Ensuring compliance with USP Chapters is a significant concern in the field of sterile compounding, particularly for small and rural facilities. This process can be both daunting and expensive, especially when managing multiple large projects simultaneously. The division of focus among these projects poses a risk of negatively impacting the desired end goals.
To tackle this challenge effectively, it is essential to conduct thorough assessments of the facility’s current state before embarking on any upgrade planning. Hold meetings involving all relevant stakeholders to determine their responsibilities and define the desired end product. This is an opportune time to address logistical concerns, such as identifying staff members who require training in cleaning practices to maintain the upgraded space, designating individuals responsible for ensuring regulatory compliance, and planning for terminal cleaning before utilizing the new area. It is highly recommended to have copies of USP <797> available for reading and discussion during these meetings, enabling everyone involved to grasp the general details of the chapter. Lack of understanding regarding USP <797> proved challenging during our own renovation, emphasizing the importance of this preparatory step.
Familiarity with both federal and state requirements is crucial for the project team. Remember that different states have varying levels of compliance mandated for USP chapters. Begin by determining if your state requires full compliance with USP Chapter <797> and carefully review any state-specific requirements that may be more stringent than those outlined in USP. For example, Connecticut has stricter regulations regarding aspects such as temperature and humidity control in sterile processing.
When selecting architects and contractors for the project, it is vital to make informed decisions rather than solely relying on past collaborations. Pharmacy management should actively participate in the selection process. If possible, evaluate other facilities where the contractor and/or architect have completed similar sterile processing suites. Investigate any issues encountered at those facilities. For instance, did the contractors and architects fully understand the legal implications of state and federal enforcement of the USP chapters? Were they knowledgeable about the necessary approvals at both state and federal levels?
We understand that the decision-making process regarding compliance service providers can be challenging and filled with uncertainties. That’s why we are here to help. Reach out to us today at 1.800.418.9289, and we will provide you with comprehensive compliance assistance tailored to your specific needs. Let us know how we can support you in achieving and maintaining compliance.