Ariz. Admin. Code § 4-23-611

Current through Register Vol. 30, No. 50, December 13, 2024

Section R4-23-611 - Pharmacy Facilities

A. Facilities. A pharmacy permittee or pharmacist-in-charge shall ensure that:

1. A pharmacy's facilities are constructed according to state and local laws and ordinances;

2. A pharmacy facility's:

a. Walls, ceilings, windows, floors, shelves, and equipment are clean and in good repair and order; and

b. Counters, shelves, aisles, and open spaces are not cluttered;

3. Adequate trash receptacles are provided and emptied periodically during the day;

4. A pharmacy facility of any pharmacy permit issued or pharmacy remodeled after February 1, 2014 provides access to toilet facilities either:

a. Within the pharmacy area, or

b. No further than a walking distance of 100 feet from the pharmacy area or an alternative distance approved by the Board or its designee;

5. The toilet facilities are maintained in a sanitary condition and in good repair;

6. All professional personnel and staff of the pharmacy keep themselves and their apparel clean while in the pharmacy area;

7. No animals, except licensed assistant animals and guard animals, are allowed in the pharmacy;

8. The pharmacy facility is kept free of insects and rodents; and

9. There is a sink with hot and cold running water, other than a sink in a toilet facility, within the pharmacy area for use in preparing drug products.

B. Supply of drugs and chemicals. A pharmacy permittee or pharmacist-in-charge shall ensure that:

1. A pharmacy maintains a stock of drugs and chemicals that:

a. Are sufficient to meet the normal demands of the trading area or patient base the pharmacy serves; and

b. Meet all standards of strength and purity as established by the official compendiums;

2. All stock, materials, drugs, and chemicals held for ultimate sale or supply to the consumer are not contaminated;

3. Policies and procedures are developed, implemented, and complied with to prevent the sale or use of a drug or chemical:

a. That exceeds its expiration date;

b. That is deteriorated or damaged by reason of age, heat, light, cold, moisture, crystallization, chemical reaction, rupture of coating, disintegration, solidification, separation, discoloration, change of odor, precipitation, or other change as determined by organoleptic examination or by other means;

c. That is improperly labeled;

d. Whose container is defective; or

e. That does not comply with federal law; and

4. The policies and procedures described in subsection (B)(3):

a. Are made available in the pharmacy for employee reference and inspection by the Board or its designee; and

b. Provide the following:

i. Any expiration-dated drug or chemical is reviewed regularly;

ii. Any drug or chemical that exceeds its expiration date, is deteriorated or damaged, improperly labeled, has a defective container, or does not comply with federal law, is moved to a quarantine area and not sold or distributed; and

iii. Any quarantined drug or chemical is properly destroyed or returned to its source of supply.

Ariz. Admin. Code § R4-23-611

Former Rules 6.6510, 6.6520, 6.6530, 6.6540, 6.6550, 6.6560, 6.6570, 6.6580, 6.6600, 6.6610, 6.6620, 6.6630, 6.6640, 6.6650, and 6.6660; Amended subsection (B) effective August 9, 1983 (Supp. 83-4). Amended effective April 1, 1995; filed with the Secretary of State January 31, 1995 (Supp. 95-1). Amended by final rulemaking at 7 A.A.R. 4253, effective September 11, 2001 (Supp. 01-3). Amended by final rulemaking at 12 A.A.R. 3032, effective October 1, 2006 (Supp. 06-3). Amended by final rulemaking at 19 A.A.R. 4165, effective February 1, 2014.