Statutes, codes, and regulations
Colorado Administrative Code
Department 1000 - Department of Public Health and EnvironmentDivision 1005 - Laboratory Services Division
Rule 5 CCR 1005-7 - Natural Medicine Testing Facility Certification and Testing
Rule 5 CCR 1005-7-10 - [Effective 1/14/2025] Natural Medicine Testing Facilities: Certificate of Analysis (COA)

5 Colo. Code Regs. § 1005-7-10

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Current through Register Vol. 47, No. 24, December 25, 2024
Rule 5 CCR 1005-7-10 - [Effective 1/14/2025] Natural Medicine Testing Facilities: Certificate of Analysis (COA)
10.1 The Natural Medicine Testing Facility shall generate a Certificate of Analysis (COA) for each Sample that the laboratory analyzes.
10.2 The Natural Medicine Testing Facility shall ensure that the COA contains the results of all requested analyses performed for the Sample.
10.3 The Natural Medicine Testing Facility shall, within 1 business day of completing analysis of a Sample, provide a copy of the COA to the submitting Natural Medicine Business and the Colorado Department of Revenue Natural Medicine Division.
10.3.1 The Natural Medicine Testing Facility shall indicate that a test result is for official compliance purposes on the COA for Samples of Natural Medicine when applicable.
10.4 The COA shall contain, at minimum, the following information:
10.4.1 Natural Medicine Testing Facility's name, address, and contact information;
10.4.2 Natural Medicine Cultivator's or Natural Medicine Manufacturer's name, address, and DOR licensee number;
10.4.3 Sample identification;
10.4.4 Sample identifying information, including Matrix type and unique Sample identifiers, including lot identification number when applicable;
10.4.5 Sample received date, and the date(s) of Sample analyses and corresponding testing results;
10.4.6 Units of measure;
10.4.7 The analytical methods, analytical instrumentation used, and corresponding Limits of Detection (LOD) and Limits of Quantitation (LOQ);
10.4.8 Reported results must include the range of estimated uncertainty which shall be reported as a ± value in the same units of measure as the test result, following best practices for significant figures and rounding; and
10.4.9 For Samples of Natural Medicine, reported tryptamine content results must provide a calculated Total Psilocin value, in addition to psilocybin and psilocin values.
10.4.9.1 A dedicated area to include any qualifiers or comments needed for interpretation, (when applicable to the test method and results being reported) to include any identified and documented discrepancies.
10.4.10 The COA may contain additional information at the discretion of the Natural Medicine Testing Facility and submitting client.
10.5 The Natural Medicine Testing Facility shall report test results for each representative Sample on the COA as follows:
10.5.1 When reporting qualitative results for each Analyte, the Natural Medicine Testing Facility shall indicate presence or absence;
10.5.2 When reporting quantitative results for each Analyte, the Natural Medicine Testing Facility shall only report results that are above the lowest concentration of calibrator or standard used in the analytical run;
10.5.3 When reporting results for any Analytes that were detected below the analytical method LOQ and above the LOD, indicate "<LOQ";
10.5.4 When reporting results for any Analytes that were not detected or detected below the LOD, indicate "ND" or "<LOD"; and
10.6 The Natural Medicine Testing Facility director or supervisory analyst shall validate the accuracy of the information contained on the COA.

5 CCR 1005-7-10

47 CR 24, December 25, 2024, effective 1/14/2025