Opening a New Pharmacy With Incomplete Registrations
A pharmacist has just purchased a closed pharmacy in Norman and plans to reopen Monday. The Oklahoma pharmacy license has been issued in the new owner’s name, and the pharmacist is designated PIC. The DEA registration is still in the prior owner’s name; a transfer application has been submitted but not approved. The prior owner’s OBNDD controlled dangerous substances registration is also still posted. A wholesaler has delivered a small opening order that includes noncontrolled drugs, Schedule III–V products, and one Schedule II product. The pharmacist wants to dispense a noncontrolled antibiotic Monday morning and a Schedule IV benzodiazepine Monday afternoon, and asks a technician to ‘put the old DEA number on the invoices until the new one comes.’
1. Can the pharmacy dispense the noncontrolled antibiotic and the Schedule IV benzodiazepine on Monday?
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Noncontrolled drugs may be dispensed only if the Oklahoma pharmacy license is active and the pharmacy is operating under a designated PIC. Controlled substances require active DEA and Oklahoma OBNDD registrations in the correct legal name and location. The prior owner's DEA and OBNDD registrations are not usable by the new owner. A pending transfer application is not approval. Therefore, the antibiotic may be dispensed if all noncontrolled requirements are met, but the benzodiazepine and all other controlled substances must not be dispensed until the new registrations are active.
2. What should be done with the controlled-substance inventory and invoices?
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- Quarantine all controlled substances in a securely locked area.
- Do not dispense, transfer, or return them without a valid registration and proper records.
- Keep the CS invoices and inventory records accurate; never alter invoices or substitute the old DEA number.
- For Schedule II transfers between registrants, use the required DEA transfer form; for Schedule III–V, use invoices and maintain records.
- Verify the OBNDD registration and DEA registration status before resuming CS dispensing.
3. How should the pharmacist respond to the technician’s suggestion to use the old DEA number?
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Telling a technician to use the old DEA number on invoices is an instruction to create false records. It could violate federal and Oklahoma controlled-substance law and jeopardize the pharmacist's license and the pharmacy's registrations. The pharmacist should correct the instruction immediately, document the correction, retrain staff, and not accept controlled substances until the registrations are active. The pharmacist should also contact the wholesaler about the premature CS delivery.