Frequently Asked Questions
The current opioid crisis has dramatically increased drug-diversion activities. Whether it’s a trusted employee, long-time client or even a relative, your company is more likely than ever to be at risk. And, ramped-up scrutiny and oversight from the DEA and state regulatory agencies have also increased your chance of an audit.
Whether you use one controlled substance or 100, the rules and regulations are the same. You face very specific security standards and recordkeeping requirements, and no matter the volume of controlled substances you purchase and use, failure to meet these requirements can have significant financial and legal consequences.
No. Anyone registered with the DEA to handle controlled substances is open to random inspection and investigation. Regardless of controlled-substance volume or number of patients, government agencies have the authority to arrive for unannounced inspections.
We perform a full, physical security analysis of your facility, review all pertinent documentation related to your controlled-substances, review and audit your record-keeping and carry out a random, blind audit of your controlled-substance inventory.
All staff members authorized to prescribe, dispense or handle controlled substances should participate in the assessment. We strive to work around your office schedule and will not affect any normal business transactions.
We will send you a pre-inspection packet to be completed in advance of the compliance audit. Audits take time and completion of the packet is vital to an efficient, effective process.
For most small to medium-sized facilities, approximately 1-3 days, plus time for delivery of findings and any remedial staff training that might be needed. Larger facilities may take up to one week. Thorough completion of the pre-inspection packet lets us assess the appropriate number of investigators required to complete the assessment in a timely fashion.
Yes. In fact, practicing audits and surprise reviews (just like fire drills) are a good thing. But the current Code of Federal Regulations – Title 21 – Food and Drugs is 300 pages long. Do you have time to study it, understand it and figure out how it applies to your practice? Do you have time to read the various audit, inspection, and recordkeeping guides? Can you figure out how the rules apply – or don’t apply – to your practice? (Reduce your stress. Let us do it all for you.)
DEA investigators take their jobs very seriously. (We know, we used to be them.) They interpret controlled-substance laws and regulations literally and expect them to be followed unconditionally. Non-compliance can lead to a referral to the United States Attorney’s Office for civil fines or criminal prosecution. Federal criminal law states that “knowing failure” to “make, keep or furnish” any record, required by regulation to be kept, is punishable by up to one year in prison and a $100,000 fine. “Negligent failure” is a civil violation punishable by fines of up to $14,502 per occurrence. Ultimately, the DEA can implement an “order to show cause” process and strip you of your controlled-substance registration.
No! We’re your partner, ally and advocate. We help you get ahead of problems and make vitally needed corrections. If we identify problems during audit and inspection, we will help you document them appropriately and recommend changes to avoid them in the future. If you are required to report them (certain discrepancies must, by law, be reported), we will assist you. If we should uncover diversion of controlled substances, it is your responsibility, per Code of Federal Regulations – Title 21, to contact the appropriate local and state authorities, as well as the DEA.
No. Every year, each DEA office compiles a list of registrants to be inspected during the year. The lists are long and cover all types of registrants. All the inspections must be completed. Additionally, state agencies are increasing the number of oversight inspections. Even if you refuse to let them enter your office (and they have the right to be there), there are legal methods (warrants, etc.) that can make the inspection subject to court order.
Ask Your Own Question
Do you have a question, Don’t hesitate to ask us we are here to help you.