Mandatory Biennial Count: Step-by-Step Guide

Did you know there are federal requirements from the United States Drug Enforcement Agency in regards to how often you must do a physical inventory recording of all your controlled substances? This strict requirement is often missed by DEA registrants and can lead to costly fines.
Here, we will take a deeper look into the requirements and how you can start implementing a protocol in your practice.
A biennial inventory count is a complete physical count of all controlled substances on hand at minimum every 2 years for each DEA registrant who has ordered drugs under their DEA license.

Per the Code of Federal Regulations Title 21 Chapter 2 section 1304.11, “after the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years.”

After the initial physical inventory recording, this biennial recording becomes the foundation on which each future count can be looked back for reference.

While avoiding fines is one very important reason to maintain accurate inventory counts, having up-to-date and accurate records is important to ensuring there is no divergent behavior happening with any controlled substances.

Although the law states biennial counts must happen ‘at least every 2 years’, it also states they can be done on a sooner timeframe. The regulation reads “the biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.” This is important to note because while the longest amount of time “allowed” may be 2 years, you really do not want to wait 2 years to find there is a large discrepancy that could have been caught and handled much sooner had there been more frequent physical counts. Some other time frames to consider would be monthly, every 3 months, twice yearly, and yearly.  

How should you perform a regular biennial count?

The focus of this count should be on performing a very thorough counting of all controlled substances within your possession. Keep in mind this should include any containers that may be in a traveling business use vehicle, everything open within the facility for use, and all the unopened backstock of containers. There are documentation requirements set forth by the DEA that must be followed.

These include:

  • The name of the substance
  • Finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);
  • The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial)
  • The number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials).
It is required also to note the time of day when the physical count was taken. The federal requirement states it must be at the beginning of business day or end of business day. It is also required that a witness be there for this physical count and documented as such.
The task of doing a physical inventory count and recording that count does not have to be hard! Preparing for the count is the best way to have a smooth process. Ensuring you give yourself enough time will remove the pressure of needing to rush through it. Depending on your practice size and amount of controlled drugs you have, this process start to finish can take several hours.
Decide well in advance if you will be doing the count at the beginning or end of day and set your schedule to allow for that time. Before the count day, go through your logbook and ensure there are no discrepancies that need reconciliation before you do your physical count. Once prepared, the day of counting should be a smooth process of counting and recording, following the steps below.

Step 1: Prepare before the day of count (reconcile logbook if needed)

Step 2: Start with one drug at a time. The DEA registrant and a secondary witness need to count all unopened container quantities. Next count all opened container quantities. Add these two quantities together to get the total quantity on hand of this drug.

Step 3: Record this number and all other required details following the list of requirements provided above. Both parties involved in the count will need to sign the document.

Step 4: Repeat for all remaining controlled substances

Step 5: Maintain this record of reference for 2 years per CFR Title 21 Chapter 2 section 1304.04

The documentation process can be tedious, not to mention having to create your own document with all the required information and retain it for 2 years in a safe place.

If you are using VetSnap for your controlled substances logging and management there is a way to simplify the biennial counts process!

VetSnap helps ease the stress and cut down the time required to do physical counts by having an easy to follow format, collecting all required documentation, and retaining this information in reports. It also saves time before the biennial count process by catching discrepancies within your logbook in real time, allowing you to make immediate logbook corrections before it becomes an issue during physical counts.
Discrepancy Caught Within VetSnap
VetSnap also features a section for recording physical counts, collecting all required information from you, ensuring nothing is missed, and stores all this information in a simple, easy to retrieve digital format that is safe and secure.
Record Physical Count Screen

The biennial counting process is no small task, and it’s no wonder hospitals try to avoid it. But it’s an important part of the compliance process which proves that you actually care about compliance, tracking your controlled substances, and are reliable DEA registrants.

VetSnap supports your compliance journey and saves time for you not only on logging but also with the biennial count. With VetSnap, you can save twice the amount of time on the biennial count, conduct it more frequently as recommended by experts, with less effort, and ensure the best compliance efforts.