Gaining Controlled Substance Compliance To Reduce Risk

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Jan Woods

Co-Founder and CEO of Ask Jan For Help, LLC

04/05/2024

Have you ever wondered if your controlled substance systems are anywhere close to meeting the DEA’s regulations? DEA controlled substance compliance is the law and the correct implementation and daily use of the DEA’s regulatory system is the key element in successfully passing a DEA audit. This is Part 1 of a multipart series on gaining DEA compliance to reduce your risk.

Current, Compete and Accurate Recordkeeping

Are your Controlled Substance records current, complete and accurate within the DEA’s Closed System? The DEA requires that Practitioners maintain complete and accurate records on a current basis for each controlled substance purchased, received, sold, stored, distributed, dispensed, or otherwise disposed of 21 CFR 1304.21(a). These records are required to provide current, complete and accurate accountability of all controlled substances from the time they are ordered by the Practitioner to the time they are administered or dispensed to the ultimate user. This DEA “Closed System” reduces the potential for diversion of controlled substances.

Are You Logging in Real Time?

The DEA’s Closed System includes every move the controlled substance takes in your practice, from ordering to the administration and dispensing of your controlled substances to the “ultimate end user.” The ultimate end user in veterinary medicine is defined as both the pet and the pet parent. But did you know that Current, Complete and Accurate recordkeeping also includes the responsibility to log in “real time” any controlled substance you remove from your lockbox for patient administration or dispensing. Current, Complete and Accurate recordkeeping can be difficult and time consuming but it is key to the successful passing of a DEA or State Controlled Substance Audit. You can save time, money and headache when logging your controlled substances by using VetSnap. VetSnap is a digital controlled substance logbook that talks to your PIMS system and records all controlled substances administered and dispensed in real time for you! In states that require PDMP reporting, VetSnap also reports the controlled substances you dispensed directly to your State’s Prescription Drug Monitoring Program for you. Just think, no more paper logs!

Biennial or Annual Inventory

Have you performed the DEA’s required Biennial Inventory (21 CFR 1304.11(c)? Please note that some states require a Controlled Substance Inventory annually. So be sure that you know and follow the most stringent regulations. To minimize your risk and improve compliance, I suggest that you perform your controlled substance inventory quarterly.

Why should you do the extra paperwork quarterly? Because one of the first things a DEA Auditor will ask to see when they knock on your door is your most recent inventory form. If you have performed your inventory quarterly, then the DEA has a lot less data to review compared to the controlled substance data that would be listed on an annual or biennial inventory form. Please remember to inventory each and every controlled substance in your practice, including all expired controlled substances. Sending your expired controlled substances to a government approved Reverse Distributor prior to performing your inventory will save you a lot of time.

Schedule II controlled substances must be listed separately from Schedule III-V controlled substances. I suggest that each Schedule be listed on a separate inventory form for clarity and ease of operation. And don’t forget that your expired controlled substances must be listed separately by Schedule as well.

Controlled Substance Reconciliation Logs and Inventory Balances

Do the balances in your Controlled Substance Reconciliation Logs match the exact balance on your Biennial, Annual or Quarterly Inventory Forms? A very important key element in passing a DEA Audit are matching balances on your Controlled Substance Inventory Forms and your Controlled Substance Reconciliation Logs. Once again, VetSnap can save you time, money and headache because it can perform both your biennial, annual and/or quarterly inventory and keep your Controlled Substance Reconciliation Logs current, complete and accurate.

In subsequent articles we will continue to explore more ways to improve controlled substance compliance, save time and reduce risk.

Please note that the State and Federal governments create, change and update regulations frequently. As of March 2024, the information contained in this article is current. Remember to check with the various governmental agencies for regulatory changes that may affect your practice. You can contact Jan Woods for regulatory help and consultation through her email at jan@janforhelp.com. © Copyright March 26, 2024, Jan Woods.