CSA Compliance: Insights & Tips from a former DEA Diversion Investigator

From new pharmacy technicians to experienced pharmacy owners, understanding and staying up to date with the Controlled Substances Act (CSA), including the Code of Federal Regulations (CFR), can feel overwhelming. While there is no universal solution for maintaining CSA compliance, there are specific things that a DEA investigator may recommend for strengthening workflows and minimizing risks.

To provide deeper insight, we connected with Jami Treantafeles, a former DEA Diversion Investigator (DI) and current Senior Director at Guidepost Solutions. With more than 12 years of experience investigating and now advising DEA registrants including manufacturers, distributors, reverse distributors, hospitals, and pharmacies, Jami brings a unique perspective on CSA compliance from both enforcement and consulting roles.

In this blog, Jami shares key insights on five essential areas of CSA compliance. These include employee training, effective controls and procedures, internal audits, regulatory changes, and internal workflows.

When asked about important training topics for pharmacies, Jami emphasized the concept of corresponding responsibility. Under 21 CFR §1306.04(a), pharmacists share a responsibility with prescribers to ensure controlled substance prescriptions are issued for a legitimate medical purpose within the usual course of professional practice. Just because a practitioner issued a prescription does not mean the pharmacist has to fill it.

A major area related to corresponding responsibility is red flag identification and resolution. A DEA investigator will evaluate a pharmacy’s ability to not just recognize potential red flags, but more importantly how to properly document and resolve them (if possible). Examples of red flags can include unusual prescribing patterns, out-of-area patients, and prescriptions paid in cash.

From her experience as a DEA investigator and compliance consultant, Jami frequently finds that ineffective training programs can fail to translate regulations into practical applications. Jami says that “having assessed registrants throughout the United States, we have found that training programs, when they exist, are often inadequate in training on controlled substance regulatory requirements.”

The gap often lies between understanding the rules and applying them in daily operations. For example, many employees know they have a corresponding responsibility but are unsure how to identify, resolve, and most importantly document these responsibilities in real time. Training programs should focus on real-world scenarios that help staff understand how regulations apply to everyday pharmacy workflows.

The CSA can evolve as new regulations and guidance are issued. As a result, CSA compliance training should also evolve. “Ongoing training ensures consistent application of policies, reinforces accountability, reduces the risk of regulatory violations, and supports a culture of compliance,” Jami explains. At a minimum, training materials should be reviewed by staff annually.

Having effective controls and procedures to guard against diversion and theft can significantly reduce risk. Under 21 CFR §1301.71(a), registrants must maintain effective controls and procedures to guard against the theft and diversion of controlled substances. Jami emphasizes that a DEA investigator will check to ensure that safeguards are implemented, and that the pharmacy can also demonstrate that they are effective.

CSA compliance issues rarely stem from a single mistake. Instead, they often develop when warning signs are ignored or documentation is incomplete. “In most enforcement cases, the issue is not a single mistake,” Jami explains. “It is a repeated failure to investigate, correct, and properly document discrepancies or warning signs.”

Based on her experience as a DEA investigator, Jami recommends several internal controls that can help reduce discrepancies:

In addition to internal controls, pharmacies should evaluate their physical security. Upgrades including a dedicated safe instead of a substantially constructed, locked cabinet, and installing alarm systems and video surveillance in storage areas can significantly strengthen diversion prevention.

The CSA requires pharmacies to conduct a biennial inventory of controlled substances (that is once every two years) and maintain complete and accurate records of all controlled substance activity such as the purchasing, receiving, dispensing, and disposal for a time period of at least two years. State regulations may impose additional, sometimes more substantial requirements. Relying solely on the CSA’s minimum requirements is rarely sufficient for effective compliance.

Regular internal audits can help identify discrepancies before more complicated issues are uncovered. Detecting an issue within a few months is far easier than investigating a discrepancy that occurred a couple years earlier. Jami recommends that pharmacies conduct internal audits at least annually. However, she notes that the ideal frequency should be risk-based.  Jami states that, “The appropriate frequency should be risk-based and proportionate to a pharmacy’s controlled substance volume and operational complexity.”

Internal audits should focus on identifying patterns that may indicate diversion and/or process failures. For example, pharmacies should be able to evaluate whether their current systems would detect diversion if it were occurring behind the scenes. Reviewing staff activity can also reveal potential issues, including unusual login behavior, after-hours access, or inconsistent documentation, especially in healthcare system pharmacies. Ultimately, the goal of an audit is to ensure that any discrepancies are identified, and then subsequently investigated, documented, and resolved.

While reporting capabilities largely vary by system, Jami highlights several reports that may be especially valuable to a DEA Investigator:

Leveraging digital dispensing or inventory systems makes it easier to analyze purchasing and dispensing trends and detect discrepancies that would be difficult and more time-consuming to identify using paper records.

In many cases, the CSA will evolve in response to new challenges and/or regulatory priorities. Staying informed is essential for maintaining strong CSA compliance.

Jami recommends that pharmacist’s reference official DEA resources for the most accurate guidance. The DEA Diversion Control Division website provides regulatory updates, guidance documents, registrant manuals, and frequently asked questions (FAQs) related to controlled substances. One particularly valuable resource to point out is the DEA’s Pharmacist Manual, which outlines the specific CFR requirements pharmacies need to adhere to.

State boards of pharmacy also provide important updates, especially when federal regulations affect existing state laws. Subscribing to state board announcements and regularly checking their websites can help pharmacies stay current.

Partnering with an experienced compliance consultant can also provide significant value. Professionals like Jami and her colleagues at Guidepost Solutions combine regulatory knowledge with real-world investigative experience. Their background as DEA Diversion Investigators and compliance specialists allows them to help pharmacies evaluate risk, develop stronger policies, and build effective, long-term compliance programs. Former DEA investigators, like Jami and her other colleagues at Guidepost Solutions, can also conduct “mock” DEA inspections to assess compliance and readiness for an actual DEA inspection.

Compliance programs should never remain static. Pharmacy operations, staffing, and regulatory expectations are constantly changing. As a result, pharmacies must regularly evaluate and adjust their workflows to maintain strong CSA compliance.

Jami recommends conducting a formal review of compliance policies and procedures at least once per year. However, additional reviews may be necessary when operational or regulatory changes occur. Effective compliance programs are built on continuous improvement.

According to Jami, several events can and should prompt a policy review:

Proactively reviewing policies and procedures helps pharmacies identify weaknesses early while showing their DEA investigator that they are committed to controlled substance safety.

CSA compliance is not simply about maintaining records or passing inspections. It plays a vital role in protecting patients, pharmacy staff, and the communities being served. Fortunately, pharmacies have access to more tools and resources than ever before. Modern compliance solutions, combined with expert guidance from professionals with DEA investigator experience, can significantly reduce risk while improving overall operational efficiency.

For many pharmacies, digital compliance platforms such as C2 Keep help bridge gaps created by outdated workflows by centralizing documentation, improving visibility, and strengthening accountability. Pharmacies that combine strong technology with expert guidance and consistent training are best positioned to build a sustainable and effective CSA compliance program.

Guidepost Solutions stands at the forefront of leadership, insight, and guidance in a world marked by complexity and uncertainty. Their mission is to navigate the intricate challenges their clients face, delivering strategic solutions that are not only effective but also ethically grounded. With over 250 seasoned professionals, each member brings a wealth of experience from the realms of compliance, security, technology, law enforcement, and public safety.

For more information about Guidepost Solutions’ DEA regulatory compliance group, controlled substances, and auditing services, click HERE.