Does division 45 require strict adherence to USP chapters 797 and 795 rules?

The correct answer recognizes that Division 45 provides a framework that allows for some flexibility when it comes to compounding rules, particularly in relation to USP chapters 797 and 795. While these chapters establish standards for compounding sterile (797) and non-sterile (795) preparations, Division 45 acknowledges that different pharmacy settings might require varying levels of adherence based on their specific circumstances, resources, and practice environments.

In practice, this means that while pharmacies are expected to follow the foundational principles laid out in the USP chapters, they may adapt certain procedures to meet the practical needs of their specific operational context. For example, smaller pharmacies with limited compounding capabilities might implement less stringent measures, provided that patient safety and the integrity of the compounded preparations are maintained. This flexibility is essential in ensuring that pharmacies can operate effectively without compromising quality and safety standards.

By allowing for adaptations based on individual settings, the regulations can be more realistic and applicable to the diverse range of pharmacy practices, hence supporting better compliance and safety outcomes overall.