Reference is to the bill as introduced.
Amend the bill, as and if amended, by striking all after the enacting words and inserting:
/ SECTION 1. Paragraph 27 of Section 44-53-110 of the 1976 Code is amended to read:
"'Marijuana' means:
(1) all species or
variety of the marijuana plant and all parts thereof whether
growing or not;
(2) the seeds of the
marijuana plant;
(3) the resin extracted
from any part of the marijuana plant;
(4) every compound,
manufacture, salt, derivative, mixture, or preparation of the
marijuana plant, marijuana seeds, or marijuana resin.
'Marijuana' does not mean:
(1) the mature stalks
of the marijuana plant or fibers produced from these stalks;
(2) oil or cake made
from the seeds of the marijuana plant;
(3) any other compound,
manufacture, salt, derivatives, mixture, or preparation of the
mature stalks (except the resin extracted therefrom);
(4) the sterilized seed
of the marijuana plant which is incapable of
germination;
(5) for
persons participating in a clinical trial or in an expanded
access program related to administering cannabidiol for the
treatment of severe forms of epilepsy pursuant to Article 18,
Chapter 53, Title 44, a drug or substance approved for the use
of those participants by the federal Food and Drug
Administration."
SECTION 2. Chapter 53, Title 44 of the 1976 Code is amended by adding:
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.
(2) 'Approved source'
means a provider approved by the federal Food and Drug
Administration which produces cannabidiol that:
(a)
has been manufactured and tested in a facility approved or
certified by the federal Food and Drug Administration or similar
national regulatory agency in another country, which has been
approved by the federal 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) 'Cannabidiol' means
a finished preparation containing, of its total cannabinoid
content, at least ninety-eight percent cannabidiol and no more
than three-tenths of one percent tetrahydrocannabinol that has
been extracted from marijuana or synthesized in a
laboratory.
(4) 'Physician' means a
doctor of medicine or doctor of osteopathic medicine licensed by
the South Carolina Board of Medical Examiners.
(5) '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.
Section 44-53-1820. (A)
A statewide investigational new drug
application may be established in this State, if approved by the
federal Food and Drug Administration, to conduct expanded access
clinical trials using cannabidiol on qualifying patients 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 may serve as the principal investigator for the
clinical trials if the physician:
(1)
Applies to and is approved by the federal Food and Drug
Administration as the
principal investigator in a statewide investigational new drug
application; and
(2)
receives a license from the federal Drug Enforcement
Administration.
(C) a 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
epilepsy. Subinvestigators also shall comply with subsection
(B)(2).
(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
federal Food and Drug Administration, federal Drug Enforcement
Administration, and the National Institute on Drug Abuse.
Section 44-53-1830. (A)
Expanded access clinical trials conducted
pursuant to a statewide investigational new drug application
established pursuant to this article only shall utilize
cannabidiol that is:
(1)
from an approved source; and
(2)
approved by the federal 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
directly from an approved source or authorized distributor for
an approved source for use in the
expanded access clinical trials.
Section 44-53-1840. (A)
A person acting in compliance with the
provisions of this article must not be subject to arrest,
prosecution, or any civil or administrative penalty, including a
civil penalty or disciplinary action by a professional licensing
board, or be denied any right or privilege, for the use,
prescription, administration, possession, manufacture, or
distribution of medical cannabis.
(B) The State must
defend a state employee against a federal claim or suit that
arises or by virtue of their good faith performance of official
duties pursuant to this article."
SECTION 3. This act takes effect upon approval by the Governor. /
Renumber sections to conform.
Amend title to conform.