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Pharmacy DEA Audits

March 29, 2020

Is your Pharmacy being audited by The dea? This is a crucial moment in your professional career. What you do, can have huge implications.

When the dea agents come – it’ll be without warning. One day, people will enter your pharmacy, show badges, ask to speak with the pharmacist/owner. They are Diversion dea-investigation-lawyers/”>Investigators with The dea.

Will you pass the audit?

Is your pharmacy compliant with dea regulations, and the controlled substances act? Is there a discrepancy in your inventory? What is your error rate?

Do you have answers to all of this?

If you don’t have the answers, the dea/defense-lawyers/dea-registration-surrenders/”>DEA could revoke your registration. You could also face personal, civil, and criminal, liabilities.

Pharmacy DEA Audits – Why is this happening?

The dea-audit-and-investigation-lawyers/”>DEA Diversion Investigators ensure pharmacies are in compliance with all laws and regulations. The main focus is the Controlled Substances Act, and the Combat Methamphetamine Epidemic Act of 2005, and the Food, drug, Cosmetic, Act, in addition to other pertinent parts of the Code of Federal Regulations.

During an audit of your pharmacy, the dea is looking at your business, your physical security, and your prescription compliance procedures.

This is happening because the dea has evidence that there is something happening at your pharmacy which is illegal.

It means that your pharmacy is prescribing drugs incorrectly, and possibly – there are criminal ramifications. The dea‘s top concern is making sure commonly abused drugs don’t get abused! Because this is the dea‘s main concern, it has to be your main concern too. It means you must focus on compliance. If an audit reveals any regulatory, or statutory violation, you could be at risk for federal and state penalties.

Common DEA violations

During dea-audit-and-investigation-lawyers/”>DEA audits, you should expect a “top to bottom,” probing of your business.

Violation of Schedule II Controlled Substances

These are considered high risk drugs for diversion due to the street value and propensity for abuse. During a pharmacy audit, the dea inspectors will spend a lot of time on your practices pertaining to schedule II narcotics and stimulants.

Examples of these drugs are: morphine, hydromorphone, methadone, meperidine, oxycodone, fentanyl, amphetamine, and others.

You cannot have error rates with Schedule II controlled substances. Any perceived issues will subject you to intense review. The DEA, in addition to the DOJ, will pursue pharmacy owners who they think are diverting schedule II drugs, turning a blind eye to possible diversion, or failing to take steps to create a compliance program.

Violations of Schedule III Controlled Substances

These substances include combinations containing less than 15 mg of hydrocodone per dose. Many of these drugs are high-risk for abuse. dea diversion investigators look at your pharmacy’s prescription and dispensing. If your pharmacy fills a high number of prescriptions for schedule III drugs you can be at risk for facilitating diversion, or not implementing adequate controls. You must show that you investigate questionable pharmacy practices. It’s likely you’ll face consequences for failing to do so. You need a dea/defense-lawyers/dea-audits-and-dea-investigations-dea-lawyers/”>DEA audit defense lawyer.

Violations Related to Schedule IV Controlled Substances

Schedule IV controlled substances include things like alprazolam, clonazepam, clorazepate, diazepam, lorazepam, midazolam, temazepam, and triazolam. The dea considers schedule IV substances supplements to schedule II or III narcotics. Pharmacies must be careful. There is no margin for error, even if there is an isolated incident – it must investigated.

Suspicious Dispensing

In addition to assessing your pharmacies compliance with controlled substances, dea-audit-and-investigation-lawyers/”>DEA audits will also look at your dispensing patterns. The dea-investigation-lawyers/”>DEA investigators will request stats of number of cash paying patients, medicaid patients, chronic pain patients, and more. When it comes to dispensing medicine, they’ll ask everything possible. Remember, they’re concerned not only with who you’re dispensing medicine to – but why you’re doing it. If the dea thinks you’re not in compliance, it can lead to fines, loss of dea registration, and medicaid exclusion. It’s likely you’ll also lose your license to practice medicine and dispense drugs permanently.

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