Ill. Admin. Code tit. 77, § 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)).
Notes
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