Ariz. Admin. Code § 4-23-603

Current through Register Vol. 30, No. 36, September 6, 2024

Section R4-23-603 - Resident-Nonprescription Drugs, Retail

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 .

Ariz. Admin. Code § R4-23-603

Adopted effective August 10, 1978 (Supp. 78-4). Amended subsection (D) paragraph (1) and added subsection (G) effective April 20, 1982 (Supp. 82-2). Amended effective August 12, 1988 (Supp. 88-3). Amended effective February 8, 1991 (Supp. 91-1). Amended 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. 1359, effective 8/2/2014. Amended by final rulemaking at 25 A.A.R. 1015, effective 6/1/2019.