Ariz. Admin. Code § R4-23-670 - Sterile Pharmaceutical Products

A. In addition to the minimum area requirement of R4-23-609(A) and R4-23-655(B) and before compounding a sterile pharmaceutical product, a pharmacy permittee, limited-service pharmacy permittee, or applicant shall provide a minimum sterile pharmaceutical product compounding area that is not less than 100 square feet of contiguous floor area, except any pharmacy permit issued or pharmacy remodeled before November 1, 2006 may continue to use a sterile pharmaceutical product compounding area that is not less that 60 square feet of contiguous floor area, until a pharmacy ownership change occurs that requires issuance of a new permit or the pharmacy is remodeled. The pharmacy permittee or the pharmacist-in-charge shall ensure that the sterile pharmaceutical product compounding area:

1. Is dedicated to the purpose of preparing and compounding sterile pharmaceutical products;

2. Is isolated from other pharmacy functions;

3. Restricts entry or access;

4. Is free from unnecessary disturbances in air flow;

5. Is made of non-porous and cleanable floor, wall, and ceiling material; and

6. Meets the minimum air cleanliness standards of an ISO Class 7 environment as defined in R4-23-110, except an ISO class 7 environment is not required if all sterile pharmaceutical product compounding occurs within an ISO class 5 environment isolator, such as a glove box, pharmaceutical isolator, barrier isolator, pharmacy isolator, or hospital pharmacy isolator.

B. In addition to the equipment requirements in R4-23-611 and R4-23-612 or R4-23-656 and before compounding a sterile pharmaceutical product, a pharmacy permittee, limited-service pharmacy permittee, or applicant shall ensure that a pharmacist who compounds a sterile pharmaceutical product has the following equipment:

1. Environmental control devices capable of maintaining a compounding area environment equivalent to an "ISO class 5 environment" as defined in R4-23-110. Devices capable of meeting these standards include: laminar airflow hoods, hepa filtered zonal airflow devices, glove boxes, pharmaceutical isolators, barrier isolators, pharmacy isolators, hospital pharmacy isolators, and biological safety cabinets;

2. Disposal containers designed for needles, syringes, and other material used in compounding sterile pharmaceutical products and if applicable, separate containers to dispose of cytotoxic, chemotherapeutic, and infectious waste products;

3. Freezer storage units with thermostatic control and thermometer, if applicable;

4. Packaging or delivery containers capable of maintaining official compendial drug storage conditions;

5. Infusion devices and accessories, if applicable; and

6. In addition to the reference library requirements of R4-23-612, a current reference pertinent to the preparation of sterile pharmaceutical products.

C. Before compounding a sterile pharmaceutical product, the pharmacy permittee, limited-service pharmacy permittee, or pharmacist-in-charge shall:

1. Prepare, implement, and comply with policies and procedures for compounding and dispensing sterile pharmaceutical products,

2. Review biennially and if necessary revise the policies and procedures required under subsection (C)(1),

3. Document the review required under subsection (C)(2),

4. Assemble the policies and procedures as a written manual or by another method approved by the Board or its designee, and

5. Make the policies and procedures available in the pharmacy for employee reference and inspection by the Board or its designee.

D. The assembled policies and procedures shall include, where applicable, the following subjects:

1. Supervisory controls and verification procedures to ensure the quality and safety of sterile pharmaceutical products;

2. Clinical services and drug monitoring procedures for:

a. Patient drug utilization reviews;

b. Inventory audits;

c. Patient outcome monitoring;

d. Drug information; and

e. Education of pharmacy and other health professionals;

3. Controlled substances;

4. Supervisory controls and verification procedures for:

a. Cytotoxics handling, storage, and disposal;

b. Disposal of unused supplies and pharmaceutical products; and

c. Handling and disposal of infectious wastes;

5. Pharmaceutical product administration, including guidelines for the first dosing of a pharmaceutical product;

6. Drug and component procurement;

7. Pharmaceutical product compounding, dispensing, and storage;

8. Duties and qualifications of professional and support staff;

9. Equipment maintenance;

10. Infusion devices and pharmaceutical product delivery systems;

11. Investigational drugs and their protocols;

12. Patient profiles;

13. Patient education and safety;

14. Quality management procedures for:

a. Adverse drug reactions;

b. Drug recalls;

c. Expired pharmaceutical products;

d. Beyond-use-dating for both standard-risk and substantial-risk sterile pharmaceutical products consistent with the requirements of R4-23-410(B)(3)(d);

e. Temperature and other environmental controls;

f. Documented process and product validation testing; and

g. Semi-annual certification of the laminar air flow hood or other ISO class 5 environment, other equipment, and the ISO class 7 environment, including documentation of routine cleaning and maintenance for each laminar air flow hood or other ISO class 5 environment, other equipment, and the ISO class 7 environment; and

15. Sterile pharmaceutical product delivery requirements for:

a. Shipment to the patient;

b. Security; and

c. Maintaining official compendial storage conditions.

E. Standard-risk sterile pharmaceutical product compounding. Before compounding a standard-risk sterile pharmaceutical product, a pharmacy permittee or pharmacist-in-charge shall ensure compliance with the following minimum standards:

1. Compounding occurs only in an ISO class 5 environment within an ISO class 7 environment, and the ISO class 7 environment may have a specified prep area inside the environment;

2. Compounding sterile pharmaceutical products from sterile commercial drugs or sterile pharmaceutical otic or ophthalmic products from non-sterile ingredients occurs using procedures that involve only a few closed-system, basic, simple aseptic transfers and manipulations;

3. Each person who compounds wears adequate personnel protective clothing for sterile preparation that includes gown, gloves, head cover, and booties. Each person who compounds is not required to wear personnel protective clothing when all sterile pharmaceutical compounding occurs within an ISO class 5 environment isolator, and the ISO Class 5 environment isolator is not inside an ISO Class 7 environment; and

4. Each person who compounds completes an annual media-fill test to validate proper aseptic technique.

F. Substantial-risk sterile pharmaceutical product compounding. Before compounding a substantial-risk sterile pharmaceutical product, a pharmacy permittee or pharmacist-in-charge shall ensure compliance with the following minimum standards:

1. Compounding parenteral or injectable sterile pharmaceutical products from non-sterile ingredients occurs only in an ISO class 5 environment within an ISO class 7 environment and the ISO class 7 environment shall not have a prep area inside the environment;

2. Each person who compounds wears adequate personnel protective clothing for sterile preparation that includes gown, gloves, head cover, and booties. Each person who compounds is not required to wear personnel protective clothing when all sterile pharmaceutical compounding occurs within an ISO class 5 environment isolator, and the ISO Class 5 environment isolator is not inside an ISO Class 7 environment; and

3. Each person who compounds completes a semi-annual media-fill test that simulates the most challenging or stressful conditions for compounding using dry non-sterile media to validate proper aseptic technique.

Notes

Ariz. Admin. Code § R4-23-670

Adopted effective November 1, 1993 (Supp. 93-4). Amended by final rulemaking at 10 A.A.R. 3391, effective October 2, 2004 (Supp. 04-3). Amended by final rulemaking at 12 A.A.R. 3981, effective December 4, 2006 (Supp. 06-4).