N.Y. Comp. Codes R. & Regs. tit. 9 § 113.15

Current through Register Vol. 46, No. 36, September 4, 2024

Section 113.15 - Laboratory Testing Requirements for Medical Cannabis

(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.

(j) The laboratory shall track and use an approved method to dispose of any quantity of medical cannabis product that is not consumed in samples used for testing. Disposal of medical cannabis shall mean that the medical cannabis has been rendered unrecoverable and beyond reclamation.

(k) Any submitted medical cannabis products that are deemed unsuitable for testing shall be returned to the registered organization under chain of custody.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 113.15

Adopted New York State Register February 22, 2023/Volume XLV, Issue 08, eff. 2/22/2023