Frequently Asked Questions

Will you report me to law enforcement if you discover diversion?

“No, we don’t leave you hanging. If we identify issues during audits or inspections, we’ll guide you in documenting them correctly and recommend preventive measures for the future. In cases where reporting is necessary (some discrepancies require it by law), we’ll assist you. However, if we uncover any controlled substance diversion, it’s your responsibility, as per Code of Federal Regulations – Title 21, to notify the relevant local, state, and DEA authorities.”

What happens if I am not in compliance?

DEA investigators approach their duties with utmost seriousness. Having been part of their ranks, we understand their unwavering commitment. When it comes to controlled-substance laws and regulations, they interpret them literally and expect strict compliance. Any deviation can have significant repercussions such as:

  • Civil and Criminal Consequences:
    Civil and Criminal Consequences:
    The stakes are high. Federal criminal law explicitly states that a “knowing failure” to maintain required records can lead to:
    Up to one year in prison.
    A hefty $100,000 fine.
    Even a “negligent failure”—a less intentional violation—constitutes a civil offense.
    Practitioners may face fines ranging from $15,876.00 to $68,4226.00 per occurrence.
    These fines can accumulate rapidly if multiple violations occur.

    Administrative Consequences:
  • DEA’s Authority and “Order to Show Cause”:
    The Drug Enforcement Administration (DEA) wields significant authority in enforcing controlled-substance regulations.
    Their power extends to initiating an “order to show cause” process.
    This legal procedure serves as a formal notice to a registrant (such as a healthcare practitioner or pharmacy) that their controlled-substance registration is under scrutiny.
    If the DEA identifies serious violations or patterns of non-compliance, they can move to revoke the registration altogether.
    The revocation of a controlled-substance registration has severe implications, affecting a practitioner’s ability to prescribe, dispense, or handle controlled substances.

What can I do to stay in compliance?

The heart of the matter lies in meticulous record-keeping.
Healthcare practitioners, pharmacies, and other registrants must maintain accurate, complete, and up-to-date records.
Any discrepancies or lapses can trigger DEA scrutiny.
Compliance extends beyond mere paperwork—it encompasses adherence to prescribing practices, dispensing protocols, and security measures.

How can I lessen my risks?

To minimize risks:
Thorough Documentation: Maintain detailed records of controlled substances transactions, prescriptions, and inventories.
Training and Education: Regularly train staff on compliance requirements.
Culture of Vigilance: Foster an organizational mindset that prioritizes adherence to regulations.
Guidance: Seek advice from DEA Compliance Consulting promptly if any issues arise. 

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