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340 Missing Hydrocodone Tablets, a Sealed Tote, and an Owner Who Wants to Wait

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340 Missing Hydrocodone Tablets, a Sealed Tote, and an Owner Who Wants to Wait

A community pharmacy with three registers completed its biennial controlled-substance inventory on May 1. A quarterly reconciliation three months later shows hydrocodone/acetaminophen 10/325 running 340 tablets short. Separately, a wholesaler shipment of oxycodone 15 mg arrived with two bottles (200 tablets) missing; the receiving technician signed the invoice as complete because the totes were sealed and the driver was in a hurry. A technician resigned abruptly two weeks ago with no notice. The owner wants to "write off" the 340 tablets as a dispensing error, adjust the perpetual inventory to match the shelf count, and hold off notifying DEA "until we are sure what happened."

1. How should the 340-tablet discrepancy be handled, and on what timeline?

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Treat it as a loss until proven otherwise, and report on the federal clock, not the owner's comfort level.

  1. Investigate before concluding, but do not delay the report to finish the investigation. Run a full accountability audit for the period: beginning count + receipts (invoices, DEA order forms/CSOS) − dispensings (including partial fills and returns to stock) − on-hand = expected loss. Review dispensing records against the perpetual inventory, cash/no-insurance transactions, voided fills, and access logs.
  2. Theft or significant loss must be reported to DEA in writing (DEA Form 106) within one business day of discovery. "Discovery" is when the pharmacy knew or should have known - not when the owner finishes the audit. If the loss turns out smaller or explains itself, a supplemental report can correct the record.
  3. Notify the Virginia Board of Pharmacy of the theft/loss as required by Board regulation, and consider a police report; the insurer will want one.
  4. Then make the record adjustment that reflects the reported loss - an adjustment documented by the Form 106, not a silent write-off.
  5. A biennial inventory must be an exact count of Schedule II substances (and of III–V) taken at the registered location and retained for two years; a discrepancy discovered afterward does not get "fixed" by restating the inventory.

"Until we are sure" is not a lawful basis for delay.

2. How should the short shipment of 200 oxycodone tablets be handled, and what does the signed invoice mean for the pharmacy's records?

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This is a receiving problem and a record problem at the same time.

  • In-transit loss is ordinarily the supplier's risk - until the pharmacy accepts the shipment. But the technician signed as complete, which makes the pharmacy's records show that 200 tablets were received. Once received on paper, a drug that is not on the shelf is a loss the pharmacy must be able to explain.
  • Corrective steps now: contact the wholesaler immediately, in writing, with the invoice number, DEA order form/CSOS reference, tote seals, and count details; request a credit and a corrected receipt record and the wholesaler's own loss documentation. Many wholesalers have a short-window claims process - act within it.
  • If the discrepancy is resolved as a wholesaler/in-transit loss, document the resolution and retain the correspondence; DEA Form 106 may still be advisable or required depending on where the loss is deemed to have occurred, and the wholesaler should be the reporting party if it never delivered.
  • If it is not resolved, treat the 200 tablets as a loss on the pharmacy's registration and report accordingly.
  • Fix the process: no signature until the count is verified against the invoice and the order form; two-person verification for CII receipts; recorded seal numbers.

3. The owner's plan is to adjust the perpetual inventory to the shelf count and say nothing yet. What are the compliance and licensure risks, and what should the PIC do instead?

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The owner's plan creates the violation it is meant to avoid.

Risks:

  • Record falsification. Making the perpetual inventory match the shelf without a documented, reported explanation means the records no longer reflect receipts and dispensings. Controlled-substance records must be complete, accurate, and maintained for two years; a silent "true-up" is indistinguishable from concealment.
  • Late reporting. Form 106 is due within one business day of discovery of a theft or significant loss; the pharmacist-in-charge and the registrant bear that duty, and the owner's business preference is not a defense.
  • Individual licensure exposure. The PIC supervises and is accountable for the pharmacy's records; a technician with abrupt departure and 340 missing tablets is a pattern that will be reconstructed by DEA or the Board from access logs and dispensing data.
  • Compounding the loss. If the departed technician is involved, delay gives time for further diversion and weakens the case.

What the PIC should do:

  1. Preserve records; deactivate the departed technician's system access immediately.
  2. Complete the audit, file Form 106 within the deadline, notify the Board, file a police report.
  3. Document the corrective action plan (perpetual inventory frequency, CII counts, two-person receipt, access controls).
  4. Put the compliance position to the owner in writing. If the owner obstructs a required report, the PIC must consider whether continued service as PIC is tenable - the PIC's license, not the owner's investment, is on the line.