Arizona Administrative Code
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
Universal Citation: AZ Admin Code R 4-23-602
Current through Register Vol. 30, No. 38, September 20, 2024
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.
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 completeness 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 missing
information. The 60-day time frame for the Board office to finish the
administrative completeness 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 completeness, 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 information within 90 days of service of
the notice of incompleteness, 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 an extension 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 extension.
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 application and fee as
specified in subsection (A).
4. For
a nonprescription drug permit applicant, a compressed 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 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 complete 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 applicant 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 determines the applicant does not meet
eligibility requirements, return the matter to the Board office.
c. If
the Board office finds deficiencies during the substantive 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 documentation until the date 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 medical gas distributor permit, and durable medical
equipment and compressed medical gas supplier permit: none.
ii.
Except as described in subsection (C)(6)(b)(i): 120 days.
c.
Overall time frame:
i. Nonprescription drug permit, compressed medical gas
distributor permit, and durable medical equipment and compressed medical gas
supplier 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.
2. If the biennial renewal fee is not paid by
November 1 of the renewal year specified in A.R.S. §
32-1931,
the permit is suspended. The permittee shall pay a penalty as provided in
A.R.S. § 32-1931 and
R4-23-205 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.
Disclaimer: These regulations may not be the most recent version. Arizona may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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