Section 12.2: Sterile Compounding Regulations
Key Takeaways
- Pharmacies performing sterile compounding must hold a Class S permit modifier (e.g., Class A-S Community, Class C-S Institutional, Class E-S Non-Resident).
- Pharmacists must complete at least 20 hours and pharmacy technicians at least 40 hours of initial ACPE-accredited sterile compounding training.
- To renew a license or registration, sterile compounding personnel must complete 2 hours of ACPE-accredited CE for low/medium risk and 4 hours for high-risk (or Category 3) sterile compounding.
- Environmental standards dictate an ISO Class 5 Primary Engineering Control (PEC), located within an ISO Class 7 buffer room, which opens into an ISO Class 8 anteroom.
- Competency testing requires a gloved fingertip test (GFT) initially 3 times with 0 CFUs, and media-fill tests initially and then at least annually or semi-annually.
Section 12.2: Sterile Compounding Regulations
Sterile compounding involves preparing medications that must be free from viable microorganisms, pyrogens, and particulate matter. The Texas State Board of Pharmacy (TSBP) regulates these activities under 22 TAC §291.133, which is designed to align with USP Chapter <797> standards.
Licensing and Class S Permits
In Texas, a pharmacy must obtain a special license modifier, known as a Class S permit, to engage in sterile compounding. This modifier is appended to the pharmacy's primary license class:
- Class A-S: A community pharmacy that compounds sterile preparations.
- Class C-S: An institutional (hospital) pharmacy that compounds sterile preparations.
- Class E-S: A non-resident (out-of-state) pharmacy that compounds sterile preparations and ships them into Texas. Non-resident pharmacies must comply with TSBP sterile compounding rules and are subject to inspection by TSBP inspectors.
Personnel Training and Continuing Education (CE)
TSBP Rule §291.133 establishes non-negotiable minimum hours for sterile compounding training consisting of didactic instruction and practical experience:
- Pharmacists: Must complete a minimum of 20 hours of instruction in sterile compounding through an accredited college of pharmacy or ACPE-accredited provider.
- Pharmacy Technicians: Must complete a minimum of 40 hours of sterile compounding instruction through an ACPE-accredited provider or ASHP-accredited training program. A pharmacy technician trainee must complete this training before they are permitted to compound sterile preparations.
- License Renewal CE: During each renewal cycle, personnel compounding Category 1 and 2 CSPs must complete at least 2 hours of ACPE-accredited CE related to sterile compounding. Those involved in high-risk sterile compounding (or Category 3 CSPs) must complete at least 4 hours of ACPE-accredited sterile compounding CE.
Cleanroom and Environmental standards
Sterile compounding must be performed in highly controlled environments divided into distinct zones, each subject to strict International Organization for Standardization (ISO) air quality classifications:
- Primary Engineering Control (PEC): Provides an ISO Class 5 environment for exposure of critical sites during compounding. Common PECs include Laminar Airflow Workbenches (LAFW), Biological Safety Cabinets (BSC), and Compounding Aseptic Isolators (CAI).
- Buffer Room (Cleanroom): The room where the PEC is located. It must maintain an ISO Class 7 air quality environment. For non-hazardous compounding, the buffer room must maintain positive pressure relative to the surrounding areas (at least 0.02 inches of water column) and have a minimum of 30 air changes per hour (ACPH).
- Ante-room: The transition area where personnel perform hand hygiene and garbing. It must maintain an ISO Class 8 air quality environment. However, if the ante-room opens into a negative-pressure buffer room (used for hazardous compounding), it must maintain an ISO Class 7 air quality environment.
- Segregated Compounding Area (SCA): A designated area containing an ISO Class 5 PEC, but the area itself is not ISO-classified. Compounding in an SCA is subject to severe beyond-use date restrictions.
| Area | ISO Air Quality Classification | Pressure Requirement | Air Changes Per Hour (ACPH) |
|---|---|---|---|
| PEC | ISO Class 5 | Positive (unless hazardous) | Constant laminar flow |
| Buffer Room | ISO Class 7 | Positive (non-hazardous) / Negative (hazardous) | Minimum 30 ACPH |
| Ante-room | ISO Class 8 (positive buffer) / ISO Class 7 (negative buffer) | Positive (relative to unclassified area) | Minimum 20 ACPH |
Competency Testing: Media-Fill and Gloved Fingertip Testing
Compounding personnel must demonstrate their aseptic technique through objective testing before they are allowed to prepare sterile medications for patient use:
- Gloved Fingertip Testing (GFT): Evaluates a person's ability to garb and glove aseptically. Personnel must perform GFT by pressing their gloved fingertips onto agar plates.
- Initial Competency: Personnel must pass GFT initially a minimum of three times (on separate garbing occasions) with zero colony-forming units (CFUs) on both hands.
- Ongoing Competency: GFT must be repeated at least annually for Category 1 and 2 CSPs, and every three months for Category 3 CSPs. The passing threshold for ongoing GFT is 3 CFUs or fewer.
- Media-Fill Testing: Evaluates aseptic technique by substituting growth-promoting media for the actual drug during a simulated compounding sequence.
- Frequency: Must be passed initially, and then re-evaluated at least annually for Category 1 and 2 CSPs, and at least every six months for high-risk or Category 3 sterile compounding.
- Outcome: The media-fill container must be incubated for 14 days and show zero evidence of microbial growth (turbidity) to pass.
Cleaning and Sanitization Frequencies
TSBP Rule §291.133 mandates minimal frequencies for cleaning and disinfecting sterile compounding areas. Cleaning must occur when no compounding is in progress:
- PEC Work Surfaces: Cleaned and disinfected at the beginning of each shift, before each batch preparation, at least every 30 minutes during continuous compounding, after spills, and when contamination is suspected.
- Counters, Work Surfaces, and Floors: Cleaned and disinfected at least daily.
- Walls, Ceilings, and Shelving: Cleaned and disinfected at least monthly.
Beyond-Use Dates (2023 USP <797> Revisions)
Under the 2023 USP <797> revisions adopted by the TSBP, sterile compounded preparations are classified into three categories based on environmental controls and the complexity of the compounding process:
- Category 1 CSPs: Compounded in a Segregated Compounding Area (SCA) with an ISO Class 5 PEC. The BUD is restricted to 12 hours or less at controlled room temperature or 24 hours or less if refrigerated.
- Category 2 CSPs: Compounded in an ISO Class 7 buffer room with an ISO Class 5 PEC. The BUD depends on whether the compound is aseptically processed or terminally sterilized, whether a sterility test is performed, and the storage temperature. For an aseptically processed Category 2 CSP that does not undergo sterility testing, the maximum refrigerated BUD is 10 Days (refrigerated) or 4 Days (controlled room temperature).
- Category 3 CSPs: Prepared under stricter environmental conditions than Category 2, including weekly cleaning, sterility testing, endotoxin testing, and stability-indicating assay data. The BUD can extend up to 180 days under refrigeration.
Which of the following correctly pairs the licensing permit modifier and the initial classroom training hours required for a pharmacy technician to perform sterile compounding under Texas pharmacy regulations?
Before a pharmacist is permitted to begin compounding sterile preparations for patient use at a new pharmacy, which of the following represents the initial competency testing requirement for gloved fingertip testing under TSBP Rule §291.133?
A hospital pharmacy compounds a sterile, non-hazardous single-dose injection in an ISO Class 5 laminar airflow workbench located inside a positive-pressure ISO Class 7 buffer room. If no sterility testing is performed, and the preparation is stored in the refrigerator, what is the maximum beyond-use date (BUD) that can be assigned under TSBP rules?