Incorporates USP 800 by reference, stating that any facility that compounds sterile products shall comply with applicable USP standards.

However, the Tennessee Board of Pharmacy website states: “The Tennessee Board of Pharmacy is currently only empowered by statute and rule to enforce applicable USP standards for sterile compounding. While the appeals process continues for these new standards with USP, the current standards for sterile compounding will continue to be enforced.”

Citations

Sterile Product Preparation

Pharmacy Rules