Section 946.400  Manufacture of Cannabis-Infused Products

a)         The Department will conduct, no more than 30 days prior to the start of the manufacturing of cannabis-infused products, a pre-operational inspection at all registered cultivation centers to determine whether the facilities, methods, practices and controls used in the manufacture, processing or holding of cannabis-infused products conform to or are operated or administered in conformity with good manufacturing practices to ensure that products for human consumption are safe and have been prepared, packed and held under sanitary conditions.

1)         Registered cultivation centers shall allow the Department to inspect the premises and all utensils, fixtures, furniture, machinery and devices used for preparing cannabis-infused products.

2)         The Department will conduct pre-operational inspections of registered cultivation centers with regard to the manufacture and preparation of cannabis-infused products under the authority of the Illinois Food, Drug and Cosmetic Act and the Food Handling Regulation Enforcement Act and the Manufacturing, Processing, Packing or Holding of Food Code.

3)         If a registered cultivation center ceases manufacturing cannabis-infused products for a period of 180 days or more, the Department shall be contacted to request a pre-operational inspection prior to restarting manufacturing operations.

4)         A registered cultivation center shall not manufacture, process, or package cannabis-infused products designed for human consumption at same time and on the same surfaces as products not designated for human consumption.

b)         A cultivation center that prepares cannabis-infused products for sale or distribution at a dispensing organization shall be under the operational supervision of a certified food protection manager as required in the Food Handling Regulation Enforcement Act.  (Section 80(a)(6) of the Act)  Management responsibilities and supervision shall be in accordance with 77 Ill. Adm. Code 730.8000 and 730.8040.

c)         All items shall be individually wrapped or packaged at the original point of preparation.  Smaller like items such as hard candies or cookies may be packaged into larger quantities in a single wrapped package.

1)         The packaging of the medical cannabis-infused product shall conform to the labeling requirements of the Illinois Food, Drug and Cosmetic Act and shall include the following information in English on each product offered for sale or distribution:

A)        The name and address of the registered cultivation center where the item was manufactured;

B)        The common or usual name of the item;

C)        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;

D)        The following phrase: "This product was produced in a medical and adult use cannabis cultivation center, not subject to public health inspection, that may also process common food allergens.";

E)        Allergen labeling as specified in the Federal Food, Drug and Cosmetic Act, Federal Fair Packaging and Labeling Act, and the Illinois Food, Drug and Cosmetic Act;

F)         The pre-mixed total weight (in ounces or grams) of usable cannabis in the food product;

G)        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;

H)        A clearly legible warning emphasizing that the product contains medical cannabis and is intended for consumption by registered qualifying patients only; and

I)         Date of manufacture and "use by" date. (Section 80(a) of the Act)

2)         Signage may be translated into additional languages as needed.

d)         The Department may institute additional labeling requirements for cannabis-infused products, including, but not limited to, measures of potency (see Department of Agriculture rules at 8 Ill. Adm. Code 1000.420(e)(8)(B) and (f)).

(Source:  Amended at 45 Ill. Reg. 6205, effective April 27, 2021)