New York Codes, Rules and Regulations
Title 10 - DEPARTMENT OF HEALTH
Chapter XIII - Medical Use of Marihuana
Part 1004 - Medical Use of Marihuana
Section 1004.10 - Registered organizations; general requirements
Universal Citation: 10 NY Comp Codes Rules and Regs ยง 1004.10
Current through Register Vol. 46, No. 12, March 20, 2024
(a) In addition to the requirements in Public Health Law and as otherwise set forth in this Part, a registered organization shall:
(1) make its books, records and
manufacturing and dispensing facilities available to the department or its
authorized representatives for monitoring, on-site inspection, and audit
purposes, including but not limited to periodic inspections and/or evaluations of
facilities, methods, procedures, materials, staff and equipment to assess
compliance with requirements set forth in article 33 of the Public Health Law and
this Part;
(i) Any deficiencies documented in a
statement of findings by the department shall require that the registered
organization submit a written plan of correction in a format acceptable to the
department within 15 calendar days of the issue date of the statement of
findings. A plan of correction shall address all deficiencies or areas of
noncompliance cited in the statement of findings and shall:
(a) contain an assessment and analysis of the
events and/or circumstances that led to the noncompliance;
(b) contain a procedure addressing how the
registered organization intends to correct each area of noncompliance;
(c) contain an explanation of how proposed
corrective actions will be implemented and maintained to ensure noncompliance
does not recur;
(d) contain the
proposed date by which each area of noncompliance shall be corrected;
(e) address any inspection finding which the
department determines jeopardizes the immediate health, safety, or well-being of
certified patients, designated caregivers or the public. Such a finding shall be
deemed a critical deficiency and shall require immediate corrective action to
remove the immediate risk, followed by the submission of a corrective action plan
within 24 hours of notification by the department of the critical deficiency. The
department will acknowledge receipt within 24 hours and respond as soon as
practicable to notify if the plan is accepted or needs modification. If the
corrective action plan needs modification, the registered organization shall
modify the plan until it is accepted by the department.
(ii) Upon written approval of the department,
the registered organization shall implement the plan of
correction.
(2) only
manufacture and dispense approved medical marihuana products in New York State in
accordance with article 33 of the Public Health Law and this Part;
(3) only manufacture and dispense approved
medical marihuana products in an indoor, enclosed, secure facility located in New
York State which may include greenhouses;
(4) submit approved medical marihuana product
samples and manufacturing materials to the department upon request, for but not
limited to, quality assurance testing or investigation of an adverse event. A
subset of each lot of medical marihuana product shall be retained by the
registered organization to allow for testing in the future if requested by the
department and shall be stored unopened as indicated on the label and in the
original packaging. This subset of medical marihuana product must be readily
identifiable as belonging to its specific lot. The quantity retained shall be a
statistically representative number of samples to allow for complete testing of
the product at least two times and shall be retained by the registered
organization for at least thirty days following the date of expiration;
(5) implement policies and procedures to notify
the department within 24 hours of the following:
(i) any adverse events;
(ii) any incident involving theft, loss or
possible diversion of medical marihuana products;
(iii) any suspected or known security breach or
other facility event that may compromise public health and/or safety, or which
requires response by public safety personnel or law enforcement; and
(iv) any vehicle accidents or incidents
occurring during transport of medical marihuana products.
(6) Within ten days of the occurrence of one of
the above events, the registered organization shall submit a complete written
incident report to the department detailing the circumstances of the event, any
corrective actions taken, and where applicable, confirmation that appropriate law
enforcement authorities were notified
(7) quarantine any lot of medical marihuana
product as directed by the department, and not transport, distribute or dispense
such lot unless prior approval is obtained from the department;
(8) dispose of unusable medical marihuana
products that have failed laboratory testing or any marihuana used in the
manufacturing processpursuant to section 1004.24 of this Part;
(9) maintain records required by article 33 of
the Public Health Law and this Part for a period of five years, unless otherwise
stated, and make such records available to the department upon request. Such
records shall include:
(i) documentation,
including lot numbers where applicable, of all materials used in the
manufacturing of the approved medical marihuana product to allow tracking of the
materials including but not limited to soil, soil amendment, nutrients,
hydroponic materials, fertilizers, growth promoters, pesticides, fungicides, and
herbicides;
(ii) cultivation,
manufacturing, packaging and labeling production records; and
(iii) laboratory testing results.
(10) post the certificate of
registration issued by the department in a conspicuous location on the premises
of each manufacturing facility and dispensing facility.
(b) Registered organizations shall not:
(1) dispense approved medical marihuana
products from the same location where the marihuana is grown or
manufactured;
(2) grow marihuana or
produce medical marihuana at any site other than a facility or site approved by
the department and set forth in the registered organization's
registration;
(3) distribute products
or samples at no cost except as may be allowed by the commissioner;
(4) make substantial alterations to the
structure or architectural design of a manufacturing or dispensing facility
without prior written approval of the department;
(5) change the composition of the entity which
is the registered organization, including but not limited to, a change in sole
proprietor, partner, director, stockholder, member or membership interest of the
registered organization without the prior written approval of the
department;
(6) materially modify or
revise its operating plan, including its policies and procedures related to
cultivation, processing, manufacturing, distributing or dispensing policies or
procedures, without prior written approval of the department;
(7) locate a dispensing facility on the same
street or avenue and within 1,000 feet of a building occupied exclusively as a
school, church, synagogue or other place of worship. The measurements in this
paragraph of this subdivision are to be taken in straight lines from the center
of the nearest entrance of the premises sought to be used as a dispensing
facility to the center of the nearest entrance of such school, church, synagogue
or other place of worship; or
(8) be
managed by or employ anyone who has been convicted of any felony of sale or
possession of drugs, narcotics, or controlled substances provided that this
provision only applies to:
(i) managers or
employees who come into contact with or handle medical marihuana; and
(ii) a conviction less than ten years (not
counting time spent in incarceration) prior to being employed, for which the
person has not received a certificate of relief from disabilities or a
certificate of good conduct under article 23 of the correction
law.
(c) In the event that a registered organization elects to cease operation of all permitted activities and to surrender its registration, the following provisions shall apply:
(1) The registered organization shall
notify the department in writing at least 120 days prior to the anticipated date
of closure of the manufacturing and each dispensing facility.
(2) Such written notice shall include a
proposed plan for closure. The plan shall be subject to department approval in
accordance with department protocols, and shall include timetables and describe
the procedures and actions the registered organization shall take to:
(i) notify affected certified patients and
designated caregivers of the closure;
(ii) properly destroy, transfer or otherwise
dispose of all the registered organization's supply of medical marihuana and
medical marihuana products;
(iii)
maintain and make available to the department all records required to be
maintained under this part for a period of five years; and
(iv) maintain compliance with these regulations
and any other conditions required by the commissioner until the approved closure
date.
(3) A registered
organization shall take no action to close a manufacturing and dispensing
facility prior to department approval of the plan for closure.
(4) A registered organization's failure to
notify the department of intent to cease any operations, failure to submit an
approvable plan, and/or to execute the approved plan may result in the imposition
of civil penalties, not to exceed $2,000, and shall be a basis for the department
to revoke the registration of the registered organization under such terms as the
department determines is appropriate based on public health and safety
considerations. In addition, the department reserves the right to exercise any
other remedies available to it.
(d) If a registered organization's application for renewal of registration is denied, the registered organization shall submit a proposed plan for closure in accordance with this section.
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