Month-end for Spravato® clinics,
and the two DEA forms around it.

Why every month, when the rule says every two years

Federal rules ask a registrant for a complete inventory of its controlled substances every two years, the biennial inventory in 21 CFR 1304.11, alongside records of everything received, dispensed and destroyed. Many states ask for more, and so do most clinics' own policies. A month suits a Spravato® clinic: short enough that a gap can still be explained by the people who were there, and long enough to be worth a signature. The biennial inventory then becomes a formality, because the months before it already add up.

What the reconciliation says

For each strength, one line of arithmetic, counted in devices rather than cartons. An 84 mg carton holds three 28 mg devices and a 56 mg carton two, and the device is the unit that makes partial doses visible.

• The equation, by strength. Opening balance, plus what was received, minus what was given to patients, destroyed, wasted from doses or returned, equals the closing balance. If the arithmetic does not close, nothing else on the page matters yet.
• Every carton's trail. Where each carton on the books at the start of the month went, and where each one received during it is now.
• What is still open. Unused devices never recorded, expired stock still counted as usable, pharmacy-supplied product past its 45 days, count discrepancies not yet resolved. An order still on its way is not one of them: nothing is on the books until its cartons arrive.
• The counts. Every physical count taken in the month, and what each one found.

Who signs, and what signing should mean

A reconciliation is a statement by a person that the month's records are complete and correct as of the day they sign. Three things follow. The signer is named, and proves who they are with their own credential rather than a shared login. What they sign is frozen: the numbers on that day, not whatever the records say next month. And if the records change afterward, because a late delivery is entered or a destruction is corrected, the signed month should say so and be signed again, rather than quietly disagreeing with its own copy.

Signing with something still open is legitimate, as long as the signature says what and why. A month with one expired carton waiting for pickup can be signed with a note; a month whose arithmetic does not close should not be signed at all.

Destruction, and the Form 41 record

When a registrant destroys controlled substances itself, the destruction is recorded on DEA Form 41 (21 CFR 1304.21(e)): what was destroyed, by product, strength and quantity, how, when and by whom. The substance must be rendered non-retrievable, and two employees handle or observe it until it is (21 CFR 1317.95(d)). An expired carton, a damaged one, and pharmacy-supplied product past Janssen's 45-day limit all end up here.

The unused remainder of a dose is a different thing. It is usually recorded as waste in the administration record, witnessed where your clinic or state requires it, rather than as a Form 41 destruction. State rules vary here more than anywhere else in this guide, so check yours.

Theft or significant loss: two deadlines

If controlled substances are stolen, or a significant quantity is lost, 21 CFR 1301.76(b) sets two steps: written notice to your DEA Field Division Office within one business day of discovery, then DEA Form 106, submitted online through DEA's Diversion Control Division, within 45 days. Whether a loss is significant is the registrant's judgment, and the regulation lists what to weigh: the quantity and the substance, whether the loss can be tied to specific people or activities, and whether it is part of a pattern.

A count that comes up one carton short is not automatically a reportable loss. It is a discrepancy to investigate, and most are a missed entry that the week's records explain. The ones that are not become a loss report, and the clock starts at discovery.

What to have ready for an inspection

• The signed reconciliation for each month, with any notes the signer added.
• The controlled-substance log for the period asked about: every receipt, dose, destruction, return and correction, with a running balance.
• The destruction record, with its witnesses.
• Physical counts, and how each discrepancy was resolved.
• Invoices or order records matched to what was received.
• Any theft or loss reports, with the dates notice was given and Form 106 was filed.

How Lucido handles it

In Lucido, month-end is a page rather than a project. The reconciliation builds itself from the controlled-substance log: the equation by strength, every carton's trail, and each open item linked to the screen that clears it. A named staff member signs it with their own password, it is kept as a record nobody can edit, and if the records change afterward Lucido flags the month. Destructions and the unused devices from doses are signed with the person's own PIN and witnessed where you require it; the destruction record is laid out as Form 41 asks; a theft or loss is tracked to both deadlines (Lucido records them, and Form 106 itself is filed on DEA's site); and the inspection pack prints the signed months and the destruction record as one binder, with no patient names. See it with the rest of the inventory, or what it costs — one flat monthly price per location, with inventory included.

Month-end is also the heart of Lucido Lite, the inventory on its own plan, for a clinic whose treatment day already runs on something it keeps. The reconciliation, the destruction record, the loss tracking and the inspection pack are the same; there is no schedule and no REMS form.

Sources

• 21 CFR 1304.11, inventory requirements
• 21 CFR 1304.21, general requirements for continuing records (Form 41)
• 21 CFR 1317.95, destruction procedures
• 21 CFR 1301.76, theft or significant loss
• DEA Form 106, filed online

Related guides

• Tracking Spravato® inventory, done properly
• The Spravato® audit question: could you produce it?
• Spravato® REMS requirements, explained in plain language