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Question 1 of 12



Please answer with Yes or No

This includes: your DEA registration certificate, state pharmacy and controlled-substance licenses, power of attorney for DEA Form 222 / CSOS signers, the prior two years of Schedule II–V purchase invoices with associated DEA-222s and CSOS records, your most recent biennial inventory, and perpetual inventory logs. 

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

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

Answer NO if:

  • Documents are expired, missing, or scattered across systems.
  • 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 be kept at least two years; Schedule II records must be maintained separately from all other records.

Question 2 of 12



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 the signature of 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 3 of 12



Please answer with Yes or No

This includes: a running (perpetual) balance for each CII, scheduled cycle counts (e.g., daily/weekly for high-risk items), documented reconciliation of physical count to perpetual balance, and prompt investigation of any discrepancy.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • You keep a perpetual balance for Schedule II drugs.
  • Cycle counts are scheduled, documented, and reconciled, with discrepancies investigated.

Answer NO if:

  • You rely only on the biennial count.
  • Counts aren't reconciled, or discrepancies aren't documented and chased down.

Remember:

  • While DEA does not mandate a perpetual inventory for every schedule, it is a recognized best practice (and required by many state boards for CIIs). Cycle counting turns a once-every-two-years snapshot into continuous diversion detection.

Question 4 of 12



Please answer with Yes or No

This includes: documented calls/notes verifying questionable prescriptions, a prescriber due-diligence file for high-volume narcotic prescribers, recorded resolution of red flags (early refills, cash pay, distance, drug cocktails), and notes on prescriptions you declined.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • You log communications with high-prescribing narcotic prescribers.
  • Red flags are identified, resolved, and documented before dispensing.

Answer NO if:

  • Prescriber verification calls aren't recorded.
  • Red flags are dispensed through without documented resolution.

Remember:

  • Under 21 CFR 1306.04, the pharmacist shares 'corresponding responsibility' for the proper prescribing and dispensing of controlled substances. Contemporaneous logs of prescriber communications and red-flag resolution are how you demonstrate you met that duty.

Question 5 of 12



Please answer with Yes or No

This includes: running the PDMP at the intervals your state requires, reviewing the patient's history for multi-prescriber/multi-pharmacy patterns, and documenting the check where required.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • You query the PDMP per your state's requirements.
  • Findings inform your dispensing decision and are documented as required.

Answer NO if:

  • PDMP checks are skipped or inconsistent.
  • Concerning histories aren't acted on or recorded.

Remember:

  • PDMP requirements are set by each state and most now mandate checks for controlled-substance dispensing. The PDMP complements — but does not replace — your corresponding-responsibility review under 21 CFR 1306.04.

Question 6 of 12



Please answer with Yes or No

This includes: pharmacists, technicians, and any staff who order, stock, dispense, or have access to controlled-substance stock or records.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

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

Answer NO if:

  • Some staff 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 7 of 12



Please answer with Yes or No

This includes: written SOPs for ordering, receiving, storage, dispensing, recordkeeping, returns, destruction, loss reporting, and diversion detection — kept current and actually followed.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • Your manual is current and reflects actual practice.
  • It covers ordering through destruction and loss reporting, and is reviewed regularly.

Answer NO if:

  • You have no manual, or it is outdated.
  • It omits key areas like returns, destruction, or diversion detection.

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 8 of 12



Please answer with Yes or No

This includes: a securely locked, substantially constructed cabinet/safe (or dispersal of CIIs throughout the stock to deter theft, as permitted), limited keyed/coded access, and alarm/surveillance for the controlled-substance area.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • CIIs are in a securely locked, substantially constructed cabinet or properly dispersed.
  • Access is limited and the area is alarmed/monitored.

Answer NO if:

  • Storage isn't substantially constructed or isn't consistently locked.
  • Access is broad or unmonitored.

Remember:

  • 21 CFR 1301.75(b) allows CIIs to be stored in a securely locked, substantially constructed cabinet OR dispersed throughout the stock of non-controlled drugs to deter theft. DEA also recommends alarms and surveillance for controlled-substance areas.

Question 9 of 12



Please answer with Yes or No

This includes: properly completed DEA-222s or electronic CSOS orders, recording the date and quantity received on each line, retaining your copy, and reconciling the order against the invoice and physical receipt.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • Each CII order is properly executed via DEA-222 or CSOS.
  • Date and quantity received are recorded and reconciled to the invoice.

Answer NO if:

  • 222/CSOS forms are incomplete or missing receipt data.
  • Orders aren't reconciled against what physically arrived.

Remember:

  • Schedule II substances may only be ordered with a DEA Form 222 or its electronic CSOS equivalent (21 CFR Part 1305). You must record the number of containers and date received on the purchaser's copy.

Question 10 of 12



Please answer with Yes or No

This includes: notifying DEA in writing within one business day of discovering a theft or significant loss, completing DEA Form 106, notifying the state board as required, and routinely reviewing data (audits, overrides, count discrepancies) for diversion. 

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • Staff know to notify DEA within one business day of a theft/significant loss.
  • You complete DEA Form 106 and monitor for diversion patterns.

Answer NO if:

  • There is no written reporting process.
  • No one routinely reviews records for diversion indicators.

Remember:

  • 21 CFR 1301.74(c) and 1301.76(b) require notifying DEA in writing within one business day of discovering a theft or significant loss, followed by DEA Form 106. 'Significant' considers the schedule, quantity, and whether the drug is a likely diversion target.

Question 11 of 12



Please answer with Yes or No

This includes: segregating non-dispensable controlled substances in secure storage, documenting them, and disposing via a DEA-registered reverse distributor or authorized on-site destruction — with DEA Form 41 records where applicable.

Answer options: Yes / No Pass = YES

YOUR ANSWER GUIDE

Answer YES if:

  • Unusable controlled substances are secured and documented.
  • Destruction uses a DEA-authorized method, with DEA Form 41 where applicable.

Answer NO if:

  • Expired stock accumulates with dispensable 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 (DEA Form 41 for inventory you destroy) as part of your binder.

Question 12 of 12



Please answer with Yes or No

This includes: a full review of registration, security, records, biennial and perpetual inventory reconciliation, 222/CSOS execution, corresponding-responsibility documentation, and diversion controls, performed by someone independent of daily operations. 

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.