Iowa Admin. Code r. 641-154.50
Current through Register Vol. 47, No. 6, September 18, 2024
Rule 641-154.50 - Content testing(1)Cannabinoids.a. For each unique lot of medical cannabidiol, and if asked to do so by a requester for other medical cannabis goods, a laboratory shall, at minimum, test for and report measurements for the following cannabinoid analytes: b. A laboratory shall report that the primary sample passed or failed THC and CBD potency testing according to guidance in the Laboratory Acceptance and Criteria Document described in subrule 154.47(1).c. For each cannabinoid analyte test, a laboratory shall issue a certificate of analysis that contains the following:(1) Concentrations of cannabinoid analytes in mg/ml for liquids and mg/g for solids, or other measures approved by the department.(2) Whether the primary sample passed or failed the test in accordance with paragraph 154.50(1)"b."d. The laboratory may test for and provide test results for additional cannabinoid analytes if asked to do so by a requester.(2)Contaminants testing.a. For each unique lot of medical cannabidiol, unless otherwise referenced in the laboratory testing requirements and acceptance criteria document described in subrule 154.47(1), a laboratory shall conduct contaminants testing for the following analytes: (1) Residual solvents and processing chemicals.(3) Microbiological impurities.b. The laboratory may test and provide test results for additional contaminants if asked to do so by a requestor.c. The department shall provide a list of contaminants for which primary samples are to be tested with corresponding action levels on the department's website (hhs.iowa.gov).d. For each contaminant for which a laboratory tests, the laboratory shall report that the primary sample passed the testing if the concentration of contaminant is at or below the action level approved by the department.e. For each contaminant for which a laboratory tests, the laboratory shall report that the primary sample failed the testing if the concentration of contaminants is above the action level approved by the department.f. If a laboratory is using gas chromatography-mass spectrometry instrumentation to analyze primary samples for contaminants and the laboratory determines that a primary sample contains contaminants or chemical analytes that are not included in the department-approved list of required tests, the laboratory shall attempt to achieve tentative identification and semiquantitative results of the contaminant analytes.g. The laboratory may test for and provide test results for additional contaminants or processing chemicals if asked to do so by a requester.h. For each primary sample tested, a laboratory shall issue a certificate of analysis that contains the following: (1) The name and concentration of each contaminant for which the primary sample was tested. 1. The concentrations shall be listed in parts per million (ppm) or other units as determined by the department.2. The laboratory shall report a result of "detected but not quantified" for any contaminant that falls below the LOQ, has a signal-to-noise ratio of greater than 3:1, and meets identification criteria.(2) Whether the primary sample passed or failed the test in accordance with paragraphs 154.50(2)"c" and "d."(3) The names and amounts of any additional contaminants identified by the laboratory.i. If the primary sample fails testing for residual solvents and processing chemicals, the lot fails laboratory testing.j. When a laboratory identifies additional contaminants in a primary sample, the laboratory shall: (1) Notify the department of the additional contaminants and the amounts detected, if applicable.(2) Refrain from issuing a final certificate of analysis until given approval to do so by the department.Iowa Admin. Code r. 641-154.50
Adopted by IAB January 31, 2018/Volume XL, Number 16, effective 3/7/2018Adopted by IAB July 10, 2024/Volume XLVII, Number 1, effective 8/14/2024