As an increasing number of provider types – including physicians and medical offices – recognize the value of compounded therapies for their patients, and as the framework to obtain medications for office use administration has evolved, there has been a greater focus on whether physicians and other medical providers may compound medications directly for immediate use. The distinction between compounding for “immediate use” and compounding for “office use” is more than a semantic nuance; it sits at the crossroads of patient safety, federal and state regulatory frameworks, and substantial enforcement risk.
For private practices, infusion centers, ambulatory surgery centers, and office-based oncology practices, understanding what is—and is not—permitted when preparing sterile medications without a patient-specific prescription is essential. Immediate-use compounding, when viewed through an office-use lens, raises distinct compliance and enforcement considerations under California’s sterile compounding rules and existing FDA regulatory oversight applicable to office-based compounding.
California’s Sterile Compounding Rule on Immediate Use
California has codified a strict framework for sterile compounding that tracks USP <797> while adding state-specific safeguards. Under California regulations, immediate-use compound sterile preparations (CSPs) may be administered only to address urgent situations in which failure to administer the CSP could result in death or intense suffering. Immediate-use CSPs must adhere to strict aseptic techniques to maintain sterility of the compounded medication.
Further, California regulations require facilities to report to the California Board of Pharmacy when failures in sterile compounding equipment or environment necessitate immediate-use compounding.
All facilities must maintain a sterile compounding environment. Compounding CSPs without a full cleanroom for immediate use must be strictly limited to cases of urgent necessity where delay could cause serious harm.
FDA Oversight Touchpoints for Office-Based Compounding
Even when compounding occurs in state-licensed settings, the FDA’s jurisdiction remains implicated and can be triggered by complaints, adverse events, or public reports of potential quality issues.
Public online complaints can, in practice, trigger both federal and state scrutiny. FDA has investigated private practices following public allegations. There are instances where allegations posted on a physician-rating website concerning inappropriate chemotherapy handling triggered FDA inspection. FDA investigators may review aseptic practices, facility conditions and documentation against USP <797> to determine whether CSPs were prepared under insanitary conditions.
Outcomes of inspections and enforcement actions against pharmacies and medical practices are often published online by the FDA, making these matters discoverable online and reputationally consequential. State boards of pharmacy and medicine, once notified, may initiate their own investigations and enforcement actions.
Key Takeaways for Office-Based Practices
From an office-use perspective, “immediate use” is not a practical substitute for office stock. For example, California’s 16 CCR 1736.1 confines immediate-use sterile compounding to documented, exigent circumstances for an identified patient, in minimal quantities, with specific recordkeeping. Because FDA oversight can be triggered by public complaints and may escalate from inspectional observations requiring a response to warning letters to criminal referrals, practices should align operations, documentation, and procurement with governing standards and treat immediate-use compounding as the last rung in a tightly constrained safety hierarchy.
How Frier Levitt Can Help
Given the complexity of sterile compounding regulation, it is important to regularly review and identify gaps in compliance with USP <797> standards. Consult with an experienced healthcare attorney at Frier Levitt to evaluate your current practices, develop policies and procedures, and navigate state licensure processes required to engage in immediate-use or other compounding activities.
