The Controlled Substances Act sets the federal rules for how controlled drugs are made, handled, and distributed. The Drug Enforcement Administration is the agency that enforces these rules. The DEA requires controlled drugs to move only through a secure, tracked system. This means that anyone who legally handles these drugs, such as manufacturers, distributors, doctors, and pharmacies, must register with the DEA, renew that registration every three years, and keep detailed records of all controlled drug transactions.
The DEA regularly inspects and audits pharmacies to make sure they are following the Controlled Substances Act. Even though these audits are called “routine,” the DEA can still take action if it believes the pharmacy broke the rules. Pharmacy owners and pharmacists should understand what can happen during an unannounced DEA audit so they are prepared. Call Aaron L. Wiley Law, P.C., today to discuss your case with an experienced federal DEA diversion attorney.
How Do I Prepare for a DEA Inspection or Audit?
Pharmacies should keep their DEA registration current and make sure their records are correct. They should also display the DEA certificate in the proper place where it can be seen. In addition, pharmacies should have clear written rules for how they handle and dispense controlled drugs, showing they take steps to prevent theft and misuse.
These rules should be part of a full compliance program that includes strong steps to prevent drug diversion and misuse. Pharmacies should train all employees on these policies when they are hired and continue training them during their employment.
Before a DEA investigation or audit happens, the pharmacy should choose one employee to handle requests for records and information from the investigator. This person should understand the pharmacy’s rules and how it follows the Controlled Substances Act. Having one main contact person also helps the rest of the staff keep working normally while the investigation or audit is taking place.
Bear in mind, it is to your benefit to be polite and cooperative during the investigation or audit. It’s fine to answer basic questions about the pharmacy and its records. But remember, you do not have to answer every question, and you do not have to submit to questioning without a lawyer. The pharmacy has the right to stay silent and to ask for legal counsel to be present.
What Should I Expect During a DEA Investigation or Audit?
The DEA will usually show up without warning, often with two investigators. They will give the owner or pharmacist in charge a consent form (Form 82) to review and sign. During the audit, they will ask the pharmacy for certain records and documents.
They will usually pick some controlled-drug prescriptions at random and review them to make sure they are valid and do not show warning signs. They will also ask for a copy of the pharmacy’s two-year inventory and its records showing how controlled drugs were bought and dispensed.
These records let the DEA compare how much of certain controlled drugs the pharmacy bought with how much it dispensed and billed. This helps them check that the numbers match and that the pharmacy is not missing any inventory during the time they review.
In general, a DEA audit should focus only on records for controlled-drug prescriptions and the pharmacy’s purchase and dispensing logs for those drugs. It should not include the pharmacy’s general financial records.
Once you understand the basics, the pharmacy owner or pharmacist in charge should take care to avoid common audit mistakes and keep following the Controlled Substances Act rules.
What Violations Are Commonly Found by DEA Investigators?
Below are some common problems and rule violations that DEA investigators often find during audits. Pharmacies should know about these issues so they can avoid them.
- Bad records for narcotic prescriptions: Pharmacies should carefully check and write down narcotic prescriptions to make sure they are medically necessary and to lower the risk of abuse or diversion.
- Disorganized records: Keep your records neat and easy to find so you can quickly show them during an audit and prove you are meeting registration, record, and inventory rules.
- High inventory error rates: Small mistakes can happen, but if inventory errors happen often, it can raise concerns and lead the DEA to look more closely at the pharmacy.
- Too many high-risk drugs dispensed: Be careful about filling large amounts of high-risk drugs, such as oxycodone 30 mg. Unusually high numbers or odd refill patterns can draw DEA attention.
- Dangerous drug combinations: Avoid filling prescriptions for risky drug mixes, such as opioids, benzodiazepines, and muscle relaxants together, because this can raise suspicions during an audit.
What Are DEA Investigators Looking For?
DEA investigators will look for warning signs that indicate a prescription isn’t valid or that the pharmacy might not be following the rules of the Controlled Substances Act. Common red flags include:
- Too many cash payments: Record all cash sales clearly. A large number of cash payments can raise concerns that the pharmacy is serving mostly cash-paying customers for controlled drugs.
- Out-of-state patients: Look closely at prescriptions from patients who live out of state, especially if you see a large number of them.
- Frequent refills without proper checks: Make sure each refill is medically needed before filling it. Don’t approve refills automatically, because that can lead to concerns about prescription fraud.
- Past warnings or failed inspections: Prior problems can have an impact on future audits. However, as long as you fixed the issues, kept records as proof, and avoided any additional shenanigans, you should be okay.
These warning signs come up often in DEA audits, so pharmacy owners and pharmacists in charge should stay alert for them. Fixing problems early and following the rules can help the pharmacy get through an audit and avoid legal trouble.
It’s best for a pharmacy to run its own checks and keep a binder with all key records ready in case of an unannounced DEA audit. If records are not organized ahead of time, it can be hard to find what the DEA asks for, and missing documents can create problems during the audit.
How a Federal DEA Diversion Attorney Can Help
As enforcement becomes stricter, pharmacies and pharmacists need to follow federal rules and watch for warning signs when filling opioid or other controlled drug prescriptions. The best way to reduce legal risk is to create and follow a strong compliance plan.
At Aaron L. Wiley Law, P.C., our federal DEA diversion lawyers understand the rules pharmacies must follow and can help you set up clear compliance steps to spot and fix red flags. To help protect your pharmacy from legal risk, call (254) 566-3860 or contact the firm online for guidance.