Docs/Draw & Waste SOP
Regulatory

Draw & Waste SOP

Standard operating procedure for recording controlled-substance draws, wastes, reversals, and dual-witness C-II requirements. Print and post this in each treatment room.

Purpose & scope

This SOP governs the real-time recording of controlled-substance draws, wastes, blind counts, reversals, and adjustments in VetRx Ledger for all Schedule II–V substances maintained at a licensed veterinary facility. It applies to every veterinarian, licensed veterinary technician, and practice manager who handles controlled substances at the facility.

Regulatory basis:21 CFR Part 1304.22(c), DEA Practitioner's Manual for Veterinarians (2006 ed.), and state board of pharmacy requirements where applicable.

Roles & responsibilities

RoleResponsibility
DEA Registrant (DVM/Owner)Ensures compliance; countersigns monthly reconciliation
Administering DVMOrders and supervises administration; enters DVM ID on DRAW events
Lead TechnicianDraws medication; enters event; serves as primary witness for C-III–V wastes
Second WitnessRequired for all C-II wastes; must be a licensed DVM or LVT distinct from the drawer

Event types

TypeWhen to useWitness required?
DRAWAny time a dose is drawn from a vial for administrationNo
WASTEAny amount discarded (e.g. remaining dose after use)Yes for C-II; recommended for C-III–V
REVERSALError correction — quantity returned to vial (rare; document reason)No, but auditable
BLIND_COUNTPeriodic physical count without adjustment; records inventory snapshotNo
ADJUSTMENTVariance correction after reconciliation review (signed off by DEA registrant)Recommended

Procedure — DRAW

  1. Retrieve the vial from the secured safe. Confirm drug name, lot, and expiry match VetRx Ledger.
  2. Open Ledger → select DRAW.
  3. Select the vial from the dropdown (scan barcode to auto-select if available).
  4. Enter quantity drawn in the labelled unit (mL, mg, or mcg — be consistent with the vial record).
  5. Enter administering DVM ID and your technician ID.
  6. Tap Submit Event. Confirm the running balance decrements correctly.
  7. Return any multi-dose vial to the safe immediately.

Procedure — WASTE (C-II)

  1. Do not discard the waste until a second witness is present and logged in.
  2. The primary recorder opens Ledger → selects WASTE → selects the vial.
  3. VetRx Ledger will prompt: "A witness session is required for C-II waste."
  4. The primary recorder clicks Create witness session. VetRx Ledger generates a short-lived session token (expires in 10 minutes).
  5. The second witness opens VetRx Ledger on their own device or login, navigates to Ledger → Witness, and enters the session token.
  6. The witness authenticates (PIN, hardware key, or biometric depending on your configuration) and submits.
  7. VetRx Ledger issues a one-time witnessToken. The primary recorder pastes or scans this token into the waste form.
  8. Both parties physically observe the waste (flush, crush, or other approved method).
  9. Primary recorder enters waste quantity and submits. Both user IDs are recorded in the append-only ledger entry.
Dual-witness is cryptographically enforced. The WASTE API will reject submissions with an expired, reused, or self-issued witnessToken. There is no override or bypass. Contact hello@grantshelf.com if you encounter an error.

Procedure — BLIND_COUNT

Perform a blind count at least monthly (ideally weekly for high-volume clinics). The person counting should not have access to the current electronic balance beforehand.

  1. Physically count every vial in the safe and note quantities on paper.
  2. Open Ledger → select BLIND_COUNT for each vial.
  3. Enter the physical count quantity. VetRx Ledger records this as a snapshot event without adjusting the running balance.
  4. After submitting all blind counts, navigate to Reconcile to compare physical counts against computed balances.
  5. Variances > 2% must be investigated and documented before the next business day.

Discrepancy response

VarianceAction
< 1%Document in reconciliation notes; monitor next cycle
1–5%Review event log for data-entry errors; submit ADJUSTMENT with DVM sign-off
> 5% or unexplainedNotify DEA registrant immediately; consider filing DEA Form 106

Record retention

All events are stored in an immutable, hash-chained ledger with hardware-backed e-signatures. VetRx Ledger retains records for a minimum of 2 years (DEA requirement) with options to export CSV or JSON chain-of-custody packages at any time. Do not delete event entries; use REVERSAL or ADJUSTMENT with documented reason instead.

Download Printable SOP Template

Download this SOP as a formatted PDF to print, sign, and file in your physical controlled substance logbook. Fill in your practice name and DEA registration number before posting. Keep a signed copy on file per 21 CFR §1304.04.

⬇ Download Daily Logging SOP PDF