Compounding is the practice of mixing or preparing medications tailored to a patient's specific needs. To ensure the safety of all products, USP 797 describes best practices for pharmacies involved in these processes. Here are a few tips for staying compliant with these important guidelines.

How to Maintain Compliance With USP 797

1. Train Your Staff

Any staff member involved in compounding should receive regular training and education reinforcement, even if they've never been cited for noncompliance. 

Your training programs should cover competencies for each employee, compounding policies and procedures, and essential rules of sterilization. Every six months, train all employees in hand-washing and sanitation, and use media-fill testing to check their skills at mixing the most complex materials your pharmacy handles. 

2. Prevent Degradation

Some of the most common medication compounding errors are related to expired products. Chemicals degrade over time, so a patient might not see results when taking expired drugs.

Some products, such as injections and infusions, need to be kept sterile, while others have less stringent requirements. Many compounding drugs need to be refrigerated, or they might only be usable for a few days. Your entire staff should understand how to take temperature records and discard products after their beyond-use dates.

3. Use the Right Facilities

According to USP 797, most compounds may be mixed in a segregated area, while hazardous materials may require a cleanroom suite. If you regularly handle chemotherapy medication or other potentially hazardous materials, staff should always use a cleanroom suite designed with advanced filtration and sanitation equipment.

If your pharmacy only handles low-risk medicines or materials that don’t require sterilization, a dedicated area may be sufficient for your needs. These rooms should be equipped with airflow systems and ventilated workbenches that minimize the risk of cross-contamination.

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