What is the federal security duty for DEA registrants?
DEA registrants must use effective controls and procedures to guard against theft and diversion, tailored to the setting and its security risks.
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What is the federal security duty for DEA registrants?
DEA registrants must use effective controls and procedures to guard against theft and diversion, tailored to the setting and its security risks.
How must pharmacies store Schedule I substances?
Schedule I substances must be kept in a securely locked, substantially constructed cabinet.
What storage alternative is allowed for Schedule II–V substances?
They generally require the same locked-cabinet storage, but may instead be dispersed throughout noncontrolled stock in a way that obstructs theft or diversion.
Who may not be employed in a role with controlled-substance access?
A person with a qualifying controlled-substance felony conviction, or whose DEA registration was denied, revoked, or surrendered for cause, may not be employed if they would have access to controlled substances.
How should pharmacies manage keys, combinations, and alarm codes?
Limit keys, combinations, and alarm codes to authorized people, and change access promptly when staff roles change or employment ends.
Which records and quantities should be reconciled to detect discrepancies?
Reconcile receipts, dispensing, returns, destruction, and on-hand quantities; investigate discrepancies promptly and document the outcome.
Must a theft be reported if the drugs are later recovered?
Yes. A theft must be reported even if the controlled substances are later recovered.
How is the significance of a controlled-substance loss assessed?
There is no fixed federal quantity threshold. Consider the business type, amount and drug, potential access, loss patterns and explanations, diversion potential, and local trends.
What immediate steps follow discovery of theft or significant loss?
Secure the site, protect people, prevent further access, preserve relevant records or video, and promptly notify the responsible pharmacist or registrant.
When must a registrant notify DEA in writing of theft or significant loss?
The registrant must notify the local DEA Field Division Office in writing within one business day of discovery; do not wait for the internal investigation to finish.
What is the deadline and method for submitting DEA Form 106?
Submit a complete and accurate Form 106 electronically through DEA’s Theft Loss Reporting system within 45 days after discovery.
How long must a copy of Form 106 be kept?
Keep a copy of the DEA Form 106 report for two years.