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.
"Accreditation"
means the procedure by which
				an authoritative body gives formal recognition that an organization is
				competent to carry out specific tasks and verifies that the appropriate quality
				management system is in place.
"Accredited nonpublic school"
means any
				nonpublic school accredited by the Iowa state board of education, excluding
				home schools.
"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.
"Aliquot"
means a portion of a sample that is
				used in an analysis.
"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 financial review by an
				independent certified public accountant 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.
"Batch number"
means a unique numeric or
				alphanumeric identifier assigned to a batch of cannabis plants by a
				manufacturer when the batch is harvested. The batch number shall contain the
				manufacturer's number and a sequence to allow for inventory and
				traceability.
"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.
"Bordering state"
means the same as defined in
				Iowa Code section
				331.910.
"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.
"CAS number"
means a unique numerical
				identifier assigned to every chemical substance described in the open
				literature by Chemical Abstracts Service.
"CBD"
means cannabidiol, Chemical Abstracts
				Service number 13956-29-1.
"CBDA"
means cannabidiolic acid, Chemical
				Abstracts Service number 1244-58-2.
"CBG"
means cannabigerol, Chemical Abstracts
				Service number 25654-31-3.
"CBN"
means cannabinol, Chemical Abstracts
				Service number 521-35-7.
"Certificate of analysis"
means the report
				prepared for the requester about the analytical testing performed and the
				results obtained by a laboratory.
"Certification"
means a procedure by which a
				third party gives written assurance (certificate of conformity) that a product,
				process or service conforms to specified requirements.
"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.
"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.
"Data-quality assessment"
means a scientific
				and statistical process that establishes whether the collected data are of the
				right type, quality, and quantity to support the intended use of the
				data.
"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. 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).
"Department"
means the Iowa department of
				public health.
"Director"
means the director of the Iowa
				department of public health.
"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 a
				violation under federal or state law of a felony under federal or state law,
				which has as an element the possession, use, or distribution of a controlled
				substance, as defined in
				21
				U.S.C. §
									802(6).
"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.
"Form and quantity"
means the types and
				amounts of medical cannabidiol allowed to be dispensed to a patient or primary
				caregiver as approved by the department subject to recommendation by the
				medical cannabidiol board and approval by the board of medicine.
"Frequency"
means the number of items
				occurring in a given category. Frequency may be determined by analytical method
				or laboratory-specific requirements for the purpose of accuracy, precision of
				the analysis, or statistical calculation.
"Health care practitioner"
means an individual
				licensed under Iowa Code chapter 148 to practice medicine and surgery or
				osteopathic medicine and surgery, a physician assistant licensed under Iowa
				Code chapter 148C, an advanced registered nurse practitioner licensed under
				Iowa Code chapter 152, or an advanced practice registered nurse under Iowa Code
				chapter 152E, who is a patient's primary care provider or a podiatrist licensed
				pursuant to Iowa Code chapter 149.
"Increment"
or
"sample
				increment"
means a smaller sample that, together with other
				increments, makes up the primary sample.
"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.
"International Electro technical Commission"
or
"IEC"
means an independent, nongovernmental membership
				organization that prepares and publishes international standards for all
				electrical, electronic, and related technologies.
"International Organization for
				Standardization"
or
"ISO"
means an independent,
				nongovernmental membership organization and the largest developer of voluntary
				international standards.
"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 state hygienic
				laboratory at the University of Iowa or any other independent medical
				cannabidiol testing facility accredited to Standard ISO/IEC 17025 by an
				International Organization for Standardization-approved accrediting body, with
				a controlled substance registration certificate from the Drug Enforcement
				Administration of the U.S. Department of Justice and a certificate of
				registration from the Iowa board of pharmacy, and approved by the department to
				examine, analyze, or test samples of medical cannabidiol or any substance used
				in the manufacture of medical cannabidiol. For the purposes of these rules, an
				independent laboratory is a laboratory operated by an entity that has no equity
				ownership in a medical cannabidiol manufacturer.
"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.
"Market withdrawal"
means the voluntary
				removal of medical cannabidiol from dispensaries and patients by a manufacturer
				for minor issues that do not pose a serious health threat.
"Mass spectrometry"
means an analytical
				technique that ionizes chemical species and sorts the ions based on their
				mass-to-charge ratio.
"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 HAWK-I, as administered by the Iowa Medicaid
				enterprise of the Iowa department of human services.
"Medical cannabidiol"
means any pharmaceutical
				grade cannabinoid found in the plant
Cannabis sativa
L. or
Cannabis indica
or any other preparation thereof that is
				delivered in a form recommended by the medical cannabidiol board, approved by
				the board of medicine, and designated in this chapter. This definition shall
				not apply to any cannabis-derived investigational product or cannabis-derived
				product approved as a prescription drug medication by the United States food
				and drug administration.
"Medical cannabidiol 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.
"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.
"Moisture content"
means the percentage of
				water in a dry sample by weight.
"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.
"Non-target organism"
means an organism that
				the test method or analytical procedure is not testing for. Non-target
				organisms are used in evaluating the specificity of a test method.
"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 of transportation
				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.
"Permanent resident"
means a natural person
				who physically resides in Iowa as the person's principal and primary residence
				and who establishes evidence of such residency by providing the department with
				one of the following:
1. A valid Iowa driver's license,
2. A valid Iowa nonoperator's identification card,
3. A valid Iowa voter registration card,
4. A current Iowa vehicle registration certificate,
5. A utility bill,
6. A statement from a financial institution,
7. A residential lease agreement,
8. A check or pay stub from an employer,
9. A child's school or child care enrollment documents,
10. Valid documentation establishing a filing for homestead or
				military tax exemption on property located in Iowa, or
11. Other valid documentation as deemed acceptable by the
				department to establish residency.
"Pharmaceutical grade"
means medical
				cannabidiol that meets standards for content, contamination, and consistency
				set by the department as determined by testing conducted at a laboratory
				pursuant to Iowa Code chapter 124E and these rules.
"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 a person who is a
				resident of this state or a bordering state, including but not limited to a
				parent or legal guardian, at least 18 years of age, who has been designated by
				a patient's health care practitioner as a necessary caretaker taking
				responsibility for managing the well-being of the patient with respect to the
				use of medical cannabidiol pursuant to the provisions of Iowa Code chapter 124E
				and these rules.
"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 may 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.
"Proficiency test sample"
means a sample
				prepared by a party independent of the testing laboratory, with a concentration
				and identity of an analyte that is known to the independent party but is
				unknown to the testing laboratory and testing laboratory personnel.
"Public or private school"
means any property
				operated by a school district, charter school, or accredited nonpublic school
				for purposes related to elementary, middle, or secondary schools or secondary
				vocation centers.
"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 assuring quality control. Quality control
				samples include but are not limited to blank samples, spike samples, duplicate
				samples, and reference material samples.
"Quantitative analysis"
means measurement of
				the quantities of chemical components present in a substance or mixture.
				Quantitative analysis typically uses a certified reference material, if
				available, to create a calibration curve.
"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.
"Reference method"
means a method by which the
				performance of an alternate method is measured or evaluated.
"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) x 100.
"Relative standard deviation"
or
"RSD"
means the standard deviation expressed as a percentage
				of the mean recovery. "RSD" is the coefficient of variation multiplied by 100.
				If any results are less than the limit of quantitation, then the absolute value
				of the limit of quantitation is used in the following equation: RSD = (s / x) x
				100, where s = standard deviation and x = mean recovery.
"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.
"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"
or
"stable"
means
				that 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 subrule 154.69(1).
"Standard operating procedure"
means a written
				document that provides detailed instructions for the performance of all aspects
				of an analysis, operation, or action.
"State"
means a state of the United States,
				the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American
				Samoa, and the Commonwealth of the Northern Mariana Islands.
"Synthetic cannabinoid"
means a designed
				compound with structural features that allow binding to the known cannabinoid
				receptors present in human cells and that produce biological effects similar to
				those of natural cannabinoids.
"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.
"Target organism"
means an organism that is
				being tested for in an analytical procedure or test method.
"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.
"Validation"
means the confirmation by
				examination and objective evidence that the particular requirements for a
				specific intended use are fulfilled.
"Written certification"
means a document
				signed by a health care practitioner, with whom the patient has established a
				patient-provider relationship, which states that the patient has a debilitating
				medical condition and identifies that condition and provides any other relevant
				information.