Pharmacy Sterile Compounding (USP 797)

This template covers the core workflow for preparing low- and medium-risk compounded sterile preparations under USP 797. It includes order verification, hand hygiene, garbing, primary engineering control preparation, aseptic manipulation, final inspection, and beyond-use date assignment. It is designed as a reusable SOP starting point, not a medication-specific recipe.

A trained pharmacy technician or pharmacist should follow the steps, with a pharmacist or other designated competent person performing oversight where required by site policy. The template works best when one role owns verification and another role performs the compounding steps. It should only be used by staff who are authorized and trained for sterile compounding.

Use it every time a sterile preparation is compounded, whether the batch is a single unit or a small run of the same formulation. It also works well as the controlled procedure for initial training, annual refreshers, and internal audits. If your workflow changes, the SOP should be reviewed and updated before the next use.

Yes, the structure is aligned to USP 797 sterile compounding expectations for documented process control, aseptic technique, and traceable batch records. It also supports ISO 9001-style documented information practices by making steps, verification, and records explicit. If your site handles hazardous drugs or special formulations, you should add the relevant local controls and safety checks.

Common failures include skipping hand hygiene, garbing in the wrong order, crowding the hood and blocking first air, and failing to document the actual beyond-use date. It also helps prevent missed order verification, contamination during manipulation, and incomplete inspection before release. Those are the kinds of deviations that often lead to non-conformance or product rejection.

Yes, and you should. Add your approved garb sequence, room classifications, cleaning agents, equipment names, local labeling rules, and release approval workflow. You can also tailor the batch record fields to match your pharmacy system, cleanroom layout, and internal escalation path.

This SOP can sit alongside your master formulation records, batch logs, cleaning logs, training records, and deviation reports. It is also easy to connect to e-signature workflows, inventory controls, and quality review checklists. The key is to keep the procedure and the record set synchronized so the batch can be traced end to end.

Do not use it unchanged for hazardous drug compounding, high-risk CSPs, or any process that requires additional engineering controls, environmental monitoring, or site-specific validation. It is also not a substitute for local policy, state board requirements, or pharmacist judgment. If your process includes special containers, unusual diluents, or extended storage, the BUD logic should be reviewed before use.