21-Point DEA Inspection Readiness Checklist
Every federal requirement your veterinary practice must satisfy under 21 CFR Part 1304 — organized by risk level, with citation references and inspector notes.
⚠️ Significant compliance gaps — address high-risk items first.
Registration & Posting
0/2DEA Certificate of Registration (Form 224) is posted visibly at each registered location.
21 CFR §1301.35 — Inspectors check for posted certificate first. Missing = immediate citation.
DEA registration is current (not expired) and the registered address matches the physical practice address.
Registration must be renewed every 3 years. An expired registration means all CS activities are illegal.
Record-Keeping (21 CFR Part 1304)
0/6All Schedule II controlled substances are recorded separately from Schedule III–V drugs.
21 CFR §1304.04(f) — C-II records must be maintained separately or readily retrievable within 2 minutes.
Each log entry includes: drug name, DEA schedule, dosage form, strength, and quantity drawn/administered/wasted.
21 CFR §1304.22 — Incomplete entries are one of the top three DEA citation triggers.
Each entry records date, time, administering DVM name, patient name, species, and weight.
Patient-level data is required for administered quantities — not just dispensed or purchased amounts.
Vial lot numbers and expiration dates are captured at the time of first draw.
Required for reconciliation and DEA-106 loss reporting. Missing lot data makes reconstructions impossible.
Running balance is maintained for each controlled substance vial and is verifiable at any point.
DEA inspectors will pull a vial and ask you to reconcile it on the spot. An unverifiable balance = red flag.
Records are legible, complete, and free from erasures or white-out. Corrections are crossed out with single line and initialed.
For paper logs: corrections must be initialed. For electronic: append-only with no deletions allowed.
Dual-Witness & Waste Protocols
0/4All Schedule II waste events are witnessed by a second licensed staff member and both parties' signatures/credentials are recorded.
Unwitnessed C-II waste is the #1 compliance failure in veterinary inspections. Every waste must have two distinct credential holders.
Witnesses are identifiable by name and license/credential number — not just initials.
Initials-only witness records are unacceptable to DEA auditors. Full name + credential required.
Wasted quantities are documented immediately at point of care — not reconstructed at end of shift.
Delayed documentation creates balance discrepancies that are hard to explain during an inspection.
Partial vial waste from multi-patient procedures is individually documented per patient.
Batching waste from multiple patients onto a single line is a frequent citation point.
Biennial Inventory
0/3A complete physical inventory of all controlled substances has been conducted within the past 24 months.
21 CFR §1304.11 — Biennial inventory is mandatory. Failure to conduct = violation regardless of otherwise clean records.
Biennial inventory is dated, signed by the responsible DVM/registrant, and links to the prior inventory.
The chain of custody between inventories must be unbroken. Each inventory references the previous one.
Schedule II counts are exact; Schedule III–V counts may use estimated amounts (but exact is preferable).
21 CFR §1304.11(c) — C-II exact count required. C-III–V: estimated if container sealed; exact if opened.
Procurement & DEA-222 / CSOS
0/2All Schedule II purchases are made using DEA Form 222 or the Controlled Substances Ordering System (CSOS).
21 CFR §1305 — Purchasing C-II without a DEA-222/CSOS order is a federal violation.
Received DEA-222 copies (Copy 3) or CSOS receipts are retained for at least 2 years and available for inspection.
DEA inspectors cross-reference purchase orders against your CS log. Missing 222s = discrepancy red flag.
Loss, Theft & DEA-106 Reporting
0/2Any theft or significant loss of controlled substances is reported to DEA on Form 106 within 1 business day of discovery.
21 CFR §1301.76 — DEA-106 must be filed even for suspected losses before cause is known. Late filing = additional violation.
All CS discrepancies are investigated immediately and outcomes documented, even if the loss is later reconciled.
Document every discrepancy investigation — resolved or not. This demonstrates due diligence to inspectors.
Access Control & Record Retention
0/2Access to controlled substances is limited to authorized DEA registrants and their authorized employees; access log or key control is maintained.
21 CFR §1301.75 — Physical security measures are required. Inspectors assess storage, access controls, and key/lock procedures.
All CS records (logs, inventory, DEA-222s, DEA-106s) are retained for a minimum of 2 years and accessible within 2 minutes of a DEA inspector's request.
21 CFR §1304.04 — The 2-minute retrieval requirement is strictly enforced. Digital or organized physical storage is essential.
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