USP 795, 797 and 800 consulting from a pharmacist who compounds
The chapters are long and inspectors are specific. We help you find the gaps, fix them in the right order, and keep records that hold up when someone asks to see them.
Creams, capsules, suspensions and other nonsterile preparations: facilities, training, records and beyond-use dates.
Injections, eye drops and other sterile preparations: cleanrooms, garbing, monitoring, testing and release.
Receiving, storing, compounding and disposing of hazardous drugs while protecting your staff.
What you get
Gap assessment
A walk through your practice against the chapters, ending in a short list of what to fix first.
SOP writing and review
Procedures written the way your team works, so people follow them.
Environmental monitoring program
Sampling plans, action levels, trend charts and what to do when a result comes back high.
Training and competency records
Checklists and observation forms for garbing, aseptic technique, cleaning and equipment.
Beyond-use dating and testing
Help deciding on BUDs, sterility and endotoxin testing, and release steps.
Hazardous drug handling
Your drug list, assessment of risk, storage, protective equipment and spill response under 800.
Cleanroom and workflow review
How people, materials and air move through your space, and where that causes problems.
Inspection preparation
A mock walk-through and a records check before a board or accreditation visit.
Sound familiar?
These are the problems pharmacies bring us most often. If one of them is yours, it can be fixed.
- You have SOPs, but they describe a pharmacy that does not match yours.
- Monitoring results are filed away and nobody looks at the trend.
- Training happened, but there is no record that proves it.
- An inspection is scheduled and you are not sure what they will ask for.
Questions about USP 795, 797 and 800 consulting
Do you work with 503A pharmacies?
Yes. Our day-to-day experience is in 503A sterile and nonsterile compounding, and that is where we are most useful.
Can you guarantee we will pass an inspection?
No one can honestly promise that. We can make sure you know where you stand, close the gaps that matter most, and have your records ready.
Do you work on site or remotely?
Both. Document review, SOPs and monitoring programs work well remotely. Facility and workflow reviews are better in person.
Other ways we help
LifeFile automation
Fewer clicks in LifeFile. Fill queues that stay in order, verification that moves, and shipping labels that print themselves.
Read morePK Software integration
Get your data out of The Compounder and into the places you need it: labels, lab results, reports and compliance records.
Read moreQuadCoreRx and pharmacy software
The QuadCoreRx platform plus tools for orders, compliance records, lab results, scheduling, labels and forms.
Read moreRphRhythm pharmacy operations
Everything it takes to run your pharmacy team in one app: schedules, time clock, time off, HR records, quality logs, the cash register and vendor passwords.
Read moreRequisto purchasing
The whole purchasing workflow in one place, from the moment staff request an item to the moment it is received.
Read moreWorkflow, logistics and supplies
Smoother filling and shipping, lower carrier bills, and the right supplies on the shelf.
Read more
Tell us what slows your pharmacy down
A few sentences is enough. You will hear back from a pharmacist within one business day, with questions or a time to talk.
Prefer email? Write to info@beyondrx.net.
Please leave out patient names and other health information.