Have you ever experienced a theft or significant loss of controlled substances, and if so was it reported to the DEA and required state and local authorities?

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Even the best-run clinics can face a situation where vials go missing or a break-in occurs. This question checks if you're prepared. "Yes" means you regularly monitor for discrepancies (through your logs and inventory checks) that might indicate a loss, and you've trained your staff to report concerns. It also means you know the procedure: if a significant loss or any theft is discovered, you will contact your local DEA field office within one business day and submit a DEA Form 106 report within 45 days, as required. You'd also notify local police if theft is suspected. Any time you answer "No," it implies a dangerous blind spot – perhaps you've never discussed this scenario with your team or wouldn't know exactly whom to alert. Time is of the essence in loss situations, so having a plan is part of compliance. (DEA also expects you to investigate internally to determine what happened and prevent it again.)

Was an initial DEA inventory conducted prior to controlled substance ordering taking place followed by a DEA biennial inventory at minimum every two years thereafter per 21 CFR 1304.11(b)(c)?

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A "Yes" means an initial inventory reflecting a "zero" starting balance for schedule II controlled substances and Schedule III-V controlled substances is on file before any controlled substances were ordered at the facility. Additionally, proper DEA biennial inventories mean that after the initial inventory was taken DEA biennial inventories were completed at least every 2 years thereafter documenting schedule II controlled substances on an inventory form separately from Schedule III-V controlled substances on another inventory form. Original DEA inventory forms must include all required information as outlined in 21 CFR 1304.04 and be physically signed and dated by the ordering DEA registrant and a witness.

Have all individuals who have been authorized to work with controlled substances been memorialized on an Authorized Personnel List that is maintained in required records and have all individuals on this list executed an Employee Screening Statement per 21 CFR 1301.90?

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The Authorized Personnel List is a living document that must be updated anytime authorized access is granted or revoked. Employee Screening Statements must be executed during the onboarding process and again annually by all authorized personnel. Executed copies must be kept onsite with other DEA required records. Any individuals who Answer "Yes" on an Employee Screening Statement are automatically disqualified from working with or in an area where controlled substances are used. While background checks and drug testing are not mandated by federal law, they are strongly recommended as a preventive measure to avoid hiring an at-risk individual.

Are all DEA required records maintained on-site for the current two-year period at the registered location in a ready and retrievable manner available for inspection per 21 CFR 1304.04?

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Include: DEA registration (Form 223), state veterinary license, any state controlled substance license, original POAs, Authorized User List, executed Employee Screening Statements, Initial Inventory, Biennial Inventory, Verified CS Invoices checked off, signed and dated during the receiving process, DEA Form-222s/222es if using CSOS, CSOS certificate if using CSOS, DEA Form-41s, DEA Form-106s, reverse distribution records, CS logs, any transfer documents.

Are all controlled substances being tracked by individual container in your logs and are all controlled substance usage instances logged as individual log entries in "real-time" with no missing information or cross-outs?

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To say "Yes," you are documenting every instance of administration and dispensing of a controlled substance in the controlled drug logs. Unopened containers being received into inventory are logged as back stock and opened containers being moved from back stock into active stock are being logged by the individual container using the starting balance and documenting every usage instance that occurs until the container is depleted. When logging liquid controlled substances, log entries clearly show the amount drawn up, the amount administered to a patient and any amount that is wasted. Each controlled substance log has a clear header reflecting the controlled substance name, strength, dosage, form, size and starting balance.

Are expired controlled substances separated out from non-expired controlled substances in storage and kept secured until sent for destruction via reverse distribution? Are leftover controlled substances resulting from patient administration properly wasted into a system such as Deterra or a Cactus Sink to render them non-retrievable prior to disposal into a biohazards waste unit?

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Here we focus on expired drugs which are different than controlled substance waste left over from patient administration or resulting from breakage or spillage that may occur during operations. Answer "Yes" if, whenever a controlled substance expires you separate it out in storage and send the expired medication to a reverse distributor to undergo final destruction via incineration. Expired controlled substances do not get wasted on-site in a system to render them "non-retrievable". Excess controlled substances leftover from patient administration and/or remaining in a container, syringe, tubing etc. must always be fully expelled into Deterra, Cactus Sink, RX Destroyer or other system to render them "non-retrievable" in accordance with 21 CFR 1300.05 prior to disposal into biohazardous waste containers. This also applies to any controlled substances rendered unusable resulting from breakage or spillage, including any broken components and/or materials like paper towels etc. used to clean up CS's spillage/breakage. A "No" would mean expired controlled substances are not sent for reverse distribution and you do not render excess controlled substances "non-retrievable" prior to disposal.

Is access to controlled substances strictly limited to a minimal number of authorized individuals and are witnesses utilized to ensure an accountability system of checks and balances?

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This question drills into who handles the drugs. Answer "Yes" if only a small, trusted group of staff (e.g. the veterinarians and perhaps a lead tech) have keys or access codes, and never unauthorized persons. It also covers whether you employ checks and balances during handling – for instance, having two staff members involved when counting inventory or when filling a controlled drug prescription (one prepares, another witnesses). Such dual-control or witness requirements (where practical) can deter theft and catch errors. If everyone in the clinic knows the safe code, or if controlled drugs are sometimes left unattended in exam rooms, that's a "No." High compliance means controlled drugs are only accessible under supervision.

Do you have Controlled Substance Standard Operating Procedures that outline how controlled substance operations are to be performed in your facility, and have authorized personnel been trained on controlled substance SOPs?

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This complements the training question but specifically asks for a written policy. Even though the law may not force you to have written SOPs, DEA investigators consider them a sign of a well-run operation. If "Yes," you likely have a manual or handbook section detailing all aspects of controlled drug handling (ordering, storage, logging, dispensing, inventory, security, etc.), and it's updated as needed. It might even include roles (e.g. "CS Manager" or responsible veterinarian) and emergency procedures. If "No," then your procedures might be more ad-hoc or word-of-mouth, which can lead to inconsistencies. Writing it down not only helps train staff consistently but also shows inspectors that you're thorough about compliance. "Yes" means you conduct training for new hires and periodic refreshers (for example, an annual meeting on controlled substance procedures or as part of team meetings) to cover topics like proper logging, security protocols, and how to spot diversion. It also implies a culture of accountability: staff know that any mishandling can result in discipline and that everyone is responsible for compliance (not just the practice owner). In some practices, staff even sign a form acknowledging they understand the controlled substance policy. Answer "No" if training is minimal or purely informal. A well-trained team is often the difference between catching a problem early or letting it grow – DEA knows this, and so should we.