GENERAL ASSEMBLY OF NORTH CAROLINA
SESSION 2015
SESSION LAW 2015-154
HOUSE BILL 766
AN ACT amending the exemption for use or possession of hemp extract and permitting the use of hemp extract as an alternative treatment for intractable epilepsy without participating in a pilot study and repealing the epilepsy alternative treatment act in 2021.
The General Assembly of North Carolina enacts:
SECTION 1. G.S. 90‑94.1 reads as rewritten:
"§ 90‑94.1. Exemption for use or possession of hemp extract.
(a) As used in this section, "hemp extract" means an extract from a cannabis plant, or a mixture or preparation containing cannabis plant material, that has all of the following characteristics:
(1) Is composed of less than
three‑tenths nine‑tenths of one percent (0.3%) (0.9%)
tetrahydrocannabinol by weight.
(2) Is composed of at least ten
five percent (10%) (5%) cannabidiol by weight.
(3) Contains no other psychoactive substance.
(b) Notwithstanding any other provision of this Chapter, an individual may possess or use hemp extract, and is not subject to the penalties described in this Chapter, if the individual satisfies all of the following criteria:
(1) Possesses or uses the hemp extract only to treat intractable epilepsy, as defined in G.S. 90‑113.101.
(2) Possesses, in close proximity to the hemp extract, a certificate of analysis that indicates the hemp extract's ingredients, including its percentages of tetrahydrocannabinol and cannabidiol by weight.
(3) Has a current hemp
extract registration card issued by the Department of Health and Human Services
under Article 5G of Chapter 90 of the General Statutes.Is a caregiver,
as defined in G.S. 90‑113.101.
(c) Notwithstanding any
other provision of this Chapter, an individual who possesses hemp extract
lawfully under this section may administer hemp extract to another person under
the individual's care and is not subject to the penalties described in this
Chapter for administering the hemp extract to the person if both of the
following conditions are satisfied:
(1) The the
individual is the person's caregiver, as defined in G.S. 90‑113.101.
(2) The individual
is registered with the Department of Health and Human Services to administer
hemp extract under G.S. 90‑113.103."
SECTION 2. G.S. 90‑113.100 reads as rewritten:
"§ 90‑113.100. Short title.
(a) This act may be cited as the "North Carolina Epilepsy Alternative Treatment Act."
(b) The purpose of this act
is to permit medical professionals to conduct limited‑scope, evidence‑based
studies exploring the safety and efficacy of treating intractable epilepsy
using hemp extract.the use of hemp extract as an alternative treatment
for intractable epilepsy.
(c) The General Assembly
finds the following:
(1) There that
there are children in this State suffering from intractable epilepsy for
which currently available treatment options have been ineffective. Hemp extract
shows promise in treating children with intractable epilepsy.
(2) Additional
study of the use of hemp extract for the treatment of intractable epilepsy
should be undertaken, and the medical research universities of the State of
North Carolina are well‑suited for this type of clinical exploration."
SECTION 3. G.S. 90‑113.101 reads as rewritten:
"§ 90‑113.101. Definitions.
(a) Caregiver. – An
individual that is at least 18 years of age and a resident of North Carolina
who is a parent, legal guardian, or custodian of a person diagnosed with
intractable epilepsy.patient and is registered with the Department of
Health and Human and Services under G.S. 90‑113.102 who possesses a written
statement dated and signed by a neurologist that states all of the following:
(1) The patient has been examined and is under the care of the neurologist.
(2) The patient suffers from intractable epilepsy.
(3) The patient may benefit from treatment with hemp extract.
(b) Caregiver
Registration Card. – A registration card issued by the Department of Health and
Human Services under this Article to a caregiver.
(c) Database. – The
Intractable Epilepsy Alternative Treatment Pilot Study database,
established by the Department of Health and Human Services pursuant to this Article,
to register caregivers, patients, and recommending neurologists.Article.
…
(g) Neurologist. – An
individual who is licensed under Article 1 of Chapter 90 of the General
Statutes, who is board certified in neurology, and is affiliated with the
neurology department at one or more of the following universities:hospitals
licensed in this State.
(1) The University
of North Carolina at Chapel Hill.
(2) East Carolina
University.
(3) Duke
University.
(4) Wake Forest
University.
(h) Patient. – A person who has been diagnosed by a neurologist with intractable epilepsy.
(i) Pilot Study.
– An evidence‑based investigation of the safety and efficacy of treating
intractable epilepsy using hemp extract conducted by one or more neurologists
registered pursuant to this Article."
SECTION 4. G.S. 90‑113.102 reads as rewritten:
"§
90‑113.102. Intractable Epilepsy Alternative Treatment Pilot Study database;
departmental duties.
(a) The Department
shall create a secure, electronic, and online secure and electronic Intractable
Epilepsy Alternative Treatment Pilot Study database registry for the
registration of pilot studies, neurologists, caregivers, and patients as
provided by this Article. All caregivers shall be required to register with
the Department. Law enforcement agencies are authorized to contact the
Department to confirm a caregiver's registration. The registry must be
accessible to law enforcement agencies in order to verify registration of
caregivers. The registry must prevent an active registration of a patient by
multiple neurologists. At a minimum, theThe database shall consist
of the following:following information to be provided by the
caregivers at the time of registration:
(1) The name and address of each
registered caregiver and the name of the pilot study the caregiver is
associated with.the caregiver.
(2) The name and address of each
registered patient and the name of the pilot study the patient is associated
with.the caregiver's patient.
(3) The name,
address, and qualifying institutional affiliation of neurologists conducting
pilot studies pursuant to this Article.
(4) The name, institutional
affiliation, affiliated registered neurologists, and parameters of pilot
studies.address, and hospital affiliation of the neurologist
recommending hemp extract as an alternative treatment for intractable epilepsy
for the patient.
(b) The
Department shall contact the county department of health where the patient
resides and provide the following information:
(1) The name and
address of the registered caregiver.
(2) Identifying
information contained on the caregiver registration card.
(c) If at any time following registration, the name, address, or hospital affiliation of the patient's neurologist changes, the caregiver shall notify the Department and provide the Department with the patient's new neurologist's name, address, and hospital affiliation."
SECTION 5. G.S. 90‑113.103 is repealed.
SECTION 6. G.S. 90‑113.104 is repealed.
SECTION 7. G.S. 90‑113.105 reads as rewritten:
"§
90‑113.105. Immunity for neurologists; medical records.confidentiality.
(a) On a case‑by‑case
basis, neurologists conducting a registered pilot study may approve of
dispensation to a registered caregiver, as approved by this Article, hemp
extract acquired from another jurisdiction.
(b) A neurologist shall not
be subject to arrest or prosecution, penalized or disciplined in any manner, or
denied any right or privilege for approving or recommending the use of hemp
extract or providing a written statement or health records to the Department
for the use of hemp extract pursuant to this Article.
(c) A neurologist
conducting a registered pilot study who signs a statement as described in
G.S. 90‑113.104(b)(3) shall do the following:
(1) Keep a record
of the evaluation and observation of a patient under the neurologist's care,
including the patient's response to hemp extract treatment.
(2) Transmit the
record described in subdivision (1) of this subsection to the Department upon
request.
(d) All medical records
received or maintained by the Department pursuant to this Article are The
identities of the caregivers, patients, and neurologists reported to the
Department pursuant to this Article are confidential and may not be
disclosed to the public are not matters of public record. However, this
information may be provided to law enforcement agencies pursuant to G.S. 9‑113.102.Nothing
in this Article is intended to alter the provisions of G.S. 8‑53 or
G.S. 8‑53.1."
SECTION 7.2. The University of North Carolina at Chapel Hill and East Carolina University may and are encouraged to, and Duke University and Wake Forest University are encouraged to, conduct research on hemp extract development, production, and use for the treatment of seizure disorders and to participate in any ongoing or future clinical studies or trials, including those exploring the safety and efficacy of treating intractable epilepsy with hemp extract.
SECTION 8. Section 5 of S.L. 2014‑53 reads as rewritten:
"SECTION 5. Section
3 of this act becomes effective upon adoption of rules pursuant to Section 4 of
this act. The remainder of this This act is effective when it
becomes law."
SECTION 8.5.(a) Article 5G of Chapter 90 of the General Statutes is repealed.
SECTION 8.5.(b) This section becomes effective July 1, 2021.
SECTION 9. Section 1 becomes effective August 1, 2015, and applies to offenses committed on or after that date. Except as otherwise provided in this act, the remainder of the act is effective when it becomes law.
In the General Assembly read three times and ratified this the 15th day of July, 2015.
s/ Daniel J. Forest
President of the Senate
s/ Tim Moore
Speaker of the House of Representatives
s/ Pat McCrory
Governor
Approved 5:30 p.m. this 16th day of July, 2015