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Title: Section 1004.14 - Laboratory testing requirements for medical marihuana

Effective Date

12/27/2017

1004.14 Laboratory testing requirements for medical marihuana.

(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 federal Drug Enforcement Administration (DEA) 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

Aflaltoxins A1, 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) 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).  If stability testing demonstrates that a product no longer retains a consistent concentration of THC and CBD pursuant to section 1004.11(a)(2), 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 subsection upon good cause shown.

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

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

Volume

VOLUME E (Title 10)

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