Iowa Administrative Code
Agency 641 - Public Health Department
Chapter 154 - Medical Cannabidiol Program
Rule 641-154.30 - Packaging and Labeling
Universal Citation: IA Admin Code 641-154.30
Current through Register Vol. 47, No. 6, September 18, 2024
(1) Trade names. A manufacturer's medical cannabidiol trade names shall comply with the following:
a. Names shall be limited
to those that clearly reflect the form's medical cannabidiol nature;
b. Any name that is identical to, or similar
to, the name of an existing nonmedical cannabidiol product is
prohibited;
c. Any name that is
identical to, or similar to, the name of an unlawful product or substance is
prohibited; and
d. Any name that
contains language that suggests using medical cannabidiol for recreational
purposes or for a condition other than a qualifying debilitating medical
condition is prohibited.
(2) Medical cannabidiol packaging.
a. Requirements of
medical cannabidiol package containers. The manufacturer shall use medical
containers that are:
(1) Of sufficient size to
accommodate a separate dispensary label containing the information described in
paragraph 154.30(2)"c";
(2) Designed to maximize the shelf life of
the contained medical cannabidiol;
(3) Tamper-evident; and
(4) Child-resistant.
b. Medical cannabidiol package prohibitions.
The packaging for medical cannabidiol shall not:
(1) Bear a reasonable resemblance to commonly
available nonmedical commercial products;
(2) Depict images other than the
manufacturer's business name or logo on the packaging;
(3) Reasonably appeal to children. More
information is provided in rule
641-154.22 (2); or
(4) Reasonably appeal to recreational or
adult use.
c.
Requirements of medical cannabidiol packaging. A manufacturer shall ensure that
all medical cannabidiol packaging includes the following information:
(1) The name of the manufacturer, and trade
name if applicable;
(2) A label
claim concentration for cannabinoid content including:
1. Tetrahydrocannabinol;
2. Tetrahydrocannabinolic acid.
Concentrations of tetrahydrocannabinolic acid may be omitted if the
manufacturer uses decarboxylation or other means to substantially remove the
acids from the product prior to testing;
3. Cannabidiol; and
4. Cannabidiolic acid. Concentrations of
cannabinolic acid may be omitted if the manufacturer uses decarboxylation or
other means to substantially remove the acids from the product prior to
testing;
(3) The number
of servings per package (excluding products intended for inhalation);
(4) The directions for use of the product,
including recommended and maximum amount by age and weight, if
applicable;
(5) All ingredients of
the product shown with common or usual names, including but not limited to any
additives, terpenes or artificial flavors, diluents and carriers, and
preservatives, listed in descending order by predominance of weight. Any
third-party hemp-derived cannabinoids in medical cannabidiol products shall be
specifically indicated on the ingredients list, separately from medical
cannabidiol produced within the manufacturer's facility;
(6) Instructions for storage, including light
and temperature requirements, if any; and
(7) The universal warning symbol provided by
the department.
d. The
following information shall be included with medical cannabidiol packaging, or
contained within a package insert:
(1) A
notice with the statement, including capitalization: "This product has not been
analyzed or approved by the United States Food and Drug Administration. There
is limited information on the side effects of using this product, and there may
be associated health risks and medication interactions. This product is not
recommended for use by pregnant or breastfeeding women. KEEP THIS PRODUCT OUT
OF REACH OF CHILDREN.";
(2) A
notice with the statement: "This medical cannabidiol is for therapeutic use
only. Use of this product by a person other than the patient listed on the
label is unlawful and may result in the cancellation of the patient's medical
cannabidiol registration card. Return unused medical cannabidiol to a
dispensary for disposal.";
A package may contain multiple labels if the information required by this rule is not obstructed.
(3) Medical cannabidiol labeling.
a. After receiving a
passing certification of analysis for a package lot from a laboratory, and
prior to distribution to dispensaries, a manufacturer shall affix a label to
each individual package of medical cannabidiol that contains the following
information:
(1) A unique lot
number;
(2) The date of
manufacture;
(3) Product expiration
date. This date shall be one year from the date of manufacture unless a
manufacturer has conducted stability studies and received approval from the
department for an extended expiration date.
b. Cannabinoid content for:
(1) Tetrahydrocannabinol;
(2) Tetrahydrocannabinolic acid.
Concentrations of tetrahydrocannabinolic acid may be omitted if the
manufacturer uses chemical decarboxylation or other means to substantially
remove the acids from the product prior to testing;
(3) Cannabidiol; and
(4) Cannabidiolic acid.
Disclaimer: These regulations may not be the most recent version. Iowa may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
