As we roll into 2025, it’s an opportune time as ever to review an organization’s controlled substances inventory. Doing so ensures compliance and supports efficiency and safety in drug handling. It also provides the chance to ensure adherence to the Drug Enforcement Administration’s (DEA) controlled substance inventory biennial review and reporting requirements.
What Are the DEA Requirements for a Biennial Inventory?
For guidance, the relevant statute is the Controlled Substances Act (CSA). But put simply, the CSA dictates that organizations must take—and report on—a chemical inventory at least every two years.
Are There Risks to Biennial Controlled Substance Inventory Noncompliance?
Failure to maintain records and conduct a biennial review can mean citations and heavy fines. Here are a few noncompliance examples:
- In one 2020 case, the federal government forced a Georgia-based pharmacy to pay $250,000 to resolve multiple allegations. These included that it “failed to complete the required biennial inventory.” The organization also had to surrender its DEA registration.
- A Connecticut pharmacy failed a DEA audit in 2018. Among the infractions was the organization’s failure to maintain a complete and accurate biennial inventory. The DEA also “found a shortage of more than 2,000 tablets of various controlled substances.” The subsequent civil settlement included $16,800 in penalties—as well as an agreement to hire an independent pharmacy consultant—yet another cost.
- In 2022, a Pennsylvania osteopath who failed to keep complete and accurate records or to perform a biennial inventories received a $489,000 fine. Additionally, the osteopath agreed to meet “compliance obligations significantly more stringent than those in the applicable laws and regulations.”
Clearly, DEA biennial inventory requirements are a serious matter—and ignoring them comes with major noncompliance risks. Even if an organization is operating legally, the DEA may levy fines—or launch a serious investigation that will consume time, energy, and effort—if biennial reports are not filed accurately and on time.
What Is the DEA Biennial Inventory Requirement?
This applies to all organizations that handle, distribute, manufacture, or dispense controlled substances. This involves populating the DEA biennial controlled substance inventory form that states their inventory totals and actions throughout the previous two years.
Who Must Comply with the DEA Biennial Inventory Requirement?
Managers in the following industries must comply with the DEA biennial inventory requirement:
- Veterinary
- Pharmaceutical
- Life sciences
- Corrections
- Healthcare (hospitals and individual providers)
- Long-term care
Exactly How Does the DEA Inventory Biennial Deadline Work?
As the name of the requirement indicates, the inventory of controlled substances must be taken every two years after the initial inventory is created. The registrant must record the following inventory changes:
- The arrival of new drugs
- The normal use of the drugs
- The elimination of expired drugs
- Shrinkage
This ensures accuracy and accountability for every drug through the entire chain of custody.
What Does the DEA Biennial Inventory Reporting Preparation Require?
Organizations must report all controlled substances on hand—as well as the status of any drugs that were previously reported or accepted after the prior inventory. The specific requirements include finding and listing:
- A list of items on hand
- Quantities
- Order numbers
- Senders
- Registration numbers
Much of this data may be found in a controlled substance inventory log.
Are There Other DEA Reporting Requirements?
Managers must ensure they can account for all unusable drug stocks. This involves formally witnessing and attesting for drugs that are expired, short dated, or that fall under out-of-specification (OOS) status.
How Should Stakeholders Record the Controlled Substance Inventory?
Hypothetically, a controlled substances inventory can be maintained in written, typewritten, or printed form at the registered location. It’s a good best practice, though, to have a cloud-based and data-driven controlled substances inventory management system.
What matters most is that the controlled substances data are accurate, thorough, and easily retrievable and shared. Such a system, if effectively implemented, makes recording, formatting, sharing, and reporting on drug information simple.
Advanced solutions, accessible via tablet or mobile devices, allow field personnel to interact with the system and upload data from stockrooms, containers, nurses’ stations, and the like in near real-time. More advanced solutions can also check for errors, and flag or autocorrect mistakes.
Where Do We Submit the Controlled Substance Inventory Information?
Stakeholders must securely file the physical inventory at the registered location to share with DEA auditors, as needed.
Are There Ways to Streamline Biennial Deadline Preparation?
In our experience, it’s best to review the controlled substances inventory at least annually. This way, the organization is also prepared in case of any sudden DEA audit—and for the biennial reporting deadline. Such diligence promotes efficiency and safety overall, providing a sole source of easily accessed truth for all stakeholders.
Why Bother Updating the Controlled Substance Inventory Before the Biennial Deadline?
Again, every organization, from the smallest pharmacy to the largest hospital chain, should always be ready for a controlled substances audit. If there are gaps in operations or faulty recoding methods or systems, an annual or quarterly inventory program will help quickly detect and remediate them.
Managers can then do root-cause analysis on why errors are creeping in and address them proactively. It’s infinitely better that internal teams find discrepancies and problems—or unsafe or un-secure practices—than for a DEA auditor to find them.
Let Us Help You with Controlled Substance Reporting
Taking an inventory of controlled substances every two years can be complex and time consuming. If you find compliance challenging, consider partnering with Triumvirate Environmental. We’re DEA-approved and offer decades of experience in the handling and disposal of controlled substances.
Start a conversation with us today about DEA controlled substance disposal. You can learn more about how we can help you stay fully compliant with controlled substances regulations—especially biennial controlled substances reporting requirements.
