What requirements must pharmacies meet to dispense compounded sterile products?

To dispense compounded sterile products, pharmacies must comply with all requirements set forth in USP 797. This chapter from the United States Pharmacopeia provides comprehensive guidelines to ensure the safe and effective preparation of sterile compounds. The standards cover various aspects, including environment controls, personnel training, sterilization procedures, and beyond, to mitigate the risk of infections and assure the integrity of the compounding process.

These guidelines are crucial because compounding sterile products carries risks associated with contamination, which can lead to serious health concerns for patients. Compliance with USP 797 helps ensure that pharmacies are maintaining high standards of practice and protecting patient safety. While FDA regulations and state laws may apply, they do not replace or supersede the specific practices mandated by USP 797 for compounded sterile preparations. This ensures a thorough approach to safety and quality in pharmaceutical compounding.