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Pharmacy DEA Audits
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Is Your Pharmacy Being Audited by the DEA?
If you’re a pharmacist or pharmacy owner, an audit from the Drug Enforcement Administration (DEA) can be a crucial moment in your professional career. The implications of this audit can be huge, and what you do during this time is critical.
The DEA Audit Process
When DEA agents arrive at your pharmacy for an audit, it will be without warning. They’ll show their badges and ask to speak with the pharmacist or owner. These individuals are Diversion Investigators with the DEA.
The purpose of these audits is to ensure that pharmacies are compliant with all laws and regulations related to controlled substances. During an audit, the DEA will look at your business practices, physical security measures, and prescription compliance procedures.
Why Are These Audits Happening?
The primary focus of these audits is on compliance with the Controlled Substances Act (CSA), Combat Methamphetamine Epidemic Act of 2005 (CMEA), Food Drug Cosmetic Act (FDCA), as well as other pertinent parts of the Code of Federal Regulations. The reason why these audits happen is because there’s evidence that something illegal may be happening at your pharmacy.
This could mean that drugs are being prescribed incorrectly or diverted for criminal purposes. The top concern for the DEA is making sure commonly abused drugs don’t get into the wrong hands – which should also be your main concern too!
Common Violations Found During DEA Audits
| Schedule II Controlled Substances Violations | |
|---|---|
| Description: | Schedule II drugs are high-risk drugs for diversion due to their 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: | Morphine, hydromorphone, methadone, meperidine, oxycodone, fentanyl, amphetamine |
| Schedule III Controlled Substances Violations | |
| Description: | Schedule III 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 practices. 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. |
| Examples: | Tylenol with codeine (less than 90mg), ketamine (less than 50mg/ml) |
| Schedule IV Controlled Substances Violations | |
| Description: | Schedule IV controlled substances include things like alprazolam, clonazepam, clorazepate,diazepam,loraepam,midazolam temazepam,and triazoalm.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 Violations | |
| Description: | In addition to assessing your pharmacy’s compliance with controlled substances, DEA audits will also look at your dispensing patterns. The DEA investigators will request stats of the number of cash-paying patients, Medicaid patients, chronic pain patients and more. When it comes to dispensing medicine, they’ll ask everything possible. Remember that they’re concerned not only with who you’re dispensing medicine to but why you’re doing it. |
