Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 850 - MEDICAL CANNABIS DISPENSARIES › Subchapter 1 - GENERAL PROVISIONS › Section 11-850-2 - Definitions

Current through June, 2024
As used in this chapter:
"Accreditation body" means an impartial organization that
					 is a signatory to the International Laboratory Accreditation Cooperation (ILAC)
					 Mutual Recognition Arrangement for Testing and which requires laboratories to
					 conform to ISO/IEC 17025, the general requirements for the competence of
					 laboratories established by the International Organization for Standardization
					 (ISO) and the International Electrotechnical Commission (IEC).
"Actual yield" means the quantity that is actually produced
					 at any appropriate step of manufacture or packaging of a particular
					 manufactured cannabis product.
"Adequate" means that which is needed to accomplish the
					 intended purpose in keeping with good public health practice.
"Allergen cross-contact" means the unintentional
					 incorporation of an allergen into cannabis or a manufactured cannabis
					 product.
"Applicant" means an individual applicant and applying
					 entity who are applying for a dispensary license pursuant to chapter 329D,
					 Hawaii Revised Statutes (HRS).
"Applying entity" means a business registered with the
					 department of commerce and consumer affairs applying for a dispensary license
					 pursuant to chapter 329D, HRS.
"Artificially derived cannabinoid" means a chemical
					 substance that is created by a chemical reaction that changes the molecular
					 structure of any chemical substance derived from the plant genus cannabis.
					 "Artificially derived cannabinoid" does not include:
(1) A naturally occurring chemical substance
				  that is separated from the plant genus cannabis by a chemical or mechanical
				  extraction process; or
(2)
				  Cannabinoids that are produced by decarboxylation from a naturally occurring
				  cannabinoid acid without the use of a chemical catalyst.
"Batch" means a specific quantity of cannabis or
					 manufactured cannabis product that is intended to be uniform and that is
					 produced during a specified time period covered by a single batch production
					 record during the same production cycle. A batch of cannabis shall contain only
					 cannabis of an identical strain that has been grown and harvested together and
					 exposed to substantially similar conditions throughout cultivation.
"Batch number" means any distinctive group of letters,
					 numbers, or symbols, or any combination of them, from which the complete
					 history of the production, packaging, labeling, and storage of a batch of
					 cannabis or manufactured cannabis products can be determined.
"Blanching" means a pre-packaging heat treatment for an
					 adequate time and at an adequate temperature to partially or completely
					 inactivate naturally occurring enzymes and to effect other physical or
					 biochemical changes.
"Business days" means Monday through Friday, excluding
					 State holidays.
"Cannabinoids" means any of the various naturally
					 occurring, biologically active, chemical constituents of cannabis that bind to
					 or interact with receptors of the endogenous cannabinoid system.
"Cannabis" has the same meaning as defined in section
					 329-121, HRS.
"Caregiver of a qualifying out-of-state patient" has the
					 same meaning as defined in section 329-121, HRS.
"Certificate of accreditation" means a certificate issued
					 by an accreditation body for a laboratory facility, entity, or site to be
					 registered in Hawaii.
"Certified laboratory" means a laboratory that is certified
					 by the department to analyze cannabis and manufactured cannabis products for
					 content, contamination, and consistency as provided in this chapter.
"Component" means any substance intended for use in the
					 production of a manufactured cannabis product, including those that may not
					 appear in the finished batch of the manufactured cannabis product.
"Contact surface" means any surface that contacts cannabis,
					 a component, or a manufactured cannabis product, and those surfaces from which
					 drainage onto the cannabis, component, or manufactured cannabis product, or
					 onto surfaces that contact the cannabis, component, or manufactured cannabis
					 product, occurs during the normal course of operations. Examples of contact
					 surfaces include containers, utensils, tables, surfaces of equipment, and
					 packaging.
"Contamination" means microbiological, chemical,
					 radiological, or physical substances that either develop in or are added to
					 cannabis, manufactured cannabis products, or ingredients and are capable of
					 causing cannabis or manufactured cannabis products to be:
(1) Unsafe for consumption or topical use, as
				  intended; or
(2) In violation of a
				  regulatory standard. "Days" as used in this chapter means calendar days unless
				  otherwise specified.
"Department" means the state department of health.
"Director" means the director of the state department of
					 health or the director's designee.
"Dispensary facility" means all property designated by a
					 dispensary licensee as a medical cannabis production center or a retail
					 dispensing location, including all property designated by the licensee as a
					 subcontracted medical cannabis production center or a subcontracted retail
					 dispensing location.
"Dispensary licensee" means an individual applicant and an
					 applying entity who are issued a license by the department and includes their
					 officers, employees, or agents.
"Dispense" or "dispensing" has the same meaning as defined
					 in section 329D-1, HRS.
"Edible cannabis products" has the same meaning as defined
					 in section 329D-10(c), HRS.
"Enclosed indoor facility" has the same meaning as defined
					 in section 329D-1, HRS.
"Final form" means the form cannabis or a manufactured
					 cannabis product is in when it is available for sale at a retail dispensing
					 location. For pre-filled and sealed containers used to aerosolize and deliver
					 cannabis orally, this is the final form of the cannabis, cannabis oils, or
					 cannabis extracts that will be placed into the sealed containers.
"Gummy" or "gummies" means a chewable soft confection made
					 primarily from sugar with gelatin or another gelling agent such as starch or
					 pectin.
"Hemp" has the same meaning as defined in section 328G-1,
					 HRS.
"Hemp product" has the same meaning as defined in section
					 328G-1, HRS.
"Individual applicant" means an individual authorized by an
					 applying entity to apply for a dispensary license pursuant to chapter 329D,
					 HRS, who shall be the primary point of contact with the department during the
					 application process and after licensing.
"Ingredient" means any substance that is used in the
					 manufacture of a manufactured cannabis product and that is intended to be
					 present in the finished batch of the manufactured cannabis product.
"Manufacture" has the same meaning as defined in section
					 329D-1, HRS, except that it excludes chemical synthesis of cannabis or its
					 psychoactive constituents.
"Manufactured cannabis product" has the same meaning as
					 defined in section 329D-1, HRS, except that it excludes chemically synthesized
					 cannabis or its psychoactive constituents.
"Medical cannabis dispensary" or "dispensary" has the same
					 meaning as defined in section 329D-1, HRS.
"Medical cannabis production center" or "production center"
					 has the same meaning as defined in section 329D-1, HRS.
"Medical use" has the same meaning as defined in section
					 329-121, HRS.
"Microorganisms" means yeasts, molds, bacteria, viruses,
					 and other similar microscopic organisms having public health or sanitary
					 concern. This definition includes species that:
(1) May have public health
				  significance;
(2) May cause
				  cannabis, a component, or a manufactured cannabis product to decompose;
				  or
(3) Indicate that the cannabis,
				  component, or manufactured cannabis product is contaminated.
"Pathogen" means a microorganism of public health
					 significance.
"Person" has the same meaning as defined in section 329D-1,
					 HRS.
"Pest" means any objectionable insect or other animal
					 including birds, rodents, flies, mites, and larvae.
"Playground" has the same meaning as defined in section
					 329D-22(b), HRS.
"Primary caregiver" has the same meaning as defined in
					 section 329-121, HRS.
"Product complaint" means any communication that contains
					 any written, electronic, or oral allegation expressing concern with the quality
					 of cannabis or a manufactured cannabis product for any reason. Examples of
					 product complaints are: Foul odor, off taste, illness or injury, disintegration
					 time, color variation, tablet size or size variation, under-filled container,
					 foreign material in a cannabis or manufactured cannabis product container,
					 improper packaging, mislabeling, or cannabis or manufactured cannabis products
					 that are superpotent, subpotent, or contain the wrong ingredient, or contain a
					 drug or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass,
					 lead).
"Production" or "produce" has the same meaning as defined
					 in section 329D-1, HRS.
"Psychoactive" means that a chemical substance changes
					 nervous system function and results in alterations in perception, mood,
					 consciousness, cognition, or behavior.
"Qualified individual" means a person who has the
					 education, training, or experience (or a combination thereof) necessary to
					 produce, package, or store clean and safe cannabis or manufactured cannabis
					 products as appropriate to the individual's assigned duties.
"Qualifying out-of-state patient" or "registered qualifying
					 out-of-state patient" has the same meaning as defined in section 329-121,
					 HRS.
"Qualifying patient" has the same meaning as defined in
					 section 329-121, HRS.
"Quality" means that the cannabis or manufactured cannabis
					 product consistently meets established specifications for content, consistency,
					 and limits on contaminants, and has been produced, packaged, labeled, and
					 stored under conditions to prevent contamination.
"Quality control operation" means a planned and systematic
					 procedure for taking all actions necessary to prevent cannabis or manufactured
					 cannabis products from being contaminated.
"Quality control personnel" means any person, persons, or
					 group within a medical cannabis production center designated to be responsible
					 for its quality control operations.
"Registered employee of a dispensary" or "authorized
					 employee of a dispensary" means an individual employed by a dispensary licensee
					 or a dispensary subcontractor, who meets all of the requirements of this
					 chapter for dispensary employees and whose name has been provided to the
					 department by the dispensary licensee.
"Representative sample" means a sample that consists of an
					 adequate number of increments that are drawn based on rational criteria, such
					 as random sampling, and that are intended to ensure that the sample accurately
					 portrays the material being sampled.
"Reprocessing" means using, in the production of cannabis
					 or a manufactured cannabis product, cannabis, manufactured cannabis products,
					 or components that have been previously removed from production and that have
					 been made suitable for use in the production of cannabis or a manufactured
					 cannabis product.
"Reserve sample" means a representative sample of cannabis
					 or manufactured cannabis product that is held for a designated period of
					 time.
"Retail dispensing location" has the same meaning as
					 defined in section 329D-1, HRS.
"Rework" means manufactured cannabis products or components
					 that have been removed from production and that have been successfully made
					 suitable for use as or in manufactured cannabis products.
"Safe moisture level" is a level of moisture low enough to
					 prevent the growth of undesirable microorganisms in the cannabis or
					 manufactured cannabis product under the intended conditions of production and
					 storage. The safe moisture level for a manufactured cannabis product is related
					 to its water activity (aw). An aw will be considered safe if adequate data are
					 available that demonstrate that the manufactured cannabis product or component
					 at or below the given aw will not support the growth of undesirable
					 microorganisms.
"Sanitize" means to adequately treat cleaned equipment,
					 containers, utensils, or any other cleaned contact surface by a process that is
					 effective in destroying vegetative cells of pathogens, and in substantially
					 reducing numbers of other microorganisms, but without adversely affecting the
					 product or its safety for the consumer.
"School" has the same meaning as defined in section
					 329D-22(b), HRS.
"Scope of accreditation" means a document issued by an
					 accreditation body which describes the methodologies, range, and parameters for
					 analyzing products for which the accreditation has been granted.
"Standard operating procedure" means written instructions
					 on how to perform tasks and descriptions of the approved or required procedures
					 for accomplishing specific quality assurance objectives.
"Subcontractor" or "contractor" has the same meaning as
					 defined in section 329D-1, HRS.
"Synthetic cannabinoid" has the same meaning as defined in
					 section 328G-1, HRS.
"Theoretical yield" means the quantity that would be
					 produced at any appropriate step of manufacture or packaging of a particular
					 manufactured cannabis product, based upon the quantity of components or
					 packaging to be used, in the absence of any loss or error in actual
					 production.
"Time/temperature control for safety product" means a
					 manufactured cannabis product that:
(1) Requires time/temperature control for
				  safety (TCS) to limit pathogenic microorganism growth or toxin formation;
				  and
(2) If regulated as a food,
				  would meet the definition of a "time/temperature control for safety food" in
				  the U.S. Food and Drug Administration 2017 Food Code (9th edition).
"Total tetrahydrocannabinol" or "total THC" means the sum
					 of the percentage by weight of:
(1)
				  Delta-9-tetrahydrocannabinolic acid (D9-THCA) multiplied by 0.877;
(2) Delta-9-tetrahydrocannabinol (D9-THC);
				  and
(3)
				  Delta-8-tetrahydrocannabinol (D8-THC).
"Water activity" or "aw" is a measure of the free moisture
					 in cannabis, a component, or a manufactured cannabis product and is the
					 quotient of the water vapor pressure of the substance divided by the vapor
					 pressure of pure water at the same temperature.