Ariz. Admin. Code § 9-17-107

Current through Register Vol. 30, No. 50, December 13, 2024

Section R9-17-107 - Time-frames

A. Within the administrative completeness review time-frame for each type of approval in Table 1.1, the Department shall:

1. Issue a registry identification card, a dispensary registration certificate, an approval to operate a dispensary, an approval of a change to a dispensary registration certificate, a laboratory registration certificate, an approval for testing, or an approval to add a parameter;

2. Provide a notice of administrative completeness to an applicant; or

3. Provide a notice of deficiencies to an applicant, including a list of the information or documents needed to complete the application.

B. An application for approval to operate a dispensary or for a change to a dispensary registration certificate is not complete until the date the applicant states on a written notice provided to the Department according to R9-17-305 or R9-17-307, as applicable, that the dispensary is ready for an inspection by the Department.

C. A laboratory's application for approval for testing or to add a parameter is not complete until the date the applicant states on a written notice provided to the Department according to R9-17-402.01 or R9-17-404.07, as applicable, that the laboratory is ready for an inspection by the Department.

D. If the Department provides a notice of deficiencies to an applicant:

1. The administrative completeness review time-frame and the overall time-frame are suspended from the date of the notice of deficiencies until the date the Department receives the missing information or documents from the applicant; and

2. The Department shall consider the application withdrawn if the applicant does not submit the missing information or documents to the Department within the time-frame in Table 1.1.

E. Within the substantive review time-frame for each type of approval in Table 1.1, the Department:

1. According to subsection (H), shall issue or deny:

a. A registry identification card, dispensary registration certificate, or laboratory registration certificate; or

b. Approval to operate a dispensary, approval for a change to a dispensary registration certificate, approval for testing, or approval to add a parameter;

2. May complete an inspection that may require more than one visit to a dispensary and, if applicable, the dispensary's cultivation site;

3. May complete an inspection that may require more than one visit to a laboratory; and

4. May make one written comprehensive request for more information, unless the Department and the applicant agree in writing to allow the Department to submit supplemental requests for information.

F. If the Department issues a written comprehensive request or a supplemental request for information:

1. The substantive review time-frame and the overall time-frame are suspended from the date of the written comprehensive request or the supplemental request for information until the date the Department receives all of the information requested, and

2. The applicant shall submit to the Department all of the information and documents listed in the written comprehensive request or supplemental request for information within the time-frame in Table 1.1.

G. If an applicant for an initial dispensary registration certificate is allocated a dispensary registration certificate as provided in R9-17-303, the Department shall provide a written notice to the applicant of the allocation of the dispensary registration certificate and issue the dispensary registration certificate.

H. If an application for an initial laboratory registration certificate is approved, the Department shall review the information and documents submitted according to R9-17-402(A)(4) and:

1. If the information and documents for at least one of the owners comply with the A.R.S. Title 36, Chapter 28.1 and this Chapter, the Department shall issue:

a. A laboratory agent registry identification card to any owner who complies with A.R.S. Title 36, Chapter 28.1 and this Chapter; and

b. The laboratory registration certificate; and

2. If the information and documents submitted according to R9-17-402(A)(4) for an owner do not comply with A.R.S. Title 36, Chapter 28.1 and this Chapter, the Department shall deny the owner a laboratory agent registry identification card and provide notice to the owner and to the laboratory that includes:

a. The specific reasons for the denial; and

b. The process for requesting a judicial review of the Department's decision pursuant to A.R.S. Title 12, Chapter 7, Article 6.

I. The Department shall issue:

1. A registry identification card, renewal of a dispensary registration certificate, an approval to operate a dispensary, an approval for a change to a dispensary registration certificate, a renewal of a laboratory registration certificate, an approval for testing, or an approval to add a parameter, as applicable, if the Department determines that the applicant complies with A.R.S. Title 36, Chapter 28.1 and this Chapter;

2. For an applicant for a registry identification card, a denial that includes the reason for the denial and the process for requesting judicial review if:

a. The Department determines that the applicant does not comply with A.R.S. Title 36, Chapter 28.1 and this Chapter; or

b. The applicant does not submit all of the information and documents listed in the written comprehensive request or supplemental request for information within 10 working days after the date of the comprehensive written request or supplemental request for information;

3. For an applicant for an initial dispensary registration certificate, if the Department determines that the dispensary registration certificate application complies with A.R.S. Title 36, Chapter 28.1 and this Chapter:

a. A dispensary registration certificate, if not all available dispensary registration certificates have been allocated according to the criteria and processes in R9-17-303; or

b. Written notice that:

i. The dispensary registration certificate application complies with A.R.S. Title 36, Chapter 28.1 and this Chapter;

ii. The applicant was not allocated a dispensary registration certificate according to the criteria and processes in R9-17-303 because all available dispensary registration certificates have been allocated according to the criteria and processes in R9-17-303; and

iii. The written notice is not a denial and is not considered a final decision of the Department subject to administrative review; or

4. For an applicant for a dispensary registration certificate, an approval to operate, an approval for a change to a dispensary registration certificate, a laboratory registration certificate, an approval for testing, or an approval to add a parameter, a denial that includes the reason for the denial and the process for administrative review if:

a. The Department determines that the applicant does not comply with A.R.S. Title 36, Chapter 28.1 or this Chapter; or

Ariz. Admin. Code § R9-17-107

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 exempt rulemaking at 26 A.A.R. 968, effective 4/20/2020. 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.