Idaho Admin. Code r. 24.36.01.701

Current through September 2, 2024

Section 24.36.01.701 - STERILE PREPARATION

01.Application. In addition to all other applicable rules in this chapter, including the rules governing Compounding Drug Preparations, these rules apply to all persons, including any business entity, engaged in the practice of sterile compounding and sterile prepackaging in or into Idaho.

02.Dosage Forms Requiring Sterility. The sterility of compounded biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals must be maintained or the compounded drug preparation must be sterilized when prepared in the following dosage forms:

a. Aqueous bronchial and nasal inhalations, except sprays and irrigations intended to treat nasal mucosa only;

b. Baths and soaks for live organs and tissues;

c. Injections (for example, colloidal dispersions, emulsions, solutions, suspensions);

d. Irrigations for wounds and body cavities;

e. Ophthalmic drops and ointments; and

f. Tissue implants.

03.Compounder Responsibilities. Compounders and sterile prepackagers are responsible for ensuring that sterile products are accurately identified, measured, diluted, and mixed and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed, as well as prepared in a manner that maintains sterility and minimizes the introduction of particulate matter;

a. Unless following manufacturer's guidelines or another reliable literature source, opened or partially used packages of ingredients for subsequent use must be properly stored as follows;

i. Opened or entered single-dose containers, such as bags, bottles, syringes, and vials of sterile products and compounded sterile preparations are to be used within one (1) hour if opened in non-sterile conditions, and any remaining contents must be discarded;

ii. Single-dose vials needle-punctured in a sterile environment may be used up to six (6) hours after initial needle puncture;

iii. Opened single-dose ampules may not be stored for any time period; and

iv. Multiple-dose containers that are formulated for removal of portions on multiple occasions because they contain antimicrobial preservatives, may be used for up to twenty-eight (28) days after initial opening or entering, unless otherwise specified by the manufacturer;

b. Water-containing compounded sterile products that are non-sterile during any phase of the compounding procedure must be sterilized within six (6) hours after completing the preparation in order to minimize the generation of bacterial endotoxins;

c. No food, drinks, or materials exposed in patient care and treatment areas may enter ante-areas, buffer areas, or segregated areas where components and ingredients of sterile preparations are prepared.

04.Environmental Controls. Except when prepared for immediate administration, the environment for the preparation of sterile preparations in a drug outlet must be in an isolated area, designed to avoid unnecessary traffic and airflow disturbances, and equipped to accommodate aseptic techniques and conditions.

a. Hoods and aseptic environmental control devices must be certified for operational efficiency as often as recommended by the manufacturer or at least every six (6) months or if relocated.

b. Filters must be inspected and replaced in accordance with the manufacturer's recommendations.

05.Sterile Preparation Equipment. A drug outlet in which sterile preparations are prepared must be equipped with at least the following:

a. Protective apparel including gowns, masks, and sterile (or the ability to sterilize) non-vinyl gloves, unless written documentation can be provided from the aseptic isolator manufacturer that any component of garbing is not necessary;

b. A sink;

c. A refrigerator for proper storage of additives and finished sterile preparations prior to delivery when necessary; and

d. An appropriate laminar airflow hood or other aseptic environmental control device such as a laminar flow biological safety cabinet, or a comparable compounding area when authorized by USP Chapter 797.

06.Documentation Requirements. The following documentation must also be maintained by a drug outlet in which sterile preparations are prepared:

a. Justification of beyond use dates assigned, pursuant to direct testing or extrapolation from reliable literature sources;

b. Training records, evidencing that personnel are trained on a routine basis and are adequately skilled, educated, and instructed;

c. Audits appropriate for the risk of contamination for the particular sterile preparation including:

i. Visual inspection to ensure the absence of particulate matter in solutions, the absence of leakage from bags and vials, and the accuracy of labeling with each dispensing;

ii. Periodic hand hygiene and garbing competency;

iii. Media-fill test procedures (or equivalent), aseptic technique, and practice related competency evaluation at least annually by each compounder or sterile prepackager;

iv. Environmental sampling testing at least upon registration of a new drug outlet, following the servicing or re-certification of facilities and equipment, or in response to identified problems with end products, staff techniques or patient-related infections, or every six (6) months.

v. Gloved fingertip sampling testing at least annually for personnel who compound low-and medium-risk level compounded sterile preparations and every six (6) months for personnel who compound high-risk level compounded sterile preparations.

vi. Sterility testing of high risk batches of more than twenty-five (25) identical packages (ampules, bags, vials, etc.) before dispensing or distributing;

d. Temperature, logged daily;

e. Beyond use date and accuracy testing, when appropriate; and

f. Measuring, mixing, sterilizing, and purification equipment inspection, monitoring, cleaning, and maintenance to ensure accuracy and effectiveness for their intended use.

07.Policy and Procedures Manual. Maintain a policy and procedures manual to ensure compliance with this rule.

Idaho Admin. Code r. 24.36.01.701

Effective March 28, 2023