Haw. Code R. § 11-850-72 - Manufactured cannabis products
(a) A dispensary
licensee may manufacture cannabis products limited to:
(1) Edible cannabis products as specified in
section 11-850-76;
(2) Ointments and skin lotions;
(3) Transdermal patches;
(4) Pre-filled and sealed containers used to
aerosolize and deliver cannabis orally, such as with an inhaler or nebulizer;
provided that the containers need not be manufactured by the licensed
dispensary but:
(A) Shall be filled only with
cannabis/ cannabis oils, or cannabis extracts manufactured by a dispensary
licensee;
(B) Shall not contain
nicotine, hemp, hemp-derived cannabinoids, tobacco-related products or any
non-cannabis derived products; and
(C) Shall be designed to be used with devices
used to provide safe pulmonary administration of manufactured cannabis
products;
(5) Devices
that provide safe pulmonary administration; provided that:
(A) The heating element of the device, if
any, is made of inert materials such as glass, ceramic, or stainless steel, and
not of plastic or rubber;
(B) The
device is distributed solely for use with single-use, pre-filled,
tamper-resistant, sealed containers that do not contain nicotine, other tobacco
products, hemp, or hemp-derived cannabinoids;
(C) The device is used to aerosolize and
deliver cannabis by inhalation, such as an inhaler, medical-grade nebulizer, or
other similar medical grade volatilization device;
(D) There is a temperature control on the
device that is regulated to prevent the combustion of cannabis oil;
and
(E) The device need not be
manufactured by the licensed dispensary; and
(6) Pre-rolled cannabis flower products as
specified in section
11-850-79.
(b) A dispensary licensee shall establish and
maintain written standard operating procedures for the manufacturing, analysis,
sale, security, storage, inventory tracking, transportation, and disposal of
manufactured cannabis products that includes but is not limited to:
(1) Safe and appropriate use of manufacturing
equipment;
(2) Safe and appropriate
storage of materials used to produce manufactured cannabis products;
(3) Effective training and monitoring of
employees and subcontractors who participate in the manufacturing or dispensing
of manufactured cannabis products;
(4) Adequate protocols for laboratory
analysis of manufactured cannabis products pursuant to this chapter;
and
(5) Safe and appropriate
storage and disposal or destruction of manufactured cannabis products at all
stages of production and sale.
(c) A dispensary licensee shall report to the
department prior to producing any manufactured cannabis products:
(1) Strains of cannabis to be used by the
dispensary to produce manufactured cannabis products;
(2) Types of manufactured cannabis products
that the dispensary will produce; and
(3) The manufacturing process or processes
the dispensary will use in producing manufactured cannabis products.
(d) Prohibited ingredients.
(1) Except for alcohol in tinctures and
caffeine naturally occurring in chocolate, no manufactured cannabis product
shall contain tobacco, nicotine, caffeine, alcohol, or any other substance not
derived from cannabis that:
(A) Is
psychoactive; or
(B) Would increase
the potency, toxicity, or addictive potential of the product or create a
potentially unsafe combination with cannabinoids.
(2) No manufactured cannabis product shall
contain:
(A) Synthetic cannabinoids;
or
(B) Artificially derived
cannabinoids.
(3) No
aerosolizeable manufactured cannabis product shall contain zirconium.
(4) No manufactured cannabis product shall
contain:
(A) Any color additives not listed in
subpart A or C of 21 C.F.R. part 73, published by the U.S. Government
Publishing Office, as amended as of April 1, 2021;
(B) Bithionol;
(C) Vinyl chloride;
(D) Halogenated salicylanilides listed in
21 C.F.R. section
700.15, published by the U.S. Government
Publishing Office, as amended as of April 1, 2021;
(E) Chloroform;
(F) Methylene chloride;
(G) Prohibited cattle material, as defined in
21 C.F.R. section
700.27, published by the U.S. Government
Publishing Office, as amended as of April 1, 2021;
(H) Mercury compounds;
(I) Hexachlorophene;
(J) Ephedrine alkaloids; or
(K) Any ingredient the department determines
would render the product injurious or hazardous to health.
(e) Prohibited components. Except
for ointments intended for topical application, skin lotions, and transdermal
patches, manufactured cannabis products shall not be manufactured with any
components that are not intended to be safe for use in manufacture of a product
for human consumption. Additives used as components in the production of
manufactured cannabis products, except for ointments intended for topical
application, skin lotions, and transdermal patches, shall be limited to those
allowed for use in food in section
11-29-8.
(f) A dispensary licensee shall not produce
manufactured cannabis products with an appearance, flavor, or smell designed to
appeal to minors.
(g) The director
may require quarantine, removal, or modification of a manufactured cannabis
product determined to present a potential health hazard.
Notes
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