Ariz. Admin. Code § 9-17-101

Current through Register Vol. 30, No. 43, October 25, 2024

Section R9-17-101 - Definitions

In addition to the definitions in A.R.S. § 36-2801, the following definitions apply in this Chapter unless otherwise stated:

1. "Accreditation" means being deemed as technically competent under ISO 17025 by the:

a. American Association of Laboratory Accreditation,

b. Perry Johnson Laboratory Accreditation,

c. ANSI National Accreditation Board,

d. International Accreditation Services, or

e. Commission on Office Laboratory Accreditation.

2. "Acquire" means to obtain through any type of transaction and from any source.

3. "Activities of daily living" means ambulating, bathing, dressing, grooming, eating, toileting, and getting in and out of bed.

4. "Amend" means adding or deleting information on an individual's registry identification card that affects the individual's ability to perform or delegate a specific act or function.

5. "Analyte" means a specific substance for which testing is performed by a laboratory.

6. "Applicant" means:

a. An individual submitting an application for a registry identification card or to amend, change, or replace a registry identification card for a qualifying patient, designated caregiver, dispensary agent, or laboratory agent;

b. An entity submitting an application for a dispensary registration certificate or approval to operate a dispensary; or

c. An individual or entity submitting an application for a laboratory registration certificate, approval to test, or approval to change parameters.

7. "Batch" means:

a. When referring to cultivated medical marijuana, a specific lot of medical marijuana that is uniform in strain, grown from one or more seeds or cuttings that are planted and harvested at the same time, and cultivated under the same conditions;

b. When referring to marijuana products, a specific amount of a marijuana product infused, manufactured, or prepared for sale from the same set of ingredients at the same time; and

c. When referring to a laboratory testing medical marijuana or a marijuana product according to R9-17-404.03, a specific set of no more than 20 samples prepared and tested during the same run using the same equipment.

8. "Batch number" means a unique numeric or alphanumeric identifier assigned to a batch by a dispensary when:

a. The batch of medical marijuana is planted, or

b. The batch of a marijuana product is infused, manufactured, or prepared for sale.

9. "Calendar day" means each day, not including the day of the act, event, or default from which a designated period of time begins to run, but including the last day of the period unless it is a Saturday, Sunday, statewide furlough day, or legal holiday, in which case the period runs until the end of the next day that is not a Saturday, Sunday, statewide furlough day, or legal holiday.

10. "Change" means:

a. When used in relation to a registry identification card, adding or deleting information on an individual's registry identification card that does not substantively affect the individual's ability to perform or delegate a specific act or function;

b. When used in relation to a place, moving to a different location;

c. When used in relation to an individual, selecting a different individual to perform specific actions;

d. When used in relation to parameters, revising a laboratory's standard operating procedures or quality assurance plan, required in R9-17-404.06, due to:

i. Adding or removing a parameter,

ii. Altering a testing method, or

iii. Using a different instrument for performing a test; and

e. When used in relation to testing results, altering the testing results in any way and for any reason.

11.."Commercial device" means a "commercial device," as defined in A.R.S. § 3-3401, that is licensed or certified according to A.R.S. § 3-3451.

12. "Contaminant" means matter, pollutant, hazardous substance, or other substance that is not intended to be part of dispensed medical marijuana or a marijuana product.

13. "Cultivation site" means the one additional location where marijuana may be cultivated, infused, or prepared for sale by and for a dispensary.

14. "Current photograph" means an image of an individual, taken no more than 60 calendar days before the submission of the individual's application, in a Department-approved electronic format capable of producing an image that:

a. Has a resolution of at least 600 x 600 pixels but not more than 1200 x 1200 pixels;

b. Is 2 inches by 2 inches in size;

c. Is in natural color;

d. Is a front view of the individual's full face, without a hat or headgear that obscures the hair or hairline;

e. Has a plain white or off-white background; and

f. Has between 1 and 1 3/8 inches from the bottom of the chin to the top of the head.

15. "Denial" means the Department's final decision not to issue a registry identification card, a dispensary registration certificate, a laboratory registration certificate, or an approval of a change of dispensary or a dispensary's cultivation site location, to an applicant because the applicant or the application does not comply with the applicable requirements in A.R.S. Title 36, Chapter 28.1 or this Chapter.

16. "Dispensary" means the same as "nonprofit medical marijuana dispensary" as defined in A.R.S. § 36-2801.

17. "Dispensary agent" means the same as "nonprofit medical marijuana dispensary agent" as defined in A.R.S. § 36-2801.

18. "Dual licensee" means the same as in A.R.S. § 36-2850.

19. "Edible food product" means a substance, beverage, or ingredient used or intended for use or for sale in whole or in part for human oral consumption.

20. "Enclosed area" when used in conjunction with "enclosed, locked facility" means outdoor space surrounded by solid, 10-foot walls, constructed of metal, concrete, or stone that prevent any viewing of the marijuana plants, and a 1-inch thick metal gate.

21. "Entity" means the same as in A.R.S. § 29-2102.

22. "Generally accepted accounting principles" means the set of financial reporting standards established by the Financial Accounting Standards Board, the Governmental Accounting Standards Board, or another specialized body dealing with accounting and auditing matters.

23. "Geographic area" means the same as in A.R.S. § 36-2803.01.

24. "In-state financial institution" means the same as in A.R.S. § 6-101.

25. "Inhalable" means intended for use through intake into the lungs of an individual.

26. "Laboratory" means the same as "independent third-party laboratory" as defined in A.R.S. § 36-2801.

27. "Laboratory agent" means the same as "independent third-party laboratory agent" as defined in A.R.S. § 36-2801.

28. "Legal guardian" means an adult who is responsible for a minor:

a. Through acceptance of guardianship of the minor through a testamentary appointment or an appointment by a court pursuant to A.R.S. Title 14, Chapter 5, Article 2; or

b. As a "custodian" as defined in A.R.S. § 8-201.

29. "Manufacture" or "manufactured" means the same as in A.R.S. § 36-2850.

30. "Marijuana establishment" means the same as in A.R.S. § 36-2850.

31. "Marijuana facility agent" means the same as in A.R.S. § 36-2850.

32. "Marijuana product" means the same as in A.R.S. § 36-2850.

33. "Matrix" means the specific components of a sample, other than the analyte being tested for.

34. "Medical record" means the same as:

a. "Adequate records" as defined in A.R.S. § 32-1401,

b. "Adequate medical records" as defined in A.R.S. § 32-1501,

c. "Adequate records" as defined in A.R.S. § 32-1800, or

d. "Adequate records" as defined in A.R.S. § 32-2901.

35. "Out-of-state financial institution" means the same as in A.R.S. § 6-101.

36. "Parameter" means the combination of a particular type of sample with a specific instrument or equipment by which the sample will be tested for a specific analyte or characteristic.

37. "Proficiency testing" means a mechanism to determine a laboratory agent's ability to analyze samples within specific acceptance criteria in which the characteristics of the samples are known by the source of the samples but are unknown to a laboratory receiving the samples from the source.

38. "Proficiency testing service" means an independent company or other person acceptable to the Department, based on ISO/IEC 17043:2010 certification, that:

a. Is the source for samples with known characteristics for proficiency testing, and

b. Assesses the acceptability of a laboratory agent's results from the samples with known characteristics during proficiency testing.

39. "Private school" means the same as in A.R.S. § 15-101.

40. "Public school" means the same as "school" as defined in A.R.S. § 15-101.

41. "Registry identification number" means the random 20-digit alphanumeric identifier generated by the Department, containing at least four numbers and four letters, issued by the Department to a qualifying patient, designated caregiver, dispensary, dispensary agent, laboratory, or laboratory agent.

42. "Revocation" means the Department's final decision that an individual's registry identification card, a dispensary registration certificate, or a laboratory registration certificate is rescinded because the individual, the dispensary, or the laboratory does not comply with the applicable requirements in A.R.S. Title 36, Chapter 28.1 or this Chapter.

43. "Sample" means:

a. A representative portion of a larger quantity of medical marijuana or a marijuana product,

b. A specific quantity of a substance or set of substances to be used for testing purposes, or

c. To collect the representative portion in subsection (39)(a).

44. "Time/temperature control for safety food" means the same as in the Food Code: 2017 Recommendations of the United States Public Health Service, Food and Drug Administration, §1-201.10.

45. "Topical" means intended for use through application to the surface of the skin of an individual.

46. "Working day" means a Monday, Tuesday, Wednesday, Thursday, or Friday that is not a state holiday or a statewide furlough day.

Ariz. Admin. Code § R9-17-101

New Section made by exempt rulemaking at 17 A.A.R. 734, effective April 14, 2011 (Supp. 11-2). Amended by final rulemaking at 18 A.A.R. 3354, with an immediate effective date of December 5, 2012 (Supp. 12-4). Amended by final exempt rulemaking at 25 A.A.R. 2421, effective 8/27/2019. Amended by final exempt rulemaking at 26 A.A.R. 734, effective 4/2/2020. Amended by final exempt rulemaking at 27 A.A.R. 111, effective 1/15/2021. Amended by exempt rulemaking at 27 A.A.R. 747, effective 5/3/2021. Amended by final expedited rulemaking at 28 A.A.R. 2562, effective 9/8/2022. Amended by final rulemaking at 29 A.A.R. 2396, effective 10/1/2023.