Chapter 44-01. Medical Marijuana

A manufacturing facility shall have every batch from a harvest lot of dried leaves and flowers, to be packaged in a container for transfer to a dispensary, tested for the following: 1. Pesticides and degradation compounds in accordance with section 33-44-01-47. 2. Microbiological…

1. A manufacturing facility shall have every process lot of cannabinoid concentrate, to be packaged in a container for transfer to a dispensary, tested for the following: a. Pesticides and degradation compounds in accordance with section 33-44-01-47. b. Microbiological contaminan…

A manufacturing facility shall have every process lot of a medical cannabinoid product, to be packaged in a container for transfer to a dispensary, tested for the following: 1. Pesticides and degradation compounds in accordance with section 33-44-01-47. 2. Microbiological contami…

Upon a manufacturing facility's request, a terpene analysis may be performed by a laboratory selected by the department as described in section 33-44-01-36. The manufacturing facility shall pay all costs associated with a terpene analysis. A manufacturing facility may include ter…

1. For compliance testing of dried leaves and flowers, a manufacturing facility shall separate each harvest lot into no larger than ten-pound batches. 2. For compliance testing of cannabinoid concentrates, a process lot is considered a batch. 3. For compliance testing of medical …

marijuana batches. When samples are taken from a harvest or process lot batch, a manufacturing facility shall: 1. Store and secure the batch in a manner that prevents the product from being tampered with or transferred prior to required tests being completed. 2. Be able to easily…

1. A batch fails pesticide and degradation compound testing if a sample does not satisfy the most stringent acceptable standard for a pesticide chemical residue in any food item as set forth in subpart C of the United States environmental protection agency's regulations for Toler…

1. Usable marijuana required to be tested for microbiological contaminants under sections 33-44-01-42, 33-44-01-43, and 33-44-01-44 must be sampled using appropriate aseptic techniques. 2. For purposes of the microbiological test, a usable marijuana sample is deemed to have passe…

A batch fails heavy metals testing if the presence of one of the following metals, at a minimum, is above the following listed limit: Parts per Million (ppm) Inorganic arsenic 0.4 Cadmium 0.3 Lead 1.0 Mercury 0.2 History: Effective October 1, 2019. 33 General Authority: NDCC 19-2…

1. A batch fails solvent testing if the presence of one of the following solvents, at a minimum, is above the action level listed in the published International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidance for industry Impuritie…

1. Dried leaves and flowers to be packaged in a container for transfer to a dispensary, must be tested for: a. Water activity; and b. Moisture content. 2. If a sample has a water activity rate of more than 0.65 aw the sample fails. 3. If a sample has a moisture content of more th…

1. Usable marijuana concentration testing must include: a. Tetrahydrocannabinol (THC). b. Tetrahydrocannabinolic acid (THCA). c. Cannabidiol (CBD). d. Cannabidiolic acid (CBDA). 2. The total tetrahydrocannabinol and total cannabidiol must be calculated as follows: a. Total tetrah…

1. If a sample fails any test, the manufacturing facility may submit a written request to the department for a reanalysis. The request must be received by the department within seven calendar days from the date the laboratory sent notice of the failed test to the manufacturing fa…

1. A laboratory shall report tentatively identified compounds to the manufacturing facility and the department. 2. Following the receipt of a tentatively identified compounds report, the department may initiate an investigation. The investigation may include requiring a sample be…

The department may require, at any time, a manufacturing facility to permit sampling of marijuana, usable marijuana, or medical marijuana waste to determine whether a manufacturing facility is in compliance with North Dakota Century Code chapter 19-24.1 and these rules. Costs of …

1. A manufacturing facility shall develop and follow a written quality control and quality assurance program. The program must be established to protect qualifying patient health and implemented in a manner to assist in complying with testing required in sections 33-44-01-42, 33-…