Senators CASH proposed the following amendment (150R094.SP.RJC):

Amend the bill, as and if amended, adding and appropriately numbered new SECTION to read:

/SECTION __. Sections 44-53-1810, 44-53-1820, and 44-53-1830 of the 1976 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 provider approved by the United States Food and Drug Administration which produces cannabidiol cannabis that:

(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;

(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) '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 debilitated 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)'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 a person with a debilitating medical condition 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.

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 cannabis cannabidiol on qualifying patients pursuant to an investigational new drug application (IND) with severe forms of epilepsy.

(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 medical 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 debilitating medical conditions severe forms 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." /