What impact does exceeding 10% of the labeled volume have on compounding safety and efficacy?

Exceeding 10% of the labeled volume in compounding can lead to inaccurate dosing, which directly affects both the safety and efficacy of the compounded preparation. When the volume of an ingredient exceeds the specified limit, it may alter the intended concentration of the active pharmaceutical ingredient (API), potentially resulting in dosages that are too high or too low. This can pose significant risks, including therapeutic failure if the dose is insufficient or adverse effects if an overdose occurs.

Moreover, accurate measurements are crucial in sterile compounding to ensure that the final product meets the required standards for both quality and safety. If the volume is not controlled, it may also compromise the sterility and stability of the preparation, leading to further complications. Therefore, maintaining strict adherence to labeling and dosing guidelines is essential for achieving predictable and safe therapeutic outcomes.