CHAPTER He-C 400
THERAPEUTIC CANNABIS PROGRAM
PART He-C 401
THERAPEUTIC CANNABIS PROGRAM – REGISTRY RULES
Statutory Authority: RSA 126-X:6, I
REVISION NOTE #1:
Document #10646
contained new rule He-C 401 on registry rules for the therapeutic cannabis program,
which were adopted by the Commissioner of the Department of Health and Human
Services on 7-23-14 and filed the same day pursuant to RSA 541-A:14, III with
the Director of Legislative Services.
Pursuant to RSA 541-A:14, IV, the Commissioner specified in a letter to
the Director an effective date of 8-1-15.
The effective date of 8-1-15 was modified by the
Commissioner to be 11-2-15 in a letter dated 7-24-15 pursuant to RSA 541-A:14,
IV, which allows an agency to change an effective date by “providing a
statement to the director of legislative services which shall indicate the new
effective date and all reasons for modifying the date. The statement shall be published by the
director of legislative services in the rulemaking register. No modified effective date shall occur
earlier than the date of publication in the rulemaking register.” The Commissioner’s letter was published in the
New Hampshire Rulemaking Register on July 30, 2015.
REVISION NOTE #2:
Document
#10964, effective 11-2-15, amended He-C 401.02, He-C 401.09, and He-C 401.11
through He-C 401.13, and adopted He-C 401.18 titled “Production of Cannabis-Infused
Products” and He-C 401.19 titled “Pre-registration.” Subsequently Document #12330, effective
7-21-17, repealed He-C 401.19 through the expedited repeal process pursuant to RSA
541-A:19-a.
Document #13220, effective
7-1-21, then adopted, repealed, readopted, or readopted with amendments all of
the rules in Part He-C 401. The rule repealed
was He-C 401.09 titled “Approval of a Severely Debilitating
or Terminal Medical Condition Not Listed as a Qualifying Medical Condition”, which
had been filed in Document #10646 and been amended by Document #10964. The rule adopted was a new He-C 401.09 titled
“Initial Application Requirements for Adult Patients
with Guardians”. Document #13220
replaced all prior filings affecting the rules in Part He-C 401.
He-C
401.01 Purpose and Scope.
(a) The purpose of these rules is to establish
the requirements for issuing registry identification cards to qualifying
patients and their designated caregivers for the therapeutic use of cannabis.
(b) Individuals who are not legal residents of
the state of New Hampshire shall not be eligible to receive registry
identification cards as qualifying patients.
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
He-C
401.02 Definitions.
(a) “Alternative treatment center (ATC)” means
“alternative treatment center” as defined in RSA 126-X:1, I, namely, “a
not-for-profit entity registered under RSA 126-X:7 that acquires, possesses,
cultivates, manufactures, delivers, transfers, transports, sells, supplies, and
dispenses cannabis, and related supplies and educational materials, to
qualifying patients and alternative treatment centers.”
(b) “Cannabis” means “cannabis” as defined in RSA
126-X:1, III, namely, “all parts of any plant of the Cannabis genus of plants,
whether growing or not; the seeds thereof; the resin extracted from any part of
such plant; and every compound, salt, derivative, mixture, or preparation of
such plant, its seeds, or resin. Such term shall not include the mature stalks
of such plants, fiber produced from such stalks, oil, or cake made from the
seeds of such plants, any other compound, salt, derivative, mixture, or
preparation of such mature stalks (except the resin extracted therefrom),
fiber, oil or cake, or the sterilized seeds of such plants which are incapable
of germination. In this chapter, cannabis shall not include hemp grown,
processed, marketed, or sold under RSA 439-A.”
(c)
“Cannabis concentrate” means any form of cannabinoid extracted from usable
cannabis plant material using an extraction method, such as water, food, carbon
dioxide, alcohol, or other solvent as allowed by He-C 402.16(j)(1)c.
(d) “Commissioner” means the commissioner of the
New Hampshire department of health and human services, or designee.
(e) “Department” means the New Hampshire
department of health and human services.
(f) “Diversion” means the obtaining or
transferring of cannabis from a legal possession or use to an illegal use or to
a person not authorized to use or obtain cannabis under RSA 126-X or He-C 401.
(g) “Designated caregiver” means “designated
caregiver” as defined in RSA 126-X:1, VI, namely, “an individual who:
(a) Is at least
21 years of age;
(b) Has agreed
to assist with one or more (not to exceed 5) qualifying patient’s therapeutic
use of cannabis, except if the qualifying patient and designated caregiver each
live greater than 50 miles from the nearest alternative treatment center, in
which case the designated caregiver may assist with the therapeutic use of
cannabis for up to 9 qualifying patients;
(c) Has never
been convicted of a felony or any felony drug-related offense; and
(d) Possesses a
valid registry identification card issued pursuant to RSA 126-X:4.”
This term includes “caregiver.”
(h) “Minor” means an individual who is under 18
years of age.
(i) “Provider” means “provider” as defined in RSA
126-X:1, VII(a), namely:
“(1) A
physician licensed to prescribe drugs to humans under RSA 329 and who possesses
an active registration from the United States Drug Enforcement Administration
to prescribe controlled substances;
(2) An advanced
practice registered nurse licensed pursuant to RSA 326-B:18 and who possesses
an active registration from the United States Drug Enforcement Administration
to prescribe controlled substances;
(3) A physician
or advanced practice registered nurse licensed to prescribe drugs to humans
under the relevant state licensing laws in Maine, Massachusetts, or Vermont and
who possesses an active registration from the United States Drug Enforcement
Administration to prescribe controlled substances and who is primarily
responsible for the patient’s care related to his or her qualifying medical
condition; or
(4) A physician
assistant licensed pursuant to RSA 328-D and who possesses an active
registration from the United States Drug Enforcement Administration to
prescribe controlled substances, with the express consent of the supervising
physician.”
(j) “Provider-patient relationship” means “provider-patient
relationship” as defined in RSA 126-X:1, VIII, namely, “a medical relationship
between a licensed provider and a patient that includes an in-person exam, a
history, a diagnosis, and a treatment plan appropriate for the licensee’s
medical specialty.”
(k) “Qualifying medical condition” means:
(1) “Qualifying
medical condition” as defined in RSA 126-X:1, IX(a), namely, “the presence of:
(1) Cancer,
glaucoma, positive status for human immunodeficiency virus, acquired immune
deficiency syndrome, hepatitis C, amyotrophic lateral sclerosis, muscular
dystrophy, Crohn’s disease, multiple sclerosis, chronic pancreatitis, spinal
cord injury or disease, traumatic brain injury, epilepsy, lupus, Parkinson’s
disease, Alzheimer’s disease, ulcerative colitis, Ehlers-Danlos syndrome, or
one or more injuries or conditions that has resulted in one or more qualifying
symptoms under subparagraph (2); and
(2) A severely
debilitating or terminal medical condition or its treatment that has produced
at least one of the following: elevated intraocular pressure, cachexia,
chemotherapy-induced anorexia, wasting syndrome, agitation of Alzheimer’s
disease, severe pain that has not responded to previously prescribed medication
or surgical measures or for which other treatment options produced serious side
effects, constant or severe nausea, moderate to severe vomiting, seizures, or
severe, persistent muscle spasms;” or
(2) “Qualifying
medical condition” as defined in RSA 126-X:1, IX(b), namely:
“(1) Moderate
to severe chronic pain.
(2) Severe pain
that has not responded to previously prescribed medication or surgical measures
or for which other treatment options produced serious side effects.
(3) Moderate or
severe post-traumatic stress disorder.”
(l) “Qualifying patient” means “qualifying
patient” as defined in RSA 126-X:1, X, namely “a resident of New Hampshire who
has been diagnosed by a provider as having a qualifying medical condition and
who possesses a valid registry identification card issued pursuant to RSA 126-X:4.”
This term includes “patient.”
(m) “Registry identification card” means “registry
identification card” as defined in RSA 126-X:1, XI, namely, “a document
indicating the date issued and expiration date by the department pursuant to
RSA 126-X:4 that identifies an individual as a qualifying patient or a
designated caregiver.” This term includes “registry ID card” used on department
forms.
(n) “Therapeutic use” means “therapeutic use” as
defined in RSA 126-X:1, XIII, namely, “the acquisition, possession,
cultivation, preparation, use, delivery, transfer, or transportation of cannabis
or paraphernalia relating to the administration of cannabis to treat or
alleviate a qualifying patient’s qualifying medical condition or symptoms or
results of treatment associated with the qualifying patient’s qualifying
medical condition. It shall not include:
(a) The use of
cannabis by a designated caregiver who is not a qualifying patient; or
(b) Cultivation
or purchase by a visiting qualifying patient; or
(c) Cultivation
by a designated caregiver or qualifying patient.”
(o) “Visiting qualifying patient” means “visiting
qualifying patient” as defined in RSA 126-X:1, XVI, namely, “a patient with a
qualifying medical condition who is not a resident of New Hampshire or who has
been a resident of New Hampshire for fewer than 30 days and is not eligible to
purchase therapeutic cannabis in New Hampshire or receive cannabis from a
qualifying New Hampshire patient.”
(p) “Written certification” means “written
certification” as defined in RSA 126-X:1, XVII, namely, “documentation of a
qualifying medical condition by a provider pursuant to rules adopted by the
department pursuant to RSA 541-A for the purpose of issuing registry
identification cards, after having completed a full assessment of the patient’s
medical history and current medical condition made in the course of a
provider-patient relationship. The date of issuance and the patient’s
qualifying medical condition, symptoms or side effects, the certifying provider’s
name, medical specialty, and signature shall be specified on the written certification.
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; amd by #10964, eff
11-2-15; ss by #13220, eff 7-1-21 (see Revision Note #2 at part heading for He-C
401)
He-C
401.03 Registry Identification Card
Required.
(a) In order to receive legal protection for the
therapeutic use of cannabis as authorized by RSA 126-X, an individual shall
apply for and receive a registry identification card for the therapeutic use of
cannabis.
(b) Qualifying patients and designated caregivers
shall possess at all times their registry identification cards while in
possession of cannabis outside their home(s).
(c) Pursuant to RSA 126-X:3, V, qualifying
patients and designated caregivers who are found to be in possession of
cannabis outside of their home(s) and are not in possession of their registry
identification cards shall be subject to a fine of up to $100.
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
He-C
401.04 Initial Application
Requirements for Qualifying Patients.
(a) Applicants for a qualifying patient registry
identification card shall submit a completed “Patient Application” form to the
department, which includes the following:
(1) Indication
whether it is an initial or renewal application;
(2) The
following applicant information:
a. Full name;
b. Date of
birth;
c. Gender;
d. Telephone
number;
e. Optional
e-mail address;
f. Mailing
address; and
g. Physical
address, if different than mailing address, except that if the applicant is experiencing
homelessness this shall not be required;
(3) The
following information about the applicant’s certifying provider:
a. First and
last name;
b. Business
address; and
c. Telephone
number;
(4) A signed
and dated release authorizing the release of relevant medical information by
the certifying provider to the department if further information about the
applicant’s qualifying medical condition or written certification is required
by the department;
(5) The name
and city or town of the applicant’s designated ATC;
(6) The
following information about the applicant’s designated caregiver, if the
applicant has designated a caregiver:
a. Full name;
b. Mailing address;
and
c. Date of
birth;
(7) A signed and
dated attestation of the following acknowledgements:
a. “I understand
that my Registry ID Card is valid for one year, unless a shorter time period is
indicated by my provider. I must renew my card every year by submitting another
application, certification, and fee.”;
b. “I
understand that if I am notified of a denial I have 30 days to appeal the decision
from the date of the notice, and that if a hearing request is not made within
that timeframe then I will have waived my right to a hearing and the action of
the Department shall become final.”;
c. “I understand
that I may not possess, between myself and my Designated Caregiver, more than
two ounces of usable cannabis.”;
d. “I
understand that I may only use therapeutic cannabis for the purpose of treating
or alleviating my qualifying medical condition.”;
e. “I
understand that I may not be under the influence of therapeutic cannabis: (1)
while operating a motor vehicle, commercial vehicle, boat, vessel, or any other
vehicle propelled or drawn by power other than muscular power; (2) in my place
of employment, without the written permission of my employer; or (3) while
operating heavy machinery or handling a dangerous instrumentality.”;
f. “I
understand that I may not smoke or vaporize therapeutic cannabis in any public
place, including a public bus or other public vehicle, or any public park,
public beach, or public field.”;
g. “I understand that I may not be in possession of
therapeutic cannabis in any of the following locations: (1) the building and
grounds of any preschool, elementary, or secondary school, which are located in
an area designated as a drug free zone; (2) a place of employment, without the
written permission of the employer; (3) any correctional facility; (4) any
public recreation center or youth center; or (5) any law enforcement
facility.”;
h. “I
understand that I may use cannabis on privately-owned real property only with
written permission of the property owner or, in the case of leased property,
with the permission of the tenant in possession of the property.”;
i. “I have
instructed a family member, caretaker, executor, and my Designated Caregiver
that, in the event of my death, the Department shall be notified within 5 days
that I have died, and that within 5 days of learning of my death, the family
member, caretaker, executor, or my Designated Caregiver shall either request
that the local law enforcement agency remove any remaining cannabis or dispose
of the cannabis in a manner that is specified in RSA 126-X:2, XIV.”;
j. “I
understand that if I am found to be in possession of therapeutic cannabis
outside of my home and I am not in possession of my Registry ID Card, I may be
subject to a fine of up to $100.”;
k. “I understand that any person(s) who makes a
fraudulent representation to a law enforcement official of any fact or circumstance
relating to the therapeutic use of cannabis to avoid arrest or prosecution
shall be guilty of a violation and may be fined $500, which shall be in
addition to any other penalties that may apply for making a false statement to
a law enforcement officer or for the use of cannabis other than use undertaken
pursuant to RSA 126-X.”;
l. “I
understand that the protections conferred by RSA 126-X for the therapeutic use
of cannabis are applicable only within New Hampshire.”;
m. “I
understand that I must be in compliance with RSA 126-X and with the administrative
rules adopted thereunder, and that the Department may revoke my Registry ID
Card for any violation of any provision of RSA 126-X or the administrative
rules adopted thereunder.”; and
n. “I understand
that by using therapeutic cannabis I may be denied rights and privileges by
federal agencies including, but not limited to, those related to employment
such as driving a commercial vehicle, those related to owning, possessing, or
purchasing a firearm and ammunition, those related to federal housing, those
related to immigration and naturalization, or the inability to pass a security
clearance.”;
(8) A signed and
dated certification that:
a. The
applicant is a resident of New Hampshire;
b. The facts as
stated in the application are accurate to the best of the applicant’s knowledge
and belief; and
c. The
applicant understands that any false statements made on the application are
punishable as unsworn falsification under RSA 641:3;
(9) A signed and
dated pledge not to divert cannabis to anyone who is not allowed to possess
cannabis pursuant to RSA 126-X, acknowledgement that diversion of cannabis
shall result in revocation of their registry identification card, and acknowledgement
that the sale of cannabis to anyone who is not a qualifying patient or a
designated caregiver is punishable as a class B felony with a sentence of a
maximum term of imprisonment of not more than 7 years, and a fine of not more
than $300,000, or both, in addition to other penalties for the illegal sale of
cannabis; and
(10) Voluntary demographic
information, as follows:
a. Race and
ethnicity;
b. Veteran
status;
c. Employment
and income;
d. Public
assistance;
e. Education;
f. Health
insurance;
g. Marital status;
and
h. Language
proficiency.
(b) In addition to (a) above, applicants shall
provide to the department the following supporting documentation:
(1) A “Written
Certification for the Therapeutic Use of Cannabis” form completed by the applicant’s
provider in accordance with He-C 401.07, except that a written certification
completed more than 6 months prior to the date of the applicant’s application
submission shall not be accepted;
(2) A fee in
accordance with He-C 401.14(b)(1); and
(3) Proof of
New Hampshire residency, as follows:
a. A copy of
the applicant’s valid, non-expired New Hampshire driver’s license or New
Hampshire state identification;
b. A copy of
the applicant’s valid, non-expired state or federal government-issued
identification that shows the applicant’s name and New Hampshire address; or
c. If
documentation in a. and b. above is unavailable, other documentation that contains
the applicant’s name and current address and which indicates New Hampshire
residency, such as:
1. A current
lease agreement or vehicle registration; or
2. A utility
bill, medical bill, property tax bill, mortgage statement, bank statement, government
check, or payroll check with a date showing that it was issued within 6 months
of the date the application was received by the department.
(c) The applicant shall submit the documents in
(a) and (b) above to:
NH Department of Health and Human Services
Therapeutic Cannabis Program
29 Hazen Drive
Concord, NH 03301
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
He-C 401.05 Initial
Application Requirements for Designated Caregivers.
(a)
Applicants for a designated caregiver registry identification card shall
submit a completed “Caregiver Application” form to the department, which
includes the following:
(1) Indication whether it is an initial or
renewal application, and if an initial application, whether the applicant
submitted the criminal record authorization form and fee to the NH department
of safety;
(2) The following applicant information:
a. Full name;
b. Date of birth;
c. Gender;
d. Telephone number;
e. Optional e-mail address;
f. Mailing address; and
g. Physical address, if different than mailing
address;
(3) The following information for each qualifying
patient the applicant will be assisting with the therapeutic use of cannabis,
which shall not exceed 5 qualifying patients, except that additional qualifying
patients shall be allowed, up to a maximum of 9, if both the designated
caregiver and the additional qualifying patients each live greater than 50 miles
from the nearest ATC:
a. Full name;
b. Mailing address;
c. Physical address, if different than mailing
address, except that if the qualifying patient is experiencing homelessness
this shall not be required; and
d. Date of birth;
(4) A signed and dated attestation of the
following acknowledgements:
a. “I understand that my Registry ID Card is
valid for one year, unless a shorter duration is indicated. I must renew my card
every year by submitting another application.”;
b. “I understand that if I am notified of a
denial I have 30 days to appeal the decision from the date of the notice, and
that if a hearing request is not made within that timeframe then I will have
waived my right to a hearing and the action of the Department shall become final.”;
c. “I understand that I may not possess, between
myself and my Qualifying Patient(s), more than two ounces of usable cannabis
per Qualifying Patient.”;
d. “I understand that as a Designated Caregiver I
am not permitted to use therapeutic cannabis, unless I am also a Qualifying
Patient, and may be subject to criminal penalties if I do so.”;
e. “I understand that as a Designated Caregiver
I am not permitted to possess any cannabis for purposes other than its
therapeutic use as permitted by RSA 126-X.”;
f. “I understand that I may not be in possession
of therapeutic cannabis in any of the following locations: (1) the building and
grounds of any preschool, elementary, or secondary school, which are located in
an area designated as a drug free zone; (2) a place of employment, without the
written permission of the employer; (3) any correctional facility; (4) any
public recreation center or youth center; or (5) any law enforcement
facility.”;
g. “I understand that in the event of my
Qualifying Patient’s death, I will, within 5 days of the death: (1) notify the Department
of the death; and (2) either request that the local law enforcement agency
remove any remaining cannabis or dispose of the remaining cannabis in a manner
that is specified in RSA 126-X:2, XIV.”;
h. “I understand that if I am found to be in
possession of therapeutic cannabis outside of my home and I am not in
possession of my Registry ID Card, I may be subject to a fine of up to $100.”;
i. “I
understand that any person(s) who makes a fraudulent representation to a law
enforcement official of any fact or circumstance relating to the therapeutic
use of cannabis to avoid arrest or prosecution shall be guilty of a violation
and may be fined $500, which shall be in addition to any other penalties that
may apply for making a false statement to a law enforcement officer or for the
use of cannabis other than use undertaken pursuant to this RSA 126-X.”;
j “I
understand that the protections conferred by RSA 126-X for the therapeutic use
of cannabis are applicable only within New Hampshire.”;
k. “I
understand that I must be in compliance with RSA 126-X and with the administrative
rules adopted thereunder, and that the Department may revoke my Registry ID
Card for any violation of any provision of RSA 126-X or the administrative
rules adopted thereunder.”; and
l. “I understand that I, by possessing
therapeutic cannabis, and my Qualifying Patient, by using therapeutic cannabis,
may be denied rights and privileges by federal agencies including, but not limited
to, those related to employment such as driving a commercial vehicle, those
related to owning, possessing, or purchasing a firearm and ammunition, those
related to federal housing, those related to immigration and naturalization, or
the inability to pass a security clearance.”;
(5) A signed and dated certification that:
a. The applicant agrees to act as the designated
caregiver for the qualifying patient named in the application;
b. The facts as stated in the application are
accurate to the best of the applicant’s knowledge and belief; and
c. The applicant understands that any false
statements made on the application are punishable as unsworn falsification
under RSA 641:3;
(6) A signed and dated pledge not to divert
cannabis to anyone who is not allowed to possess cannabis pursuant to RSA 126-X,
acknowledgement that diversion of cannabis shall result in revocation of their registry
identification card, and acknowledgement that the sale of cannabis to anyone
who is not a qualifying patient or a designated caregiver is punishable as a
class B felony with a sentence of a maximum term of imprisonment of not more
than 7 years, and a fine of not more than $300,000, or both, in addition to
other penalties for the illegal sale of cannabis; and
(7) Voluntary demographic information, as
follows:
a. Race and ethnicity;
b. Veteran status;
c. Employment and income;
d. Public assistance;
e. Education;
f. Health insurance;
g. Marital status; and
h. Language proficiency.
(b)
In addition to the materials in (a) above, for each applicant the
department shall also receive the results of a state and federal criminal
history records check from the division of state police, department of safety. An
application shall not be considered complete without the results of a state and
federal criminal history records check.
(c)
In order for the department to receive the results of a state and
federal criminal history records check, an applicant shall submit to the
division of state police the following:
(1) A criminal history record information
authorization form, as provided by the division of state police, which
authorizes the release of any felony convictions to the department;
(2) A complete set of electronic fingerprints
taken by a qualified law enforcement agency or an authorized employee of the
department of safety; and
(3) The required fee.
(d)
In the event that, after 2 attempts, the applicant’s electronic
fingerprints are invalid due to insufficient pattern, the department shall, in
lieu of the criminal history records check, accept the results of police
clearances showing no felony convictions from every city, town, or county where
the person has lived during the past 5 years, including any out-of-state
residency, received from the division of state police.
(e)
The applicant shall submit the documents in (a) above to:
NH Department
of Health and Human Services
Therapeutic
Cannabis Program
29 Hazen Drive
Concord,
NH 03301
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
He-C
401.06 Provider Requirements.
(a) The department shall accept written
certifications for the therapeutic use of cannabis only from providers who possess,
at the time of signing the certification, the following:
(1) For
providers in New Hampshire, an active license, in good standing, pursuant to
RSA 329 for physicians, pursuant to RSA 326-B:18 for advanced practice
registered nurses, or pursuant to RSA 328-D for physician assistants;
(2) For
providers in Maine, Massachusetts, and Vermont, an active license, in good
standing, pursuant to the relevant state licensing laws in Maine,
Massachusetts, or Vermont, except that a license for a naturopathic doctor shall
not be acceptable; and
(3) For all providers
in (1) and (2) above, an active registration from the United States Drug Enforcement
Administration to prescribe controlled substances.
(b) A provider issuing a written certification
shall:
(1) Have a
provider-patient relationship with the patient, as defined in He-C 401.02(j);
(2) If a
provider licensed in Maine, Massachusetts, or Vermont, be primarily responsible
for the patient’s care related to the patient’s qualifying medical condition,
pursuant to RSA 126-X:1, VII(a)(3);
(3) If a
physician assistant, have the express consent of the supervising physician,
pursuant to RSA 126-X:1, VII(a)(4);
(4) Conduct a
full assessment of the patient’s medical history and current medical condition
which includes:
a. An in-person
physical examination of the patient, which shall not be via telemedicine,
except that telemedicine shall be allowed for New Hampshire providers for
follow-up visits related to cannabis certification and treatment and for
recertifications completed by the same certifying provider;
b. A medical
history of the patient, including a prescription history;
c. A review of
laboratory testing, imaging, and other relevant tests;
d. Appropriate
consultations;
e. A documented
diagnosis of the patient’s current medical condition; and
f. The
development or documentation of a treatment plan for the patient appropriate
for the provider’s specialty;
(5) Explain the
potential health effects of the therapeutic use of cannabis:
a. To the patient;
or
b. In the case
of a patient who is a minor, to the minor’s custodial parent or legal guardian
with responsibility for health care decisions for the patient, which shall be
inclusive of potential risks and benefits of the therapeutic use of cannabis;
(6) Follow the
patient clinically at appropriate intervals at the discretion of the provider
to provide follow-up care and treatment to the patient for the patient’s qualifying
medical condition including, but not limited to, physical examinations, to
determine the health effects of cannabis for treating the patient’s qualifying
medical condition or associated symptom for which the written certification was
issued;
(7) Maintain
medical records for all patients for whom the provider has issued a written
certification which support the written certification;
(8) Make a copy
of such records which support the written certification available to the
department, and otherwise provide information to the department upon request
about the patient’s qualifying medical condition, to ensure compliance with RSA
126-X and He-C 401; and
(9) If the
provider has recommendations or instructions for the therapeutic use of
cannabis for the patient, be permitted to send such recommendations or
instructions to the patient’s designated ATC. Such recommendations shall be
securely transmitted.
(c) A provider shall not consider a patient to
have a qualifying medical condition if a patient who has had a diagnosis of a
qualifying medical condition in the past no longer actively has a qualifying
medical condition, unless the symptoms related to such qualifying medical
condition are mitigated by the therapeutic use of cannabis.
(d) Providers shall not issue a written
certification for themselves or for the provider’s immediate family members.
(e) A provider shall not:
(1) Offer a
discount or other thing of value to a patient who uses or agrees to use a
particular ATC;
(2) Examine a
patient in relation to issuing a written certification at a location where cannabis
is sold or distributed; or
(3) Hold any
economic interest in an ATC, including but not limited to employment at an ATC,
if the provider issues written certifications to patients.
(f) Providers may rescind or otherwise withdraw a
written certification which they have previously issued, for cause, including,
but not limited to, the provider making a determination that the patient:
(1) No longer has
a qualifying medical condition;
(2) Should
discontinue using cannabis;
(3) Falsified
information that was the basis of the provider’s written certification;
(4) Did not
adhere to the provider’s treatment plan for the patient; or
(5) Should no
longer be certified for the therapeutic use of cannabis for another compelling
reason.
(g) To rescind or otherwise withdraw a previously
issued written certification, the certifying provider shall submit the
following information on the “Written Certification Withdrawal” form:
(1) Qualifying
patient name;
(2) Qualifying
patient date of birth;
(3) Certifying
provider name;
(4) Medical
practice phone number;
(5) Reason for
withdrawal of the written certification; and
(6) Certifying
provider’s dated signature of a statement of withdrawal for the reason in (5)
above.
(h) Providers may extend the duration of a
written certification, as follows:
(1) Providers
may extend the duration of a written certification that they previously issued
which has a duration of less than one year, per He-C 401.07(b)(7);
(2) The
extension period shall not be for a duration longer than the maximum duration
of a registry identification card established in RSA 126-X:4, IV;
(3) An extension
request shall be submitted prior to the expiration of the qualifying patient’s
registry identification card; and
(4) An extension
request shall not require the submission of a new written certification, a new patient
application, or a new fee.
(i) To extend the duration of a written
certification, the certifying provider shall submit written notice to the
department by submitting the following information on the “Written Certification
Extension” form:
(1) Qualifying
patient name;
(2) Qualifying
patient date of birth;
(3) Certifying
provider name;
(4) Medical practice
phone number;
(5) Length of
extension; and
(6) Certifying
provider’s dated signature.
(j) Upon receipt of the completed written notice
in (i) above, the department shall issue a new registry identification card
with a new expiration date.
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
He-C
401.07 Written Certification
Requirements.
(a) The certifying provider shall complete a
“Written Certification for the Therapeutic Use of Cannabis” form, which includes
the following:
(1) Indication
whether it is an initial or renewal certification;
(2) The
following patient information:
a. Full name;
b. Mailing
address;
c. Telephone
number; and
d. Date of
birth; and
(3) The
following provider information:
a. Full name;
b. Name of
medical practice;
c. Office
mailing address;
d. Office
telephone and fax numbers;
e. Optional
email address;
f. State license
number;
g. Indication
that the provider is a physician, an advanced practice registered nurse, or a
physician assistant;
h. Active US
Drug Enforcement Administration registration number; and
i. Medical
specialty, as appropriate for the provider type.
(b) On the “Written Certification for the
Therapeutic Use of Cannabis” form, the provider shall:
(1) Certify
that the patient has a qualifying medical condition, as defined in He-C
401.02(j) and RSA 126-X:1, IX(a) or (b), by:
a. Providing
the patient’s name;
b. Indicating
which condition(s) the patient has; and
c. Signing and dating
the certification;
(2) Indicate
whether the written certification is based on an in-person physical examination
that was conducted via telemedicine;
(3) Certify
that the provider has a provider-patient relationship with the patient, as follows:
“I have completed a full assessment of my patient’s
medical history and current medical condition in accordance with He-C 401.06(b)(4)
made in the course of a provider-patient relationship”;
(4) Certify
that the provider explained the potential health effects of the therapeutic use
of cannabis:
a. To the
patient; or
b. In the case
of a patient who is a minor, to the patient’s custodial parent or legal
guardian with responsibility for health care decisions for the patient, which
shall be inclusive of the potential risks and benefits of the therapeutic use
of cannabis;
(5) Certify
that the provider possesses an active license in good standing with the state
of New Hampshire or the state of Maine, Massachusetts, or Vermont and is
either:
a. A physician,
an advanced practice registered nurse, or a physician assistant licensed in New
Hampshire to prescribe drugs to humans under RSA 329, RSA 326-B:18, or RSA
328-D, respectively, and who possesses an active registration from the United
States Drug Enforcement Administration to prescribe controlled substances; or
b. A physician
or an advanced practice registered nurse licensed in Maine, Massachusetts, or
Vermont to prescribe drugs to humans under the relevant state licensing laws,
who possesses an active registration from the United States Drug Enforcement
Administration to prescribe controlled substances, and who is primarily
responsible for the patient’s care related to the patient’s qualifying medical
condition;
(6) Certify
that the facts as stated in the written certification are accurate to the best
of the provider’s knowledge and belief and that the provider understands that
any false statements made on the written certification are punishable as
unsworn falsification under RSA 641:3; and
(7) Indicate
the duration for which the registry identification card shall be valid, if for a
shorter duration than one year from the effective date of the card, except that
if this is not indicated, the card shall default to a duration of one year.
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
He-C 401.08 Initial
Application Requirements for Minor Patients.
(a) The minor
applicant’s custodial parent(s) or legal guardian who is responsible for the
health care decisions of the minor applicant shall complete and submit the
“Minor Patient Application” form described in (c) below.
(b) The “Minor
Patient Application” form shall be a combined application for both the minor
applicant and the designated caregiver applicant(s).
(c) The minor applicant’s custodial parent(s) or
legal guardian shall include the following on the “Minor Patient Application”:
(1) Indication
whether it is an initial or renewal application, and if an initial application,
whether the criminal record authorization form and fee have been sent to the NH
department of safety;
(2) The
following minor applicant information:
a. Full name;
b. Date of
birth;
c. Gender;
d. Mailing
address; and
e. Physical
address, if different than mailing address, except that if the minor applicant
is experiencing homelessness this shall not be required;
(3) The
following information about the designated caregiver applicant(s):
a. Full name;
b. Date of
birth;
c. Gender;
d. Phone number;
e. Optional e-mail
address;
f. Mailing
address, if different than the minor applicant; and
g. Physical
address, if different than the minor applicant;
(4) The
following information about the minor applicant’s certifying providers:
a. First and
last name;
b. Business
address; and
c. Telephone
number;
(5) A signed
and dated release authorizing the release of relevant medical information by
the certifying providers to the department if further information about the minor
applicant’s qualifying medical condition or written certification is required
by the department;
(6) The name
and city or town of the designated ATC;
(7) Signed and
dated attestation(s) of the following minor patient requirements:
a. “I am the
custodial parent or legal guardian responsible for the health care decisions of
the applicant.”;
b. “The applicant’s
certifying providers have explained to me the potential risks and benefits of
the therapeutic use of cannabis.”;
c. “I consent
to allow the applicant’s therapeutic use of cannabis.”;
d. “I consent
to serve as the applicant’s Designated Caregiver and to control the acquisition
of cannabis and the frequency of the therapeutic use of cannabis by the applicant.”;
e. “I
understand that if I am not approved to be a Designated Caregiver, then the
applicant’s application to be a Qualifying Patient shall not be approved.”; and
f. If
applicable, “I share legal custody of the applicant, and I have notified the other
parent or guardian with legal custody of the applicant in advance of submitting
this application by having provided to the other parent or guardian a copy of
the completed Application form and the completed Written Certification forms.”;
(8) Signed and
dated attestation(s) of the following acknowledgements:
a. “I
understand that Registry ID Cards are valid for one year, unless a shorter duration
is indicated. Cards must be renewed every year by submitting another
application and fee.”;
b. “I understand
that if I am notified of a denial, I have 30 days to appeal this decision from
the date of the denial notice, and that if a request for a hearing is not made
within that timeframe then I will be deemed to have waived my right to a
hearing and the action of the Department shall become final.”;
c. “I
understand that I may not possess, between myself and my Qualifying Patient(s),
more than two ounces of usable cannabis per Qualifying Patient.”;
d. “I
understand that as a Designated Caregiver I am not permitted to use therapeutic
cannabis, unless I am also a Qualifying Patient, and may be subject to criminal
penalties if I do so.”;
e. “I understand
that my Qualifying Patient may only use therapeutic cannabis for the purpose of
treating or alleviating their qualifying medical condition.”;
f. “I
understand that as a Designated Caregiver I am not permitted to possess any
cannabis for purposes other than its therapeutic use as permitted by RSA
126-X.”;
g. “I
understand that my Qualifying Patient may not be under the influence of
therapeutic cannabis: (1) while operating a motor vehicle, commercial vehicle,
boat, vessel, or any other vehicle propelled or drawn by power other than
muscular power; (2) in their place of employment, without the written permission
of the employer; or (3) while operating heavy machinery or handling a dangerous
instrumentality.”;
h. “I
understand that my Qualifying Patient may not smoke or vaporize therapeutic
cannabis in any public place, including a public bus or other public vehicle,
or any public park, public beach, or public field.”;
i. “I
understand that my Qualifying Patient and I may not be in possession of therapeutic
cannabis in any of the following locations: (1) the building and grounds of any
preschool, elementary, or secondary school, which are located in an area
designated as a drug free zone; (2) a place of employment, without the written
permission of the employer; (3) any correctional facility; (4) any public
recreation center or youth center; or (5) any law enforcement facility.”;
j. “I
understand that my Qualifying Patient may use cannabis on privately-owned real
property only with written permission of the property owner or, in the case of
leased property, with the permission of the tenant in possession of the
property.”;
k. “I
understand that in the event of my Qualifying Patient’s death, I will, within 5
days of the death: (1) notify the Program of the death; and (2) either request
that the local law enforcement agency remove any remaining cannabis or dispose
of the remaining cannabis in a manner that is specified in RSA 126-X:2, XIV.”;
l. “I
understand that if my Qualifying Patient or I am found to be in possession of
therapeutic cannabis outside of our home and we are not in possession of a Registry
ID Card, we may be subject to a fine of up to $100.”;
m. “I
understand that any person(s) who makes a fraudulent representation to a law
enforcement official of any fact or circumstance relating to the therapeutic
use of cannabis to avoid arrest or prosecution shall be guilty of a violation
and may be fined $500, which shall be in addition to any other penalties that
may apply for making a false statement to a law enforcement officer or for the
use of cannabis other than use undertaken pursuant to this RSA 126-X.”;
n. “I
understand that the protections conferred by RSA 126-X for the therapeutic use
of cannabis are applicable only within NH.”;
o. “I
understand that my Qualifying Patient and I must be in compliance with RSA
126-X and with the administrative rules adopted thereunder, and that the
Department may revoke a Registry ID Card for any violation of any provision of
RSA 126-X or the administrative rules adopted thereunder.”; and
p. “I
understand that I, by possessing therapeutic cannabis, and my Qualifying
Patient, by using therapeutic cannabis, may be denied rights and privileges by
federal agencies including, but not limited to, those related to employment
such as driving a commercial vehicle, those related to owning, possessing, or
purchasing a firearm and ammunition, those related to federal housing, those
related to immigration and naturalization, or the inability to pass a security clearance.”;
(9) Signed and
dated certification(s) that:
a. The minor applicant
is a resident of New Hampshire;
b. The facts as
stated in the application are accurate to the best of the designated caregiver
applicant’s knowledge and belief; and
c. The designated
caregiver applicant understands that any false statements made on the
application are punishable as unsworn falsification under RSA 641:3;
(10) A signed and
dated pledge not to divert cannabis to anyone who is not allowed to possess
cannabis pursuant to RSA 126-X, acknowledgement that diversion of cannabis
shall result in revocation of their registry identification card, and acknowledgement
that the sale of cannabis to anyone who is not a qualifying patient or a
designated caregiver is punishable as a class B felony with a sentence of a
maximum term of imprisonment of not more than 7 years, and a fine of not more
than $300,000, or both, in addition to other penalties for the illegal sale of
cannabis; and
(11) Voluntary demographic
information, as follows:
a. For the minor
applicant, race and ethnicity; and
b. For the
designated caregiver applicant(s):
1. Race and
ethnicity;
2. Veteran
status;
3. Employment
and income;
4. Public
assistance;
5. Education;
6. Health
insurance;
7. Marital
status; and
8. Language
proficiency.
(d) In cases where
parents share legal custody of a minor applicant, and both parents are not
listed on the application, the parent submitting an application shall notify
the other parent with legal custody of the minor applicant in advance of
submitting the application to the department by providing to the other parent a
copy of the completed application and the completed written certifications.
(e) In addition to
the application described in (c) above, the following shall also be submitted:
(1) Two written
certifications, described in He-C 401.07, from 2 different providers, one of
whom shall be a pediatrician;
(2) Proof of NH
residency, as described in He-C 401.04(b)(3), for either the minor applicant or
one of the designated caregiver applicants;
(3) A fee in
accordance with He-C 401.14(b)(2); and
(4) In cases
where a minor applicant’s legal guardian is not a custodial parent, the legal
guardian shall submit with the application proof of legal guardianship.
(f) In addition to the materials in (c) and (e)
above, for each designated caregiver applicant the department shall also
receive the results of a state and federal criminal history records check from
the division of state police, department of safety, as described in He-C
401.05(d) and (e). An application shall not be considered complete without the
results of a state and federal criminal history records check.
(g) The documents in (c) and (e) above shall be submitted
to:
NH Department of Health and Human Services
Therapeutic Cannabis Program
29 Hazen Drive
Concord, NH
03301
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
He-C
401.09 Initial
Application Requirements for Adult Patients with Guardians.
(a) The patient applicant’s
legal guardian who is responsible for the health care decisions of the patient applicant
shall complete and submit the “Guardianship Patient Application” form described
in (c) below.
(b) The “Guardianship
Patient Application” form shall be a combined application for both the patient
applicant and the designated caregiver applicant(s).
(c) The patient applicant’s legal guardian shall
include the following on the “Guardianship Patient Application” form:
(1) Indication
whether it is an initial or renewal application, and if an initial application,
whether the caregiver applicant submitted the criminal record authorization
form and fee to the NH department of safety;
(2) The
following patient applicant information:
a. Full name;
b. Date of
birth;
c. Gender;
d. Optional telephone
number;
e. Optional
e-mail address;
f. Mailing
address; and
g. Physical
address, if different than mailing address, except that if the patient
applicant is experiencing homelessness this shall not be required;
(3) The
following information about the designated caregiver applicant(s):
a. Full name;
b. Date of
birth;
c. Gender;
d. Phone number;
e. Optional e-mail
address;
f. Mailing
address, if different than the patient applicant; and
g. Physical address,
if different than the patient applicant;
(4) The
following information about the patient applicant’s certifying provider:
a. First and
last name;
b. Business
address; and
c. Telephone
number;
(5) A signed
and dated release authorizing the release of relevant medical information by
the certifying provider to the department if further information about the
patient applicant’s qualifying medical condition or written certification is
required by the department;
(6) The name
and city or town of the designated ATC;
(7) Signed and
dated attestation(s) of the following acknowledgements:
a. “I
understand that Registry ID Cards are valid for one year, unless a shorter
duration is indicated. Cards must be renewed every year by submitting another application
and fee.”;
b. “I
understand that if I am notified of a denial I have 30 days to appeal the
decision from the date of the notice, and that if a hearing request is not made
within that timeframe then I will have waived my right to a hearing and the
action of the Department shall become final.”;
c. “I
understand that I may not possess, between myself and my Qualifying Patient,
more than two ounces of usable cannabis per Qualifying Patient.”;
d. “I
understand that as a Designated Caregiver I am not permitted to use therapeutic
cannabis, unless I am also a Qualifying Patient, and may be subject to criminal
penalties if I do so.”;
e. “I
understand that my Qualifying Patient may only use therapeutic cannabis for the
purpose of treating or alleviating their qualifying medical condition.”;
f. “I
understand that as a Designated Caregiver I am not permitted to possess any cannabis
for purposes other than its therapeutic use as permitted by RSA 126-X.”;
g. “I
understand that my Qualifying Patient may not be under the influence of
therapeutic cannabis: (1) while operating a motor vehicle, commercial vehicle,
boat, vessel, or any other vehicle propelled or drawn by power other than
muscular power; (2) in their place of employment, without the written
permission of the employer; or (3) while operating heavy machinery or handling
a dangerous instrumentality.”;
h. “I
understand that my Qualifying Patient may not smoke or vaporize therapeutic
cannabis in any public place, including a public bus or other public vehicle,
or any public park, public beach, or public field.”;
i. “I understand
that my Qualifying Patient and I may not be in possession of therapeutic
cannabis in any of the following locations: (1) the building and grounds of any
preschool, elementary, or secondary school, which are located in an area
designated as a drug free zone; (2) a place of employment, without the written
permission of the employer; (3) any correctional facility; (4) any public
recreation center or youth center; or (5) any law enforcement facility.”;
j. “I
understand that my Qualifying Patient may use cannabis on privately-owned real
property only with written permission of the property owner or, in the case of
leased property, with the permission of the tenant in possession of the
property.”;
k. “I
understand that in the event of my Qualifying Patient’s death, I will, within 5
days of the death: (1) notify the Department of the death; and (2) either
request that the local law enforcement agency remove any remaining cannabis or
dispose of the remaining cannabis in a manner that is specified in RSA 126-X:2,
XIV.”;
l. “I
understand that if my Qualifying Patient or I am found to be in possession of
therapeutic cannabis outside of our home and we are not in possession of a Registry
ID Card, we may be subject to a fine of up to $100.”;
m. “I understand that any person(s) who makes a
fraudulent representation to a law enforcement official of any fact or
circumstance relating to the therapeutic use of cannabis to avoid arrest or
prosecution shall be guilty of a violation and may be fined $500, which shall
be in addition to any other penalties that may apply for making a false
statement to a law enforcement officer or for the use of cannabis other than
use undertaken pursuant to this RSA 126-X.”;
n. “I
understand that the protections conferred by RSA 126-X for the therapeutic use
of cannabis are applicable only within New Hampshire.”;
o. “I
understand that my Qualifying Patient and I must be in compliance with RSA
126-X and with the administrative rules adopted thereunder, and that the
Department may revoke a Registry ID Card for any violation of any provision of
RSA 126-X or the administrative rules adopted thereunder.”; and
p. “I
understand that I, by possessing therapeutic cannabis, and my Qualifying
Patient, by using therapeutic cannabis, may be denied rights and privileges by
federal agencies including, but not limited to, those related to employment
such as driving a commercial vehicle, those related to owning, possessing, or
purchasing a firearm and ammunition, those related to federal housing, those
related to immigration and naturalization, or the inability to pass a security
clearance.”;
(8) Signed and
dated certification(s) that:
a. The patient
applicant is a resident of New Hampshire;
b. The facts as
stated in the application are accurate to the best of the designated caregiver
applicant’s knowledge and belief; and
c. The designated
caregiver applicant understands that any false statements made on the application
are punishable as unsworn falsification under RSA 641:3;
(9) Signed and
dated pledge(s) not to divert cannabis to anyone who is not allowed to possess
cannabis pursuant to RSA 126-X, acknowledgement that diversion of cannabis
shall result in revocation of their registry identification card, and acknowledgement
that the sale of cannabis to anyone who is not a qualifying patient or a
designated caregiver is punishable as a class B felony with a sentence of a
maximum term of imprisonment of not more than 7 years, and a fine of not more
than $300,000, or both, in addition to other penalties for the illegal sale of
cannabis; and
(10) Voluntary demographic
information, as follows:
a. Race and
ethnicity;
b. Veteran
status;
c. Employment
and income;
d. Public
assistance;
e. Education;
f. Health
insurance;
g. Marital status;
and
h. Language
proficiency.
(d) In cases where co-guardians
share legal custody of an adult patient applicant, and both co-guardians are
not listed on the application, the guardian submitting an application shall
notify the other guardian with legal custody of the adult patient applicant in advance
of submitting the application to the department by providing to the other
guardian a copy of the completed application and the completed written certification.
(e) In addition to
the application described in (c) above, the following shall also be submitted:
(1) A written
certification, described in He-C 401.07;
(2) Proof of NH
residency for the patient applicant, as described in He-C 401.04(b)(3), except
that if this information is not available for the patient applicant, it shall
be submitted for one of the designated caregiver applicants;
(3) A fee in
accordance with He-C 401.14(b)(5); and
(4) Proof of legal
guardianship for each designated caregiver applicant listed on the application.
(f) In addition to the materials in (c) and (e)
above, for each designated caregiver applicant the department shall also
receive the results of a state and federal criminal history records check from
the division of state police, department of safety, as described in He-C
401.05(d) and (e). An application shall not be considered complete without the
results of a state and federal criminal history records check.
(g) The documents in (c) and (e) above shall be submitted
to:
NH Department of Health and Human Services
Therapeutic Cannabis Program
29 Hazen Drive
Concord, NH
03301
Source. (See Revision Note #2 at part heading for He-C 401) #13220, eff 7-1-21
He-C 401.10 Processing
of Applications and Issuance of Registry Identification Cards.
(a) An application
for initial approval as a qualifying patient or a designated caregiver shall be
complete when the department determines that all information and supporting
documentation required by He-C 401.04, He-C 401.05, He-C 401.06, He-C 401.08,
or He-C 401.09 have been received.
(b) If an
application does not contain all of the items required by He-C 401.04, He-C
401.05, He-C 401.06, He-C 401.08, or He-C 401.09 the department shall notify
the applicant, and the applicant’s certifying provider in the case of a written
certification, in writing within 10 days specifying any information or
supporting documentation required to be submitted before the application can be
processed.
(c) If after written
notice in (b) above the applicant, or the applicant’s provider in the case of a
written certification, fails to provide the missing information or supporting
documentation, including payment of the required fee, within 30 days of such
notice, the application shall be considered incomplete.
(d) If the missing
information or supporting documentation, including payment of the required fee,
is not received within 6 months of the notice, the application shall be
considered closed, and that applicant may reapply by re-submitting all required
application materials, including the required fee(s), anew.
(e) The department
shall approve an applicant as a qualifying patient if the department determines
that:
(1) The applicant has submitted to the department
a complete application and the required supporting documentation in accordance
with He-C 401.04;
(2) The applicant is a resident of New Hampshire;
(3) The
applicant’s provider has completed a written certification that meets the
requirements of He-C 401.07 and has certified that the applicant has a
qualifying medical condition which meets the definition in He-C 401.02(j);
(4) All information submitted is accurate;
(5) No basis for denial, as established in He-C
401.12(a), exists;
(6) In the case of a minor patient, all
requirements in He-C 401.08 have been met; and
(7) In the case of an adult patient with
guardian(s), all requirements in He-C 401.09 have been met.
(f) The department
shall approve an applicant as a designated caregiver if the department
determines that:
(1) The applicant has submitted to the department
a complete application and required supporting documentation in accordance with
He-C 401.05;
(2) The applicant is at least 21 years old;
(3) Based upon the results of the criminal
history records check or the police clearances received, the applicant has
never been convicted of a felony;
(4) The qualifying patient(s) listed on the
caregiver application has designated the caregiver applicant as the qualifying
patient’s caregiver;
(5) The number of qualifying patients listed on
the caregiver application does not exceed 5, except that additional qualifying
patients shall be allowed, up to a maximum of 9, if both the designated
caregiver and the additional qualifying patients each live greater than 50
miles from the nearest ATC;
(6) All information submitted is accurate; and
(7) No basis for denial, as established in He-C
401.12(a), exists.
(g) Pursuant to RSA
126-X:4, III, the department shall act on a complete application, including all
supporting documentation and the required fee, for either a qualifying patient
or a designated caregiver within 15 calendar days of its receipt. This
timeframe shall not apply to applications that are determined to be incomplete.
(h) Within 5
calendar days of the determination to approve an application for either a
qualifying patient or a designated caregiver, the department shall issue to the
applicant a registry identification card.
(i) The department
shall send notice of the qualifying patient’s approval to the patient’s certifying
provider, including:
(1) The expiration date of the patient’s registry
identification card;
(2) The name of and contact information for the
ATC the patient has designated; and
(3) Information about providing recommendations
or instructions to the ATC regarding the patient’s therapeutic use of cannabis,
described in He-C 401.06(b)(9).
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
He-C 401.11 Registry
Identification Card Expirations, Exceptions, and Procedures for Renewals.
(a) A registry identification card shall be valid
on the date of issuance and expire one year later on the last day of the month
it was issued unless a shorter time period is established in accordance with (d)
below.
(b) To renew a registry identification card and
prevent a possible lapse in registration, each qualifying patient and
designated caregiver shall complete and submit to the department application
materials pursuant to He-C 401.04, He-C 401.05, He-C 401.08, or He-C 401.09 at
least 30 days prior to the expiration of their current registry identification
card, except that:
(1) For
designated caregivers, the criminal history records check results required by
He-C 401.05(c) shall not be required, but the designated caregiver shall
complete, sign under penalties set forth in RSA 641:3 for unsworn
falsification, date, and submit a “Designated Caregiver’s Attestation of No
Felony Conviction” form, which states that the individual has not been convicted
of a felony offense in New Hampshire or any other state, provided there has not
been a lapse in registration of more than one year;
(2) For
qualifying patients who have not changed their mailing address or physical address,
proof of NH residency required by He-C 401.04(b)(3) shall not be required; and
(3) For
qualifying patients who have guardians, guardianship documentation required by
He-C 401.08(e)(4) and 401.09(e)(4) shall not be required, regardless of any
lapse in registration, unless there has been a change in guardianship.
(c) Applications for renewal shall be processed
and registry identification cards shall be issued in accordance with He-C
401.10.
(d) Exceptions to (a) above shall be as follows:
(1) If the qualifying
patient’s certifying provider indicates on the written certification that the
certification should be valid for a shorter duration, then the registry
identification card shall be valid for the shorter duration indicated, subject to
extension in accordance with He-C 401.06(h);
(2) If the
qualifying patient’s certifying provider rescinds or otherwise withdraws the
patient’s written certification pursuant to He-C 401.06(f) and (g), the
registry identification card shall become void upon notification by the
department to the qualifying patient;
(3) A
designated caregiver’s registry identification card shall be deactivated upon
notification by the department to the designated caregiver that all the
qualifying patients for whom the individual is acting as designated caregiver
either have lost their status as qualifying patients or have rescinded or
otherwise ended the designation, subject to reactivation in accordance with
He-C 401.13(k); and
(4) If an
applicant’s payment is returned for insufficient funds, and the applicant does
not remit full payment in accordance with RSA 6:11-a within 10 days of the
department’s written notice:
a. The registry
identification card shall be deactivated, subject to reactivation upon receipt
of full payment within 6 months of the notice; and
b. After 6
months, the case shall be considered closed, and that applicant may reapply by
submitting all required application materials, including the required fees.
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; amd by #10964, eff
11-2-15; ss by #13220, eff 7-1-21 (see Revision Note #2 at part heading for He-C
401)
He-C
401.12 Denial of an Application,
Enforcement Actions, and Administrative Appeals.
(a) The department shall deny an initial or renewal
application for a registry identification card if:
(1) The applicant previously had a registry
identification card revoked for violating the provisions of RSA 126-X or He-C 401;
(2)
The department determines that the information provided in the application
or supporting material was misleading, false, or fraudulent;
(3) The applicant previously had a registry
identification card denied for providing in the application or supporting material
information that was determined to be misleading, false, or fraudulent;
(4)
The department determines that the information provided in the
application or supporting documentation did not meet the requirements of RSA 126-X or He-C 401;
(5)
A minor applicant’s custodial
parent or legal guardian is not approved to be a designated caregiver, except that if both parents are listed on the minor patient
application as designated caregivers, and only one designated caregiver
applicant is denied, the minor patient’s application to be a qualifying patient
shall not be denied; or
(6)
A legal guardian of an adult
applicant with a guardian is not approved to be a designated caregiver, except that if co-guardians are listed on the adult
guardianship application as designated caregivers, and only one designated caregiver
applicant is denied, the patient’s application to be a qualifying patient shall
not be denied.
(b) The department shall revoke a qualifying
patient or designated caregiver’s registry identification card for any of the
following:
(1)
Violation
of any provision of RSA 126-X or He-C 401;
(2)
Submission
of misleading, false, or fraudulent information in the application or
supporting documentation;
(3)
Fraudulent
use of a registry identification card;
(4)
Selling,
distributing, or giving cannabis to any unauthorized person;
(5) Tampering, falsifying, altering, modifying, duplicating, or allowing
another person to use, tamper, falsify, alter, modify, or duplicate a registry
identification card;
(6)
A designated caregiver has been convicted of a felony in this or any
other state;
(7)
A qualifying patient or designated
caregiver is an inmate at a correctional facility;
(8)
A qualifying patient is no longer a
resident of New Hampshire;
(9)
A qualifying patient used cannabis in a manner that puts others at risk
of their health, safety, or welfare, or has failed to take reasonable precautions to avoid
putting others at such risk; and
(10)
A qualifying patient or designated caregiver produces cannabis
concentrate using an extraction method that is prohibited by He-C 401.18.
(c) At the time of denying an application for a
registry identification card or revoking a registry identification card, the
department shall send to the applicant or cardholder written notice that sets
forth:
(1)
The action to be taken by the department;
(2)
The reason(s) for the action; and
(3)
The right of an applicant or cardholder to a hearing in accordance with
He-C 200 before the enforcement action becomes final.
(d) An applicant or cardholder shall have 30 days
from the date of the notice of the enforcement action to request a hearing to
contest the action.
(e) If a request for a hearing is not made pursuant
to (d) above, the applicant or cardholder shall be deemed to have waived their right
to a hearing.
(f) Hearings under this section shall be
conducted in accordance with He-C 200.
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; amd by #10964, eff
11-2-15; ss by #13220, eff 7-1-21 (see Revision Note #2 at part heading for He-C
401)
He-C
401.13 Requirements for Notifications.
(a) A qualifying patient shall notify the
department in writing of any of the following:
(1)
A change to the qualifying patient’s name or address, within 10 days of
such change;
(2)
The designation of a caregiver if the patient has not already done so on
an initial or renewal application, the removal of a designated caregiver, or both;
(3) A change to the qualifying patient’s
designated ATC; or
(4) A registry identification card has been lost,
stolen, or destroyed, within 10 days of the discovery of the loss, theft, or
destruction.
(b) A designated caregiver shall notify the
department in writing of any of the following:
(1)
A change to the designated caregiver’s name or address, within 10 days of
such change;
(2)
A change to the designated caregiver’s qualifying patient(s);
(3) A registry identification card has been lost,
stolen, or destroyed, within 10 days of the discovery of the loss, theft, or
destruction; or
(4)
Immediately upon being convicted of a felony in this or any other state.
(c) The notifications in (a)(1), (3), and (4) and
(b)(1) and (3) above may be on a “Change of Information / Lost Card” form,
which shall include the following information:
(1)
Name, date of birth, and phone number;
(2)
For a name or address change, the new name, address, or both;
(3)
For change of ATC, the current ATC and the new ATC; and
(4)
For a replacement registry identification card, indication that a
registry identification card has been lost, stolen, or destroyed, and the
submission of the required fee pursuant to He-C 401.14(b)(4).
(d) The notifications in (a)(2) and (b)(2) above may
be on a “Caregiver Designation / Removal” form, which shall include the
following information, as applicable:
(1) To be completed by the qualifying patient:
a. The
qualifying patient’s name, date of birth, and registry identification card
number;
b. The name of
the person(s) being designated, removed, or both, as the qualifying patient’s designated
caregiver; and
c. The
qualifying patient’s dated signature; and
(2) To be completed by the designated caregiver:
a. The designated
caregiver’s name and date of birth;
b. Acceptance
of the designation to act as a caregiver for the qualifying patient listed in
(1)a. above;
c. Indication
that the caregiver is either:
1. Currently a
designated caregiver, and the current registry identification card number; or
2. Not
currently a designated caregiver, and that the individual understand that a separate
and complete caregiver application must be submitted to the department;
d. Indication
that the designated caregiver shall no longer serve as designated caregiver for
the qualifying patient listed on the form; and
e. The
designated caregiver’s dated signature.
(e) If a qualifying patient’s certifying provider
provides written notice to the department pursuant to He-C 401.06(f) and (g) to
rescind or otherwise withdraw a written certification which the provider previously
issued, the qualifying patient’s:
(1) Application shall be considered incomplete if the registry
identification card has not yet been issued, and the applicant shall be issued
a refund of the application fee; or
(2) Registry identification
card shall become void upon notification by the department to the qualifying
patient.
(f) Upon learning of the death of a qualifying
patient, a surviving family member, caretaker, executor, or the qualifying
patient’s designated caregiver shall:
(1)
Notify the department that the qualifying patient has died, within 5
days of the death; and
(2)
Within 5 days of the death, dispose of any remaining cannabis by either:
a. Requesting a
local law enforcement agency to remove the remaining cannabis; or
b. Mixing the
remaining cannabis with other ingredients such as soil to render it unusable.
(g) As applicable, the department shall notify a
qualifying patient or designated caregiver of any changes described in (a)
through (f) above regarding their designated caregiver or qualifying patient,
respectively.
(h) A new registry identification card shall be
issued within 20 days for any change to a qualifying patient’s or designated
caregiver’s name or address.
(i) If a qualifying patient or designated
caregiver loses their registry identification card, whether due to loss, theft,
or destruction:
(1) They shall notify the department in writing within 10 days of
losing the card;
(2) They shall
submit payment of a fee pursuant to RSA 126-X:4, IX(f), and He-C 401.14(b)(4)
if they want a replacement card; and
(3) Within 5
days of such notification and payment, the department shall issue a new registry
identification card.
(j) A designated caregiver’s registry
identification card shall become void upon notification by the department to
the designated caregiver that all the qualifying patients for whom the
individual is acting as designated caregiver either have lost their status as
qualifying patients or have rescinded or otherwise ended the designation.
(k)
A voided registry identification card in (j) above shall be reactivated if a new qualifying patient
designates the caregiver, and the designated caregiver accepts that
designation, within the designated caregiver’s current registration period.
(l) A registry identification card that is
outdated, has expired, has been voided, except in the case of (j) above, or has
been revoked shall be destroyed by the cardholder.
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; amd by #10964, eff
11-2-15; ss by #13220, eff 7-1-21 (see Revision Note #2 at part heading for He-C
401)
He-C
401.14 Schedule and Payment of Fees.
(a) All fees required by this section shall be
paid as follows:
(1) By check or
money order for the exact amount of the fee or fine made payable to “Treasurer
– State of New Hampshire”;
(2) A money order or
certified check shall be required when payment has been made to the department
by check, and such check was returned for insufficient funds; and
(3) Any payment submitted to the department in the form of a
check or money order and returned to the state for
any reason shall be processed in accordance
with RSA 6:11-a.
(b) The department shall charge the following fee
amounts:
(1) For a
qualifying patient’s initial and renewal application, as required by He-C
401.04(b)(2), the fee shall be $50;
(2) For an
initial or renewal application for a minor patient, as required by He-C
401.08(e)(3), the fee shall be $50, even if there are 2 designated caregiver
applicants;
(3) For an initial
or renewal application for a guardianship patient, as required by He-C 401.09(e)(3),
the fee shall be $50, even if there are 2 designated caregiver applicants; and
(4) For issuance
of a replacement registry identification card due to loss, theft, or destruction,
pursuant to He-C 401.13(i), the fee shall be $10.
(c) There shall be
no fee for an application to become a designated caregiver.
(d) In the case of
(b)(2) and (b)(3) above, there shall be no additional fee if the second designated
caregiver is added after the patient has been approved and been issued a
registry identification card.
(e) All fees shall
be non-refundable.
(f) Notwithstanding (e) above, the department
shall issue a refund of an application fee if:
(1) Informed that
the patient applicant has died before the registry identification card has been
issued; or
(2) A written
certification is withdrawn by the certifying provider in accordance with He-C
401.13(e) before the registry identification card has been issued.
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
He-C 401.15 Confidentiality.
(a) The department shall maintain the
confidentiality of all information about applicants, qualifying patients,
designated caregivers, certifying providers, and ATCs that is contained in the
department’s registry, as provided by RSA 126-X, He-C 400, and the Health
Insurance Portability and Accountability Act (HIPAA) at 45 CFR 160, 162 and
164, as applicable.
(b) Notwithstanding (a) above, information in (a)
above shall be used and disclosed by the department to:
(1) Authorized employees of the department in the course
of their official duties;
(2) An individual or entity pursuant to an order from a
court of competent jurisdiction;
(3) Law
enforcement personnel in accordance with RSA 126-X:4, XI(b)(1)-(3), but such
information shall be limited to:
a. The location
associated with a qualifying patient, designated caregiver, or ATC; and
b. Whether a person
is a qualifying patient or a designated caregiver;
(4) Law
enforcement personnel in accordance with RSA 126-X:4, XI(b)(5), regarding
information related to falsified or fraudulent information submitted to the
department where counsel has made a legal determination that there is probable
cause to believe the information is false or falsified;
(5) The NH
board of medicine, the NH board of nursing, or the appropriate regulatory
entity in Maine, Massachusetts, or Vermont, pursuant to RSA 126-X:4, VII(c),
and RSA 126-X:2, VIII, but such information shall be related to the conveyance
of concerns regarding provider conduct;
(6) The health
and human services oversight committee established under RSA 126-X:13, to the
NH board of medicine, and the NH board of nursing in the department’s annual
data report required by RSA 126-X:10, except that only deidentified, aggregate
data required by RSA 126-X:10, IV, shall be released;
(7) To a
qualifying patient, a qualifying patient’s certifying provider, or a qualifying
patient’s designated caregiver for the purposes of carrying out these rules;
(8) To an
individual or entity pursuant to a release signed by the qualifying patient, designated
caregiver, certifying provider, or authorized ATC agent; and
(9) Individuals
or entities for the purposes of public health, health care operations, or
research if such release is consistent with all applicable HIPAA standards,
pursuant to RSA 126-X:10, VI.
(c) In order for information to be disclosed to
law enforcement personnel in accordance with (b)(3) above, the following shall
have occurred:
(1) Local or
state law enforcement personnel shall have detained or arrested an individual
who claims to be engaged in the therapeutic use of cannabis;
(2) A local or
state law enforcement officer shall have submitted a sworn affidavit to the
department affirming that they have probable cause to believe cannabis is
possessed at a specific address; or
(3) A local or
state law enforcement officer shall have submitted a sworn affidavit to the
department affirming that they have probable cause to believe a specific
individual possesses cannabis, and has also provided the person’s name and
address or name and date of birth.
(d) In accordance with RSA 126-X:4, II-a, the
department shall maintain the confidentiality of all criminal history records
information received.
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
He-C
401.16 Visiting Qualifying Patients.
(a) For a visiting qualifying patient, “provider”
means, pursuant to RSA 126-X:1, VII(b), “an individual licensed to prescribe
drugs to humans in the state of the patient’s residence and who possesses an
active registration from the United States Drug Enforcement Administration to
prescribe controlled substances.”
(b) Pursuant to RSA 126-X:2, V, a valid registry
identification card, or its equivalent, that is issued under the laws of
another state, district, territory, commonwealth, or insular possession of the
United States that allows, in the jurisdiction of issuance, a visiting
qualifying patient to possess cannabis for therapeutic purposes, shall have the
same force and effect as a valid registry identification card issued by the
department in this state, provided that:
(1) The
visiting qualifying patient shall also produce a statement from their provider
stating that the visiting qualifying patient has a qualifying medical condition
as defined in RSA 126-X:1, IX; and
(2) A visiting
qualifying patient shall not cultivate or purchase cannabis in New Hampshire or
obtain cannabis from ATCs or from a qualifying patient or designated caregiver.
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
He-C
401.17 Waivers.
(a) An individual seeking waivers of specific
rules in He-C 401 shall submit a written request for a waiver to the department
that includes:
(1)
The specific
reference to the rule for which a waiver is being sought;
(2)
A full
explanation of why a waiver is necessary;
(3)
A full
explanation of alternatives proposed, which shall be equally as protective of
public and patient health and safety as the rule from which a waiver is sought;
and
(4)
The period of time for which the waiver is sought.
(b) Waivers shall not exceed 12 months, or the
current registry identification card expiration date.
(c) A request for waiver shall be granted if the
department determines that the alternative proposed by the applicant or
licensee:
(1)
Meets
the objective or intent of the rule for which the waiver is sought; and
(2)
Does not
negatively impact the health or safety of any qualifying patient or the public.
(d) The individual’s subsequent compliance with
the alternatives approved in the waiver shall be considered equivalent to
complying with the rule from which waiver was sought.
(e) No provision or procedure prescribed by statute
shall be waived.
Source. (See
Revision Note #1 at part heading for He-C 401) #10646, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
He-C
401.18 Production of Cannabis-Infused
Products. A qualifying patient or
designated caregiver may produce cannabis concentrate only through either a
food or water-based extraction method. All other extraction methods shall be
prohibited.
Source. (See
Revision Note #1 at part heading for He-C 401) #10964, eff 11-2-15; ss by #13220, eff 7-1-21
(see Revision Note #2 at part heading for He-C 401)
PART He-C 402
ALTERNATIVE TREATMENT CENTERS
He-C
402.01 Purpose. The purpose of this part is to set forth the
registration requirements for alternative treatment centers (ATCs) pursuant to
RSA 126-X.
Source. #10731, eff
11-25-14; ss by #12653, eff 11-1-18
He-C
402.02 Scope. This part shall relate to the application,
registration, and operation of ATCs and related matters pursuant to RSA 126-X.
Source. #10731, eff
11-25-14; ss by #12653, eff 11-1-18
He-C
402.03 Definitions.
(a)
“Administrative remedy” means an action imposed upon an ATC in response to an
area of noncompliance.
(b) “Administrator” means the individual
appointed by the ATC to be responsible for all aspects of the daily operation
of the registered premises.
(c) “Advertising” means all representations
disseminated in any manner or by any means, other than by labeling or as
allowed in He-C 402.23, for the purpose of inducing, directly or indirectly,
the purchase of cannabis or cannabis-infused products (CIP).
(d)
“Alternative treatment center (ATC)” means “alternative treatment center” as
defined in
RSA 126-X:1, I, namely, “a not-for-profit entity registered under RSA 126-X:7
that acquires, possesses, cultivates, manufactures, delivers, transfers,
transports, sells, supplies, and dispenses cannabis, and related supplies and
educational materials, to qualifying patients, designated caregivers and ATCs.”
For the purpose of this definition,
“not-for-profit” means a corporation that is registered with the NH secretary
of state under RSA 292 and is a charitable trust pursuant to RSA 7:19 et seq
for the benefit of qualifying patients.
(e) “Applicant” means a not-for-profit
corporation seeking a registration to operate an ATC pursuant to RSA 126-X.
(f) “Area of noncompliance” means any action,
failure to act, or other set of circumstances that causes an ATC to be out of
compliance with RSA 126-X, He-C 402, or other state law or local ordinance.
(g)
“ATC agent (agent)” means “alternative treatment center agent” as defined in
RSA 126-X:1, II, namely, “a principal officer, board member, employee, manager,
or volunteer of an alternative treatment center who is 21 years of age or older
and has not been convicted of a felony or any felony drug-related offense.” This term includes executive employees and
corporate officers.
(h)
“ATC technician” means an employee of
the ATC who has been trained to dispense cannabis to qualifying patients and
their designated caregivers.
(i)
“Batch number” means any distinct group
of numbers, letters, or symbols, or any combination thereof, assigned to a
specific harvest batch of cannabis or a specific batch of cannabis concentrate.
(j)
“Cannabinoid profile” means the concentration, measured in percent by weight or
volume, of tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarian (THCV),
cannabichromene (CBC), cannabidiol (CBD), cannabidiolic acid (CBDA),
cannabidivarin (CBDV), cannabigerol (CBG), and cannabinol (CBN) contained in
the cannabis sample to be tested or saleable cannabis product.
(k) “Cannabis” means “cannabis” as defined in RSA
126-X:1, III, namely, “all parts of any plant of the Cannabis genus of plants,
whether growing or not; the seeds thereof; the resin extracted from any part of
such plant; and every compound, salt, derivative, mixture, or preparation of
such plant, its seeds, or resin. Such
term shall not include the mature stalks of such plants, fiber produced from
such stalks, oil, or cake made from the seeds of such plants, any other
compound, salt, derivative, mixture, or preparation of such mature stalks
(except the resin extracted therefrom), fiber, oil or cake, or the sterilized
seeds of such plants which are incapable of germination.”
(l)
“Cannabis concentrate” means any form of cannabinoid extracted from usable
cannabis plant material using an extraction method, such as water, food, carbon
dioxide, alcohol, or other chemical solvent as allowed by He-C 402.16(j)(1)c.
(m) “Cannabis-infused product (CIP)” means a
product infused with cannabis that is intended for use or consumption, other
than by smoking, including but not limited to edible products, ointments,
aerosols, oils, tinctures, and cannabis concentrate products prepared for dispensing.
These products, when created or sold by an ATC, shall not be considered a food
or a drug.
(n) “Cannabis waste” means:
(1)
Any unusable cannabis, including the seeds, stalks, stems, branches, and
roots or root ball of the cannabis plant;
(2)
Any usable, or previously or potentially usable, cannabis, cannabis
concentrate, or CIP that is discarded, found to contain contaminants, or is
otherwise recalled; and
(3)
Any usable cannabis or CIP that is returned to the ATC for whatever reason.
(o)
“Child-resistant” means packaging that
is:
(1)
Designed or constructed to be significantly difficult for children under
5 years of age to open and not difficult for adults to use properly;
(2)
Opaque so that the product cannot be seen from outside the packaging;
and
(3)
Closable for any product intended for more than a single use or
containing multiple servings.
(p) “Commissioner” means the commissioner of the
New Hampshire department of health and human services, or his or her designee.
(q)
“Compliance monitoring” means an on-site inspection of the registered premises
by the department to monitor compliance with RSA 126-X or He-C 402, investigate
a complaint, or verify the implementation of a plan of correction which
addresses an area of noncompliance.
(r) “Contaminant” means mold, fungus, bacterial diseases, rot, pests,
non-organic pesticides, mildew, mycotoxins, heavy metals,
and any chemical listed in He-C 402.34, Table 402.3.
(s) “Cultivation” means a method or process of growing
cannabis regardless of whether the growing medium is soil, soil-based,
hydroponic, aeroponic, aquaponic, or other method.
(t)
“Cultivation location’’ means a locked, indoor, and enclosed site under the
control of an ATC where cannabis is cultivated and processed, and which is
secured with one or more locks or other security devices in accordance with RSA
126-X and He-C 402.24, and which can be at a separate location from the
dispensing portion of the ATC.
(u) “Days” means calendar days unless otherwise specified
in the rule.
(v) “Department” means the New Hampshire
department of health and human services.
(w) “Designated caregiver’’ means “designated
caregiver” as defined in RSA 126-X:1, VI, namely, “an individual who:
(1)
Is at least 21 years of age;
(2)
Has agreed to assist with one or more (not to exceed 5) qualifying
patient’s therapeutic use of cannabis, except if the qualifying patient and
designated caregiver each live greater than 50 miles from the nearest ATC, in
which case the designated caregiver may assist with the therapeutic use of
cannabis for up to 9 qualifying patients;
(3)
Has never been convicted of a felony or any felony drug-related offense;
and
(4)
Possesses a valid registry identification card issued pursuant to RSA 126-X:4.”
(x) “Directed plan of correction” means a plan
developed and written by the department that specifies the actions the ATC
shall take to correct identified areas of noncompliance.
(y) “Dispense” means to distribute, give away, or
sell one or more doses of cannabis or CIP to a qualifying patient or designated
caregiver to be administered or taken at a different location than the ATC.
(z) “Dispensing error” means an error related to
the dispensing of cannabis including, but not limited to, dispensing a quantity
of cannabis that exceeds the amount a qualifying patient is allowed to obtain
in a 10-day period, dispensing cannabis to a person who has not registered with
the ATC, or dispensing cannabis that is mislabeled.
(aa) “Diversion” means the obtaining or
transferring of cannabis from a legal possession or use to an illegal use or to
a person not authorized to use or obtain cannabis under RSA 126-X or He-C 401
or 402.
(ab) “Duress alarm” means a silent security alarm
system signal generated by the entry of a designated code into an arming
station in order to signal that the alarm user is being forced to turn off the
system.
(ac)
“Emergency plan” means a document outlining the responsibilities of ATC
personnel in an emergency.
(ad)
“Executive employee” means an individual who is responsible for the oversight
or business management of the operations of the ATC, such as the chief
executive officer (CEO) or executive director (ED), chief operations officer
(COO) or director of operations, chief financial officer (CFO) or director of
finance, administrator, director of human resources, chief medical officer,
chief security officer, director of production or cultivation, director of
retail or dispensing, and any other individual responsible for the oversight or
business management of one or more of the ATC operations or primary functions.
(ae) “Geographic area” means an area of the state
of New Hampshire designated for use in the request for application process to
encourage the geographic separation of ATCs throughout the state, but which
does not limit in any way the choice of a qualifying patient to register with
any ATC, and includes:
(1)
“Geographic area 1” means Belknap, Rockingham, and Strafford counties;
(2)
“Geographic area 2” means Hillsborough and Merrimack counties;
(3)
“Geographic area 3” means Cheshire and Sullivan counties, and the town
of Hanover and the city of Lebanon in Grafton County; and
(4) “Geographic area 4” means
Carroll, Coos, and Grafton counties, not including the town of Hanover and the
city of Lebanon in Grafton County.
(af) “Harvest batch” means a specifically
identified quantity of processed cannabis, every portion or package of which is
uniform in strain, cultivated using the same herbicides, pesticides, and
fungicides, and harvested at the same time.
(ag) “Holdup alarm” means a silent alarm signal
generated by the manual activation of a device intended to signal a robbery in
progress.
(ah) “Inspection” means the process followed by
the department to determine an applicant’s or an ATC’s compliance with RSA
126-X and He-C 402 or to respond to allegations of noncompliance with RSA 126-X
or He-C 402.
(ai)
“Known allergen” means milk, egg, fish, crustacean shellfish, tree nuts, wheat,
peanuts, and soybeans.
(aj) “Limited access area” means a building, room,
or other contiguous area of the registered premises where cannabis or CIP is grown,
cultivated, stored, packaged, processed for sale, or disposed, where controls
of such cultivation functions can be accessed, where security system equipment and recordings are located, where servers containing
qualifying patient and inventory data are located, and where access is limited
to authorized personnel to enhance security.
(ak) “Panic alarm” means an audible security alarm
system signal generated by the manual activation of a device intended to signal
a life threatening or emergency situation requiring a law enforcement response.
(al)
“Paraphernalia” means accessories, devices, and other equipment, such as
smoking pipes or vaporizers, that facilitate the therapeutic use of cannabis.
This term includes “cannabis-related supplies.”
(am) “Plan of correction (POC)” means a plan
developed and written by the ATC, which specifies the actions that will be taken
to correct identified areas of noncompliance.
(an) “Procedure” means an ATC’s written,
standardized method of performing duties and providing services.
(ao) “Provider” means:
(1)
A physician or an advanced practice registered nurse licensed to prescribe
drugs to humans under RSA 329 or 326-B:18, respectively, and who possesses an
active registration from the United States Drug Enforcement Administration to
prescribe controlled substances; or
(2)
A physician or an advanced practice registered nurse licensed to
prescribe drugs to humans under the relevant state licensing laws in Maine,
Massachusetts, or Vermont, who possesses an active registration from the United
States Drug Enforcement Administration to prescribe controlled substances, and
who is primarily responsible for the patient’s care related to his or her
qualifying medical condition.
(ap) “Qualifying medical condition” means
“qualifying medical condition” as defined in RSA 126-X:1, IX.
(aq)
“Qualifying patient” means “qualifying patient” as defined in RSA 126-X:1, X,
namely “a resident of New Hampshire who has been diagnosed by a provider as
having a qualifying medical condition and who possesses a valid registry
identification card issued pursuant to RSA 126-X:4.”
(ar)
“Registered premises” means the building(s) that comprises the physical
location(s) that the department has approved for the registered ATC to conduct operations
in accordance with its registration to include the cultivation, processing,
storage, and dispensing of cannabis, CIP, and the sale or provision of
paraphernalia, cannabis-related supplies, and educational material.
(as) “Registration certificate” means the document
issued to an applicant or registrant at the start of operation as an ATC, and
annually thereafter, which authorizes operation in accordance with RSA 126-X
and He-C 402, and includes the name of the ATC, the name of the business, the
physical address, the effective dates, the name of the ATC administrator, the
registration number, and any waivers granted.
(at) “Registry identification card” means
“registry identification card” as defined in RSA 126-X:1, XI, namely, “a
document indicating the date issued and expiration date by the department
pursuant to RSA 126-X:4 that identifies an individual as a qualifying patient
or a designated caregiver.”
(au) “Reportable incident” means:
(1)
Confidential information accessed or disclosed in violation RSA 126-X or
He-C 402;
(2)
Loss of or discrepancies in cannabis inventory including but not limited
to theft or diversion;
(3)
Unauthorized intrusion or entry into the registered premises;
(4)
When there is reason to believe there is a violation of RSA 126-X or
department rules by an ATC or its agents;
(5)
Alarm activation requiring a response by public safety personnel;
(6)
Failure of the security alarm system for a period greater than 8 hours;
(7)
Any accident occurring during transport of cannabis or CIP; or
(8)
Dispensing errors.
(av) “Seedling” means “seedling” as defined in RSA
126-X:1, XII, namely, “a cannabis plant that has no flowers and is less than 12
inches in height and less than 12 inches in diameter.”
(aw) “Statement of findings” means a document
issued by the department following an inspection or investigation identifying
areas in which the ATC is not in compliance with He-C 402 or RSA 126-X and
which sets forth the evidence that supports the findings of noncompliance.
(ax)
“Therapeutic use” means “therapeutic use” as defined in RSA 126-X:1, XIII,
namely, “the acquisition, possession, cultivation, preparation, use, delivery,
transfer, or transportation of cannabis or paraphernalia relating to the
administration of cannabis to treat or alleviate a qualifying patient’s
qualifying medical condition or symptoms or results of treatment associated
with the qualifying patient’s qualifying medical condition. It shall not include:
(1)
The use of cannabis by a designated caregiver who is not a qualifying
patient; or
(2)
Cultivation or purchase by a visiting qualifying patient; or
(3)
Cultivation by a designated caregiver or qualifying patient.”
(ay) “Unusable cannabis” means “unusable cannabis”
as defined in RSA 126-X:1, XIV, namely, “any cannabis, other than usable
cannabis, including the seeds, stalks, and roots of the plant.”
(az) “Usable cannabis” means “usable cannabis” as
defined in RSA 126-X:1, XV, namely, “the dried leaves and flowers of the cannabis
plant and any mixture or preparation thereof, but does not include the seeds,
stalks, and roots of the plant and does not include the weight of any
non-cannabis ingredients combined with cannabis and prepared for consumption as
food or drink.”
(ba)
“Visiting qualifying patient” means “visiting qualifying patient” as defined in
RSA 126-X:1, XVI, namely, “a patient with a qualifying medical condition who is
not a resident of New Hampshire or who has been a resident of New Hampshire for
fewer than 30 days and is not eligible to purchase therapeutic cannabis in New
Hampshire or receive cannabis from a qualifying New Hampshire patient.”
(bb) “Written certification” means documentation
of a qualifying medical condition by a provider for the purpose of issuing
registry identification cards, after having completed a full assessment of the
patient’s medical history and current medical condition in accordance with He-C
401.06(b)(2) and made in the course of a provider-patient relationship, and
which includes the date of issuance, the patient’s qualifying medical
condition, symptoms or side effects, the certifying provider’s name, medical
specialty, and signature.
Source. #10731, eff
11-25-14; amd by #10961, eff 10-23-15; ss by #12653, eff 11-1-18
He-C 402.04 Fees.
(a) Each ATC shall be assessed a fee for its
allocated portion of the expenses of the program, as follows:
(1) The
department shall determine actual program expenses for the previous state fiscal
year (SFY);
(2) The department shall determine the
actual allocation of program expenses based on each ATC’s percentage of the
total quantity of ounces of usable cannabis dispensed from the previous SFY;
(3) The
department shall determine the prior year adjustment for each ATC based on (1)
and (2) above;
(4) The department shall determine projected program
expenses for the next SFY, including expenses for personnel and other expenses
related to the administration of the program, minus the projected revenue to be
received as application fees from qualifying patients and designated
caregivers;
(5) The department shall add to the projected program
expenses in (4) above any remaining balance of program expenses from the prior
SFY to determine the balance due to the department; and
(6) The total
balance due in (5) above shall be allocated among each of the 4 ATCs based on
each ATC’s percentage of the total quantity of ounces of usable cannabis
projected to be dispensed in the upcoming SFY and after applying the prior year
adjustment for each ATC.
(b) Each ATC shall pay to the department the
allocated amount in (a)(6) above within 30 days of the department’s notice
stating the balance due.
(c) If a new ATC joins the program during a SFY,
the department shall recalculate the allocation among all the ATCs for that
SFY.
(d) All fees shall be non-refundable and
non-transferable.
(e) All fees shall be made payable to the
“Treasurer, State of New Hampshire.”
(f) Any fees submitted to the department in the
form of a check or money order and returned to the state for any reason, shall
be processed in accordance with RSA 6:11-a.
(g) Other fees for ATCs shall be as follows:
(1) The request for application (RFA) submission
fee shall be $3000;
(2)
The RFA selection fee, which will be credited to the new ATC as part of the
allocation described in (c) above, shall be $20,000;
(3) For a change in name, the fee shall be $250;
(4) For a change in administrator, the fee shall
be $250; and
(5) For a change in location, the fee shall be
$30,000.
(h) All funds received under this section shall
be deposited to the non-lapsing registry identification card and certificate
account established pursuant to RSA 126-X:11.
Source. #10731, eff
11-25-14; ss by #12076, eff 1-1-17; ss by #12653, eff 11-1-18
He-C 402.05 Registration of ATCs.
(a)
Only an ATC that is currently registered by the department and has been
issued a registration certificate may cultivate and dispense cannabis or CIP to
qualifying patients and designated caregivers who have been issued a registry
identification card from the department. However, an entity that has been issued a
conditional registration certificate in accordance with (i) below may perform
all operations described in He-C 402 appropriate for that location, in
anticipation that the entity will become fully operational.
(b)
Each ATC selected as part of the RFA process shall provide to the
department the fee of $20,000 in accordance with He-C 402.04(g)(2) within 10
days of the department’s notice that the entity has been selected. Failure to
provide the fee within the required timeframe shall result in forfeiture of the
selection and shall prevent the entity from submitting an application in (c) below.
(c)
Each ATC selected as part of the RFA process shall submit the following
to the department within 90 days of the department’s notice that the entity has
been selected:
(1) A completed application:
a. Signed by the applicant or 2 of the corporate
officers affirming the following:
“I affirm that I have
read and understand the requirements of RSA 126-X and the rules adopted
thereunder and that the premises are in compliance with that statute and
rule. I understand that providing false
or misleading information shall be grounds for denial, suspension, or
revocation of the registration and the imposition of a fine.”; and
b. Containing the following information:
1. The name of the ATC;
2.
The physical address of the ATC
and, if applicable, the physical address of a second location for cultivation
and processing operated by the ATC;
3. The mailing address of the ATC if different
from the physical address;
4. The telephone number of the ATC;
5. The name of the ATC’s administrator; and
6. The email address for the ATC’s administrator,
and for the ATC if different;
(2) A “Certificate of Good Standing” issued by
the NH secretary of state authorizing the ATC to do business as a
not-for-profit corporation in the state of New Hampshire;
(3)
Proof of registration with the NH attorney general’s office as a charitable
trust under
RSA 7:19 et seq for the benefit of qualifying patients;
(4) A copy of the ATC’s articles of agreement;
(5) A copy of the ATC’s bylaws;
(6) A statement detailing any instances in which
a prospective board member, corporate officer, or executive employee who
previously ran a business or managed or sat on the board of directors of a
corporation was convicted, fined, censured, or had a registration,
certification, or license suspended or revoked in any administrative or
judicial proceeding, or any instances in which the business or corporation
itself was subject to such an action, if this information was not included in
the RFA application;
(7) A floor plan of the prospective ATC, to
include a complete description and layout of the indoor, enclosed, locked
facility, in which all limited access areas are clearly indicated in the
diagram of the registered premises, reflecting walls, partitions, counters, and
all areas of entry and exit. Said diagram shall also show all propagation,
vegetation, flowering, processing, production, storage, disposal, and retail
sales areas;
(8) An organization chart indicating ATC board
members, executive employees, and corporate officers. The chart shall contain,
or be accompanied by a list of, the names of the individuals occupying these positions;
(9) Resumes for the ATC board members, executive
employees, and corporate officers;
(10)
The name, address, and date of birth of each executive employee, corporate
officer, and member of the board of directors of the ATC, if the resumes in (9)
above do not contain this information;
(11) Written local approvals as follows:
a. For an existing building, the following
written local approvals shall be obtained no more than 90 days prior to
submission of the application, from the following local officials or if there
is no such official(s), from the board of selectmen or mayor:
1. The health officer verifying that the
applicant complies with all applicable local health requirements, drinking
water and wastewater requirements;
2. The building official verifying that the
applicant complies with all applicable state building codes and local building
ordinances;
3. The zoning official verifying that the
applicant complies with all applicable local zoning ordinances; and
4. The fire chief verifying that the applicant
complies with Saf-C 6000, the state fire code, including, but not limited to,
the applicable chapter of National Fire Protection Association (NFPA) 101, as
adopted by the commissioner of the department of safety under RSA 153, and as amended
pursuant to RSA 153:5, I, by the state fire marshal with the board of fire
control, and local fire ordinances applicable for an agricultural processing
and retail sales facility; or
b. For a building under construction or
undergoing renovation:
1. The local approvals of the construction or
renovation plans; and
2. The final local approvals required by a.
above shall be submitted upon completion of the construction or renovation
project;
(12)
The results of a federal and NH state criminal records check conducted by the
NH department of safety for every corporate officer, board member, and
executive employee pursuant to RSA 126-X:8, IV(a), and RSA 126-X:4, II-a;
(13) If the ATC uses a private water supply,
documentation that the water supply has been tested in accordance with and
meets the requirements of RSA 485 and Env-Dw 700, or if a public water supply
is used, a copy of a water bill;
(14) The distance, in feet, from any pre-existing
designated drug-free school zone located within 1320 feet of the registered
premises;
(15)
A list of all persons or entities not included in the RFA and having direct or
indirect authority over the management or policies of the ATC, including the
members of the not-for-profit corporation, and a list of all persons or
entities contributing $5000 or more of the initial capital to operate an ATC,
including capital that is in the form of land or buildings. Identify any
conditions on such funds or property; and
(16) Documentation of liability insurance coverage
in the amount of 2 million dollars.
(d)
The applicant shall mail or hand-deliver the documents in (c) above to:
Department
of Health and Human Services
Health
Facilities Administration
Therapeutic
Cannabis Program
129
Pleasant Street
Concord,
NH 03301
(e)
An application for an initial registration shall be complete when the
department determines that all items required by (c) above have been received.
(f)
If an application does not contain all of the items required by (c)
above, the department shall notify the applicant in writing of the items
required before the application can be processed.
(g)
The department shall deny a registration certificate request in
accordance with RSA 126-X:8,V, after reviewing the information in (c)(12) above
if it determines that a corporate officer, a board member, or executive
employee has been convicted of a felony in this or any other state.
(h) Following an inspection, a notice
of registration approval shall be issued if the department determines that an applicant
requesting an initial registration is in full compliance with RSA 126-X and
He-C 402, including payment of all applicable fees.
(i)
Notwithstanding (h) above, if an entity intends to have a cultivation
location separate from its dispensing location, and if it completes
construction of either location before it completes construction of the other
location, the department shall issue a conditional registration certificate
authorizing the entity to perform all operations described in He-C 402 applicable
to that location, provided that:
(1) The entity has submitted an application for a
registration certificate;
(2) The entity has paid all non-refundable fees
required under He-C 402.04;
(3) The entity has received local approvals for the
location required under He-C 402.05(c)(11); and
(4) The location has been inspected by the
department and found to be in full compliance with RSA 126-X and these rules.
(j)
If a conditional registration certificate is issued under (i) above, the
entity shall not open its other location and until such time as the department
has inspected the other location, found it to be in full compliance with RSA
126-X and these rules, and informed the entity in writing that it may open its
other location.
(k)
In the event that a conditional registration certificate is issued under
(i) above and the entity does not subsequently open its dispensing location pursuant
to RSA 126-X:7, VIII, any cannabis cultivated or CIP produced shall either be
transferred or sold to another NH ATC or, if such sale or transfer is not
possible, shall be considered waste and shall be destroyed and discarded as
waste in accordance with He-C 402.22 under the supervision of the department.
Source. #10731, eff
11-25-14; ss by #10961, eff 10-23-15; ss by #12076, eff 1-1-17; ss by #12653,
eff 11-1-18
He-C
402.06 Renewal Requirements for ATCs.
(a)
An ATC’s registration certificate shall be effective for one year and
shall expire on June 30 of the following year unless a completed application
for renewal is received prior to the expiration of the current registration.
(b) Each ATC shall complete and submit
to the department the application described in He-C 402.05(c)(1) at least 120
days prior to the expiration of the current registration.
(c)
The ATC shall submit with the renewal application:
(1) The materials required by:
a. He-C 402.05(c)(3);
b. He-C 402.05(c)(4) and (5), if either has
changed;
c. He-C 402.05(c)(6),
for new board members, corporate officers, and executive employees, or new
instances involving existing board members, corporate officers, and executive employees;
d. He-C 402.05(c)(7), if changed;
e. He-C 402.05(c)(8), if there are new board
members, corporate officers, and executive employees, or if existing roles have
changed;
f. He-C 402.05(c)(9),
for new board members, corporate officers, and executive employees; and
g. He-C 402.05(c)(10),
for new board members, corporate officers, and executive employees, or if
existing information has changed;
(2)
If the ATC uses a private water supply, documentation that the water supply has
been annually tested in accordance with and meets the requirements of RSA 485
and Env-Dw 700;
(3)
A request for renewal of any existing non-permanent waiver previously granted
by the department, in accordance with He-C 402.26, if applicable; and
(4)
A copy of any existing, non-permanent variances and any new variances applied
for or granted by the state fire marshal, in accordance with Saf-C 6005.03 and
Saf-C 6005.04.
(d)
Following an inspection as described in He-C 402.28, a registration certificate
shall be issued if the department determines that the ATC:
(1) Submitted an application containing all the
items required by (c) above as applicable, prior to the expiration of the
current registration;
(2) Has submitted a POC that has been accepted by
the department and implemented by the ATC if areas of noncompliance were cited
at the last inspection or investigation; and
(3) Is in compliance with RSA 126-X and He-C 402.
Source. #10731, eff
11-25-14; amd by #10961, eff 10-23-15; ss by #12076, eff 1-1-17; ss by #12653,
eff 11-1-18
He-C
402.07 Requirements for
Organizational or Service Changes.
(a)
The ATC shall provide the department with written notice at least 30 days prior
to changes in mailing address or name.
(b)
When there is a change in the name, the ATC shall submit to the department a
copy of the certificate of amendment from the New Hampshire secretary of state,
if applicable.
(c)
In the case of a change in physical
location, at least 90 days prior to the move, an ATC shall submit the
information required by He-C 402.05(c)(1), (6), (7), (11), (13), and (14) for
the new location, and a new registration certificate shall be issued by the
department in accordance with He-C 402.05(h).
An ATC shall not open at the new location until final approval is
provided by the department.
(d) In the case of a change in physical location,
the current registration certificate shall expire and a new registration
certificate shall be issued for the new location by the department which shall
be valid until the expiration date of the prior registration certificate.
(e) An inspection by the department shall be
conducted in accordance with He-C 402.28 prior to operation for changes in the
physical location of the ATC.
(f) A change of ownership of the ATC shall not be
allowed.
(g) The ATC shall notify the department whenever
there is a proposed change in corporate officers, board members, or executive
employees.
(h) The results of a federal and NH state
criminal records check shall be submitted to the department for any change in
corporate officers, board members, or executive employees of an ATC.
(i) The ATC shall inform the department in
writing with 30 days advance notice, or as soon as practicable in the event of
a death or other extenuating circumstances which would make impossible such
notice, when there is a change in administrator and provide the department with
the following:
(1) A resume identifying the name and
qualifications of the new administrator; and
(2)
The results of a criminal records check from the NH department of safety for
the new administrator.
(j) The name of the new administrator shall be
subject to public disclosure upon the effective date of the change, but the
information contained in (i)(1)-(2) above shall remain confidential.
(k)
A revised registration certificate shall be issued for changes in the ATC name,
location, administrator, mailing address, or when a waiver is granted.
(l)
The ATC shall notify the department at least 90 days in advance of any
renovations or new construction that alter the floor plan of the registered
premises.
(m) Renovations or new construction at the ATC
shall comply with all local and state building and fire codes based on the
intended use of the registered premises.
(n) Local approvals shall be required for the
fire department, building code enforcement, and zoning for all renovations and
new construction at the ATC.
(o) An inspection by the department shall be conducted
in accordance with He-C 402.28 prior to operation for all renovations and new
construction at the ATC.
(p) An ATC shall provide notice of closure or cessation
of services as follows:
(1) Written notice shall be provided
to the department, and to all qualifying patients and designated caregivers
registered with the ATC, no later than 60 days prior to the intended closure;
(2)
Written notice provided to qualifying patients and designated caregivers
shall be mailed in non-descript envelopes that do not identify the ATC in any
way; and
(3)
Notice of the closure shall be prominently posted in the ATC.
Source. #10731, eff
11-25-14; amd by #10961, eff 10-23-15; ss by #12653, eff 11-1-18
He-C
402.08 Prohibitions.
(a) An ATC shall not dispense or otherwise
transfer cannabis to a person other than a registered qualifying patient or his
or her designated caregiver except that it may acquire cannabis from or sell
cannabis to another New Hampshire ATC as allowed by RSA 126-X:8, XV(b)(3), and
pursuant to He-C 402.
(b) Only an ATC technician shall dispense
cannabis, CIP, paraphernalia, or cannabis-related supplies to qualifying patients
and designated caregivers.
(c) No ATC agent shall dispense cannabis samples
to any person.
(d)
No ATC agent shall sell anything other than cannabis, CIP, paraphernalia,
cannabis-related supplies, and educational materials about cannabis.
(e) No ATC or ATC agent shall violate the
confidentiality provisions of He-C 402.25.
(f) No cannabis or CIP shall be consumed on the
registered premises or grounds of the ATC.
(g) An ATC shall not dispense cannabis or CIP
unless labeled and packaged in accordance with He-C 402.19.
(h)
No ATC technicians, employees, or agents shall make home deliveries of cannabis,
CIP, paraphernalia, or cannabis-related supplies, or dispense such products
anywhere except at the ATC dispensary location.
(i)
An ATC shall not adulterate cannabis or CIP, including with drugs or
medication, alcohol, psychoactive additives, or illicit substances, except that
alcohol may be used in the extraction process to create a cannabis concentrate
and may be present as necessary in CIP that are tinctures.
(j) The ATC shall not advertise their location,
products, or services in a manner prohibited by He-C 402.23.
(k) ATC agents shall not falsify any
documentation required by law or provide false or misleading information to the
department.
(l) No ATC agent or persons connected to an ATC
shall:
(1)
Accept or solicit any form of pecuniary remuneration from a provider, or
offer any form of pecuniary remuneration to a provider except if the provider
is employed by the ATC and the provider does not issue written certifications
to patients;
(2)
Offer a discount or other thing of value to a patient who uses or agrees
to use a particular provider;
(3) Permit a provider to examine a
patient in relation to issuing a written certification at a location where
cannabis is sold or distributed; or
(4)
Provide an economic benefit to a provider who issues written
certifications to patients.
(m)
The prohibitions in (l) above shall not be construed to prohibit an ATC from
providing information to potentially qualifying patients about providers in the
community who may issue written certifications, provided, however, that the
prohibitions in (l) above are not violated.
(n) No ATC shall be located in a zoned
residential district or within a pre-existing drug-free school zone.
Source. #10731, eff
11-25-14; amd by #10961, eff 10-23-15; ss by #12653, eff 11-1-18
He-C
402.09 Policies and Procedures.
(a) Each ATC shall comply with all relevant state
and local laws, rules, codes, and ordinances, as applicable.
(b) Each ATC shall develop and implement a set of
detailed written operating procedures and policies governing the operation of
the ATC, to include, but not be limited to, the following:
(1)
Security measures in compliance with RSA 126-X, He-C 402.17(a), and He-C
402.24;
(2)
Employee security policies, including personal safety and crime
prevention techniques;
(3)
A description of the ATC’s hours of operation and after-hours contact
information, which is updated and provided to the department as changes occur,
and made available to local law enforcement officials upon request;
(4)
Storage of cannabis in compliance with He-C 402.17;
(5)
Description of the various strains of cannabis to be cultivated and
dispensed, and the types of CIP to be dispensed, subject to the following:
a. Descriptions shall
also be categorized by relative cannabinoid concentration, for example, high
and low THC and CBD strains and products; and
b. Brand names or commercial names of cannabis
strains shall not be utilized in any public manner, including on labels or
being posted on an ATC’s website, social media site, or newsletters, except
that such brand names or commercial names may be made available to qualifying
patients and designated caregivers at the dispensary or by direct communication
with the patient or caregiver, such as by phone or direct email communication;
(6)
Procedures to ensure accurate recordkeeping, including inventory protocols;
(7)
Plans for quality control, including procedures to avoid contaminants in
compliance with He-C 402.14 through He-C 402.18;
(8)
Personnel policies which govern all ATC agents, including volunteers, and
which comply with He-C 402.31, and personnel records which comply with He-C
402.32;
(9)
A staffing plan that will ensure staffing that covers business hours and
meets operational requirements in a manner that meets the needs of qualifying
patients and designated caregivers;
(10)
Emergency procedures, including a disaster plan, with procedures to be
followed in case of fire or other emergencies, and a plan for continuing
operations in the case of such an event;
(11)
A mandatory policy that prohibits the consumption of alcohol, tobacco,
and illicit drugs in the workplace;
(12)
A policy on the possession and use of therapeutic cannabis at the
workplace by ATC agents who are qualifying patients which is consistent with
the limitations established in RSA 126-X:3 or which may prohibit such possession
and use;
(13) A plan describing how confidential information
will be maintained and the method by which release of information from a qualifying
patient’s record shall occur in accordance with He-C 402.25;
(14)
A description of the ATC’s education activities in accordance with RSA
126-X and He-C 402.21;
(15)
The procedures by which the ATC determines the price it charges for
cannabis, CIP, paraphernalia, and cannabis-related supplies, and a record of the
prices charged, which records shall be maintained as required by He-C
402.32(a);
(16)
Written policies and procedures for the production and distribution of
cannabis and CIP, which shall include but not be limited to:
a. Methods for identifying, recording,
and reporting diversion, theft, or loss, and for correcting all errors and
inaccuracies in inventories;
b.
A procedure for handling voluntary and mandatory recalls of cannabis. Such
procedure shall be adequate to deal with recalls due to any action initiated at
the request or order of the department, and any voluntary action by an ATC to
remove defective or potentially defective cannabis from the market, as well as
any action undertaken to promote public health and safety;
c. A procedure for ensuring that any
outdated, damaged, deteriorated, mislabeled, or contaminated cannabis is
segregated from other cannabis and destroyed pursuant to He-C 402.22. This
procedure shall provide for written documentation of the disposition of the
cannabis; and
d.
Policies and procedures for the transfer, acquisition, or sale of
cannabis between ATCs;
(17)
A policy for the discipline of ATC agents who engage in unsafe practices
with regard to the operation of the ATC, including the immediate dismissal of
any agent who diverts cannabis;
(18)
The applicant’s plan for making cannabis, CIP, paraphernalia, and
cannabis-related supplies available on an affordable basis to qualifying
patients with verified financial hardship:
a.
Which shall include qualifying patients enrolled in Medicaid or
receiving Supplemental Security Income or Social Security Disability Insurance;
b.
Which identifies the extent to which the plan includes other qualifying
patients with verified financial hardship, and if so, the method by which
financial hardship is determined;
c.
Which shall include an alternate price list or percentage discount; and
d.
Which shall not include an administrative fee for determining such hardship;
(19)
A policy that requires ATC employees and volunteers to receive approval
from the ATC’s administrator, or designee, to speak at independently sponsored
events, to write articles for publication, or to otherwise engage in a public
manner on the subject of therapeutic cannabis, and if such approval is granted,
requires the ATC agent to disclose his or her employment or relationship with
the ATC and, as applicable, make clear that the event, presentation, or article
is not one that is sponsored or sanctioned by the ATC and that the person does
not represent the ATC;
(20)
Any rule in He-C 402 that requires a policy or procedure; and
(21)
Policy and procedure review, including:
a.
Reviewing all policies and procedures at least annually and documenting
such review; and
b.
Revising them as needed.
Source. #10731, eff
11-25-14; ss by #12653, eff 11-1-18
He-C
402.10 Operational Requirements.
(a) An ATC shall be required to be a not-for-profit
corporation registered under RSA 292 and in good standing with the NH secretary
of state.
(b) An ATC shall operate on a not-for-profit basis
as a charitable trust pursuant to RSA 7:19 et seq. for the benefit of
qualifying patients.
(c) An ATC shall ensure that its property, real
and personal, revenue, and expenses are managed and controlled in furtherance
of its not-for-profit purpose and that the board and all persons delegated by
the board to manage and control its property, real and personal, revenue, and
expenses shall have a fiduciary duty to benefit its patients and further its
not-for-profit purpose.
(d) All transactions, financial or otherwise,
shall be consistent with the not-for-profit provisions of RSA 126-X and for the
benefit of qualifying patients.
(e) An ATC shall have bylaws that, at a minimum,
include:
(1)
Mission or purpose;
(2)
Criteria for, composition of, and terms of the board of directors,
including that the board, pursuant to RSA 126-X:7, IV(a)(4):
a. Includes at least one physician, advance
practice registered nurse, or pharmacist licensed to practice in New Hampshire,
except that such medical professional shall not maintain an ownership interest
in the ATC;
b. Includes at least one patient qualified to
register as a qualifying patient; and
c. Consists of a majority of New Hampshire
residents;
(3)
Requirements for board meetings;
(4)
Procedures for the selection and replacement of corporate officers,
their governance and duties;
(5)
Provisions relative to dissolution of the not-for profit corporation’s
assets, which shall ensure that they are treated in accord with its
not-for-profit purpose and for the benefit of qualifying patients;
(6)
A conflict of interest policy governing the board and corporate officers;
and
(7)
A financial policy governing financial transactions, that ensures they
are in the corporation’s best interest and are consistent with the
not-for-profit purpose of the corporation and RSA 7:19-a.
(f) The ATC shall be open for business for a
sufficient number of hours to meet the needs of qualifying patients and
designated caregivers, at a minimum of 20 hours per week. Such hours shall be
posted at the ATC, published on the ATC’s website if the ATC maintains a
website, and made available to local law enforcement officials upon request.
(g)
The ATC shall ensure the presence of an ATC technician whenever a qualifying
patient or designated caregiver is in the dispensing area.
(h)
At no time shall there be fewer than 2 ATC agents at each location of the
registered premises during all hours of operation, including when the ATC is
open for business and whenever the ATC’s operations require agents to be
present at the registered premises, except that an executive employee shall be
allowed to be on-site at the registered premises, on a limited basis, for a
specific identified need, with the approval of the administrator, and in accordance
with the ATC’s written policy including documentation of such instances.
(i) An ATC shall have an identification system in
place for all ATC agents that meets the requirements of He-C 402.31.
(j) An ATC shall limit access to the registered premises
to only those persons authorized to have access in accordance with He-C 402.24.
(k) The ATC shall post the following documents as
follows:
(1)
At the dispensing location, the current registration certificate issued
in accordance with RSA 126-X, all statements of findings issued by the
department in the prior year for both the dispensing location and the cultivation
location, and the hours of operation, in a public and conspicuous area; and
(2)
At the cultivation location, the current registration certificate issued
in accordance with RSA 126-X and all statements of findings issued by the
department in the prior year, for both the dispensing location and the
cultivation location, in a conspicuous area.
(l) The ATC shall immediately report the
diversion, loss, or theft of any cannabis to the appropriate law enforcement
authority and to the department.
(m) Any disciplinary action taken against an
agent pursuant to He-C 402.09(b)(17) shall be reported to the department.
(n) An ATC shall submit an incident report to the
department no later than the next business day after it discovers a reportable
incident.
(o) Incident reports shall include the following:
(1)
The ATC name and contact information;
(2)
A description of the incident, including its cause, and identification
of injuries, if applicable;
(3)
The name(s) of agents or other persons involved in the incident, if
applicable;
(4)
The date and time of the incident;
(5)
The action taken in direct response to the incident;
(6)
The identity of any law enforcement or emergency personnel contacted or
allowed into the registered premises as a result of the incident; and
(7)
The signature of the person reporting the incident.
(p) The ATC shall maintain a current database of qualifying
patients and designated caregivers who have registered with the ATC, which
shall be updated to include:
(1)
The list transmitted by the department on a daily, monthly, or as-needed
basis to the ATC, which includes a list of the names, registry identification
numbers, and contact information of qualifying patients and designated
caregivers who have registered with that ATC or who are no longer registered
with that ATC; and
(2)
Any other updates provided by the department.
(q) The ATC shall submit an annual report to the
department, not later than August 1, containing the following information for the previous state fiscal year ending
on June 30:
(1)
The strains of cannabis dispensed,
which shall also be categorized by the concentration of cannabinoids based on
the cannabinoid profile, for example, high and low THC and CBD strains, the
forms of prepared cannabis dispensed, and the effectiveness,
as reported by the qualifying
patient or designated caregiver,
of cannabis used;
(2) Satisfaction
of qualifying patients with the ATC and with the therapeutic cannabis program
in general, including information received from qualifying patients via a
satisfaction survey administered by the ATC;
(3) Any product
recalls and cannabis batches destroyed, including the date, amount, and reasons
therefor;
(4) A
description of the ATC efforts to educate qualifying patients and designated
caregivers;
(5) The annual
financial report of the ATC including:
a. The revenue
received for the sale of cannabis by the form of cannabis, either flower or
CIP, the type of CIP, and the category
of cannabis based on the concentration of cannabinoids, for example, high and
low THC and CBD strains; and
b. The
expenditures, liabilities, and monetary reserves available;
(6) A report of
the total number of qualifying patients and designated caregivers served;
(7) A description of the ATC’s program for reduced
cost for qualifying patients with documented financial hardship to include the
number of qualifying patients eligible for the reduction, the amount of the
reductions, and the total amount of the discounts provided;
(8) Information
about security issues, including an aggregate report of all reportable
incidents;
(9) Information
about best practices, including any recommendations for program improvement;
(10)
Information about any complaints received by the ATC from qualifying
patients, designated caregivers, or the general public; and
(11) A
description of the efforts and activities of the ATC that contribute to the
ATC’s mission as a charitable trust to benefit qualifying patients.
(r) Within 10 days of filing the annual report
required by RSA 7:28 with the office of the New Hampshire attorney general
charitable trusts unit, the ATC shall file the report with the department.
Source. #10731, eff
11-25-14; amd by #10961, eff 10-23-15; ss by #12653, eff 11-1-18
He-C 402.11 Acquisition and Transportation of Cannabis.
(a) An ATC may acquire cannabis and CIP from, or
sell cannabis and CIP to, another New Hampshire ATC.
(b) Transportation of cannabis and CIP shall be
permitted as follows:
(1)
Between ATCs;
(2)
From an ATC to a laboratory for testing;
(3)
From an ATC to a waste disposal or compost site, except that the requirements
in this section shall not apply to the transportation of cannabis waste
rendered unusable in accordance with He-C 402.22; and
(4)
To and from different locations of the registered ATC.
(c) Transportation of cannabis and CIP shall be
conducted by at least one ATC employee.
(d) An ATC shall create a transport manifest for
each transportation event, to include:
(1)
Departure date and time of departure;
(2)
Name, location address, and registration certificate number of the
originating ATC;
(3)
Name, location address, and registration certificate number, as
applicable, of the destination entity;
(4) Product type and quantity, in weight, of all
product to be transported;
(5)
Estimated time of arrival, which shall be the on same date as the
product’s departure; and
(6)
Name(s) of the ATC employee(s) transporting the product.
(e) The originating ATC shall transmit a copy of
the transport manifest to the destination entity prior to transport.
(f) The transport manifest shall be signed and
dated by an ATC authorized employee upon departure at the originating ATC,
other than an employee providing transport, and by an authorized employee of
the receiving entity upon arrival, other than an employee providing transport.
(g) The destination entity shall verify and
document the type and quantity of the transported product against the transport
manifest transmitted in (e) above and return a copy of the signed and verified
transport manifest to the originating ATC.
(h) All cannabis and CIP transported shall be
tracked as inventory in accordance with He-C 402.13.
(i) All cannabis and CIP transported shall be
packaged in accordance with He-C 402.19(b)(5).
(j) All cannabis and CIP shall be transported in
containers so as not to be visible or recognizable from outside the vehicle.
(k) All cannabis and CIP shall be transported in
locked containers:
(1) Except that an ATC may choose
instead to have 2 ATC employees conduct the transportation;
(2)
Except when being transported between different ATCs, which shall
require the transport to be conducted by 2 ATC employees; and
(3)
Except when the cannabis sample is being transported for testing.
(l) When the use of locked transport containers
is required by (k) above, ATC employees providing transport shall not have
access to the key to the locked transport containers.
(m) The vehicle shall not bear any markings to
indicate that the vehicle is transporting cannabis and CIP nor shall it bear
the name of the ATC.
(n) The vehicle shall travel directly to the
receiving entity, without stopping.
(o) When unforeseen circumstances require the vehicle
to stop unexpectedly, for example, if stopped by a law enforcement officer or
if there is a personal emergency, a detailed log shall be created describing:
(1)
The reason for the stop;
(2)
The duration of the stop;
(3)
The location of the stop; and
(4)
The activities of those persons exiting the vehicle, if applicable.
(p) In no case shall a vehicle transporting
cannabis and CIP be left unattended at any time.
(q) ATC
employees providing transport shall have communication access with personnel at
the originating entity at all times that the vehicle contains cannabis and CIP.
(r) All records required by this section shall be
maintained for a minimum of 4 years.
(s) Any vehicle used to transport cannabis and
CIP shall be properly registered and inspected in the state in which it is
registered.
Source. #10731, eff
11-25-14; ss by #12653, eff 11-1-18
He-C
402.12 Permitted Quantities of
Cannabis at an ATC.
(a) An ATC shall not possess or cultivate
cannabis in excess of the following quantities:
(1) Three mature cannabis plants, 12
seedlings, and 6 ounces of usable cannabis for each qualifying patient who has
registered with the ATC to provide him or her with cannabis for therapeutic
use; and
(2) Up to an additional 80 mature
cannabis plants, 160 seedlings, and 80 ounces of usable cannabis, including for
start-up operations, to assist with a failed batch of cannabis, to allow
sufficient quantity of cannabis for new qualifying patients, or to fill
requests for the sale of cannabis to other ATCs.
(b) The quantities in (a) above shall be
inclusive of all cannabis or CIP possessed or being cultivated at all registered
premises under the control of the ATC.
Source. #10731, eff
11-25-14; ss by #12653, eff 11-1-18
He-C
402.13 Inventory.
(a)
The ATC shall establish ongoing inventory controls and procedures for
the conduct of inventory reviews and comprehensive inventories of cannabis,
which shall enable the ATC to detect any diversion, theft, or loss in a timely
manner.
(b)
An ATC shall maintain its inventory of cannabis plants and usable
cannabis to reflect the projected needs of currently registered qualifying
patients and new qualifying patients as required by He-C 402.12.
(c)
An ATC shall conduct an initial comprehensive inventory on the date it
first dispenses cannabis and maintain a real-time record of its inventory of
cannabis plants, including mature plants, seedlings, and clones, usable cannabis,
including cannabis that is being processed and cannabis that is ready for
dispensing, and CIP, to include at a minimum:
(1)
The date and time of the inventory;
(2)
The summary of inventory findings; and
(3)
The names of the employee(s) conducting the inventory.
(d)
An ATC shall also maintain a real-time record of its inventory of all
damaged, defective, expired, or contaminated cannabis and CIP prepared for
waste disposal, but this inventory shall not be included in the cannabis
inventory limit established in He-C 402.12.
(e)
An ATC shall be able to reconcile all on-premises and in-transit cannabis
each day at the close of business, and shall be able to document such inventory
reconciliation upon request of the department for any day within the current
registration period.
(f)
An ATC shall establish inventory controls and procedures for the conduct
of inventory reviews, which shall include a monthly comprehensive inventory.
(g)
An ATC shall utilize an electronic inventory tracking system.
(h)
All scales used to weigh usable cannabis for purposes of assessing
inventory and packaging and dispensing cannabis shall be certified annually by
a licensed NH service technician in accordance with RSA 438 and Agr 1400.
Documentation of such certification shall be made available to the department
upon request.
(i)
If an ATC uses an extraction method to produce cannabis concentrate for
use in the production of CIP, the amount of usable cannabis contained in the
concentrate shall be based on the cannabinoid profile of the concentrate, and
not the amount of the concentrate itself nor the amount of cannabis used to
create the concentrate, as follows:
(1)
250 milligrams of total active cannabinoid shall equal one gram of
usable cannabis;
(2)
The total active cannabinoid amount shall be the combined amounts of
cannabinoids in the concentrate as indicated by the cannabinoid profile; and
(3)
The amount of usable cannabis contained in the concentrate, as
determined by (1) and (2) above, shall be included in the inventory limit
established in He-C 402.12.
Source. #10731, eff
11-25-14; ss by #12653, eff 11-1-18
He-C 402.14 Cultivation and General Processing.
(a)
Only an ATC shall be permitted to cultivate cannabis.
(b) All phases of the cultivation of cannabis
shall take place in designated, locked, indoor, limited access areas that are
monitored by a surveillance camera system in accordance with He-C 402.24.
(c) Safe growing methods that are as consistent
as practicable with U.S. Department of Agriculture organic requirements at 7
CFR Part 205 shall be used.
(d) The cultivation process shall be designed to
limit contamination, including, but not limited to, mold, fungus, bacterial
diseases, rot, pests, non-organic pesticides, mildew, and any other harmful
contaminant.
(e) A pesticide product may be applied to
cannabis if:
(1)
It is approved for organic cultivation in accordance with the
requirements of the national organic program, 7 CFR Part 205; and
(2)
The active ingredients contained in the pesticide product are exempt
from federal registration under Section 25(b) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA).
(f) Only persons who are licensed in accordance with
RSA 430:33 shall be permitted to apply those pesticides in (e) above to
cannabis.
(g) No chemical listed in He-C 402.34 shall be used
in any way in the cultivation of cannabis.
(h) An ATC shall process only the leaves and
flowers of the female cannabis plant, which shall be:
(1)
Well cured and free of seeds and stems;
(2)
Free of dirt, sand, debris, and other foreign matter;
(3)
Free of contamination by mold, mildew, rot, other fungus, bacterial
diseases, pests, pest wastes, and any other harmful contaminant; and
(4)
Prepared and handled on food-grade stainless steel tables.
Source. #10731, eff
11-25-14; ss by #12653, eff 11-1-18
He-C 402.15 Testing.
(a) Each batch of cannabis harvested and each
batch of cannabis concentrate produced shall be tested in accordance with this
section.
(b) The testing required by this
section shall be performed by an independent laboratory located in New
Hampshire and licensed under RSA 151 and He-P 808.
(c) Each batch of cannabis
harvested shall be tested for:
(1)
The cannabinoid profile; and
(2)
Contaminants as described in (e) below.
(d) Each batch of cannabis concentrate produced
shall be tested for the
cannabinoid profile.
(e) The testing required by (c)(2) above shall
meet the following standards:
(1)
For purposes of testing for microbiologicals and mycotoxins, a cannabis
sample shall be deemed to have passed if it does not exceed the limits set
forth in Table 402.1 below:
Table
402.1 – Contaminant Limits
Cannabis Material |
Viable Aerobic Bacteria
(CFU/g) |
Yeast & Mold (CFU/g) |
Viable Coliforms (CFU/g) |
Bile-tolerant Gram Negative
Bacteria (CFU/g) |
E. Coli (pathogenic strains)
& Salmonella spp. |
Mycotoxins (alfatoxin B1,
alfatoxin B2, alfatoxin O1, alfatoxin O2, ochratoxin A) |
|
Harvested Cannabis |
105 |
104 |
103 |
103 |
None
detected in 1 gram |
<20 μg /kg
of material |
|
Cannabis Concentrate |
104 |
103 |
102 |
102 |
None
detected in 1 gram |
<20 μg /kg
of material |
|
CFU: colony forming unit |
|
||||||
(2)
For purposes of testing for heavy metals, a cannabis sample shall be
deemed to have passed if it does not exceed the limits set forth in Table 402.2
below:
Table
402.2 – Contaminant Limits
Heavy Metal |
Limit |
Arsenic |
4,206 ppb |
Cadmium |
2,704 ppb |
Lead |
8,712 ppb |
Mercury |
8,712 ppb |
ppb: parts per billion |
(f) The department shall require testing for the
presence of prohibited pesticides and prohibited chemicals listed in He-C
402.34, Table 402.3, as follows:
(1)
Testing shall be conducted for cannabis harvested at each cultivation
location;
(2)
Testing shall be conducted at least quarterly;
(3)
The department shall directly notify the laboratory when such testing
shall be conducted;
(4)
Testing shall be conducted on samples provided to the laboratory for
testing required by (c) above, or, if no samples have been provided at the time
of notification in (3) above, on samples provided to the laboratory as directed
by the department;
(5)
Testing results shall be sent from the laboratory to the department; and
(6)
A cannabis sample shall be deemed to have passed if no individual
prohibited pesticide or chemical for which the laboratory tested is detected
above 10 parts per billion.
(g) Each batch of solvent-based cannabis
concentrate shall be tested for residual solvents, which, except for ethanol
and isopropanol, shall not exceed 500 parts per million.
(h) The ATC shall segregate and withhold from use
each batch of harvested cannabis and cannabis concentrate until the laboratory
has completed its testing and either:
(1)
The ATC receives written notice of
passing results from the laboratory; or
(2) In the case of testing required in (f) above, the
ATC receives written notice from the department that the batch has passed.
(i) In addition to test results described in
(f)(5) above, the laboratory shall send to the department copies of each test
result that fails to meet the standards in (e) and (g) above.
(j) Any cannabis batch whose test sample fails to
pass the standards in (e)-(g) above shall be destroyed and discarded as waste
in accordance with He-P 402.22.
(k) An ATC shall be required to have cannabis or
CIP re-tested for its cannabinoid profile when the department determines that
there is reason to believe that the cannabinoid profile on the label does not
accurately reflect the actual cannabinoid profile. Copies of the testing results shall be sent
to the department from the laboratory.
(l) Where testing indicates that the cannabinoid
profile on the label does not accurately reflect its contents, the department
shall:
(1) If the product
is determined to be safe and of sufficient quality for continued sale or use:
a. Place
conditions on the continued sale of such product, such as requiring re-labeling
and the issuance of disclaimers or notifications to patients and caregivers;
and
b. For product
that has already been dispensed, order the issuance of notifications to patients
and caregivers who have purchased the product, including the option for
returning the product to the ATC for either replacement or refund; or
(2) If the product
is determined not to be safe or of sufficient quality for continued sale or
use:
a. For product
that has not yet been dispensed, order the destruction of such product; and
b. For product
that has already been dispensed, order a recall of the product, including
replacement or refund to patients, and order destruction of the product.
(m) The ATC shall maintain the results of all
testing for no less than 4 years.
(n) The department shall require additional
testing, copies of results for which shall be sent to the department, order
recalls, or order destruction of cannabis or CIP:
(1)
In the event it has evidence of tampering or product
contamination;
(2)
In order to determine the presence or absence of contaminants; or
(3)
In order to verify the accuracy of labeling.
(o) The testing laboratory shall supply
documentation to the ATC of the test sample size requirements, for all analytes
tested, to determine a minimum yet adequate amount of cannabis required by the
laboratory to perform the testing required by this section.
(p) The ATC shall develop and implement a policy
describing the procedures used to collect and provide samples for testing,
which meets the following requirements:
(1) The ATC
shall utilize a statistically valid sampling methodology to ensure that each
sample is a random, homogenized sample; and
(2) The ATC
shall document each sample collection, to include batch information, collecting
agent information, and chain of custody information.
(q) Laboratories and laboratory employees shall
be permitted to possess cannabis on the premises of the laboratory for the
purpose of testing in accordance with this section.
(r) ATCs shall be responsible for all costs
associated with the testing of cannabis samples.
(s) No ATC agent shall have any financial or
other interest in a laboratory providing testing services in accordance with
this section.
(t) No individual employee of a laboratory
providing testing services for ATCs may receive direct financial compensation from
any ATC.
(u) All storage of cannabis at a laboratory
providing cannabis-testing services shall comply with He-C 402.17.
(v) An ATC shall develop and implement a quality
assurance policy regarding the testing of cannabis and CIP for cannabinoid profile
and contaminants, not including pesticides, in addition to the required testing
described in this section, as follows:
(1) The policy
shall include provisions for regular and periodic testing of cannabis flower
and finished CIP products so that a representative sample of flower and CIP
types are tested throughout the registration period;
(2) The ATCs
shall work with the testing laboratory for this purpose; and
(3) Any
product, the results of which do not match the original testing results or the
results printed on the label, within a margin of error established by the
laboratory, or which is found to contain contaminants above the thresholds
established in (e) above, shall be withheld from sale or use, the testing
results shall be reported to the department, and shall be subject to the
actions described in (j) or (l) above.
Source. #10731, eff
11-25-14; ss by #10961, eff 10-23-15; ss by #12653, eff 11-1-18
He-C
402.16 Production of Cannabis-Infused
Products.
(a) Except for registered qualifying patients or
designated caregivers, subject to the limitations in He-C 401.18, only a
registered ATC shall be permitted to produce CIP.