I recently had an unusual DEA audit, after conclusion of which the DEA decided to penalize my client for not keeping CSOS records for 3 years. Why did I call this case unusual? For a number of reasons.
First of all, because this issue had never come up in any of my previous audits. Secondly, because federal law requires pharmacies to keep CSOS records only for 2 years (not 3!). See 21 CFR §1311.60. This is a reason why your wholesaler provides access through its online CSOS platform to only the last two years of purchases.
The DEA took a stance that under California law, a pharmacy must keep acquisition records for 3 years. We argued that the DEA is a federal agency and therefore, it should enforce only the provisions of the Controlled Substances Act and not a state law or a regulation (this is a province of the State Board of Pharmacy). While we would have likely prevailed if we went to court against the DEA on this issue, the pharmacy decided to settle (which is understandable considering the uncertainty and costs associated with such an action).
It’s unclear whether the DEA has started a trend of requiring 3 years of CSOS records (when you can only provide them with the last 2 years through your CSOS platform). But you might want to start thinking about downloading your CSOS information and archiving it for 3 years.
While this was an unusual case, the DEA regularly audits CSOS information and records. Some issues that I often see in my DEA audit cases are:
– lack of a record of the quantity or each item received and the date received (See 21 CFR 1305.22(g));
– sharing CSOS certificates (See 21 CFR 1311.30);
– maintaining certificates of employees who are no longer with the pharmacy. (See 21 CFR 1311.30).
Although CSOS record-keeping might not be at the top of your risk assessment, it could potentially cause significant monetary penalties if a pharmacy does not properly maintain CSOS records or fails to properly order controlled substances due to the issues with its CSOS certificates. We recommend reviewing the above federal regulations to ensure compliance and downloading your CSOS history from your wholesaler’s CSOS platform so you are able to produce this information to your Board or the DEA.