Compounding Sterile Preparations Without a Cleanroom
You are a pharmacist at a small rural hospital in Texas. The hospital has a 10-bed inpatient unit and an outpatient infusion center. The pharmacy prepares sterile compounds, including total parenteral nutrition (TPN) and chemotherapy, in a small room adjacent to the pharmacy. The room has a laminar airflow hood but no separate cleanroom. The hospital administrator wants to expand services to include more complex sterile compounding, such as high-risk level (CSP) preparations. The current setup uses a single hood in a room with a door that opens to the pharmacy. The room has a sink and a refrigerator. The pharmacy is licensed as a Class C (hospital) pharmacy. The hospital is not licensed as a sterile compounding pharmacy. The administrator asks you to start preparing high-risk CSPs next week. What are the requirements, and what should you do?
1. What are the Texas requirements for sterile compounding, and what classification does this pharmacy fall under?
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Under 22 TAC §291.133, a pharmacy that compounds sterile preparations must comply with USP <797> standards. Texas classifies sterile compounding into three categories: low-risk, medium-risk, and high-risk. The pharmacy must have a designated cleanroom with an ISO Class 7 or better environment for high-risk compounding, and an ISO Class 5 hood. The current setup with a single hood in a room without a cleanroom is not compliant for high-risk compounding. The pharmacy must also have environmental monitoring, written procedures, and trained personnel. The hospital pharmacy is a Class C pharmacy, but sterile compounding requires additional certification and inspection by the Board. The pharmacy must not begin high-risk compounding until it meets the requirements.
2. What steps should you take before expanding to high-risk compounding?
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You should inform the administrator that the current facility does not meet USP <797> requirements for high-risk compounding. You must not start high-risk compounding without a compliant cleanroom, environmental monitoring, and validation. You should consult with the Board, upgrade the facility, and develop written policies and procedures. You should also ensure that personnel are trained and that the pharmacy has a quality assurance program. Until then, you may continue low-risk and medium-risk compounding if compliant. You should document your recommendations and the administrator's decision.