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

A.      Permit. A person, including the following, shall not sell or dis- tribute 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 offi- cer or other authorized officer of the law as defined in A.R.S. § 32-1901(5).

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 deterio- rated 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 provide written notice by mail, facsimile, or e-mail to the Board office within ten days of changes involving the telephone number, facsimile number, e-mail address, mailing address, or name of business.

H.      Change of ownership. No less than 14 days before a change of ownership occurs that involves changes of stock ownership of 30% or more of the voting stock of a corporation or an existing and continuing corporation that is not actively traded on any securities market or over-the-counter market, the prospective owner shall submit a completed application form and fee as specified in subsection (C).

I.        Relocation. No less than 30 days before an existing nonpre- scription drug permittee relocates, the permittee shall submit a completed application for relocation electronically or manu- ally 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 nonprescrip- tion 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 pre- cursors.

K.      Permit renewal. Permit renewal shall be as specified in 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 nonprescrip- tion drug in a vending machine shall comply with the follow- ing requirements:

1.        Each individual vending machine is considered an outlet and shall have a Board-issued nonprescription drug per- mit;

2.        Each nonprescription-drug-permitted vending machine shall display in public view an identification seal, fur- nished by the Board, containing the permit number, vend- ing 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(5) as follows:

a.         The owner, manager, or other staff of the nonpre- scription 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-per- mitted 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 regu- lated chemical in a vending machine is prohibited; and

8.        Under no circumstance may expired drugs be sold or dis- tributed.

Historical Note

Adopted effective August 10, 1978 (Supp. 78-4).

Amended subsection (D) paragraph (1) and added sub- section (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. 1364, effective August 2, 2014

(Supp. 14-2).