DEA Controlled Substance Audits and Investigations

The Drug Enforcement Administration (DEA) frequently conducts audits and inspections of prescribers, dispensers and wholesalers.

Are you ready?

Thankfully, our team of compliance professionals includes experienced audits and investigators who have handled hundreds of controlled substance inspections can help you! 

What does the DEA audit or inspect during an audit?

DEA diversion investigators are responsible for combing the nation’s physicians, pharmacists, and controlled substance distributors inspecting for compliance with the controlled substances act 21 U.S.C. 801 et. seq. The DEA typically investigates the following areas:

  • Controlled substance storage
  • Recordkeeping
  • Provider documentation
  • Mid-level delegation
  • Security of controlled substances
  • Dispensing records

They typically show up unannounced and seek permission to inspect your practice by issuing a notice of inspection. Many practices, that don’t have a government contact policy are ill equipped for this visit and let the DEA roam their practice often looking in impermissible areas. DEA registrants such as physicians and pharmacists don’t know that they can ask the DEA to return at a later date.

Once inside, the DEA is sure to conduct a complete audit and generally find non-compliance in just about any practice they inspect. Unless the practice has done a pre-inspection utilizing CCG Healthcare’s compliance team, that is.

Providers who have engaged in a compliance program and mock inspections proceed through the DEA audit and inspection process with peace of mind and confidence. Those ill prepared will generally be fearful of DEA action against their registration or even potential criminal indictment.

What action can the DEA take when it finds non-compliance?

If the DEA finds areas of non-compliance it can take administrative action such as revoking a DEA registration, civil action which includes a suit for monetary damages for each violation, or even criminal action which could include an indictment for violation of the controlled substances act. Potential sanctions include:

  • A DEA memorandum of agreement restricting prescribing and dispensing
  • DEA order to show cause proceedings
  • Suspension or revocation of a DEA registration
  • Civil monetary penalties
  • A federal injunction prohibiting prescribing and dispensing
  • Criminal indictment
  • Forfeiture of property
  • Entry in to the National Practitioner’s Databank

What are the most common areas of DEA non-compliance?

  • Failure to properly store controlled substance records
  • Poor provider documentation
  • Pre-signing blank prescription pads
  • Improper mid-level delegation
  • Improper storage of controlled substances
  • Exceeding DATA 2000 buprenorphine patient load
  • Poor drug counts

For those concerned about a DEA audit or investigation – there’s hope. The Department of Justice 2020 Manual discussing corporate compliance program clearly states that entities who engage in regular auditing or monitoring get the benefit of the doubt.

That’s where we come into play. We can do it for you.

By conducting pre-inspections utilizing qualified a qualified compliance firm such as CCG Healthcare you can show the DOJ and DEA that you are serious about compliance. Without a compliance program issues such as theft, loss, poor documentation, or employee misconduct can put a target on the back of the company or the owner. But, when a healthcare company has a robust compliance plan complete with mock DEA audits, inspections, and policies and procedures along with staff training – the DOJ gives the provider the benefit of the doubt.

DOJ audits and inspections can also be frightening for the staff. The appearance of the DEA can deeply impact morale. This is why during our mock DEA audits and inspections we train staff to expect routine audits and inspections and train them exactly how to smoothly handle a DEA audit or investigation to ensure that the company puts the right foot forward in cooperation and compliance.

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