Temporary Closure and Controlled-Substance Transfers
A Louisiana independent pharmacy will close for 12 days for a floor-to-ceiling renovation. The owner plans to move all CII-CV inventory to a sister pharmacy five miles away, have a registered technician transport the drugs in her personal car in locked totes, and transfer them back when the store reopens. The pharmacy will post a 'closed for remodeling' sign, leave the phone forwarded to the sister store, and continue to use the same DEA registration and pharmacy permit. The PIC will be on vacation for the first four days, and the sister pharmacy's PIC will sign for the drugs. The owner asks whether this plan is acceptable and what records are needed. The pharmacy has 14,000 dosage units of CII, including 6,000 oxycodone tablets; the alarm system will remain active.
1. What regulatory issues arise from closing the pharmacy for 12 days and moving controlled substances?
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A temporary closure is not just an internal business decision. The pharmacy should notify the Louisiana Board of Pharmacy under its closure/relocation rules and confirm whether the permit remains valid during the closure. It should also coordinate with DEA because controlled substances are being transferred to another registrant. Continuing to use the same DEA registration while the drugs are at another site is not automatically permissible; the transfer must be documented as a transfer between registrants, not a loan.
The PIC absence for the first four days is a separate issue: the pharmacy must have proper PIC coverage and cannot leave controlled-substance custody undefined. The sister pharmacy's PIC can sign for receipt, but only if that pharmacy is authorized to receive the drugs and the transfer records are complete before movement.
2. How should the CII and CIII-V transfers be documented and secured?
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Schedule II transfers between registrants require the proper DEA transfer document, commonly DEA Form 222 or an approved electronic equivalent, completed before the drugs move. The receiving pharmacy must be eligible to receive those schedules. CIII-V transfers require invoices or other readily retrievable records showing drug, strength, quantity, date, and the identities of the sending and receiving registrants. The sending pharmacy should keep copies of all transfer documents and update its perpetual inventory.
Security matters: locked totes alone may not be enough for a technician transporting 6,000 oxycodone tablets in a personal car. The pharmacy should use a secure chain-of-custody, preferably a registered carrier or two-person transport, and document who had custody at each step. The receiving pharmacy should verify quantities immediately and report any discrepancy.
3. What should the pharmacist-in-charge do before the pharmacy reopens?
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Before reopening, the PIC should reconcile all controlled-substance transfers back to the pharmacy, confirm that the DEA registration and pharmacy permit are still appropriate for the reopened location, and verify that the alarm, safe, and access controls are working. The PIC should also ensure that the Board has been notified of the closure and reopening if required, and that patients with pending prescriptions were transferred or otherwise handled.
If any drugs are missing or records are incomplete, the pharmacy should not simply reopen and 'fix it later.' It should investigate, document, and report losses as required. The owner's plan is acceptable only after the Board and DEA requirements are built into the schedule, not after the fact.