Lawriter - OAC - 3796:4-2-05 Testing laboratory reporting.

3796:4-2-05 Testing laboratory reporting.

(A) A testing laboratory performing analysis on medical marijuana shall input the results of analysis into the inventory tracking system. The department may require a testing laboratory to submit, in portable document format (.pdf), an electronic copy of the results of analysis of any batches and lots tested to an email address specified and maintained by the department.

(B) A testing laboratory performing analysis on medical marijuana shall create a unique certificate of analysis for each batch or lot tested, which shall include, at minimum:

(1) The name and license number of the testing laboratory where the analysis was performed;

(2) The name and license number of the cultivator or processor from whom the sample was received;

(3) The registered name of the medical marijuana strain or medical marijuana product that was registered with the department;

(4) A unique batch or lot number as defined in rule 3796:1-1-01 of the Administrative Code that will match the sample of medical marijuana or medical marijuana products with a batch or lot, in order to facilitate any warnings or recalls the department deems appropriate;

(5) The date or dates on which each test was performed;

(6) A grid or table listing all tests performed, and indicating "pass" or "fail" for each, as defined in rule 3796:4-2-04 of the Administrative Code.

(7) The cannabinoid profile of the sample, including the percentage content by weight for, at minimum:

(a) Delta-9-tetrahydrocannabinol (THC);

(b) Delta-9-tetrahydrocannabinolic acid (THCA);

(c) Cannabidiol (CBD);

(d) Cannabidiolic acid (CBDA); and

(e) Cannabinol (CBN);

(8) Moisture content;

(9) Water activity;

(10) Results of analysis for foreign matter contamination;

(11) Quantitative results of analysis for microbial contamination;

(12) Quantitative results of analysis for heavy metal contamination;

(13) Quantitative results of analysis for pesticide and fertilizer residue;

(14) Quantitative results of analysis for mycotoxins;

(15) Quantitative results of analysis for residual solvents; and

(16) The signature of the laboratory manager or scientific director certifying the analysis.

(C) The certificate of analysis may contain the following:

(1) Results of quantitative analysis of additional cannabinoids for which the laboratory is able to obtain a standard for comparison;

(2) Results of quantitative analysis of terpenes for which the laboratory is able to obtain a standard for comparison;

(D) A certificate of analysis shall not contain any sum totals of cannabinoids or terpenes, except THC content as defined in paragraph rule 3796:1-1-01 of the Administrative Code.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03