Section 0080-10-01-.04 - [Effective until 12/25/2024] MANUFACTURING(1) General requirements.(a) In production of HDC products, manufacturers shall:1. Assign each product batch a unique batch number;2. Not add nicotine to any HDC product; and3. Not use dimethylsulfoxide in any HDC product.(2) Inhalable HDC products. (a) A person shall not manufacture or distribute an inhalable HDC product made with a non-hemp derived cannabinoid ingredient unless the ingredient is listed in and the concentration of the ingredient is authorized under the federal Food and Drug Administration (FDA) inactive ingredient database at https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm.(b) A person shall not manufacture or distribute an inhalable HDC product in which any of the following substances are used in its manufacture:2. Medium-chain triglycerides;(c) A person shall not manufacture or distribute an inhalable HDC product unless its water activity is less than 0.65 and its total combined yeast and mold count is less than 100,000 colony forming units per gram.(3) Solvents. A person shall not manufacture or distribute an HDC product in which solvents were used in its manufacture. Use of the following substances are allowable exceptions: water, vegetable glycerin, vegetable oils, animal fats, butane, propane, carbon dioxide, ethanol, isopropanol, acetone, heptane, ethyl acetate, and pentane. (a) If butane, propane, heptane, or pentane are used as solvents, the solvent must be documented on its COA as at least 99 percent purity.(b) If water, vegetable glycerin, vegetable oils, animal fats, carbon dioxide, ethanol, isopropanol, acetone, or ethyl acetate are used as solvents, the solvent must be food grade according to FDA standards under 21 CFR Part 174.Tenn. Comp. R. & Regs. 0080-10-01-.04
Emergency rules filed 6/28/2024; exp. through 12/25/2024 (Emergency).Authority: T.C.A. §§ 4-3-203 and 43-27-211.