Start with your categories
The current chapter sorts compounded sterile preparations into Category 1, Category 2 and Category 3. The category decides the room you need, the beyond-use dates you may assign and how much testing is required. Confirm which categories you really make. Many gaps come from assigning Category 2 dates to work done under Category 1 conditions.
Seven areas to walk through
- People: training, garbing competency with gloved fingertip sampling, and media-fill testing, each on schedule and documented for every person who compounds.
- Facility: room classification, pressure differentials, temperature and humidity, monitored and recorded.
- Certification: rooms and hoods certified on schedule, with the reports read and signed, not just filed.
- Environmental monitoring: air and surface sampling at the required frequency, action levels defined, and a written response to every result over the limit.
- Cleaning: daily, monthly and sporicidal steps with the right agents, contact times and logs.
- Records: master formulation records and compounding records complete for every batch.
- Release: beyond-use dates you can support, sterility and endotoxin testing where the chapter requires it, and a clear check before anything leaves.
Where pharmacies most often fall short
- The SOP says one thing and staff do another.
- Monitoring results are filed and never trended.
- Training was done, but one person's record is missing.
- A result came back high and nothing shows what was done about it.
- A certification report lists a deviation that nobody followed up.
Trace one batch
Pick one recent batch and follow it backwards: the release check, the test results, the compounding record, the person who made it, that person's competency records, the room's monitoring results that week and the last certification report. One batch traced end to end shows more than any checklist.
What to do with the results
Rank the gaps by risk to patients first and risk at inspection second. Fix them in that order, document each fix and check again in a few weeks. Remember that your state board of pharmacy may add requirements on top of the chapter, so read both.
Reviewed 2026-11-12 by a practicing pharmacist. This guide is general information, not legal advice. Check the current USP chapters, your state board of pharmacy rules and your software agreements before you act on it.