New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.14 - Laboratory testing requirements for medical marihuana

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Medical marihuana products produced by a
				registered organization shall be examined in a laboratory located in New York
				State that is licensed by the department's Bureau of Narcotic Enforcement and
				approved for the analysis of medical marihuana by the department in accordance
				with article 5 of the Public Health Law and Subpart 55-2 of this
				Title.
(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 laboratory performing medical marihuana
				testing.
(c) For final product
				testing, the registered organization shall submit to the laboratory a
				statistically significant number of samples containing the final medical
				marihuana product equivalent to the sealed medical marihuana product dispensed
				to the patient (e.g., liquid extract in a sealed bottle or intact sealed bottle
				of capsules). Upon prior written approval of the department, a registered
				organization may submit to the laboratory the final medical marihuana product
				sample packaged in a quantity less than that which would be provided to the
				patient if the sample is prepared and packaged in the identical manner as the
				product provided to the patient.
(d) Testing of the final medical marihuana
				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 marihuana product including but not limited to water or growing
				materials. Testing may also be performed on the final marihuana extract e.g.
				for cannabinoid profile verification or contaminant testing.
(e) Sampling and testing of each lot of final
				medical marihuana product shall be conducted with a statistically significant
				number of samples and with acceptable methodologies, approved by the
				department, such that there is assurance that all lots of each medical
				marihuana product are adequately assessed for contaminants and the cannabinoid
				profile is consistent throughout.
(f) Testing of the cannabinoid profile shall
				include, at a minimum, those analytes specified in section
				1004.11(c)(2) of
				this Part.
(g) Testing for
				contaminants in the final medical marihuana product shall include but shall not
				be limited to those analytes listed below. The department shall make available
				a list of required analytes and their acceptable limits as determined by the
				commissioner.
Analyte:
E. coli
Pseudomonas (for products to be vaporized)
Salmonella species
Enterococcus species
Bile tolerant gram negative bacteria, specifically including
				  Klebsiella species
Clostridium botulinum
Aspergillus species
Mucor species
Penicillium species
Thermophilic Actinomycetes species
Aflatoxins B1, B2, G1, G2
Ochratoxin A
Antimony
Arsenic
Cadmium
Chromium
Copper
Lead
Nickel
Zinc
Mercury
Any pesticide used during production of the medical marihuana
				  product
Any growth regulator used during production of the medical
				  marihuana product
Any other analyte as required by the
				  commissioner
(h)
				laboratories performing final product testing pursuant to this section must
				report all results to the department, in a manner and timeframe prescribed by
				the department.
(i) Stability
				testing shall be performed on each brand and form of medical marihuana product
				as follows:
(1) For testing of open products,
				stability testing shall be performed for each extract lot, at time zero when
				opened and then, at a minimum, at 60 days from the date of first analysis. This
				shall establish use of the product lot 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 by an approved laboratory to determine the actual
				expiration date of an unopened product.
(3) For stability testing of both opened and
				unopened products, each brand shall retain a total THC and total CBD
				concentration in milligrams per single dose that is consistent with section
				1004.11(c)(3) of
				this Part. If stability testing demonstrates that a product no longer retains a
				consistent concentration of THC and CBD pursuant to section
				1004.11(a)(2) of
				this Part, the product shall be deemed no longer suitable for dispensing or
				consumption. The department may request further stability testing of a brand to
				demonstrate the ongoing stability of the product produced over time.
(4) The department may waive any of the
				requirements of this subdivision upon good cause shown.