Current through Register Vol. 48, No. 12, March 22, 2024
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.