Arizona Administrative Code (Last Updated: November 17, 2016) |
Title 4. PROFESSIONS AND OCCUPATIONS |
Chapter 23. BOARD OF PHARMACY |
Article 6. PERMITS AND DISTRIBUTION OF DRUGS |
Section R4-23-602. Permit Application Process and Time-frames
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A. A person applying for a permit shall:
1. Submit a completed application for the desired permit electronically or manually on a form furnished by the Board, and
2. Submit with the application form:
a. The documents specified in the application form, and
b. The permit fee specified in R4-23-205(D).
B. The Board office shall deem an application form received on the date the Board office electronically or manually date- stamps the form.
C. Time-frames for permits.
1. The Board office shall finish an administrative complete- ness review within 60 days from the date the application form is received.
a. The Board office shall issue a written notice of administrative completeness to the applicant if no deficiencies are found in the application form.
b. If the application form is incomplete, the Board office shall provide the applicant with a written notice that includes a comprehensive list of the miss- ing information. The 60-day time-frame for the
Board office to finish the administrative complete- ness review is suspended from the date the notice of incompleteness is served until the applicant provides the Board office with all missing information.
c. If the Board office does not provide the applicant with written notice regarding administrative com- pleteness, the application form shall be deemed complete 60 days after receipt by the Board office.
2. An applicant with an incomplete application form shall submit to the Board office all of the missing information within 90 days of service of the notice of incompleteness.
a. If an applicant cannot submit all missing informa- tion within 90 days of service of the notice of incom- pleteness, the applicant may send a written request for an extension to the Board office postmarked or delivered no later than 90 days from service of the notice of incompleteness;
b. The written request for an extension shall document the reasons the applicant is unable to meet the 90- day deadline; and
c. The Board office shall review the request for an extension of the 90-day deadline and grant the request if the Board office determines that an exten- sion of the 90-day deadline will enable the applicant to assemble and submit the missing information. An extension shall be for no more than 30 days. The Board office shall notify the applicant in writing of its decision to grant or deny the request for an exten- sion.
3. If an applicant fails to submit a complete application form within the time allowed, the Board office shall close the applicant's file. An applicant whose file is closed and who later wishes to obtain a permit shall submit a new applica- tion and fee as specified in subsection (A).
4. For a nonprescription drug permit applicant, a com- pressed medical gas distributor permit applicant, and a durable medical equipment and compressed medical gas supplier permit applicant, the Board office shall issue a permit on the day that the Board office determines an administratively complete application form is received.
5. Except as described in subsection (C)(4), from the date on which the administrative completeness review of an application form is finished, the Board office shall com- plete a substantive review of the applicant's qualifications in no more than 120 days.
a. If an applicant is found to be ineligible, the Board office shall issue a written notice of denial to the applicant.
b. If an applicant is found to be eligible, the Board office shall recommend to the Board that the appli- cant be issued a permit. Upon receipt of the Board office’s recommendation, the Board shall either issue a permit to the applicant or if the Board deter- mines the applicant does not meet eligibility require- ments, return the matter to the Board office.
c. If the Board office finds deficiencies during the sub- stantive review of the application form, the Board office shall issue a written request to the applicant for additional documentation.
d. The 120-day time-frame for a substantive review for the issuance or denial of a permit is suspended from the date of the written request for additional docu- mentation until the date that all documentation is received. The applicant shall submit the additional documentation according to subsection (C)(2).
e. If the applicant and the Board office mutually agree in writing, the 120-day substantive review time- frame may be extended once for no more than 45 days.
6. For the purpose of A.R.S. § 41-1072 et seq., the Board establishes the following time-frames for permits:
a. Administrative completeness review time-frame: 60 days.
b. Substantive review time-frame:
i. Nonprescription drug permit, compressed med- ical gas distributor permit, and durable medical equipment and compressed medical gas sup- plier permit: none.
ii. Except as described in subsection (C)(6)(b)(i): 120 days.
c. Overall time-frame:
i. Nonprescription drug permit, compressed med- ical gas distributor permit, and durable medical equipment and compressed medical gas sup- plier permit: 60 days.
ii. Except as described in subsection (C)(6)(c)(i): 180 days.
D. Permit renewal.
1. To renew a permit, a permittee shall submit a completed application for permit renewal electronically or manually on a form furnished by the Board with the biennial renewal fee specified in R4-23-205(D).
2. If the biennial renewal fee is not paid by November 1 of the renewal year specified in A.R.S. § 32-1931, the per- mit is suspended. The permittee shall pay a penalty fee as provided in A.R.S. § 32-1931 and R4-23-205(G)(2) to vacate the suspension.
3. Time-frames for permit renewals. The Board office shall follow the time-frames established in subsection (C).
E. Display of permit. A permittee shall conspicuously display the permit in the location to which it applies.
Historical Note
Former Rules 6.2100, 6.2200, 6.2300, 6.2400, 6.2500,
6.2600, 6.2610, 6.2620, 6.2630, 6.2640, and 6.2650.
Amended effective August 10, 1978 (Supp. 78-4).
Amended effective August 9, 1983 (Supp. 83-4).
Repealed effective August 12, 1988 (Supp. 88-3). New
Section adopted effective August 5, 1997 (Supp. 97-3). Amended by final rulemaking at 6 A.A.R. 4589, effective November 14, 2000 (Supp. 00-4). Amended by final
rulemaking at 20 A.A.R. 1364, effective August 2, 2014
(Supp. 14-2).