Synopsis
As the pharmacy community waits for the imminent release of updates to USP 797, many are speculating how these changes will impact compounding practice, while others have chosen to ignore the discussion altogether, justifying their position by claiming there is a lack of sufficient evidence-based data to support the notion that changes to cleanrooms and compounding practices are needed at all. However, the fact remains that USP 797 represents a best practice for the compounding of sterile preparations. Even in the absence of specific legal requirements, pharmacists should assess the chapter’s applicability to their practice and change their procedures as they deem necessary. This exercise can protect both the pharmacist and the patient, and can assist pharmacists in maintaining compliance with current standards.
