"Having evaluated and inspected over 700 veterinary facilities, I’ve seen firsthand the financial impact that DEA violations can have. The DEA can cite a maximum fine of $15,691 per violation. I have observed at least 11 violations on average while inspecting facilities, which could amount to potential fines of $172,601. On the client projects Simple Solutions has collaborated with Cubex on, we have seen veterinary clients significantly reduce the potential for these violations with the implementation of electronic controlled substance logging and storage – two areas that many veterinary facilities consistently struggle with".

Kelley Detweiler, Partner, Simple Solutions for Vets.

What is the worst case scenario for time it could take to resolve the discrepancies in an audit process. Sounds like you’re saying weeks? Is that 3,5, more?
Excluding registration issues, I have been onsite with facilities remediating record keeping issues for up to a week. In some cases have been onsite for as long as a week helping remediate multiple different issues, left and then returned again. It really depends on what has been maintained and simply needs to be organized properly and what is missing and has to be tracked down.

If the facility does not have proper security in place that also can take quite a bit of time to procure the necessary equipment, get it installed and implemented. Security remediation timelines vary but it is not uncommon for it to take 2-4 weeks.

What part takes the most time? Is it legal due diligence? Implementing and documenting new procedures? Going through records and providing context on each citation? Other?
DEA and state registration and licensing issues take the most time as well as record keeping.

Are their specific citation types that take longer to resolve than others? If so, which? How much time?
Yes – failure to have all required registrations. (ex: many states require a state controlled substance license. If you operate in one of those states you MUST have an active state license in place before you apply for a DEA registration or your DEA registration will be denied. Additionally, if you have a state license but it lapses and is not renewed, or if you switch locations and don’t update your state license your DEA can be denied for renewal or revoked.

Recordkeeping is also one of the most time-consuming areas to remediate. The DEA requires two years of CS recordkeeping, but many states have enacted more stringent recordkeeping laws that require you to keep records even longer. EX: IL requires five years of recordkeeping.

RE citations: if you have been cited for multiple areas of noncompliance the DEA may issue a Letter of Admonition (LOA) which essentially is a slap on the wrist giving you a list of things that need to be corrected. Sometimes the DEA may tell you when they will be returning to make sure all required corrections have been made. Other times they don’t.

More serious that an LOA is a Memorandum of Agreement (MOA) wherein the DOJ/DEA require an oversight program to be put in place to make sure the registrant is doing everything according to DEA requirements. for clients I have assisted under an MOA this is a three year period.

Reg licensing and registration – what’s the longest you have seen that waiting period become? What happens in the meantime while waiting for gov parties to respond? Can they still be in practice?
I was working with a facility that realized during the process of transferring DEA registrants that the incoming registrant taking over had been denied a renewal for their state CS license. Because a state CS license must be valid and in place before a DEA registration is, this registrant had to wait until the state licensing board resolved the issue for why their renewal was denied and then finally renewed and updated to reflect the location they were taking over as the registrant at before they could update their DEA to the new location. The entire process took five months.None of the former registrant’s CS inventory could be transferred because there was no legal registrant at the facility to transfer them to (transfers can only take place between registrants, they cannot be transferred to a facility). All CS inventory had to be sent for reverse distribution.During that five months, the prior registrant had already left so the facility had to practice without using any CS because there was no legal DEA registrant of record tied to that location.