The Missing 222s, the Missed Inventory, and a Break-In Nobody Reported
During a scheduled inspection, a DEA diversion investigator and a North Dakota Board inspector review a busy retail pharmacy. The records show that the last biennial inventory was taken 26 months ago, that three completed DEA Form 222s cannot be located, and that the perpetual inventory is off by 412 oxycodone 30 mg tablets. The pharmacist-in-charge explains that nine days ago someone pried open the controlled substance safe overnight; 412 tablets of oxycodone 30 mg and 480 mL of promethazine-codeine syrup are missing. The night pharmacist discovered the break-in the next morning, told the PIC, and the store filed a police report. No one notified DEA or the Board. The PIC says he was "waiting to finish the internal investigation" and thought the police report "covered it." He also mentions that last month the pharmacy destroyed 200 expired alprazolam tablets by dropping them into the sharps container.
1. What were the pharmacy's reporting obligations after the break-in, and by when? Evaluate the PIC's explanation.
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On discovery of a theft or significant loss of a controlled substance, the registrant must notify the DEA field division office in writing within one business day of discovery and must complete and submit DEA Form 106 (Report of Theft or Loss of Controlled Substances). The clock runs from discovery, not from the end of an internal investigation and not from the police report date. The Board of Pharmacy must also be notified under state requirements, and the police report should be referenced but does not substitute for either filing. The Form 106 should describe what was taken, the quantities and strengths, how the loss was discovered, and what security changes followed.
The PIC's explanation fails on every point. "Waiting to finish the investigation" is precisely what the rule forecloses - the report is filed while the facts are still being established, and it may be supplemented later. A police report goes to local law enforcement and does not reach DEA. Nine days of silence on a Schedule II theft is a standalone violation, and it compounds the diversion risk if the stolen tablets are being sold. In addition, the pharmacy should immediately secure the safe, review access logs and camera footage, and reconcile inventory. A significant unexplained loss also triggers the obligation to correct the records so the perpetual inventory reflects reality.
2. Address the inventory and recordkeeping findings: the 26-month-old biennial inventory and the three missing Form 222s. What must the pharmacy do now?
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A biennial inventory is mandatory at least every two years, taken on any date within two years of the prior one, with all controlled substances counted - an exact count for Schedule II - recorded as of opening or close of business, signed, and retained for two years with the other controlled substance records. At 26 months, the pharmacy has no compliant inventory and cannot demonstrate the starting point for its accountability. The remedy is not backdating; it is to take a complete inventory now, on a specific date and time, signed by the person who took it, and then reinstate a calendar control so the next one falls within 24 months.
The missing 222s are receipts of Schedule II substances, so their loss breaks the chain of accountability for purchases. The pharmacy should request copies from the suppliers, reconstruct receipt records using supplier invoices and shipping documents, and document the reconstruction. A new power of attorney should be executed so ordering can continue, and current powers of attorney must be on file. The pharmacy should physically segregate and inventory all Schedule II stock, run a receipt-to-dispensing reconciliation for oxycodone, and retain the entire reconstruction file with the inspection record. Expect the investigator to treat the missing forms and the 412-tablet shortfall as one accounting problem.
3. Was the destruction of the expired alprazolam acceptable? Describe the compliant options and the records required.
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No. Alprazolam is a Schedule IV controlled substance, and a controlled substance becomes a regulated waste the moment it expires; dropping it into a sharps container destroys it without a witness, without documentation, and without any way to show that 200 dosage units were actually destroyed rather than diverted. An undocumented disappearance of that size would look identical to a loss on the next reconciliation.
Compliant options are: transfer to a DEA-registered reverse distributor with a record of the transfer; on-site destruction by a method that renders the drug non-retrievable, witnessed by two authorized employees, documented on DEA Form 41 and retained; or use of a DEA-compliant collection receptacle or mail-back program where the registrant is authorized to do so. Whichever route is chosen, the record must show drug, strength, quantity, date, method, and the identities of the persons involved, and must be kept with the controlled substance records. The pharmacy should also check Board rules and environmental requirements for pharmaceutical waste, and separate controlled from non-controlled waste streams. Given the inspection findings, the pharmacy should self-audit the last destruction events before the investigator gets to them.