Haw. Code R. § 11-850-2
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:
"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:
"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:
"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:
"Total tetrahydrocannabinol" or "total THC" means the sum of the percentage by weight of:
"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.
Haw. Code R. § 11-850-2