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SOP-180EMSSOP

Controlled Substance Handling

DEA-compliant ordering, storage, administration, and waste of controlled medications.

Read before using

This is a template. It is not your department's policy.

Tailboard templates are drafted as generic starting points aligned to national standards. They are nota substitute for your department's own review or for adoption through your Authority Having Jurisdiction (AHJ). For topics carrying significant exposure (use of force, medical scope, civil rights), route through qualified counsel before adoption.

Every placeholder marked [BRACKETED] must be completed before adoption. Every section must be reviewed against your department's staffing, apparatus, water supply, EMS scope, geography, and the specific laws of your state. What applies to a career department in a city may not apply to a volunteer department in a rural jurisdiction, and vice versa.

Standards, regulations, and best practices are updated regularly. Verify the current edition of every standard cited before adopting this document. Once adopted, this document becomes your department's responsibility — not Tailboard's.

Want this tailored to your department?

Open it in the Policy Builder. Answer a few questions about your staffing, apparatus, and conditions — we'll adapt every section to match.

Number

SOP-180

Version

1.0

Last reviewed

2026-05-01

Next review

2027-05-01

Summary

This SOP establishes how [DEPARTMENT NAME] handles DEA-scheduled controlled substances from acquisition through administration to waste — meeting federal and state regulatory requirements and preventing diversion.

Definitions

Controlled Substance
A drug or substance regulated under the federal Controlled Substances Act (CSA), scheduled I–V by the DEA. EMS commonly carries Schedule II (e.g., fentanyl, morphine, ketamine, hydromorphone) and Schedule IV (e.g., midazolam, lorazepam).
Diversion
Any unauthorized acquisition, use, or transfer of a controlled substance.
Witnessed Waste
Disposal of unused medication with documentation by a second licensed provider witnessing the actual destruction.

Purpose

To establish a documented, auditable chain of custody for every controlled substance carried by [DEPARTMENT NAME] — from order through administration or waste.

Scope

Applies to all members who handle controlled substances on or off any [DEPARTMENT NAME] unit, and to all administrative personnel who order, audit, or oversee controlled substances.

Authority & Registration

  • Controlled substances are obtained under the DEA registration of the medical director or an institutional registrant.
  • Members may possess and administer controlled substances only within their certification scope and the medical director's standing orders or contemporaneous online orders.
  • Diversion is a federal crime.

Acquisition & Receipt

  1. Orders are placed by the Controlled Substance Officer or designee.
  2. Receipt requires two licensed providers — one verifies count against the order, one witnesses.
  3. Discrepancies are reported to the Controlled Substance Officer the same day.
  4. Sealed containers are not opened until issued to a unit.

Storage

  • Stored in a locked, two-key safe or substance-locking system in each apparatus and at the station.
  • Access is logged electronically or in writing every time the safe is opened.
  • Temperature monitoring as required by the manufacturer. Excursions reported.
  • Apparatus safes are inventoried at every shift change by an off-going and on-coming provider together.
  • Station safes are inventoried daily.

Shift-Change Inventory

  1. Both providers count the contents of every controlled substance compartment.
  2. Quantity, lot number, expiration date verified against the log.
  3. Both providers sign the inventory log.
  4. Discrepancies — pause the shift change and notify the Controlled Substance Officer.

Administration

  1. Order from standing orders or online medical control.
  2. Verify the right patient, right medication, right dose, right route, right time.
  3. Administer per protocol; document time, dose, route, lot, expiration, and provider in the PCR.
  4. Patient response documented immediately and at reassessment.
  5. Any unused portion is wasted in accordance with the waste protocol below.

Waste

  • Waste is performed at the bedside or as soon as possible after the patient encounter.
  • A second licensed provider witnesses the actual destruction (denaturing).
  • Denaturing methods per manufacturer / state guidance — typically a pharmaceutical disposal device.
  • Both providers document waste amount, method, witness, and time in the controlled substance log and the PCR.
  • Waste is never deferred to a later shift, dispatched 'returning home' for later disposal, or stored in personal pockets.

Damaged / Expired / Recalled Substances

  • Removed from active inventory immediately.
  • Stored in a marked locked container until properly disposed.
  • Disposal via reverse distributor or per state law — documented with disposal certificate.
  • Damaged ampules / vials reported and reconciled.

Drug Diversion Prevention

  • Random unannounced audits at minimum quarterly.
  • Patterns of waste rounding, missing doses, or unusual administration frequency are reviewed.
  • All members must immediately report suspected diversion to the Controlled Substance Officer and the EMS chief.
  • Reporting in good faith is protected.
  • Members suspected of diversion are removed from clinical duty pending investigation.
  • Confirmed diversion is reported to the DEA, state regulatory board, and law enforcement as required.

Documentation

  • Acquisition: order, receipt, witness signatures.
  • Storage access: every safe entry, by provider and time.
  • Shift-change inventory: counts, signatures, discrepancies if any.
  • Administration: in the PCR with the elements listed above.
  • Waste: in the controlled substance log with two-provider documentation.
  • Damaged / expired: disposal certificates retained.
  • All records retained for the period required by state law and DEA — minimum 2 years federal, often longer state.

Responsibilities

Controlled Substance Officer

  • Maintains the program.
  • Orders and receives substances.
  • Conducts audits.
  • Investigates discrepancies and suspected diversion.
  • Liaison to the medical director, DEA, and state.

Medical Director

  • Provides scope authority for administration.
  • Reviews any diversion or significant discrepancy.
  • Approves substance list and protocols.

All Members

  • Complete shift-change inventories accurately.
  • Administer per scope and protocol.
  • Witness and document waste at the time of waste.
  • Report suspected diversion immediately.

Training

  • Initial controlled substance training at onboarding.
  • Annual refresher.
  • Targeted training after any significant event.

References

  • DEA Controlled Substances Act21 USC §801 et seq.
  • DEA Practitioner's Manualdeadiversion.usdoj.gov
  • State EMS Controlled Substance Rules[INSERT STATE]
  • NAEMSP Controlled Substance Guidancenaemsp.org

Adapt this template

Before this template becomes your department's policy, review the following items and adjust accordingly. Anything else that does not match your operation should be updated as well.

  • Name your Controlled Substance Officer and medical director.
  • List your specific substance inventory.
  • Describe your safe system (e.g., Knox eGen, ePCR-linked dispenser).
  • Adjust state-specific requirements (e.g., PDMP reporting, witness requirements).
  • Cross-reference Patient Care Report Documentation and Quality Improvement SOPs.

Adoption signature

Adopted by (Name, Rank)
Signature
Effective date
Next scheduled review

Before adoption checklist

  • ☐Replace [DEPARTMENT NAME] throughout the document.
  • ☐Complete every [BRACKETED] placeholder.
  • ☐Confirm the current edition of every cited standard.
  • ☐Check against your state statutes and state fire marshal rules.
  • ☐Route for chief review. Topics with significant exposure (use of force, medical scope) also go through qualified counsel.
  • ☐Confirm alignment with any mutual-aid agreements.
  • ☐Schedule a training plan for the new policy before effective date.
  • ☐Announce adoption in writing to all members. Archive the prior version.
  • ☐Set the next review date — annually at minimum.