Current through Register Vol. 30, No. 38, September 20, 2024
A.Permit. A person, including the following,
shall not sell or distribute a nonprescription drug without a current
Board-issued permit:
1. A grocer;
2. Other non-pharmacy retail outlet;
or
3. Mobile or non-fixed location
retailer, such as a swap-meet vendor.
B.A medical practitioner licensed under
A.R.S. Title 32 is exempt from the requirements of subsection (A).
C.Application. To obtain a permit to sell a
nonprescription drug, a person shall submit :
1. A completed application form and fee as
specified in R4-23-602; and
2.
Documentation of compliance with local zoning laws, if required by the Board.
D.Drug sales. A
nonprescription drug permittee:
1. Shall sell
a drug only in the original container packaged and labeled by the manufacturer;
and
2. Shall not package,
repackage, label, or relabel any drug.
E. Inspection. A nonprescription drug
permittee shall consent to inspection during business hours by a Board
compliance officer or other authorized officer of the law as defined in A.R.S.
§
32-1901.
F.Quality control. A nonprescription drug
permittee shall:
1. Ensure that all drugs
stocked, sold, or offered for sale are:
a.
Kept clean;
b. Protected from
contamination, excessive heat, cold, sunlight, and other deteriorating factors;
c. In compliance with federal law;
and
d. Received from a supplier
with a current Board-issued permit as specified in
R4-23-601(A).
2. Develop and implement a program
to ensure that:
a. Any expiration-dated drug
is reviewed regularly;
b. Any drug,
that exceeds its expiration date, is deteriorated or damaged, or does not
comply with federal law, is moved to a quarantine area and not sold or
distributed; and
c. Any quarantined
drug is destroyed or returned to its source of supply.
G. Notification. A nonprescription
drug permittee shall submit using the permittee's online profile or provide
written notice by mail, fax, or e-mail to the Board office within 10 days of
changes involving the telephone or fax number, e-mail or mailing address, or
business name.
H. Change of
ownership. A nonprescription drug permittee shall comply with
R4-23-601(F).
I.Relocation. No less than 30 days before an
existing nonprescription drug permittee relocates, the permittee shall submit a
completed application for relocation electronically or manually on a form
furnished by the Board, and the documentation required in subsection
(C).
J.Records. A nonprescription
drug permittee shall:
1. Retain records of the
receipt and disposal of nonprescription drugs as required in R4-23-601(D),
and
2. Comply with the requirements
of A.R.S. §
32-1977
and federal law for the retail sale of methamphetamine precursors.
K. Permit renewal. To renew a
nonprescription drug permit, the permittee shall comply with
R4-23-602(D).
L.Nonprescription drug vending machine outlet. In
addition to the requirements of R4-23-601, R4-23-602, and subsections (A)
through (K), a person selling or distributing a nonprescription drug in a
vending machine shall comply with the following requirements:
1. Each individual vending machine is
considered an outlet and shall have a Board-issued nonprescription drug
permit;
2. Each
nonprescription-drug-permitted vending machine shall display in public view an
identification seal, furnished by the Board, containing the permit number,
vending machine's serial number, owner's name, and telephone contact
number;
3. Each
nonprescription-drug-permitted vending machine is assigned a specific location
that is within a weather-tight structure, protected from direct sunlight, and
maintained at a temperature not less than 59° F and not greater than
86° F;
4. Each nonprescription
drug sold in a vending machine is packaged and labeled in the manufacturer's
original FDA-approved container;
5.
A nonprescription-drug-permitted vending machine is subject to inspection by a
Board compliance officer or other authorized officer of the law as defined in
A.R.S. §
32-1901 as
follows:
a. The owner, manager, or other
staff of the nonprescription drug permittee shall provide access to the
contents of the vending machine within 24 hours of a request from a Board
compliance officer or other authorized officer of the law; or
b. The Board compliance staff shall have
independent access to the vending machine;
6. Before relocating or retiring a
nonprescription-drug-permitted vending machine, the owner or manager shall
notify the Board in writing. The notice shall include:
a. Permit number;
b. Vending machine's serial number;
c. Action planned (relocate or retire);
and
d. If retiring a vending
machine, the disposition of the nonprescription drug contents of the vending
machine;
7. The sale or
distribution of a precursor chemical or regulated chemical in a vending machine
is prohibited ; and
8. Under no
circumstance may expired drugs be sold or distributed .
