A controlled substance inventory reconciled to the milligram as it moves, with the registrant deciding every difference
Every milligram of every controlled substance accounted for, with differences found within hours.
See one case, screen by screen ↓A Schedule I powder is weighed out on Monday, written into the usage log on Monday afternoon, and counted at the start of next month. If the log says 25.0 mg and the balance said 27.8 mg, nobody knows until the safe comes up 2.8 mg short — and by then the registrant has to work backwards through usage logs, balance printouts, notebook entries and receipts to find out which line is wrong.
Meanwhile the rules do not wait. An unexplained shortfall that could be a significant loss needs a written notice to the DEA field office within one business day of discovery and a Form 106 within 45 days. The biennial inventory has to be counted exactly for open Schedule I–II containers, every on-site destruction needs two witnesses, and an inspector can ask for all of it, by registration, on any day.
Estimated hours from the first count to a signed record, by hand and with the solution.
Five specialist agents read, post, reconcile and record every movement; the registrant decides every difference.
Wednesday, October 7. The monthly counts start at 07:40 in Building 4 and the vivarium. By 07:58 one Schedule I vial is 2.8 mg short and one Schedule II bottle is 4.5 mL short. Here is what happens next, screen by screen, in the working solution.
Omar holds registration RH0412337 for Schedules I–V. His home screen shows 10 of 14 containers balanced to the milligram, 2 open variances from today’s counts, a DEA notice clock at 31 hours, and the biennial inventory ready to sign. The storage map colours each safe by its state: Safe A has a variance, Cabinet V1 a possible loss.
“Every milligram across 3 registrations and 7 storage locations — reconciled as it moves, ready for an inspector any day.”
Sam Patel counts Safe A at 07:40 with Dana Okafor as witness. CS-1187, a 500 mg vial of NWB-7731 HCl, should hold 412.6 mg — 500.0 mg received, 87.0 mg withdrawn, 0.4 mg waste. The balance reads 409.8 mg. That is 2.8 mg outside the ±0.2 mg tolerance for an open Schedule I powder, which is counted exactly.
Omar presses one button. The Intake reader reads nine records — the usage log, six balance printouts, notebook PK-118-0412 and the CSOS receipt. The Ledger keeper recomputes the expected balance, and the Reconciliation checker compares every usage-log line with its balance printout and notebook entry. The Loss assessor checks whether what is left could be a loss.
Loss assessor: “Every milligram explained by one transcription error — not a loss.”
The Oct 5 withdrawal for study PK-118 was 27.8 mg, not 25.0 mg. Balance printout #1182 shows the vial going from 23.4973 g to 23.4695 g, and Lena Ortiz’s notebook records 27.8 mg dissolved in 2.78 mL. Only usage-log line 8 says 25.0 mg. Correcting it balances CS-1187 to 0.0 mg against the 07:40 count — confidence 0.97, every value cited.
An explanation must be supported by two independent records.
Omar has three choices: correct line 8 to 27.8 mg, treat it as a possible loss, or ask Lena Ortiz first. He corrects it. The correction is a new signed line; the original 25.0 mg stays visible, struck through. Lena co-signs as the person who logged it, and Omar signs with the meaning “I approve this correction as the registrant”.
Lena Ortiz: “I logged this line; the printout is correct.”
In the vivarium, CS-0950 — a Schedule II euthanasia solution, Pentavel 390 mg/mL, in Cabinet V1 under registration RC2290458 — should hold 41.5 mL. It holds 37.0 mL. Every logged withdrawal matches an animal-protocol record and the count was witnessed. The Loss assessor scores the significant-loss factors of 21 CFR 1301.76: the quantity (about one procedure day), the substance and the diversion potential are significant; the individuals linked are not determined. It starts the one-business-day clock at 07:58.
“The agents do not name anyone — that is for your investigation.”
The Intake reader exports Cabinet V1’s badge-and-PIN access log for Sep 23 – Oct 7 and matches each opening to a usage-log line or a count. Five match. On Oct 6 at 19:52 the cabinet was opened for 3 minutes with card 4471, a shared night-shift card, and there is no log line to go with it.
The Loss assessor drafts the written notice to the Special Agent in Charge and the Form 106 fields: unexplained loss, not in transit; 4.5 mL (1,755 mg); a double-locked cabinet with badge and PIN; corrective actions — the shared night-shift card disabled, weekly counts for Cabinet V1, an access review. Dana Okafor, the compliance lead, reviews it; Omar signs and sends it 31 hours before the deadline. The Form 106 draft is saved, due Nov 21.
Never sent to the DEA without the registrant’s signature.
Registration RH0412337’s biennial inventory is drafted from today’s counts, as of opening of business on Oct 7, within two years of the Nov 1, 2024 inventory. Nine lines by schedule — open Schedule I–II containers counted exactly and kept separately, Schedule III–IV estimated where the rule allows, sealed containers by number. Each line links to its container and count sheet. It stays on site; it is not sent to the DEA.
“Taken by Sam Patel, witnessed by Dana Okafor at 07:40–08:05.”
The Record drafter assembles the pack for RH0412337 from signed records: the registration, the biennial and 24 monthly inventories, Form 222 and CSOS orders, receipts, usage logs with Schedule I–II kept separately, Form 41 destruction records, loss reports, corrections, the storage and key lists, and procedures SOP-CS-01 to SOP-CS-07. Anything still open is listed first, so it is closed before an investigator asks.
A read-only link for the investigator expires in 14 days, and every view is on the audit trail.
The same morning’s counts, seen by the five people who carry them — what their month looked like, and what it looks like now.
Five specialist agents read, post, reconcile and record every movement; the registrant decides every difference.
Reads balance printouts, notebook entries, usage logs, CSOS and Form 222 receipts, invoices and destruction records into movements.
Posts each movement to the perpetual inventory for its container and keeps the running balance.
Compares expected and counted balances under the schedule rules, then looks across sources for the explanation.
Assesses unexplained shortfalls against the significant-loss factors, starts the clock and drafts the notice and Form 106.
Drafts monthly and biennial inventories, destruction records and inspection packs for e-signature.
Decides every difference and e-signs. The agents propose; a named person decides.
Registrants, the compliance lead and lab staff can ask in plain words — or tell it what to change. Answers cite the records they rest on.
Why is Safe A off by 2.8 mg?
One transcription error — not a loss. On Oct 5 Lena Ortiz weighed 27.8 mg of NWB-7731 HCl for PK-118: the balance printout and her notebook agree. The usage log says 25.0 mg. Correcting line 8 balances the container to 0.0 mg. It needs your signature and Lena’s.
What is due to the DEA this week?
The written notice for the Pentavel shortfall, by Oct 8, 17:00; the Form 106 for the same loss by Nov 21; and the CSOS receipt NWB-26-0241 to record now. The biennial inventory is ready to sign today — it stays on site and is not sent to the DEA.
What does the biennial inventory need?
At least every two years, as of opening or close of business. Open Schedule I–II containers: exact count. Schedule III–V: estimate unless a container holds more than 1,000 units. Sealed: number of containers. Your RH0412337 inventory — 9 lines, as of opening of business Oct 7 — is drafted and ready to sign.
Add a rule: count Schedule I safes weekly
Done. New rule: count every Schedule I safe weekly, Mondays at opening of business. Safe A and Safe L-1 get a prefilled weekly count sheet; the first is Mon Oct 12. Other locations stay monthly.
13 screens from the working solution, on its sample data. Pick one to see it large.
Tolerances, count cadence, signers and witnesses are settings. Changes take effect at once and are on the audit trail.
| Setting | Default | Choose from |
|---|---|---|
| Tolerance · Schedule I–II powders | ±0.2 mg | Set with − / + |
| Tolerance · Schedule I–II solutions | ±0.1 mL | Set with − / + |
| Count cadence | Monthly · first business day | Monthly · Weekly for Schedule I, monthly for others · Biennial only |
| Witness on every count | On | On · Off |
| Treat any unexplained Schedule I–II shortfall as a possible loss | On | On · Off |
| Corrections signed by | Registrant + person who logged | Registrant + person who logged · Registrant only |
| Destruction witnesses | Sam Patel and Dana Okafor | Sam Patel and Dana Okafor · Sam Patel and Lena Ortiz · Ravi Menon and Dr. Maya Chen |
| Loss notices signed by | Registrant + compliance lead | Registrant + compliance lead · Registrant only |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample lab data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · Regulations named as context: 21 CFR 1304 (records and inventories) · 21 CFR 1301.76 (loss reporting) · 21 CFR 1317.95 (destruction). People, companies and products named on this page are fictional — characters and sample data in the working solution.
Software that keeps a perpetual inventory of every controlled substance container — receipts, withdrawals, waste, transfers, destruction and counts — and the records the DEA expects behind it. This solution adds agents that read the source records, post every movement, reconcile each count and draft the inventories and notices for the registrant to sign.
The Ledger keeper keeps an expected balance for each container from its records. When a count is posted, the Reconciliation checker compares it with the expected balance under the tolerance for that schedule, and if it is outside, looks across the usage log, balance printouts, notebook entries and receipts for the explanation. An explanation needs two independent records behind it.
No. The Loss assessor scores an unexplained shortfall against the significant-loss factors, starts the one-business-day clock and drafts the written notice and the Form 106. The registrant decides — report it, record why it is not significant, or ask the team — and nothing is sent without the registrant’s signature.
The Record drafter drafts it from the day’s counts and the ledger, as of opening or close of business, by schedule: exact counts for open Schedule I–II containers, estimates for Schedule III–V where the rule allows, sealed containers by number. Every line links to its container and count sheet, and the registrant signs it.
Yes, but posted lines are never edited. A correction is a new line that points to the original and gives the reason and the evidence; it is signed by the person who logged the line and by the registrant, and the original stays visible, struck through.
Yes. In the working solution, a Leiden site runs under its Dutch Opium Act licence for List I and II, with its own register and national inspector. The same agents read its records with those rules.
Yes. The agents read, post, reconcile and draft; they never close a variance, never name a person as responsible and never send anything to the DEA. Every difference is decided and signed by the registrant, and every step is on the audit trail.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your registrations, SOPs, storage locations and a sample of your usage logs, printouts and counts — and it goes live once every quality gate has passed. We walk you through it on your own records first.
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