The New PIC's First Monday

Sequencing matters - patient safety, then legal exposure, then paperwork.

1. Pull the recalled lot now (Monday morning). Quarantine every unit with the matching lot, stop dispensing from it, and start the recall log (date received, product, lot, quantity on hand, quantity dispensed, patients identified, actions taken, date closed). Recall handling is a patient-safety act, not an inspection-preparation act.
2. Deactivate the former PIC's CSOS certificate and revoke the Form 222 power of attorney in writing (Monday). A power of attorney for DEA Form 222 must be revoked in writing, with the revocation retained in the pharmacy's records; leaving a departed pharmacist able to order Schedule I/II substances in the pharmacy's name is an uncontrolled access problem and a straight line to a 'significant loss' finding.
3. Take a complete, accurate controlled substance inventory dated the day it is taken (Monday or Tuesday). A biennial inventory that is 26 months stale means the pharmacy's accountability baseline is gone. Do not backdate, and do not 'reconstruct' a two-year-old inventory. Take today's count, sign and date it, and keep it with the required records.
4. Report the PIC change to IDFPR (immediately). The pharmacy's registration records must reflect who is actually in charge; the previous PIC's unreported departure is a live deficiency that gets worse the longer it stands.
5. Investigate the fourteen unaccounted promethazine–codeine bottles (this week). Non-controlled? No - promethazine with codeine is a Schedule V controlled substance. Reconcile purchases against receipts and dispensed quantities. If the shortage is unexplained, treat it as a possible significant loss and evaluate the DEA reporting obligation (Form 106 to the field division, written notice within one business day of discovery of a theft or significant loss).
6. Segregate the expired fentanyl (this week, no destruction yet). Disposition requires DEA-compliant destruction or a reverse distributor; it is not a trash-can decision.

Notifications in play: IDFPR (PIC change; loss/theft as required by the Act), DEA (significant loss if confirmed; power-of-attorney revocation is internal documentation rather than a filing), and the recall notice's own instructions.

Expired fentanyl (Schedule II). It stays in the locked cabinet, segregated and labeled, until it is destroyed or transferred. Two compliant routes: (a) on-site destruction by the registrant with at least two authorized employees witnessing and documenting the destruction, or (b) transfer to a DEA-registered reverse distributor. Either way the quantity destroyed must reconcile against the inventory records. Fentanyl patches get special care: don't let them sit unsecured in a 'to be destroyed' bin that anyone can reach, and don't return them to a wholesaler unless that wholesaler is authorized to take them back.

The promethazine–codeine (Schedule V). It is a controlled substance and gets the same accountability treatment. First, determine whether the shortage is real: search receiving records, invoices, the returns bin, and dispensing history. If it cannot be explained, document the investigation and evaluate whether it meets the 'significant loss' threshold - DEA requires written notice of a theft or significant loss, and the pharmacy cannot simply write it off. If it turns out to be an unrecorded return to a wholesaler, document that instead; an explained discrepancy is not a loss.

What must never happen: pouring either product down the sink or into the trash; backdating an inventory or a receiving record to make the numbers close; destroying controlled substances without a witness and a written record; or letting the expired fentanyl stay commingled with current stock because 'it's the same drug.'

Reportable / notifiable:

• PIC change to IDFPR - clearly required; the pharmacy's registration must identify its pharmacist-in-charge.
• Controlled substance loss - if the fourteen bottles are genuinely unaccounted for, DEA written notice is required within one business day of discovery, and Illinois imposes its own notification duties under the Pharmacy Practice Act and the Illinois Controlled Substances Act. Discovery happened on her watch, on her Monday.
• Recall - not a 'report,' but a documented action with prescriber/patient notification matched to the recall classification.
• The stale biennial inventory itself - not a standalone report, but it will be an inspection finding and it destroys the pharmacy's ability to prove anything else was compliant.

What 'I just got here' gets her: almost nothing. The pharmacist-in-charge is responsible from the day she is designated, and the designation is what IDFPR records. Once she discovers a deficiency she has two choices - remediate and document, or own the consequence. Her best defense is a dated, same-day written record: what she found, when, what she did about it, and who she notified. A new PIC who discovers a 26-month-old inventory and takes a clean one that afternoon looks diligent; one who discovers it and does nothing until an inspection looks complicit.

Also worth flagging to herself: if she reports a loss that predates her tenure, she should be candid about the timeline. Regulatory bodies generally distinguish remediation from concealment more favorably than they distinguish old problems from new ones.