New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle B - Division of Alcoholic Beverage Control › Chapter II - Rules of the Office of Cannabis Management › Part 113 - Medical Cannabis › Section 113.15 - Laboratory Testing Requirements for Medical Cannabis

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Medical cannabis products produced by a
				  registered organization shall be examined by an independent laboratory
				  physically located in New York State that is permitted by the Office and
				  approved for the analysis of medical cannabis in accordance Article 3 of the
				  Cannabis Law, and this Part. A laboratory licensed by the New York State
				  Department of Health to conduct medical cannabis testing shall be deemed a
				  "permittee" and must continue to comply with all applicable sections set forth
				  in Subpart 55-2 of Title 10 NYCRR, in addition to this Part.
(b) No board member, officer, manager, owner,
				  partner, principal stakeholder or member of a registered organization, or such
				  persons' immediate family member, shall have an interest or voting rights in
				  the independent laboratory performing medical cannabis testing.
(c) For final product testing, a
				  statistically significant number of samples from the registered organization
				  containing the final medical cannabis product equivalent to the sealed medical
				  cannabis product dispensed to the patient (e.g., liquid extract in a sealed
				  bottle or intact sealed bottle of capsules) shall be collected and submitted
				  for final product testing in a manner approved by the Office.
(d) Testing of the final medical cannabis
				  product is mandatory. However, at the option of the registered organization,
				  testing may be performed on components used for the production of the final
				  medical cannabis product, including but not limited to water or growing
				  materials. Testing may also be performed on intermediate cannabis extract (e.g.
				  for phytocannabinoid profile verification or contaminant testing).
(e) Sampling and testing of each lot of final
				  medical cannabis product shall be conducted with a representative sample of a
				  cannabis product batch by collecting a minimum number of sample increments
				  relative to the batch size as set forth in guidance provided by the
				  Office.
(f) Testing of the
				  phytocannabinoid profile shall include, at a minimum, those analytes specified
				  in section 113.12(b)(1) of
				  this Part.
(g) Testing for
				  contaminants in the final medical cannabis product shall include analytes,
				  pesticides, or growth regulators determined by the Office. The Office shall
				  make available a list of required analytes, pesticides or growth regulators for
				  final product testing and the acceptable limits as determined by the
				  Office.
(h) Independent
				  laboratories performing final medical cannabis product testing pursuant to this
				  section must report all results, which includes, but is not limited to, a
				  certificate of analysis, to the Office, in a manner and timeframe prescribed by
				  the Office.
(i) Stability testing
				  shall be performed by a registered organization or permitted independent
				  laboratory on each medical cannabis product as follows:
(1) For testing of open products, stability
				  testing shall be performed, at time zero when opened and then, at a minimum, at
				  sixty (60) days from the date of first analysis. This shall establish use of
				  the product within a specified time once opened.
(2) For testing of unopened products, until
				  stability studies have been completed, a registered organization may assign a
				  tentative expiration date based on available stability information. The
				  registered organization must concurrently have stability studies conducted to
				  determine the actual expiration date of an unopened product.
(3) For stability testing of both opened and
				  unopened cannabis products, each cannabis product shall retain a total THC and
				  CBD concentration in milligrams per single serving that is consistent with
				  paragraph 113.12(b)(2) of this Part. If the product no longer retains a
				  consistent concentration of THC and CBD pursuant to paragraph 113.12(b)(2) of
				  this Part, the product shall be deemed no longer suitable for consumption and
				  destroyed by the registered organization in accordance with section
				  113.25 of this Part. The Registered
				  Organization shall demonstrate the ongoing stability over time of any product
				  form produced as deemed necessary by, but not limited to, product stability
				  concerns or complaints, new stability information about cannabis, for internal
				  audit, or as requested by the Office and shall provide such documentation
				  whenever requested from the Office.
(4) The Office may waive any of the
				  requirements of this subsection upon good cause shown.