are prohibited from serving as a medical cannabis establishment agent or principal.

    (C)  The department shall create a tiered structure for the identification, investigation, and resolution of potential violations of this article and department regulations.

    (D)  Medical cannabis establishments must be granted a reasonable resolution period established by the department to implement corrective actions acceptable to the department.

    (E)   The department shall create a progressive penalty structure for violations of this article and department regulations.

    (F)   The department is authorized to impose monetary penalties on a medical cannabis establishment for violations of this article.

    (G)  If a medical cannabis establishment's license is denied, suspended, or revoked, then the medical cannabis establishment may request a hearing in the Administrative Law Court, and is not subject to the requirements set forth in Section 44-1-60, within thirty days of the receipt of written notification of the denial, suspension, or revocation.

 

    Section 44-53-2520.  (A)  The department shall establish registry identification application and renewal fees and medical cannabis establishment application, licensing, and renewal fees provided:

       (1)   the fees may not be established in an amount that is anticipated to generate more revenue than the department determines is reasonably necessary to administer the program;

       (2)   the registry identification application and renewal fees charged to qualifying patients and designated caregivers must be no greater than the costs of processing the applications and issuing registry identification cards;

       (3)   the department shall provide discounts for qualifying patient application and renewal fees based upon a qualifying patient's household income and shall waive all applicable fees for veterans; and

       (4)   the department shall establish and charge an inspection fee in an amount to be determined by the department to cover the expense to the department for conducting an inspection.

    (B)  The Board of Pharmacy shall establish application, permit, and renewal fees for therapeutic cannabis pharmacies. The fees may not be established in an amount that exceeds what the Board of Pharmacy determines is reasonably necessary to administer the program.

    (C)  The department shall establish a South Carolina Medical Cannabis Program Fund to ensure the availability of funds necessary to carry out the department's responsibilities under this article. All monies the department collects pursuant to this article must be deposited into the fund. The fund must be used solely for the direct costs of implementation, administration, and enforcement of this article.

    (D)  Notwithstanding any other provision of law, the department and Board of Pharmacy shall periodically adjust fees charged pursuant to this article to ensure there is no surplus and to avoid generating more revenue than is necessary to administer the program.

 

    Section 44-53-2530.  (A)  The department may develop, seek any necessary federal approval for, and carry out research programs relating to the medical use of cannabis. Participation in any research program must be voluntary on the part of a qualifying patient, designated caregiver, or physician.

    (B)  The department shall collect data on the efficacy and safety of cannabis products from qualifying patients who voluntarily provide this information. The department may require therapeutic cannabis pharmacies to collect that information from qualifying patients who voluntarily provide it.

    (C)  Physicians who issue written certifications may, but are not required to, participate in data collection.

 

    Section 44-53-2540.  (A)  The department shall provide a report to the General Assembly by the second Tuesday of each year addressing the effectiveness of the medical cannabis program operated pursuant to this article and recommendations for any changes to the program.

    (B)  The report must, without disclosing any identifying information about cardholders, physicians, qualifying patients, designated caregivers, or medical cannabis establishments, contain the following, at a minimum:

       (1)   the number of registry identification card applications submitted, approved, and renewed;

       (2)   the number of qualifying patients and designated caregivers served by each medical cannabis establishment during the report year;

       (3)   the nature of the debilitating medical conditions of the qualifying patients by percentage, and a breakdown of qualifying patients by the following age groups:

           (a)   0 to 10 years of age;

           (b)   11 to 17 years of age;

           (c)   18 to 23 years of age;

           (d)   24 to 35 years of age;

           (e)   36 to 49 years of age;

           (f)   50 to 65 years of age;

           (g)   over 65 years of age.

    Within each age group, the report must provide a breakdown, by percentage, of debilitating medical conditions of the qualifying patients;

       (4)   the efficacy of, and side effects reported to, or satisfaction or dissatisfaction with cannabis products on a yes-no questionnaire as submitted by qualifying patients in a voluntary, anonymous survey, which may be conducted online by the department;

       (5)   the number of registry identification cards denied, suspended, or revoked;

       (6)   the number of physicians providing written certifications for qualifying patients and a breakdown of how many physicians wrote certifications in the following numbers:

           (a)   1 to 100;

           (b)   101 to 249;

           (c)   250 to 500;

           (d)   501 to 750;

           (e)   751 to 1,000; and

           (f)   over 1000;

       (7)   the number and type of medical cannabis establishments by county;

       (8)   the percentage of all physicians providing written certifications who accounted for eighty percent of the total annual prescriptions written;

       (9)   the total revenue of the South Carolina Medical Cannabis Program fund and the total expenses of the department in administering the program; and

       (10) a year-by-year chart showing the total number of annual certifications, the total number of registry identification cards issued, and the total number of fourteen-day supply purchases made.

    (C)  After four years, the department shall evaluate the efficacy of cannabis as medicine and make a recommendation with regard to the rescheduling of cannabis on a lower schedule in the State of South Carolina.

 

    Section 44-53-2550.  The department shall require annually from a medical cannabis establishment proof of liability coverage of no less than one million dollars.

 

    Section 44-53-2560.  Members of the General Assembly and immediate family members, as defined in Section 8-13-100(18), may not operate, directly or indirectly, receive financial payments of any kind from, or directly own a medical cannabis establishment until July 1, 2029, and are prohibited from being a medical cannabis establishment agent or a medical cannabis establishment principal. This exclusion does not apply to members and their immediate family members if the member recused himself from voting on this act.

 

SECTION 5.  Article 31, Chapter 5, Title 56 of the S.C. Code is amended by adding:

 

    Section 56-5-3910. (A)  It is unlawful for a driver of a motor vehicle to vaporize cannabis products as defined in Section 44-53-2010 while operating the motor vehicle.

    (B)  A person who violates this provision is guilty of a misdemeanor and, upon conviction, must be fined not more than one hundred dollars or imprisoned for not more than thirty days.

 

SECTION 6.  A. Sections 44-53-1810 through 44-53-1830 of the S.C. Code are amended to read:

 

    Section 44-53-1810.  As used in this article:

    (1) "Academic medical center" means a research hospital that operates a medical residency program for physicians and conducts research that involves human subjects, and other hospital research programs conducting research as a subrecipient with the academic medical center as the prime awardee. A South Carolina research university shall be considered an "academic medical center" for the purpose of this article.

    (2) "Approved source" means:

       (a) a provider approved by the United States Food and Drug Administration which produces cannabidiol cannabis that: has been manufactured and tested in a facility approved or certified by the United States Food and Drug Administration; or

       (b) a medical cannabis establishment licensed by the South Carolina Department of Health and Environmental Control pursuant to the South Carolina Compassionate Care Act.

       (a) has been manufactured and tested in a facility approved or certified by the United States Food and Drug Administration or similar national regulatory agency in another country which has been approved by the United States Food and Drug Administration;  and

       (b) has been tested in animals to demonstrate preliminary effectiveness and to ensure that it is safe to administer to humans.

    (3)(a) "Cannabidiol" means a finished preparation containing, of its total cannabinoid content, at least 98 percent cannabidiol and not more than 0.90 percent tetrahydrocannabinol by volume that has been extracted from marijuana or synthesized in a laboratory. "Cannabis" means:

           (i) all parts of any plant of the cannabis genus of plants, whether growing or not;

           (ii) the seeds of the plant;

           (iii) the resin extracted from any part of the plant; and

           (iv) every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or resin.

       (b) "Cannabis" does not mean:

           (i) the mature stalks of the plant;

           (ii) fiber produced from the stalks;

           (iii) oil or cake made from the seeds of the plant; or

           (iv) a product approved as a prescription medication by the United States Food and Drug Administration.

    (4) "Designated caregiver" means a person who provides informal or formal care to a qualifying patient, with or without compensation, on a temporary or permanent or full-time or part-time basis and includes a relative, household member, day care personnel, and personnel of a public or private institution or facility. "Debilitating medical condition" means a diagnosis of one or more of the following that also results in a debilitating condition:

       (a) cancer;

       (b) multiple sclerosis;

       (c) a neurological disease or disorder, including epilepsy;

       (d) glaucoma;

       (e) post-traumatic stress disorder;

       (f) Crohn's disease;

       (g) sickle cell anemia;

       (h) ulcerative colitis;

       (i) cachexia or wasting syndrome;

       (j) autism;

       (k) severe or persistent nausea in a person who is not pregnant, that is related to end-of-life or hospice care, or who is bedridden or homebound because of a condition;

       (l) a chronic medical condition causing severe and persistent muscle spasms;

       (m) a chronic medical condition causing severe and persistent pain; or

       (n) a terminal illness with a life expectancy of less than one year in the opinion of the person's treating physician.

    (5) "Pharmacist" means an individual health care provider licensed by this State to engage in the practice of pharmacy.

    (6)(5) "Physician" means a doctor of medicine or doctor of osteopathic medicine licensed by the South Carolina Board of Medical Examiners.

    (7)(6) "Qualifying patient" means anyone who suffers from Lennox-Gastaut Syndrome, Dravet Syndrome, also known as severe myoclonic epilepsy of infancy, or any other form of refractory epilepsy that is not adequately treated by traditional medical therapies a person with a debilitating medical condition.

 

    Section 44-53-1820.  (A) A statewide investigational new drug application may be established in this State, if approved by the United States Food and Drug Administration to conduct expanded access clinical trials using cannabidiol cannabis on qualifying patients with severe forms of epilepsy pursuant to an investigational drug application (IND).

    (B) Any physician who is board certified and practicing in an academic medical center in this State and treating patients with severe forms of epilepsy one or more debilitating conditions may serve as the principal investigator for such clinical trials if such physician:

       (1) applies to and is approved by the United States Food and Drug Administration as the principal investigator in a statewide investigational new drug application; and

       (2) receives a license from the United States Drug Enforcement Administration.

    (C) Such physician, acting as principal investigator, may include subinvestigators who are also board certified and who practice in an academic medical center in this State and treat patients with severe forms of debilitating medical conditions.of epilepsy. Such subinvestigators shall comply with subsection (B)(2) of this section.

    (D) The principal investigator and all subinvestigators shall adhere to the rules and regulations established by the relevant institutional review board for each participating academic medical center and by the United States Food and Drug Administration, the United States Drug Enforcement Administration, and the National Institute on Drug Abuse.

    (E) Nothing in this article prohibits a physician licensed in South Carolina from applying for Investigational New Drug authorization from the United States Food and Drug Administration.

 

    Section 44-53-1830.  (A) Expanded access clinical trials conducted pursuant to a statewide investigational new drug application established pursuant to this chapter only shall utilize cannabidiol  cannabis which is:

       (1) from an approved source;  and

       (2) approved by the United States Food and Drug Administration to be used for treatment of a condition specified in an investigational new drug application.

    (B) The principal investigator and any subinvestigator may receive cannabidiol  cannabis directly from an approved source or authorized distributor for an approved source for use in the expanded access clinical trials.

    (C) A qualifying research facility registered by the South Carolina Department of Health and Environmental Control may receive and possess cannabis and cannabis products for research purposes.

     

 

B.     Article 18, Chapter 33, Title 44 is renamed "Julian's Law: Investigational New Drug Applications: Expanded Access Cannabis Clinical Trials".

 

SECTION 7.  Article 4, Chapter 53, Title 44 of the S.C. Code is repealed.

 

SECTION 8.  (A)  After the effective date of this act, the South Carolina Department of Health and Environmental Control shall:

       (1)   create a commission pursuant to Section 44-53-2370, as added by this act, within thirty days;

       (2)   develop a written certification form pursuant to Section 44-53-2050, as added by this act, no later than 45 days after the effective date of this act;

       (3)   promulgate regulations pursuant to Section 44-53-2080(A), as added by this act, after no later than one year after the effective date of this act;

       (4)   engage a company to create the necessary software for an electronic patient registry pursuant to Section 44-53-2090(A), as added by this act, after no later than one hundred twenty days;

       (5)   develop a safety information flyer pursuant to Section 44-53-2510, as added by this act, after no later than ten days after the effective date of regulations promulgated pursuant to Section 44-53-2090(A);

       (6)   establish a secure web-based verification system pursuant to Section 44-53-2400, as added by this act, within one year;

       (7)   promulgate regulations pursuant to Section 44-53-2530, as added by this act, after no later than one year;

       (8)   begin accepting applications for licensure pursuant to Section 44-53-2420, as added by this act, no later than thirty days after the effective date of regulations promulgated pursuant to Section 44-53-2380; and

       (9)   evaluate all complete and timely submitted applications and issue licenses pursuant to Section 44-53-2420 for no later than six months after the effective date of regulations being promulgated.

    (B)  If the South Carolina Department of Health and Environmental Control fails to promulgate regulations to implement this act within two years of the effective date of this act, then a qualifying patient may commence an action in the South Carolina Administrative Law Court to compel the South Carolina Department of Health and Environmental Control to perform the actions mandated by the provisions of this act.

    (C)  No later than thirty days after the effective date of this act, the South Carolina Board of Medical Examiners shall approve a three-hour continuing medical education course on cannabis products, pursuant to Section 44-53-2060(A)(5)(a), as added by this act.

    (D)  After the effective date of this act, the South Carolina Board of Pharmacy shall:

       (1)   promulgate regulations pursuant to Section 44-53-2080, as added by this act, after no later than one year;

       (2)   begin accepting applications for therapeutic cannabis pharmacies pursuant to Section 44-53-2070, as added by this act, no later than thirty days after the effective date of regulations promulgated pursuant to Section 44-53-2080; and

       (3)   evaluate all complete and timely submitted applications and issue therapeutic cannabis permits no later than six months after the effective date of regulations being promulgated.

 

SECTION 9.  SECTIONS 1 through 8 shall be repealed by operation of law if a federal court, pursuant to a filing by the United States of America or one of its authorized executive agencies, issues a final order declaring that those SECTIONS have been preempted by the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, more commonly known as the "Controlled Substances Act.

 

SECTION 10. This act shall be repealed eight years after first sales of medical cannabis from a therapeutic cannabis pharmacy to a qualifying patient. No later than 18 months prior to this repeal, the department shall survey all qualifying patients and designated caregivers enrolled in the program, certifying practitioners, medical cannabis establishments, and other stakeholders and invite public comment on whether the program should be re-enacted and if any changes should be made. No later than one year prior to this repeal, the department shall issue a written report to the South Carolina General Assembly that includes, but is not limited, to information compiled from previous annual reports, and that includes:

    (1) results from a survey and public comment;

    (2) the status of medical cannabis in other states, federally, and in other nations;

    (3) the department's findings on the appropriate number and geographical density of licenses for cultivation centers, processing facilities, therapeutic cannabis pharmacies, and independent testing laboratories;

    (4) the department's findings on the effectiveness of integrated operators and independent business types at providing patients a variety of product choices at reasonable prices;

    (5) any information submitted to the department by the Medical Cannabis Advisory Board;

    (6) a copy of each annual report provided to the South Carolina General Assembly which addresses the effectiveness of the medical cannabis program pursuant to Section 44-53-2550(A);

    (7) any recommendation for changes to the program provided to the General Assembly as part of the annual report pursuant to Section 44-53-2550 (A);

    (8) all data collected regarding the safety and efficacy of cannabis products pursuant to Section 44-53-2540 (B);

    (9) any research studies conducted pursuant to Section 44-53-2540(A);

    (10) the recommendation with regard to the scheduling of cannabis in the State of South Carolina pursuant to Section 44-53-2550(C);

    (11) an analysis of the effectiveness of the contracted seed-to-sale system;

    (12) the total annual sales made through licensed therapeutic cannabis pharmacies;

    (13) the total number of South Carolina residents employed within the South Carolina medical cannabis industry;

    (14) a list of the municipalities which have chosen to opt out of allowing medical cannabis establishments from operating within their jurisdiction;

    (15) information regarding and recalls which must include the medical cannabis establishment, the type and number of products recalled for each recall issued, and the number of patients who were sold recalled products;

    (16) a document which provides a description of the violation of department regulations, if any, including the penalties, fines, suspensions and/or revocation of licenses;

    (17) the number of violations by practitioners, if any; and

    (18) any other information that the department considers to be material to an assessment by the General Assembly on whether to renew this act.

 

SECTION 11. The repeal or amendment by this act of any law, whether temporary or permanent or civil or criminal, does not affect pending actions, rights, duties, or liabilities founded thereon, or alter, discharge, release or extinguish any penalty, forfeiture, or liability incurred under the repealed or amended law, unless the repealed or amended provision shall so expressly provide.  After the effective date of this act, all laws repealed or amended by this act must be taken and treated as remaining in full force and effect for the purpose of sustaining any pending or vested right, civil action, special proceeding, criminal prosecution, or appeal existing as of the effective date of this act, and for the enforcement of rights, duties, penalties, forfeitures, and liabilities as they stood under the repealed or amended laws.

 

SECTION 12. If any section, subsection, paragraph, subparagraph, sentence, clause, phrase, or word of this act is for any reason held to be unconstitutional or invalid, such holding shall not affect the constitutionality or validity of the remaining portions of this act, the General Assembly hereby declaring that it would have passed this act, and each and every section, subsection, paragraph, subparagraph, sentence, clause, phrase, and word thereof, irrespective of the fact that any one or more other sections, subsections, paragraphs, subparagraphs, sentences, clauses, phrases, or words hereof may be declared to be unconstitutional, invalid, or otherwise ineffective.

 

SECTION 13. This act takes effect upon approval by the Governor.

----XX----