What must be included in the documentation of non-sterile compounding?

In the documentation of non-sterile compounding, it is essential to include precise details about the components used and their respective quantities. This requirement ensures that the compounding process is transparent, reproducible, and adheres to safety standards. By documenting the ingredients along with their amounts, regulators and other practitioners can verify that the compounding was conducted according to established formulas and guidelines, which is important for maintaining quality and consistency in medication preparation.

In the context of compounding practices, detailed records help with accountability and provide a clear reference in case of any quality issues or patient inquiries. Additionally, should a product need to be traced back due to an adverse event, having thorough documentation enhances the ability to investigate and rectify situations promptly.

The requirement for documentation to include components and their quantities is grounded in regulatory guidelines aimed at ensuring the safety and efficacy of compounded medications, thus reinforcing the significance of maintaining high standards in pharmacy practices.