This blog post summarizes the key takeaways from Susannah Herkert’s session at the 2026 Diversion Symposium. Susannah is a former DEA investigator and current expert at Guidepost Solutions. To stream the session, click here.
Red Flags & Responsibilities: Navigating DEA Compliance in Retail Pharmacy
While much of the conversation around drug diversion focuses on inpatient hospital settings, the retail pharmacies associated with hospitals are under increasing scrutiny from the DEA. In a recent session at the Bluesight Diversion Symposium, Susannah Herkert shared critical insights into why the DEA is showing up on-site and how pharmacies can protect their patients, their staff, and their licenses.
Why the DEA is Knocking: The “Outlier” Factor
The DEA is increasingly using data to drive their inspections. One of the biggest triggers for an on-site visit is outlier ordering activity.
- The Trend: Due to shortages and opioid settlements, quotas have changed. If your hospital’s retail pharmacy is ordering significantly higher quantities of Schedule II stimulants than other pharmacies in your ZIP code, you will likely be flagged.
- The Solution: Know your data. If you are an outlier, ensure you have documented, valid reasons why your volume differs from the chain pharmacy down the street.
Accountability: From “Meds to Beds” to Couriers
A common misconception is that accountability shifts once a medication leaves the pharmacy shelf. Susannah warns that the retail pharmacy registration is responsible for the controlled substance until it is in the hands of the end-user.
- Meds to Beds: If a tech or nurse is delivering a script to a bedside, the pharmacy remains accountable during transport.
- Theft Reporting: Any theft (even one pill) or “significant loss” must be reported to the DEA within one business day of discovery.
Master the “Corresponding Responsibility”
As a pharmacist, you are the last line of defense. The law dictates a 50/50 split of responsibility between the prescriber and the dispenser.
“Just because a doctor wrote it doesn’t mean you’re required to fill it.” — Susannah Herkert
To meet your “corresponding responsibility,” you must ensure the prescription is for a legitimate medical purpose within the usual course of professional practice. This includes:
- Resolving Red Flags: Such as “Holy Trinity” combinations (opioids, benzos, and muscle relaxants), early refills, or cash payments.
- Documentation: If you “eyeballed it” and felt it was okay, but didn’t write down why, the DEA considers that a failure. If it isn’t documented, it didn’t happen.
Best Practices for Recordkeeping & Inventory
The DEA favors retail pharmacy audits because the records are often more straightforward than complex hospital systems. To stay compliant:
- Biennial Inventory: Conduct a physical count of all controlled substances (including those awaiting destruction) every two years.
- Separation of Duties: The person ordering the drugs should not be the same person receiving the drugs and checking the invoices.
- Readily Retrievable: You should be able to produce any DEA-required document before an investigator leaves your facility at the end of the day.
The “Tyranny of Turnover” and the Power of Training
Training shouldn’t be a “one and done” event during onboarding. With high staff turnover, gaps in compliance knowledge happen quickly.
- Standardization: Use “compliance aids” or stamps for invoices to ensure staff consistently document the date received and initial the quantities.
- Culture of Compliance: Shift the mindset from “checking boxes” to “saving lives.” Detecting diversion isn’t just about avoiding a $19,246 per violation fine; it’s about preventing overdoses and protecting coworkers from the disease of addiction.
Key Compliance Checklist
| Requirement | Action Item |
| Theft/Loss | Report to DEA within 1 business day of discovery. |
| Inventory | Perform a full physical count at least every 2 years. |
| Invoices | Mark date received and circle/check quantities for every shipment. |
| Red Flags | Document the resolution of every flag in the patient record. |
| Training | Conduct annual “knowledge checks” beyond initial onboarding. |
Bottom Line: The DEA’s goal is to maintain a closed system of distribution. By implementing effective controls—from human resources background checks to rigorous internal audits—your pharmacy can remain a safe, compliant environment for the community.
Is your pharmacy currently documenting the resolution of “red flag” prescriptions to ensure they are “readily retrievable” for a DEA audit?