DEA Audits

DEA Audit Attorney in Contra Costa County

Understanding the DEA and DEA Audits

What is the DEA?

The Drug Enforcement Administration (DEA) is a branch of the U.S. Department of Justice. The DEA has the legal authority to conduct unannounced inspections of physician’s offices, controlled substance storage locations, laboratories, pharmacies, and any location licensed to store or dispense controlled substances. It is important to remember that the DEA is a law enforcement agency with special powers, including the ability to assess civil and criminal penalties. These penalties can range from a simple letter of admonition, which can trigger a medical board inquiry, to more severe consequences. Our physician lawyers view a DEA audit as a potential red flag for a larger investigation.

What is a DEA Audit?

A DEA audit is a law enforcement search of premises and records to ensure compliance with the rules and regulations governing the prescription, storage, and distribution of controlled substances. This is not just a routine audit; it can be part of or escalate into a criminal investigation.

While DEA audits are often routine and may involve cursory in-and-out comparisons and record reviews, they can be daunting if your practice is not set up for accurate tracking of distribution and prescription writing. For example, a 2011 case involved an honest medical practitioner and pharmacy being fined after a DEA audit.

Conclusion

DEA audits can be a significant concern for medical practitioners. It is crucial to ensure your practice is compliant with all regulations to avoid potential penalties and larger investigations. If you need assistance, our experienced physician lawyers are here to help.

DEA Audit Example: Dr. H Aaron Blaser

Case Overview

In the case of Dr. H Aaron Blaser, a dentist in Ketchum, Idaho, the DEA discovered a shortage of approximately 72,100 milligrams of Demerol. An audit of a nearby pharmacy also revealed an inability to account for a quantity of opiates. Although no criminal wrongdoing was alleged, a $35,000 civil fine was imposed. In most states, this fine would also trigger a medical board investigation.

Implications in Today’s Environment

Violations of this type would result in more serious sanctions in today’s opioid crisis environment. While the Blaser case was primarily a tracking issue, there has been a significant increase in DEA citations for storage issues. Fines can be imposed even without any deliberate wrongdoing. Notably, even 12 years after the event, the DEA press release still associates Dr. Blaser with this citation.

Preparing for a DEA Audit

Understanding DEA Inspections

A hostile DEA inspection is often designed to catch you off guard. If the DEA conducts an inspection late in the day or during holiday times, it may indicate they are looking for potentially serious violations. Regardless of whether the inspection is hostile (suggesting suspicion of criminal conduct) or truly civil or administrative, certain standards will always apply.

Proactive Preparation

For larger practices or those at high risk, we recommend comprehensive training to prepare for a sudden DEA audit. It is crucial to ensure that staff is well-versed in applicable federal and state regulations, storage regulations, and audit compliance procedures. In particular, audit-related records (in/out records) should be readily available and internally consistent.

Conclusion

This example underscores the importance of meticulous record-keeping and compliance with DEA regulations. Even minor discrepancies can lead to substantial fines and long-lasting reputational damage. If you need assistance navigating DEA audits and ensuring compliance, our experienced team is here to help.

Electronic Prescriptions – Be Careful

DEA audits, rule violations and controlled substance prescription abuse are a constant threat to practices that rely significantly on controlled substances for proper patient care. Changing opioid prescription rules, underground regulations and political pressures can lead to a DEA audit or medical board investigation. It is important to ensure that your electronic practices are consistent with current rules. Our physician lawyers can review your practice to ensure that you are DEA compliant.

Telemedicine or electronic prescriptions are addressed by DEA regulations which specify the conditions under which controlled substance prescriptions may be issued electronically. Before any electronic prescription or pharmacy application may be used to transmit prescriptions, a third party must audit the application for compliance with the requirements of 21 CFR part 1311. Alternatively a certifying organization whose certification process has been approved by DEA must verify and certify that the application meets the requirements of 21 CFR part 1311.

Contact Us Today

First Name
Please enter your first name.
Last Name
Please enter your last name.
Phone
Please enter your phone number.

This isn't a valid phone number.
Email
Please enter your email address.

This isn't a valid email address.
Are you a new client?
Please make a selection.
How can we help you?
Please enter a message.
By submitting, you agree to be contacted about your request & other information using automated technology. Message frequency varies. Msg & data rates may apply. Text STOP to cancel. Acceptable Use Policy

What are the DEA Rules?

You need to access accurate summaries of the DEA rules or better yet, review the rules themselves. The DEA storage Rules are found at 21 CFR 1301.71. Have you ever scanned (or even read in detail !) The rules are right there in Chapter 2 of the CFR’s (21 CFR Chapter 2) Take the time to read them and our pre-audit investigation can assist you in making sure you are compliant.

The office should have a discreet location for the inspection record review to take place and do not be shocked when the licensee/registrant of the facility is required to sign a DEA 82 form which is voluntary consent to the search/audit. Likewise do not fumble for keys or codes to access storage locations for controlled substances.

You should expect to produce

Current usage logs
Disposal records• Access to controlled substance storage cabinet or safe
Purchasing records which will include invoices, packing slips, DEA Form 222 records.
Each scheduled substance should have a separate folder.
Waste or breakage-spillage reports (DEA Form 41)
Theft/significant loss reports (DEA Form 106)

We recommend recording the audit although this may be seen as a hostile act by some DEA investigators. In the balance however, it is useful if the audit is overly aggressive or has significant negative findings which you intend to contest.

If the audit is routine the DEA may verbally or in writing provide suggestions for improvement. This is usually done in good faith and is not an investigative tactic. Be careful however in asking questions as the question itself may open a new area of investigation.

Stay In The Know

Visit Our Blog

DEA Rules Can Get Complicated

Many violations are the fault of such complex rules that the average medical practitioner or pharmacist can inadvertently step outside of the vague and often discretionary rules. The following is from a 2022 federal case where (in a footnote) the federal court summarized some of the DEA rules. It is akin to studying quantum physics. The basic rules are outlined. That part is easy – but specifically what are the rules? What are the standards? The rules describe WHAT but not HOW and not WHY.

As DEA registrants in the closed-delivery system established by the CSA and its implementing regulations for the flow of controlled substances through the pharmaceutical supply chain, see 21 U.S.C. §§ 801 et seq.; 21 C.F.R. §§ 1301 et seq., participants in each of these sectors bear significant and independent responsibilities to ensure the safety and integrity of the supply of prescription opioids to the public, including the essential duty to provide effective controls and procedures to guard against diversion of these controlled substances. See CT1 MSJ Order re CSA Duties at 14–19 (docket no. 2483) (In re Opiate, 2019 WL 3917575, at *7-9 (N.D. Ohio Aug. 19, 2019)) (the CSA and its implementing regulations require manufacturers and distributors to: design and operate a system to identify suspicious orders of controlled substances, inform the DEA of suspicious orders when discovered, and not ship such orders unless due diligence reasonably dispels the suspicion); Order Denying MTD at 15 (docket no. 3403), In re Opiate, 477 F. Supp.3d 613, 624-25 (N.D. Ohio 2020) (21 C.F.R. § 1301.71(a) requires all DEA registrants, including manufacturers, distributors, and pharmacies, to provide effective controls and procedures to guard against diversion of controlled substances); Daubert Order re Rafalski at 3–5 (docket no. 3929), In re Opiate, 2021 WL 4060359, at *2-3 (N.D. Ohio Sept. 7, 2021) (citing Rafalski CT3 Rpt. at 8–9).

In re National Prescription Opiate Litigation (N.D. Ohio, Aug. 17, 2022, No. 18-OP-45032) 2022 WL 3443614, at *29, judgment entered (N.D. Ohio, Aug. 22, 2022, No. 1:17-MD-2804) 2022 WL 4099669

The courts are completely aware of the ambiguity. Another federal lcourt in City of Huntington v. AmerisourceBergen Drug Corporation (S.D.W. Va., July 4, 2022, No. CV 3:17-01362) 2022 WL 2399876, at *11 outlined the subjectivity of the rules:

Substantial compliance with the relevant security requirements may be deemed sufficient by the DEA. 21 C.F.R. § 1301.71(b). “A registrant’s regulatory obligations under the CSA, … and [its] implementing regulations do not require strict compliance. Only substantial compliance is required.” In re Nat’l Prescription Opiate Litig., No. 1:17-MD-2804, 2021 WL 3917174, at *3 (N.D. Ohio Sept. 1, 2021). “A determination of substantial compliance … is a fact-intensive inquiry … and whether a defendant has substantially complied with the CSA is a question of fact.” Id.; see also In re Nat’l Prescription Opiate Litig., No. 1:17-MD-2804, ––– F.Supp.3d ––––, ––––, 2022 WL 671219, at *6 (N.D. Ohio Mar. 7, 2022) (“[T]he ultimate determination of whether a defendants’ compliance was substantial, or whether it falls somewhere short of that mark, is best left to a jury.”).

City of Huntington v. AmerisourceBergen Drug Corporation (S.D.W. Va., July 4, 2022, No. CV 3:17-01362) 2022 WL 2399876, at *11

Our office has serious constitutional concerns regarding these vague rules. We believe that these vague rules violate the constitution. We look at the decision of the U.S. Supreme Court in Connally v. General Construction Co. (1926). In Connally the court held that a law is unconstitutionally vague when people “of common intelligence must necessarily guess at its meaning.” Whether or not the law regulates free speech, if it is unduly vague it raises serious problems under the due process guarantee, which is applicable to the federal government by virtue of the Fifth Amendment and to state governments through the Fourteenth Amendment.

In Kolender v. Lawson (1983), the Supreme Court explained that “the void-for-vagueness doctrine requires that a penal statute define the criminal offense with sufficient definiteness that ordinary people can understand what conduct is prohibited and in a manner that does not encourage arbitrary and discriminatory treatment.”

This void for vagueness defense works with many aspects of medical regulation because the rules are often political and sometimes not clearly expressed. We have used this defense in medical board cases and criminal cases as well.

Client Testimonials

Contra Costa County Location - National Reputation for Excellence

“I'm an Attorney and would highly recommend him to other professionals (and others alike) because he's the very BEST at what he does”
Dan Horowitz handled my complex business issue with magnanimity, compassion, care, promptness, and utmost professionalism. I'm an Attorney and would highly recommend him to other professionals (and others alike) because he's the very BEST at what he does and has an uncanny knack at finding unique resolutions with unparalleled speed and efficiency. What is quite outatanding is that he treats each client with kindness and compassion as if a family member

Lovely K.
“We went to trial and he was in control of the courtroom. He was totally prepared.”
He told me that he hadn't lost a trial in a long time and he didn't want mine to break the streak. I didn't either! We went to trial and he was in control of the courtroom. He was totally prepared. But I was still worried because the prosecutor was very good as well. Daniel was confident but honest. The jury really liked him. As you can tell, he won my case because I am here, writing this review. Thank you.

Michael M.
“I won my case and I am very lucky.”
He is very tough. He made me listen to him and work his way. He was right. It worked. I won my case and I am very lucky.

Avvo Reviewer
“He believed in me and listened to what I had to say.”
I can not say enough about Mr. Horowitz and his staff. Brook was amazing to myself and my family. My case was very unique. He believed in me and listened to what I had to say. I highly recommend him and his staff. Yvett Bline

Yvett Bline

View All Reviews

Contact Us Today

We’re Ready to Help

Fill Out the Form Below to Get in Touch With Our Dedicated Team

First Name
Please enter your first name.
Last Name
Please enter your last name.
Phone
Please enter your phone number.

This isn't a valid phone number.
Email
Please enter your email address.

This isn't a valid email address.
Are you a new client?
Please make a selection.
How can we help you?
Please enter a message.
By submitting, you agree to be contacted about your request & other information using automated technology. Message frequency varies. Msg & data rates may apply. Text STOP to cancel. Acceptable Use Policy

Why You Should Choose Us

We Have the Team to Help You

2 Certified Criminal Defense Specialists
1 Medical Doctor
1 MBA
1 Chiropractor