Packaging and Labeling of Medical Cannabis and Cannabis-Infused Products

TITLE 8: AGRICULTURE AND ANIMALS CHAPTER I: ILLINOIS DEPARTMENT OF AGRICULTURE SUBCHAPTER v: LICENSING AND REGULATIONS PART 1000 COMPASSIONATE USE OF MEDICAL CANNABIS PILOT PROGRAM SECTION 1000.420 PACKAGING AND LABELING OF MEDICAL CANNABIS AND CANNABIS-INFUSED PRODUCTS Section 1000.420  Packaging and Labeling of Medical Cannabis and Cannabis-Infused Products a)         Each cannabis product produced for sale shall be registered with the Department on forms provided by the Department. Each product registration shall include a label and the required registration fee (Section 1000.140).  The registration fee is for the name of the product offered for sale and one fee shall be sufficient for all package sizes. b)         All harvested cannabis intended for distribution to a dispensing organization must be packaged in a sealed, labeled, medical cannabis container. c)         Packaging of any product containing cannabis shall be child-resistant and light-resistant consistent with current standards, including the Consumer Product Safety Commission standards referenced by the Poison Prevention Act. d)         Each cannabis product shall be labeled by the cultivation center prior to sale to a dispensary and each label shall be securely affixed to the package and shall state in legible English: 1)         The name and P.O. Box of the registered cultivation center where the item was manufactured; 2)         The common or usual name of the item and the registered name of the cannabis product that was registered with the Department pursuant to subsection (a); 3)         A unique serial number that will match the product with a producer batch and lot number to facilitate any warnings or recalls the Department or producer deems appropriate; 4)         The date of final testing and packaging, if sampled, and the identification of the independent testing laboratory; 5)         The date of manufacture and "use by" date; 6)         The quantity (in ounces or grams) of cannabis contained in the product; 7)         A pass/fail rating based on the laboratory's microbiological, mycotoxins, and pesticide and solvent residue analyses, if sampled; 8)         Content List A)        A list of the following, including the minimum and maximum percentage content by weight for subsections (d)(8)(A)(i) through (iv): i)          delta-9-tetrahydrocannabinol (THC); ii)         tetrahydrocannabinolic acid (THCA); iii)        cannabidiol (CBD); iv)        cannabidiolic acid (CBDA); and v)         any other ingredients besides cannabis. B)        The acceptable tolerances for the minimum percentage printed on the label for any of subsections (d)(8)(A)(i) through (iv) shall not be below 85% or above 115% of the labeled amount; 9)         A statement that the product is for medical use and not for resale or transfer to another person. e)         Medical Cannabis-Infused Products.  All items shall be individually wrapped or packaged at the original point of preparation. The packaging of the medical cannabis-infused product shall conform to the labeling requirements of the Illinois Food, Drug and Cosmetic Act and, in addition to the other requirements set forth in this Section, shall include the following information in English on each product offered for sale or distribution: 1)         All ingredients of the item, including any colors, artificial flavors and preservatives, listed in descending order by predominance of weight shown with common or usual names; 2)         The following phrase: "This product was produced in a medical cannabis cultivation center not subject to public health inspection that may also process common food allergens."; 3)         Allergen labeling as specified in the Federal Food, Drug and Cosmetics Act, Federal Fair Packaging and Labeling Act, and the Illinois Food, Drug and Cosmetic Act; 4)         The pre-mixed total weight (in ounces or grams) of usable cannabis in the package (the pre-mixed weight of medical cannabis used in making a cannabis-infused product shall apply toward the limit on the total amount of medical cannabis a registered qualifying patient may possess at any one time); 5)         A warning that the item is a medical cannabis-infused product and not a food must be distinctly and clearly legible on the front of the package; 6)         A clearly legible warning emphasizing that the product contains medical cannabis and is intended for consumption by registered qualifying patients only; 7)         Ingredients List A)        A list of the following ingredients, including the minimum and maximum percentage content by weight for subsections (e)(7)(A)(i) through (iv): i)          delta-9-tetrahydrocannabinol (THC); ii)         tetrahydrocannabinolic acid (THCA); iii)        cannabidiol (CBD); iv)        cannabidiolic acid (CBDA); and v)         any other ingredients besides cannabis. B)        The acceptable tolerances for the minimum percentage printed on the label for any of subsections (e)(7)(A)(i) through (iv) shall not be below 85% or above 115% of the labeled amount. f)         THC and CBD Container Content and Restriction Each individually packaged medical cannabis-infused product, even if comprised of multiple servings, shall include the total milligram content of THC and CBD and may not include more than a total of 100 milligrams of active THC. g)         The label shall not contain any of the following information: 1)         Any false or misleading statement or design; 2)         Any seal, flag, crest, coat of arms or other insignia likely to mislead the qualified patient to believe that the product has been endorsed, made or used by the State of Illinois or any of its representatives; or 3)         Depictions of the product, cartoons or images other than the cultivation center's logo.  Medical cannabis-infused products shall not bear a reasonable resemblance to any product available for consumption as a commercially available candy. h)         It is a violation for anyone other than the end user to alter, obliterate or destroy any label attached to a medical cannabis container to administer the product. i)          For each commercial weighing and measuring equipment device used at a facility, the cultivation center must: 1)         Ensure that the commercial device is licensed pursuant to the Weights and Measures Act and the associated administrative rules (8 Ill. Adm Code 600); 2)         Maintain documentation of the licensure of the commercial device; and 3)         Provide a copy of the license of the commercial device to the Department for review upon request.