Ariz. Admin. Code § R4-23-673 - Limited-service Mail-order Pharmacy

A. The limited-service pharmacy permittee shall design and construct the limited-service mail-order pharmacy to conform with the following requirements:

1. A dispensing area devoted to stocking, compounding, and dispensing prescription medications, which is physically separate from a non-dispensing area devoted to non-dispensing pharmacy services;

2. A dispensing area of at least 300 square feet if three or fewer persons work in the dispensing area simultaneously;

3. A dispensing area that provides 300 square feet plus 60 square feet for each person in excess of three persons if more than three persons work in the dispensing area simultaneously;

4. Space in the dispensing area permits efficient pharmaceutical practice, free movement of personnel, and visual surveillance by the pharmacist;

5. A non-dispensing area of at least 30 square feet for each person working simultaneously in the non-dispensing area; and

6. Space in the non-dispensing area permits free movement of personnel and visual surveillance by the pharmacist; or

B. The limited-service pharmacy permittee shall design and construct the limited-service mail-order pharmacy to conform with the following requirements:

1. A contiguous area in which both dispensing and non-dispensing pharmacy services are provided;

2. A contiguous area of at least 300 square feet if three or fewer persons work in the area simultaneously;

3. A contiguous area that provides 300 square feet plus 60 square feet for each person in excess of three persons if more than three persons work in the area simultaneously; and

4. Space in the contiguous area permits efficient pharmaceutical practice, free movement of personnel, and visual surveillance by the pharmacist.

C. The limited-service pharmacy permittee shall ensure that the limited-service mail-order pharmacy complies with the standards for area, personnel, security, sanitation, and equipment set forth in R4-23-608, R4-23-609(B) through (H), R4-23-610 (A) and (C) through (F), R4-23-611, and R4-23-612.

D. The pharmacist-in-charge of a limited-service mail-order pharmacy shall authorize only pharmacists, interns, pharmacy technicians, pharmacy technician trainees, compliance officers, drug inspectors, peace officers acting in their official capacities, support personnel, other persons authorized by law, and other designated personnel to be in the limited-service mail-order pharmacy.

E. The pharmacist-in-charge of a limited-service mail-order pharmacy shall ensure that prescription medication is delivered to the patient or locked in the dispensing area when a pharmacist is not present in the pharmacy.

F. In addition to the delivery requirements of R4-23-402, the limited-service pharmacy permittee shall, during regular hours of operation but not less than five days and a minimum 40 hours per week, provide toll-free telephone service to facilitate communication between patients and a pharmacist who has access to patient records at the limited-service mail-order pharmacy. The limited-service pharmacy permittee shall disclose this toll-free number on a label affixed to each container of drugs dispensed from the limited-service mail-order pharmacy.

G. The pharmacist-in-charge of a limited-service mail-order pharmacy shall ensure that the written policies and procedures for pharmacy operations and drug distribution include the following:

1. Prescription orders;

2. Clinical services and drug utilization management for:

a. Drug utilization reviews,

b. Inventory audits,

c. Patient outcome monitoring,

d. Drug information, and

e. Education of pharmacy and other health professionals;

3. Duties and qualifications of professional and support staff;

4. Controlled substances;

5. Drug product procurement;

6. Drug compounding, dispensing, and storage;

7. Patient profiles;

8. Quality management procedures for:

a. Adverse drug reactions,

b. Drug recalls,

c. Expired and beyond-use-date drugs,

d. Medication or dispensing errors, and

e. Education of professional and support staff;

9. Recordkeeping;

10. Sanitation;

11. Security;

12. Drug delivery requirements for:

a. Transportation,

b. Security,

c. Temperature and other environmental controls,

d. Emergency provisions, and

13. Patient education.

Notes

Ariz. Admin. Code § R4-23-673

Adopted effective April 5, 1996 (Supp. 96-2). Amended by final rulemaking at 10 A.A.R. 1192, effective May 1, 2004 (Supp. 04-1). Amended by final rulemaking at 10 A.A.R. 4453, effective December 4, 2004 (Supp. 04-4).