Ariz. Admin. Code § 4-23-410

Current through Register Vol. 30, No. 45, November 8, 2024

Section R4-23-410 - Current Good Compounding Practices

A. This Section establishes the current good compounding practices to be used by a pharmacist licensed by the Board, in a pharmacy permitted by the Board, and in compliance with applicable federal and state law governing the practice of pharmacy.

B. A pharmacy permittee shall ensure compliance with the provisions in this subsection.

1. All substances for compounding that are received, stored, or used by the pharmacy permittee:

a. Meet official compendium requirements;

b. Are of high quality, such as Chemically Pure (CP), Analytical Reagent (AR), certified American Chemical Society (ACS), or Food Chemical Codex (FCC) grade; or

c. Are obtained from a source that, in the professional judgment of the pharmacist, is acceptable and reliable.

2. Before compounding a pharmaceutical product in excess of the quantity dispensed in anticipation of receiving valid prescriptions for the pharmaceutical product, a pharmacist, employed by the pharmacy permittee, shall establish a history of compounding valid prescriptions for the pharmaceutical product.

3. Neither the pharmacy permittee nor a pharmacist employed by the pharmacy permittee provides a compounded pharmaceutical product to a pharmacy, medical practitioner, or other person for dispensing or distributing except that a compounded pharmaceutical product may be provided to a medical practitioner to administer to a patient of the medical practitioner if each container is accompanied by the written list required in subsection (I)(5) and has a label that includes the following:

a. The pharmacy's name, address, and telephone number;

b. The pharmaceutical product's name and the information required in subsection (I)(4);

c. A lot or control number;

d. A beyond-use-date based upon the pharmacist's professional judgment, but not more than the maximum guidelines recommended in the Pharmacy Compounding Practices chapter of the official compendium unless there is published or unpublished stability test data that shows a longer period is appropriate;

e. The statement "Not For Dispensing;" and

f. The statement "For Office or Hospital Administration Only."

4. A pharmacy or pharmacist may advertise or otherwise promote the fact that the pharmacy or pharmacist provides prescription compounding services.

C. A pharmacy permittee shall ensure compliance with the organization, training, and personnel issues in this subsection.

1. Before dispensing a compounded pharmaceutical product, a pharmacist:

a. Inspects and approves or rejects, or assumes responsibility for inspecting and approving or rejecting, components, pharmaceutical product containers and closures, in-process materials, and labeling;

b. Prepares or assumes responsibility for preparing all compounding records;

c. Reviews all compounding records to ensure that no errors occur in the compounding process;

d. Ensures the proper use, cleanliness, and maintenance of all compounding equipment; and

e. Documents by hand-written initials or signature in the compounding record the completion of the requirements of subsections (C)(1)(a), (b), (c), and (d).

2. A pharmacist engaged in compounding:

a. Complies with the current good compounding practices and applicable state pharmacy laws;

b. Maintains compounding proficiency through current awareness, training, and continuing education; and

c. Ensures that personnel engaged in compounding wear:

i. Clean clothing appropriate to the work performed; and

ii. Protective apparel, such as coats, aprons, gowns, gloves or masks to protect the personnel from chemical exposure and prevent pharmaceutical product contamination.

D. A pharmacy permittee shall ensure the security, safety, and quality of a compounded pharmaceutical product by conforming with the following standards:

1. Implement procedures to exclude from direct contact with components, pharmaceutical product containers and closures, in-process materials, labeling, and pharmaceutical products, any person with an apparent illness or open lesion that may adversely affect the safety or quality of a compounded pharmaceutical product, until the illness or lesion, as determined by competent medical personnel, does not jeopardize the safety or quality of a compounded pharmaceutical product; and

2. Require all personnel to inform a pharmacist of any health condition that may adversely affect a compounded pharmaceutical product.

E. A pharmacy permittee shall provide compounding facilities that conform with the standards in this subsection.

1. In addition to the minimum area requirements of R4-23-609, R4-23-655, or R4-23-673, the compounding area:

a. Complies with the requirements in R4-23-611; and

b. Has sufficient space to permit efficient pharmacy practice, free movement of personnel, and visual surveillance by a pharmacist.

2. If sterile pharmaceutical product or radiopharmaceutical product compounding is performed, the compounding area complies with the requirements of R4-23-670, R4-23-681, and R4-23-682.

3. A clean, dry, and temperature-controlled area and, if required, a refrigerated area, in which to store properly labeled containers of bulk drugs, chemicals, and materials used in compounding, that complies with state statutes and rules.

F. To protect pharmaceutical product safety, identity, strength, quality, and purity, a pharmacy permittee shall ensure that equipment and utensils used in pharmaceutical product compounding are:

1. Of appropriate design, adequate size, and suitably located for proper operation, cleaning, and maintenance;

2. Made of material that is not reactive, additive, or absorptive when exposed to components, in-process materials, or pharmaceutical products;

3. Cleaned and protected from contamination before use;

4. Inspected and determined suitable for use before initiation of compounding operations; and

5. Routinely inspected, calibrated, or checked to make proper performance certain.

G. A pharmacy permittee shall ensure that the pharmacist-in-charge establishes, implements, and complies with procedures to prevent cross-contamination when pharmaceutical products that require special precautions to prevent cross-contamination, such as penicillin, are used in a compounding procedure. The procedures shall include either the dedication of equipment or the meticulous cleaning of contaminated equipment before its use in compounding other pharmaceutical products.

H. A pharmacy permittee shall ensure that the pharmacist-in-charge establishes, implements, and complies with control procedures for components and pharmaceutical product containers and closures, either written or electronically stored with printable documentation, that conform with the standards in this subsection.

1. Components and pharmaceutical product containers and closures are:

a. Stored off the floor,

b. Handled and stored to prevent contamination, and

c. Rotated so the oldest approved stock is used first.

2. Container closure systems comply with official compendium standards.

3. Pharmaceutical product containers and closures are clean and made of material that is not reactive, additive, or absorptive.

I. A pharmacy permittee shall ensure that the pharmacist-in-charge establishes, implements, and complies with pharmaceutical product compounding controls that conform with the standards in this subsection.

1. Pharmaceutical product compounding procedures are available in either written form or electronically stored with printable documentation:

a. To ensure that a finished pharmaceutical product has the identity, strength, quality, and purity it is purported or represented to possess, the procedures include, for each pharmaceutical product compounded, a description of:

i. The components, their manufacturer, lot number, expiration date, and amounts, the order of component addition, if applicable, and the compounding process;

ii. The equipment and utensils used; and

iii. The pharmaceutical product container and closure system proper for the sterility and stability of the pharmaceutical product as it is intended to be used.

b. To test the pharmaceutical product being compounded, the procedures monitor the output and validate the performance of compounding processes that may cause variability in the final pharmaceutical product, including assessing:

i. Dosage form weight variation;

ii. Adequacy of mixing to ensure uniformity and homogeneity; and

iii. Clarity, completeness, and pH of solutions, if applicable.

2. Components for pharmaceutical product compounding are accurately weighed, measured, or subdivided. To ensure that each weight, measure, or subdivision is correct as stated in the compounding procedures, a pharmacist:

a. Checks and rechecks, or assumes responsibility for checking and re-checking, the operations at each stage of the compounding process; and

b. Documents by hand-written initials or signature the completion and accuracy of the compounding process.

3. Compounding equipment and utensils are properly cleaned and maintained.

4. In addition to the labeling requirements of A.R.S. § 32-1968(D), the label contains:

a. A statement, symbol, designation, or abbreviation that the pharmaceutical product is a compounded pharmaceutical product, and

b. A beyond-use-date as specified in subsection (B)(3)(d).

5. A written list of the compounded pharmaceutical product's active ingredients is given to the patient at the time of dispensing.

6. When a component is removed from its original container and transferred to another container, the new container label contains, in full text or an abbreviated code system, the following:

a. The component name,

b. The manufacturer's or supplier's name,

c. The lot or control number,

d. The weight or measure,

e. The beyond-use-date as specified in subsection (B)(3)(d), and

f. The transfer date.

J. A pharmacy permittee shall ensure that the pharmacist-in-charge stores any quantity of compounded pharmaceutical product produced in excess of the quantity dispensed in accordance with subsection (B):

1. In an appropriate container with a label that contains:

a. A complete list of components or the pharmaceutical product's name;

b. The preparation date;

c. The assigned lot or control number; and

d. A beyond-use-date as specified in subsection (B)(3)(d); and

2. Under conditions, dictated by the pharmaceutical product's composition and stability characteristics, that ensure its strength, quality, and purity.

K. A pharmacy permittee shall ensure that the pharmacist-in-charge establishes, implements, and complies with recordkeeping procedures that comply with this subsection:

1. Pharmaceutical product compounding procedures and other records required by this Section are maintained by the pharmacy for not less than seven years, and

2. Pharmaceutical product compounding procedures and other records required by this Section are readily available for inspection by the Board or its designee.

Ariz. Admin. Code § R4-23-410

Adopted effective August 5, 1997 (Supp. 97-3). 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).