Ariz. Admin. Code § 9-17-317.01

Current through Register Vol. 30, No. 45, November 8, 2024

Section R9-17-317.01 - Analysis of Medical Marijuana or a Marijuana Product

A. Before offering a batch of medical marijuana or of a marijuana product for sale or dispensing to a qualifying patient or designated caregiver, a dispensary shall ensure that:

1. Except as provided in subsection (A)(2) or (3), each batch of medical marijuana or marijuana product is tested in compliance with requirements in R9-17-404.03, R9-17-404.04, and Table 3.1;

2. Each batch of a marijuana product is tested according to requirements in R9-17-404.03, R9-17-404.04, and Table 3.1 for, as applicable:

a. At least potency and microbial contaminants other than mycotoxins if the marijuana product was prepared from another marijuana product, such as a concentrate or tincture, that is in compliance with requirements in R9-17-404.03, R9-17-404.04, and Table 3.1, using none of the following:

i. A temperature above which any analyte could chemically decompose or react with a component of the marijuana product;

ii. A pressure above which any analyte could chemically decompose or react with a component of the marijuana product;

iii. A process by which any analyte in the marijuana product that is in compliance with requirements in R9-17-404.03, R9-17-404.04, and Table 3.1 may be further concentrated; or

iv. A solvent other than water; or

b. All analytes except:

i. Ethanol if the marijuana product is intended to contain ethanol; or

ii. For a marijuana product intended for topical application, isopropanol if the marijuana product is intended to contain isopropanol; and

3. If the results of testing of the dispensary's medical marijuana and marijuana products for heavy metals, according to R9-17-404.03, indicate that the medical marijuana and marijuana products are in compliance with Table 3.1 for a period of at least six consecutive months:

a. Each batch of medical marijuana or a marijuana product is tested according to requirements in R9-17-404.03, R9-17-404.04, and Table 3.1 for all analytes except heavy metals; and

b. At least once every three months, each batch of medical marijuana or a marijuana product is tested according to requirements in R9-17-404.03 and Table 3.1 for heavy metals.

B. A dispensary shall ensure that:

1. Until laboratory testing has been completed and testing results received by the dispensary that comply with requirements in R9-17-404.03, R9-17-404.04, and Table 3.1, a batch of marijuana or of a marijuana product is stored in a location away from medical marijuana and marijuana products offered for dispensing;

2. Except as provided in subsection (D), only one sample of each batch of medical marijuana or marijuana product is collected according to ANSI/ASQ Standard Z1.4 (2018), General Inspection Level II, incorporated by reference, including no future editions, and available at https://asq.org/quality-resources/z14-z19, including:

a. Use, as applicable, of one of the following sampling methods:

i. Top, middle, and bottom sampling using a sample thief, a device consisting of two nested tubes with one or more aligned slots through which a sample may be collected and then sealed into the inner tube by rotating the outer tube;

ii. Star pattern sampling from the top, middle, and bottom of each storage container;

iii. Collecting discrete incremental units of a batch, such as every tenth unit or every twentieth drop; or

iv. Quartering until the sample reaches the size specified in subsection (B)(3); and

b. For sampling methods specified in subsections (B)(2)(a)(i) through (iii), quartering the volume of the aggregated portions collected to obtain the sample size specified in subsection (B)(3);

3. The size of the sample provided to a laboratory is sufficient for testing and, if necessary, retesting;

4. Each sample in subsection (B)(3) is packaged in a container made of:

a. The same material that would be used for dispensing, or

b. Another material that will not react with or leach into the sample;

5. Each packaged sample is labeled with the:

a. The dispensary's registry identification number;

b. The amount, strain, and batch number of the medical marijuana or marijuana product;

c. The analytes for which testing is being requested;

d. The storage temperature for the marijuana or marijuana product; and

e. The date of sampling;

6. A packaged sample in subsection (B)(4) is submitted to a laboratory that:

a. Has a laboratory registration certificate issued by the Department, and

b. Is approved for testing by the Department for an analyte for which testing is being requested;

7. Except as specified in subsections (A)(2) and (3) and (C)(1), as applicable, the samples in subsection (B)(4) are tested for each analyte specified in Table 3.1 by a laboratory that is approved by the Department for testing the analyte;

8. Only batches of marijuana or marijuana products for which laboratory testing results in subsection (B)(7) are in compliance with the requirements in R9-17-404.03, R9-17-404.04, and Table 3.1 are offered for sale or dispensing; and

9. Except as provided in subsection (C), any batch of marijuana or marijuana product that does not comply with the requirements in R9-17-404.03, R9-17-404.04, and Table 3.1 is remediated, if applicable, or destroyed according to policies and procedures.

C. If a dispensary receives a final report of testing, specified in R9-17-404.06(B)(3), from a laboratory that indicates that a batch of medical marijuana or marijuana product does not comply with the requirements in R9-17-404.03, R9-17-404.04, and Table 3.1, the dispensary:

1. Within seven days after receiving the final report of testing, may request retesting of the remaining portion of the sample in subsection (B)(4) for all analytes that do not comply with the requirements in R9-17-404.03, R9-17-404.04, and Table 3.1 by no more than two other laboratories that are independent of a laboratory conducting a test included in the final report of testing and that are approved by the Department for testing the analytes;

2. If the final report of testing conducted according to subsection (C)(1) from another, independent laboratory indicates that any analyte tested for according to subsection (C)(1) does not comply with the requirements in R9-17-404.03, R9-17-404.04, and Table 3.1, shall remediate, if applicable, or destroy the batch of medical marijuana or marijuana product according to policies and procedures; and

3. If the final report of testing from each of the two other independent laboratories, allowed according to subsection (C)(1), indicates that all analytes tested for according to subsection (C)(1) comply with the requirements in R9-17-404.03, R9-17-404.04, and Table 3.1

, may offer the batch of medical marijuana or marijuana product for sale or dispensing

.

D. A dispensary may request retesting of a batch of medical marijuana or marijuana product using a second sample if:

1. The batch of marijuana or marijuana product is still in the possession of the dispensary;

2. The dispensary receives notification from the Department, a marijuana establishment, or another dispensary that indicates that the final report of testing from a laboratory, specified in R9-17-404.06(B)(3), for the batch of medical marijuana or marijuana product may be inaccurate;

3. The dispensary:

a. If the notification in subsection (D)(2) is from a marijuana establishment or another dispensary, informs the Department that the final report of testing may be inaccurate, providing the name of the notifying dispensary or marijuana establishment;

b. Collects the second sample according to subsections (B)(2) and (3);

c. Packages and labels the sample according to subsections (B)(4) and (5); and

d. Submits the sample to a second, independent laboratory that is approved by the Department for testing the analytes; and

4. The dispensary follows the requirements in subsections (C)(1) through (3) in determining whether the batch of medical marijuana or marijuana product:

a. May be offered for sale or dispensing, or

b. Is required to be remediated, if applicable, or destroyed.

E. A dispensary shall ensure that remediation of a batch of marijuana or of a marijuana product that has undergone laboratory testing and does not comply with the requirements in R9-17-404.03, R9-17-404.04, and Table 3.1:

1. Is performed according to policies and procedures,

2. Uses a method that is appropriate to address an analyte not in compliance with Table 3.1, and

3. Does not introduce or produce a substance in a concentration that is known to be harmful to humans.

F. If a batch of medical marijuana or a marijuana product is remediated, a dispensary shall submit samples from the remediated batch for laboratory testing according to subsection (B).

G. A dispensary shall provide to the Department upon request a sample of the dispensary's inventory of medical marijuana or a marijuana product of sufficient quantity to enable the Department to conduct an analysis of the medical marijuana or marijuana product.

Ariz. Admin. Code § R9-17-317.01

Adopted by final exempt rulemaking at 26 A.A.R. 734, effective 4/2/2020. Amended by exempt rulemaking at 26 A.A.R. 2991, effective 11/1/2020. Amended by final exempt rulemaking at 27 A.A.R. 111, effective 1/15/2021. 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.