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Question 1 of 10



Please answer with Yes or No

This includes: your EMS agency DEA registration certificate, state controlled-substance license, state EMS service license/certificate, the prior two years of Schedule II–V purchase invoices with associated DEA Form 222s / CSOS records, your most recent biennial inventory, and current controlled-substance logs.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • Your DEA and state controlled-substance documents are current.
  • They are organized in a single 'ready and retrievable' file or system.

Answer NO if:

  • Documents are expired, missing, or scattered.
  • You could not produce them within minutes of a request.

Remember:

  • 'Readily retrievable' (21 CFR 1300.01) means records can be located and produced quickly. Invoices, DEA-222s, and inventories must generally be kept for at least two years.

Question 2 of 10



Please answer with Yes or No

This includes: medics, EMTs (where state scope allows access), supervisors, and logistics staff who order, stock, administer, or have keys/codes to controlled substances.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • Every person with access has passed a background check.
  • Drug screening is in place per your policy and state requirements.

Answer NO if:

  • Some personnel with access have not been screened.
  • Screening lapsed or was never extended to existing staff.

Remember:

  • 21 CFR 1301.76(a) directs registrants not to employ persons with access to controlled substances who have a felony conviction related to controlled substances or a revoked DEA registration. Screening demonstrates due diligence.

Question 3 of 10



Please answer with Yes or No

This includes: written SOPs for ordering, receiving, storage, administration, documentation, wasting, restocking, drug-box exchange, and crew-to-crew handoff of controlled substances.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • Your manual is current and reflects how crews actually operate.
  • It covers ordering through wasting and is reviewed regularly.

Answer NO if:

  • You have no manual, or it is outdated.
  • It omits EMS realities like drug-box exchange or crew handoff.

Remember:

  • While DEA does not dictate a specific SOP format, written procedures are how you demonstrate effective controls against diversion (21 CFR 1301.71). 'Current' means reviewed and updated on a defined schedule.

Question 4 of 10



Please answer with Yes or No

This includes: a full review of registration, security, records, inventory reconciliation, waste documentation, and diversion controls performed by someone independent of daily operation

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • A qualified reviewer audited controlled-substance compliance within 24 months.
  • Findings were documented and corrective actions tracked.

Answer NO if:

  • No mock audit has occurred in the past two years.
  • Reviews were informal and undocumented.

Remember:

  • Mock inspections reveal diversion risks and recordkeeping gaps before they become violations. Reviewers with DEA or diversion-investigation experience add the most value.

Question 5 of 10



Please answer with Yes or No

This includes: a securely locked safe or cabinet at the base, plus a secured, access-controlled compartment or locked box on each ambulance/unit — not an unsecured drug bag left in an open cab.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • Base storage is a securely locked, substantially constructed cabinet/safe.
  • Each unit has secured, access-limited storage with logged access.

Answer NO if:

  • Storage is not substantially constructed or not consistently locked.
  • Units carry controlled substances without secured, controlled access.

Remember:

  • 21 CFR 1301.75 requires controlled substances be stored in a securely locked, substantially constructed cabinet. For mobile EMS, that security expectation extends to each unit and to access controls (keys, codes, tamper-evident seals).

Question 6 of 10



Please answer with Yes or No

This includes: partial-dose waste after patient administration, expired or damaged product, and any product removed from inventory — each recorded with drug, amount, date, and both signatures.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • Every waste event is witnessed by a second authorized person.
  • Each event is documented with drug, amount, date, and both signatures.

Answer NO if:

  • Waste is sometimes done by one person.
  • Documentation is incomplete or reconstructed after the fact.

Remember:

  • Two-person witnessed waste with contemporaneous documentation is a widely required standard under state EMS rules and a recognized best practice. The witness should observe the actual waste, not just sign the log.

Question 7 of 10



Please answer with Yes or No

This includes: shift-change counts, signatures at every handoff, reconciliation against administration/run reports, and tracking of sealed drug boxes exchanged with hospitals or supply points. 

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • Counts are reconciled at each shift change and restock.
  • Drug-box exchanges are logged with seal numbers and signatures.

Answer NO if:

  • Counts are skipped, delayed, or not signed.
  • Discrepancies are noticed late or not investigated.

Remember:

  • EMS is high-risk because controlled substances move across many hands and locations. Per-shift counts, seal tracking, and reconciliation to run reports close the gap that rotating crews create.

Question 8 of 10



Please answer with Yes or No

This includes: an inventory taken on the registration's effective date and at least every two years, recording each substance and count, the date, whether taken at opening (12:01 AM) or close (11:59 PM) of business, and signed by the person who conducted it.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • You have an initial inventory and one taken within the last two years.
  • It includes counts, date, time-of-day basis, and a signature.

Answer NO if:

  • You cannot locate a compliant inventory.
  • Required elements (counts, date, signature) are missing.

Remember:

  • 21 CFR 1304.11 requires an initial inventory and a new inventory at least every two years. Schedule II items require an exact count; Schedules III–V may be estimated unless the container holds more than 1,000 dosage units.

Question 9 of 10



Please answer with Yes or No

This includes: filing DEA Form 106 for theft/significant loss, notifying DEA in writing upon discovery, notifying state authorities as required, and an active diversion-monitoring program (audits, anomaly review, follow-up on discrepancies). 

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • Staff know to report a theft/significant loss immediately.
  • You file DEA Form 106 and monitor for diversion patterns.

Answer NO if:

  • There is no written reporting process.
  • No one actively reviews logs for diversion indicators.

Remember:

  • 21 CFR 1301.74(c) and 1301.76(b) require notifying DEA upon discovery of a theft or significant loss and completing DEA Form 106. 'Significant' is judged by factors including the schedule, quantity, and whether the substance is a likely diversion target.

Question 10 of 10



Please answer with Yes or No

This includes: segregating non-usable controlled substances in secure storage, documenting them, and disposing via a DEA-registered reverse distributor or other authorized method — never simply discarded or held indefinitely.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • Non-usable controlled substances are secured and documented.
  • Destruction uses a DEA-authorized method (e.g., reverse distributor).

Answer NO if:

  • Expired stock accumulates with usable inventory.
  • Disposal is undocumented or done by unauthorized means.

Remember:

  • Controlled substances must remain secured until destroyed, and disposal must follow DEA rules (21 CFR Part 1317). Keep destruction records (e.g., DEA Form 41 where applicable) as part of your binder.