Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 154 - Medical Cannabidiol Program › Rule 641-154.1 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
For the purposes of these rules, the following definitions
				shall apply:
"Acceptance criteria"
means the specified
				limits placed on characteristics of an item or method that are used to
				determine data quality.
"Action level"
means the threshold value that
				provides the criterion for determining whether a sample passes or fails a test
				performed pursuant to these rules.
"Advertisement"
means all representations
				disseminated in any manner or by any means, other than by labeling, for the
				purpose of inducing, or that are likely to induce, directly or indirectly, the
				purchase of medical cannabidiol.
"Analyte"
means a chemical, compound, element,
				bacteria, yeast, fungus, or toxin to be identified or measured.
"Analytical batch"
means a group of samples
				that are prepared together for the same analysis and analyzed sequentially
				using the same instrument calibration curve and common analytical quality
				control checks.
"Analytical method"
means a technique used
				qualitatively or quantitatively to determine the composition of a sample or a
				microbial contamination of a sample.
"Audit"
means a review by authorized personnel
				that includes select scope engagement or other methods of review that analyze
				operational or compliance issues.
"Background investigation"
means a thorough
				review of an entity, an owner, investors, and employees conducted by the
				department of public safety, including but not limited to state and national
				criminal history records, credit records, and internal revenue service
				records.
"Batch"
means a specifically identified
				quantity of dried flower and other cannabis plant matter that is uniform in
				strain or cultivar, harvested at the same time, and cultivated using the same
				pesticides and other crop inputs.
"Biosecurity"
means a set of preventative
				measures designed to reduce the risk of transmission of:
1. Infectious diseases in crops;
2. Quarantined pests;
3. Invasive alien species;
4. Living modified organisms.
"Cannabinoid"
means a chemical compound that
				is unique to and derived from cannabis.
"Cannabis"
means seeds, plants, cuttings, or
				plant waste material from Cannabis sativa L. or Cannabis indica used in the
				manufacture of medical cannabidiol.
"CBD"
means cannabidiol, Chemical Abstracts
				Service number 13956-29-1.
"CBDA"
means cannabidiolic acid, Chemical
				Abstracts Service number 1244-58-2.
"Certificate of analysis"
means the report
				prepared for the requester about the analytical testing performed and the
				results obtained by a laboratory.
"Certified"
means that a laboratory
				demonstrates to the satisfaction of the department its ability to consistently
				produce valid data within the acceptance limits as specified in the
				department's requirements for certification and meets the minimum requirements
				of this chapter and all applicable regulatory requirements.
"Certified reference material"
means a
				reference material prepared by a certifying body.
"Combusted"
means the addition of a flame to
				medical cannabidiol or raw flower cannabis for the purposes of burning for
				inhalation, or smoking cannabis.
"Consumable hemp product"
means a hemp
				product that includes a substance that is metabolized or is otherwise subject
				to a biotransformative process when introduced into the human body.
1. A consumable hemp product may be
			 introduced into the human body by ingestion or absorption by any device
			 including but not limited to an electronic device.
2. A consumable hemp product may exist in a
			 solid or liquid state.
3. A hemp
			 product is deemed to be a consumable hemp product if it is any of the
			 following:
* Designed by the processor, including the manufacturer, to be
				introduced into the human body.
* Advertised as an item to be introduced into the human
				body.
* Distributed, exported, or imported for sale or distribution
				to be introduced into the human body.
"Consumable hemp product"
includes but is not
				limited to any of the following:
1. A
			 noncombustible form of hemp that may be digested, such as food; internally
			 absorbed, such as chew or snuff; or absorbed through the skin, such as a
			 topical application.
2. Hemp
			 processed or otherwise manufactured, marketed, sold, or distributed as food, a
			 food additive, a dietary supplement, or a drug.
"Consumable hemp product"
does not include a
				hemp product if the intended use of the hemp product is introduced into the
				human body by any method of inhalation, as prohibited under Iowa Code section
				204.14A.
"Crop input"
means any substance applied to
				or used in the cultivation and growth of a cannabis plant.
"Crop input"
includes but is not limited to
				pesticides, fungicides, fertilizers, and other soil or medium
				amendments.
"Date of expiration"
means one year from the
				date of issuance of the medical cannabidiol registration card by the department
				of transportation.
"Date of issuance"
means the date of issuance
				of the medical cannabidiol registration card by the department.
"Debilitating medical condition"
means any of
				the following:
1. Cancer, if the
			 underlying condition or treatment produces one or more of the following:
* Severe or chronic pain.
* Nausea or severe vomiting.
* Cachexia or severe wasting.
2. Multiple sclerosis with severe and
			 persistent muscle spasms.
3.
			 Seizures, including those characteristic of epilepsy.
4. AIDS or HIV as defined in Iowa Code
			 section 141A.1.
5. Crohn's disease.
6. Amyotrophic lateral sclerosis.
7. Any terminal illness with a probable life
			 expectancy of under one year, if the illness or its treatment produces one or
			 more of the following:
* Severe or chronic pain.
* Nausea or severe vomiting.
* Cachexia or severe wasting.
8. Parkinson's disease.
9. Chronic pain.
10. Severe, intractable autism with
			 self-injurious or aggressive behaviors.
11. Post-traumatic stress disorder.
12. Corticobasal degeneration.
13. Ulcerative colitis.
14. Any medical condition that is recommended
			 by the medical cannabidiol board and adopted by the board of medicine by rule
			 pursuant to Iowa Code section
			 124E.5 and that is listed in
			 653-subrule 13.15(1).
"Dispensary"
means an individual or entity
				licensed by the department to dispense medical cannabidiol to patients and
				primary caregivers pursuant to Iowa Code chapter 124E and these rules.
"Dispensary"
includes the employees and
				agents of the dispensary.
"Dispensary facility"
means any secured
				building, space, grounds, and physical structure of a dispensary licensed by
				the department to dispense medical cannabidiol and where the dispensing of
				medical cannabidiol is authorized.
"Dispense"
or
"dispensing"
means to supply medical cannabidiol to patients pursuant to Iowa Code chapter
				124E and these rules.
"Disqualifying felony offense"
means the same
				as defined in Iowa Code section
				124E.2.
"Edible medical cannabidiol products"
means
				food items containing medical cannabidiol.
"Edible medical cannabidiol products"
does
				not include pills, tinctures, oils, or other forms of medical cannabidiol that
				may be consumed orally or through the nasal cavity that do not contain food or
				food additives; provided that food or food additives used as carriers,
				excipients, or processing aids shall not be considered food or food
				additives.
"Field duplicate sample"
means a sample that
				is taken in the identical manner and from the same batch, process lot, or lot
				being sampled as the primary sample. A field duplicate sample is analyzed
				separately from the primary sample and is used for quality control only.
"Health care practitioner"
means the same as
				defined in Iowa Code section
				124E.2.
"Inspection"
means an on-site evaluation by
				the department; the department of public safety; or a department-approved
				independent consultant of facilities, records, personnel, equipment,
				methodology, and quality assurance practices for compliance with these
				rules.
"Investor"
means a person making a cash
				investment of at least 5 percent interest in an applicant or licensed
				manufacturer or dispensary with the expectation of receiving financial
				returns.
"Laboratory"
means the same as defined in
				Iowa Code section 124E.2.
"Limit of detection"
or
"LOD"
means the lowest quantity of a substance or analyte that
				can be distinguished from the absence of that substance within a stated
				confidence limit.
"Limit of quantitation"
or
"LOQ"
means the minimum concentration of an analyte in a
				specific matrix that can be reliably quantified while also meeting predefined
				goals for bias and imprecision.
"Lot"
means a specific quantity of medical
				cannabidiol that is uniform and intended to meet specifications for identity,
				strength, purity, and composition, and that is manufactured, packaged, and
				labeled during a specified time period according to a single manufacturing,
				packaging, and labeling record.
"Lot number"
means a unique numeric or
				alphanumeric identifier assigned to a lot by a manufacturer when medical
				cannabidiol is produced. The lot number shall contain the manufacturer's number
				and a sequence to allow for inventory, traceability, and identification of the
				plant batches used in the production of a lot of medical cannabidiol.
"Manufacture"
or
"manufacturing"
means the process of converting harvested
				cannabis plant material into medical cannabidiol.
"Manufacturer"
means an individual or entity
				licensed by the department to produce medical cannabidiol and distribute it to
				dispensaries pursuant to Iowa Code chapter 124E and these rules.
"Manufacturer"
includes the employees and
				agents of the manufacturer.
"Manufacturing facility"
means any secured
				building, space, grounds, and physical structure of a manufacturer for the
				cultivation, harvesting, packaging, processing, storage, and distribution of
				cannabis or medical cannabidiol and where access is restricted to designated
				employees of a manufacturer and escorted visitors.
"Matrix"
means the component or substrate
				that contains the analyte of interest.
"Matrix spike duplicate"
means a duplicate
				sample prepared by adding a known quantity of a target analyte to a field
				sample matrix or other matrix that is as closely representative of the matrix
				under analysis as possible.
"Matrix spike sample"
means a sample prepared
				by adding a known quantity of the target analyte to a field sample matrix or to
				a matrix that is as closely representative of the matrix under analysis as
				possible.
"Medical assistance program"
means IA Health
				Link, Medicaid Fee-for-Service, or hawki, as administered by the Iowa Medicaid
				enterprise of the department.
"Medical cannabidiol"
means the same as
				defined in Iowa Code section
				124E.2.
"Medical cannabidiol waste"
means medical
				cannabidiol that is unused, unwanted, damaged, defective, expired, or
				contaminated and that is returned to a dispensary or manufacturer for
				disposal.
"Medical cannabis goods"
means medical
				cannabidiol process lots, medical cannabidiol products, and cannabis plant
				material, including dried tissue.
"Method blank"
means an analyte-free matrix
				to which all reagents are added in the same volumes or proportions as are used
				in sample preparation.
"National criminal history background check"
means fingerprint processing through the department of public safety and the
				Federal Bureau of Investigation (FBI) and review of records on file with
				national organizations, courts, and law enforcement agencies to the extent
				allowed by law.
"Owner"
means a person with a 5 percent or
				greater ownership interest in an applicant or licensed manufacturer or
				dispensary.
"Patient"
means a person who is a permanent
				resident of the state of Iowa who suffers from a debilitating medical condition
				that qualifies for the use of medical cannabidiol pursuant to Iowa Code chapter
				124E and these rules.
"Patient registration number"
means the
				unique identification number issued to a patient by the department upon
				approval of a patient's application by the department as described in these
				rules.
"Percent recovery"
means the percentage of a
				measured concentration relative to the added (spiked) concentration in a
				reference material, matrix spike sample, or matrix spike duplicate.
"Plant material"
means any plant of Cannabis
				sativa L. or Cannabis indica, or any part thereof, including flowers, leaves,
				trichomes, and tissue.
"Plant material waste"
means plant material
				that is not used in the production of medical cannabidiol in a form allowable
				under these rules.
"Primary caregiver"
means the same as defined
				in Iowa Code section 124E.2.
"Primary care provider"
means any health care
				practitioner involved in the diagnosis and treatment of a patient's
				debilitating medical condition. "Primary sample" means a portion of a batch,
				process lot, or lot that is used for testing for identity, strength, purity,
				and composition.
"Process lot"
means any amount of cannabinoid
				concentrate or extract that is uniform, produced from one or more batches, and
				used for testing for identity, strength, purity, and composition prior to being
				packaged.
"Product expiration date"
means the date
				after which a medical cannabidiol product shall not be sold by a manufacturer
				or a dispensary.
"Production"
or
"produce"
means:
1. Cultivating or harvesting
			 plant material;
2. Processing or
			 manufacturing; or
3. Packaging of
			 medical cannabidiol.
"Proficiency test"
means an evaluation of a
				laboratory's performance against preestablished criteria by means of
				interlaboratory comparisons of test measurements.
"Qualitative analysis"
means identification
				of an analyte in a substance or mixture.
"Quality assurance"
means a set of operating
				principles to produce data of known accuracy and precision.
"Quality assurance"
encompasses employee
				training, equipment preventative maintenance procedures, calibration
				procedures, and quality control testing, among other things.
"Quality control"
means a set of measures
				implemented within an analytical procedure to ensure that the measurement
				system is operating in a state of statistical control in which errors have been
				reduced to acceptable levels.
"Quality control samples"
means samples
				produced and used for the purpose of ensuring quality control. Quality control
				samples include but are not limited to blank samples, spike samples, duplicate
				samples, and reference material samples.
"Reagent"
means a compound or mixture added
				to a system to cause a chemical reaction or to test if a reaction occurs. A
				reagent may be used to tell whether or not a specific chemical substance is
				present by causing a reaction to occur with the chemical substance.
"Recall"
means the return of medical
				cannabidiol from patients and dispensaries to a manufacturer because of the
				potential for serious health consequences from the use of the medical
				cannabidiol.
"Reference material"
means a material
				containing a known concentration of an analyte of interest that is in solution
				or in a homogeneous matrix. Reference material is used to document the bias of
				the analytical process.
"Relative percent difference"
or
"RPD"
means a comparative statistic used to calculate
				precision or random error. RPD is calculated using the following equation: RPD
				= absolute value (primary sample measurement - duplicate sample measurement) /
				([primary sample measurement + duplicate sample measurement] / 2) Ã—
				100.
"Requester"
means a person who submits a
				request to a licensed testing laboratory for state-mandated testing of medical
				cannabis goods. The requester may be a licensed manufacturer or the
				department.
"Residual solvents and processing chemicals"
means volatile organic chemicals that are used or produced in the manufacture
				or production of medical cannabidiol.
"Restricted access area"
means a building,
				room, or other contiguous area on the premises where plant material is grown,
				cultivated, harvested, stored, packaged, or processed for sale under control of
				the manufacturer, and where no person under the age of 18 is permitted.
"Sample"
means a representative part of or a
				single item from a larger whole or group.
"Sanitize"
means to sterilize, disinfect, or
				make hygienic.
"Security alarm system"
means the same as
				defined in rule 661-277.2 (100C).
"Semiquantitative analysis"
means less than
				quantitative precision and does not involve a full calibration. Analyte
				identification is based on a single-point reference or high-probability library
				match. The determination of amount uses the ratio of the unknown chemical
				analyte to that of a known analyte added to the sample before analysis.
				Uncertainty for semiquantitative results is higher than for quantitative
				results.
"Significant figures"
means the number of
				digits used to express a measurement.
"Stability study"
or
"studies"
means the process of determining the shelf-life or
				expiration date of a medical cannabidiol product. After storage of an unopened
				package of medical cannabidiol at a licensed manufacturing facility or
				dispensary facility, the contents shall not vary in concentrations of THC and
				CBD by more than an amount determined by the department and listed in the
				laboratory testing requirements and acceptance criteria document described in
				641-Chapter 154.
"Standard operating procedure"
means a
				written document that provides detailed instructions for the performance of all
				aspects of an analysis, operation, or action.
"Synthetic or semisynthetic cannabinoid"
means a cannabinoid extracted from a cannabis plant, a cannabis flower, a hemp
				plant, or hemp plant parts with a chemical makeup that is changed after
				extraction to create a different cannabinoid or other chemical compound by
				applying a catalyst other than heat or light.
"Synthetic or semisynthetic cannabinoid"
includes but is not limited to any tetrahydrocannabinol created from
				cannabidiol.
"Tamper-evident"
means that one or more
				one-time-use seals are affixed to the opening of a package, allowing a person
				to recognize whether or not the package has been opened.
"Testing laboratory record"
means information
				relating to the testing laboratory and the analyses it performs that is
				prepared, owned, used, or retained by the laboratory and includes electronic
				files and video footage.
"THC"
or
"delta-9 THC"
means
				tetrahydrocannabinol, Chemical Abstracts Service number 1972-08-3.
"THCA"
means tetrahydrocannabinolic acid,
				Chemical Abstracts Service number 23978-85-0.
"Total tetrahydrocannabinol"
means 87.7
				percent of the amount of tetrahydrocannabinolic acid plus the amount of
				tetrahydrocannabinol.
"Tracking number"
means the sales
				identification number assigned by a dispensary to a transaction at the time of
				the sale of a medical cannabidiol product. "Trade name" means the name that
				manufacturers give to a product or range of products.
"Validation"
means the confirmation by
				examination and objective evidence that the particular requirements for a
				specific intended use are fulfilled.
"Valid photo identification"
means any of the
				following for a patient or primary caregiver:
(1) a valid Iowa driver's license,
(2) a valid Iowa nonoperator's identification
			 card, or
(3) an alternative form of
			 valid photo identification. An individual who possesses or is eligible for a
			 driver's license or a nonoperator's identification card shall present such
			 document as valid photo identification. An individual who is ineligible to
			 obtain a driver's license or a nonoperator's identification card may apply for
			 an exemption and request submission of an alternative form of valid photo
			 identification. An individual who applies for an exemption is subject to
			 verification of the primary caregiver's identity through a process established
			 by the department to ensure the genuineness, regularity, and legality of the
			 alternative form of valid photo identification.
"Vaporization"
means the heating of a medical
				cannabidiol concentrate or extract to a specific temperature using a device.
				For the purposes of these rules, vaporization does not include raw or dried
				cannabis flower.
"Written certification"
means a document
				signed by a health care practitioner, with whom the patient has established a
				patient-provider relationship, that states that the patient has a debilitating
				medical condition and identifies that condition and provides any other relevant
				information.