Animal Health Solutions

41 Q3 2020 | Animal Health Solutions Recordkeeping Controlled substance compliance starts with recordkeeping. Recordkeeping is the backbone of DEA compliance, and good recordkeeping should tell a complete story from the time controlled substances are ordered and enter to your facility, to the time they are dispensed and/or disposed of. Your chances of having a positive interaction with the DEA are greatly increased if you have consistent and accurate recordkeeping. Do not cross-contaminate controlled substance inventory records. Remember that Schedule II controlled substances must be kept separate from all other substances, and this includes corresponding records and invoices. Biennial inventory The starting point for all controlled substance recordkeeping is your biennial inventory. If the DEA were to show up at your facility, one of the first things the investigator will ask you for is the most recent copy of your biennial inventory (which should be part of your DEA "readily retrievable" file). For those unaware, your biennial inventory is a documented, physical inventory taken of all controlled substances on hand at your facility. The Controlled Substances Act ("CSA") requires inventory of controlled substances to be conducted initially (when your DEA registration has been issued) and biennially thereafter. According to DEA regulations, a biennial inventory must be completed every two years, on any date within two years of the previous biennial inventory date. [21 CFR 1304.11(c)]. 1 Your biennial inventory must include all controlled substances on hand, their form (i.e., liquid, tablet, diskette, or powder), quantity and strength. Conduct your biennial inventory every year at the same time that you conduct your annual inventory to ensure that your biennial inventory is always up to date. If you can conduct a biennial inventory quarterly- even better. The goal is to keep the DEA at bay by always having a three to six-month time frame available so there's no reason for them to go back any further. Discrepancies Once you've completed your biennial inventory, resolve any discrepancies identified between your biennial count and controlled substance logbook records. Discrepancies that cannot be reconciled must be investigated further to determine the cause for the discrepancy. Remember that any significant losses or confirmed theft must be reported on a DEA Form-106, as well as to the appropriate state regulatory authorities and local law enforcement. Remember that any significant losses or confirmed theft must be reported on a DEA Form-106, as well as to the appropriate state regulatory authorities and local law enforcement. Reconciliation Reconciliation. Most of us dread the task (if we do it at all); but when it comes to compliance oversight, you are required to maintain an accurate, running balance of your controlled substance inventories. Once discrepancies have been resolved, this is your chance to implement a schedule for conducting regular inventory reconciliations. The minimum reconciliation standard for veterinary facilities should be weekly; however, as a best practice we recommend that all facilities routinely conduct reconciliations at the end of every shift. To simplify the reconciliation process, you can also routinely conduct "cycle counts" by placing controlled substances into categories (according to schedule works well) and reconcile one category at a time. Also referred to as "streamlining inventory reconciliation through cycle counting", this allows you to systematically count controlled substances on a continuous basis and prioritize reconciliation by breaking the larger process into smaller, manageable tasks that are easier to complete. Remember, unexpected circumstances such as a fire or break-in would warrant the need for additional reconciliations to be conducted. Streamline inventory reconciliation by conducting routine cycle counts that allow you to systematically count controlled substance on a continuous basis and prioritize reconciliation by breaking the larger process into smaller, manageable tasks that are easier to complete.

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