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When are controlled-substance inventories required?

Take an initial inventory when first engaging in activities that require controlled-substance records, then take a new inventory at least every two years.

What if a registrant has no controlled substances at initial inventory?

Record a zero-stock initial inventory; an empty stock does not remove the initial inventory requirement.

What basic details belong in an inventory record?

Record the date, whether the count was taken at the opening or close of business, and the controlled substances on hand.

When is an exact physical inventory count required?

Schedule I and II drugs require an actual physical count. For Schedules III–V, an estimate is generally permitted, except for containers holding more than 1,000 tablets or capsules, which require an exact count.

What product and quantity details should an inventory include?

Record the drug, strength and dosage form, container size, number of containers, and total quantity.

Which controlled-substance transactions must be recorded?

Keep a complete, accurate, current record of controlled substances received, sold, delivered, transferred, or otherwise disposed of.

Does federal law require a perpetual inventory?

Federal rules do not require a perpetual inventory, but transaction records should make stock changes explainable.

What is the federal minimum retention period for required records?

Retain required records and inventories for at least two years and make them available for inspection by authorized DEA personnel.

How do record-separation rules differ by schedule?

Keep Schedule II inventory and records separately from other pharmacy records. Schedule III–V records may be separate or kept in a readily retrievable format.

What should you do when a count does not match the records?

Promptly recount and review source documents, date ranges, returns, voids, adjustments, and access logs. Document the discrepancy and corrective action in a dated, attributable audit trail; do not silently overwrite the original entry.

Does a clerical inventory correction alone require DEA Form 106?

A clerical correction should be documented internally; a count adjustment alone does not require DEA Form 106.

What are the reporting deadlines for suspected theft or significant loss?

Notify the local DEA Field Division in writing within one business day of discovery and submit a complete DEA Form 106 within 45 days.