Frequently Asked Questions
Why do I need TITAN? My practice has never had any issues.
I only use a few controlled substances. Should I be concerned?
Isn’t my practice too small for the DEA to notice?
What takes place during a compliance audit?
Who participates in the compliance audit and will it disrupt my office?
What is required to prepare for a compliance audit?
How long does a compliance audit take?
Can I do reviews, assessments and changes myself?
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.)
What’s the worst the DEA or other agencies can do to me?
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 $15,040 per occurrence. Ultimately, the DEA can implement an “order to show cause” process and strip you of your controlled-substance registration.
Will TITAN arrest or report my staff to law enforcement if they discover diversion?
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.
Is there some way to prevent regulatory agencies from inspecting my practice?
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.