The state board auditor doesn’t accept ‘I think it was in that spreadsheet’
DSCSA lot-level tracking, DEA schedule compliance, cold chain logs, and beyond-use dating. Every record timestamped, every transaction traceable, every audit answered in under 5 minutes.
What happens when the state board walks in
The State Board of Pharmacy inspector walks in at 2 PM on a Tuesday. No appointment. They want to see:
- Your DEA controlled substance register — Schedule II through V, with running balances, receipt records, and dispensing logs for the last 2 years.
- DSCSA transaction records — lot-level transaction information, transaction history, and transaction statements for every drug product received.
- USP 797/800 temperature logs — continuous monitoring records for refrigerators, freezers, and controlled room temperature storage.
- Lot-level traceability — pick any product on your shelf, trace it back to the distributor invoice.
You have the records. Somewhere. The DEA log is in the binder. The DSCSA data is in... three different spreadsheets? The temperature log from last month is on that clipboard by the fridge. Maybe.
This audit is going to take a while.
Six compliance capabilities built for US pharmacy regulation
Not a generic checklist bolted onto inventory software. Purpose-built registers, formats, and workflows for the regulations you actually face.
DSCSA Lot-Level Tracking
Package-level serialization tracking as required by Drug Supply Chain Security Act. Transaction information, history, and statements maintained.
DEA Schedule Compliance
Schedule II-V controlled substance register. Biennial inventory reporting in DEA format. Running balance with automatic reconciliation.
Cold Chain Monitoring
USP 797/800 temperature logging. Multi-refrigerator monitoring. Continuous logging with excursion documentation and alerts.
Lot-Level Traceability
Pick any product. See the full chain: distributor → invoice → lot number → stock entry → every sale. Under 30 seconds.
Beyond-Use Dating
USP 795/797 compounding preparation tracking. BUD calculation based on preparation type. Automatic expiry assignment.
Reverse Distribution
Near-expiry return tracking. Generate 222 forms for controlled substance returns. Documented chain of custody.
Temperature monitoring that stands up to inspection
Your vaccine refrigerator should maintain 2-8°C. Your insulin should be stored at 2-8°C. Your certain antibiotics at 15-25°C.
When the power went out for 45 minutes last Thursday, did you document it? Did you assess which products were affected? Did you follow the temperature excursion protocol?
ShelfLifePro logs temperatures continuously (with compatible sensors) or via manual twice-daily entries. When a limit is breached, you get an alert. The system documents the excursion, the duration, and which products were affected.
When the inspector asks about that power outage, you show them the log, the excursion report, and the disposition decision.
Continuous Logging
Compatible Bluetooth sensors log every 5 minutes. Manual option: staff enter temperatures twice daily. Either way, the record exists.
Excursion Alerts
Configurable thresholds per refrigerator. Breach detected? Alert goes out immediately. Not at the next morning check — now.
Disposition Documentation
Which products were affected. How long the excursion lasted. What action was taken. Inspector asks? You hand them the report.
Five reports that answer 90% of inspection questions
Every report available as PDF, Excel, or on-screen. Date range filters. Full audit trail.
DEA Biennial Inventory
Schedule II-V inventory in DEA-compliant format. Running balance, receipt and disposition records. Ready for biennial inventory submission.
DSCSA Transaction Reports
Transaction information, transaction history, and transaction statements per DSCSA requirements. Lot-level serialization data.
Temperature Compliance Log
USP 797/800 compliant temperature records by unit, date range, and storage zone. Excursion incidents with corrective action documentation.
Lot Traceability Report
Full chain for any product: distributor invoice → lot number → stock entry → every sale transaction. Searchable by lot or product.
Beyond-Use Dating Report
Compounding preparation log with BUD calculations, preparation type, ingredients, and assigned expiry dates per USP 795/797.
Pharmacy compliance FAQs
The questions pharmacists ask before signing up (and the honest answers)
The next audit is coming. Your compliance records should be ready before you are.
Start your free trial. Get your compliance reports running before the inspector arrives.