A DEA inspection can happen at any time and the repercussions of a non-compliance coming to lightcan be quite detrimental. Professional guidance can help in coming out of the inspection unscathed!
The Department of Justice Drug Enforcement Administration (DEA) forms the central authority for enforcing federal laws and regulations pertaining to controlled substances across the USA. To check that all the regulations – including DEA veterinary ones – are being followed perfectly, the DEA conducts periodic unannounced inspections to audit registered physicians, pharmacies and laboratories that prescribe, dispense or administer controlled substances.
According to the DEA policy, at least 2 investigators will conduct the inspection - a DEA Diversion Investigator accompanied by either a DEA Special Agent or Task Force Officer. Their focus is on analyzing whether the facility is in full compliance with the record-keeping and security protocols. Along with this, they will also check how knowledgeable the registrant and other authorized personnel are about the federal and state regulations regarding security, ordering, storage and administration of controlled substances.
In case any non-compliance or violation comes to light during the inspection, the DEA may issue a Letter of Admonition, decree a $10,000 fine for each violation, suspend or revoke the registration or even invoke legal proceedings for a prison sentence.
How will the inspection will play out?
The DEA team may ask the authorized personnel to provide:
- Controlled substance license and DEA Certificate of Registration
- Authorized personnel logwith screening statements
- Most recent inventory – can be initial or biennial
- Current general and usage logs/prescription logs
- Purchasing records like invoices, packing slips, etc.
- Breakage-spillage reports, if applicable
- Theft/significant loss reports, if applicable
- Disposal records
Additionally, they may request access to the controlled substance storage cabinet or safe. The registrant or authorized personnel may be required to physically count, weigh or otherwise inventory the substances. They may even take some original records/copies or controlled substances offsite.
Therefore, a DEA registered facility should always have an action plan for immediately retrieving the records during a DEA inspection. The registrant as well as the authorized agents should be prepared to walk the DEA team through the typical daily handling and usage of controlled substances. And it goes without saying that they should be well-versed with the applicable policies and procedures.
In sum, the prudent approach is to always stay prepped for a DEA inspection. Having professional assistance in this regard can ensure that an unannounced DEA inspection proceeds smoothly without any hiccups or penalties. Compliance firms – like Titan Group (https://titangroupdea.com/) – will provide a clear understanding of the DEA regulations – including veterinary DEA regulations - pertaining to the handling of those substances. They will also educate the registrant and staff on what specific violations can result in civil actions.
Apart from this, the compliance professionals will check the security arrangements and recordkeeping procedures to ensure that everything is fool proof and above board at all times. They even conduct mock inspections to identify gaps so that there remains no room for errors at any time!
