Checklist template

Controlled substance handling for pharmacies

A ready-to-use checklist with 111 items in 6 sections, covering Storage, Perpetual inventory, Receiving, Dispensing checks, Disposal, Records. Use it as-is in Bindy, or adapt it to your own standards in minutes.

  • 6 Sections
  • 111 Items
  • 91 Yes / No checks
  • 6 Scored ratings
  • 121 Points

Use this template How audits work

1. Storage 18 items

  1. Controlled substances that local regulation requires to be secured are kept in a locked safe or cabinet, or dispersed among other stock where regulation and company policy allow it Yes / No 1 pt
  2. The safe or cabinet was found locked at the time of the visit Yes / No 1 pt
  3. The safe or cabinet is bolted to the floor or wall Yes / No 1 pt
  4. Only pharmacists, or staff authorized in writing, hold the key or combination Yes / No 1 pt
  5. Safe keys are carried by the pharmacist on duty, not left in a drawer or on a hook Yes / No 1 pt
  6. The combination or access codes were changed when the last person with access left the pharmacy Yes / No 1 pt
  7. Date the safe combination or access codes were last changed Date
  8. The time-delay lock is switched on, where the safe has one Yes / No 1 pt
  9. Controlled substances loaded in counting machine cells or cassettes are limited to those company policy allows Yes / No 1 pt
  10. The safe cannot be seen from the public side of the pharmacy counter Yes / No 1 pt
  11. Stock inside the safe is arranged by drug and strength with labels facing out Yes / No 1 pt
  12. Expired or damaged controlled substances are kept in a marked container, apart from active stock Yes / No 1 pt
  13. No controlled substance stock bottle is on the counter outside of a fill in progress Yes / No 1 pt
  14. Filled controlled substance prescriptions waiting for pickup are stored as company policy requires Yes / No 1 pt
  15. The dispensary gate or door is locked whenever no pharmacist is present Yes / No 1 pt
  16. The safe or cabinet holds all the stock that must be locked, with none overflowing to an open shelf Yes / No 1 pt
  17. Refrigerated controlled substances are kept in a locked box or locked refrigerator, where local regulation or company policy requires it Yes / No 1 pt
  18. Physical security of controlled substances Rating
    • Locked, restricted and out of sight 5 pts
    • Secured with lapses in key or code control 3 pts
    • Found unlocked or accessible to unauthorized staff 1 pt

2. Perpetual inventory 20 items

  1. A perpetual inventory is kept for each controlled substance that local regulation or company policy requires, by drug, strength and dosage form Yes / No 1 pt
  2. The balance is updated at the time of each fill, not in a batch at the end of the day Yes / No 1 pt
  3. The inspector's count of 5 controlled substances matched the perpetual balance Yes / No 1 pt
  4. Controlled substances counted by the inspector Number
  5. Controlled substances counted where the count differed from the perpetual balance Number
  6. The remaining quantity is counted after each fill and noted on the stock bottle or in the record Yes / No 1 pt
  7. Opened stock bottles are counted exactly, not estimated Yes / No 1 pt
  8. Liquid controlled substances are measured at each count, with the manufacturer's overfill accounted for Yes / No 1 pt
  9. A full count of the perpetual inventory is reconciled at the frequency set by company policy Yes / No 1 pt
  10. Date of the last full reconciliation Date
  11. The last full reconciliation is signed by the pharmacist and a second person Yes / No 1 pt
  12. Each discrepancy in the last 90 days has a written explanation of its cause Yes / No 1 pt
  13. Discrepancies that could not be explained were escalated as company policy requires Yes / No 1 pt
  14. Only a pharmacist can adjust a perpetual balance Yes / No 1 pt
  15. Every adjustment carries a reason Yes / No 1 pt
  16. The adjustment report for the last 30 days has been reviewed and initialed by the pharmacy manager Yes / No 1 pt
  17. Adjustments made to perpetual balances in the last 30 days Number
  18. The periodic controlled substance inventory required by local regulation is on file Yes / No 1 pt
  19. A full inventory was taken at the last change of pharmacist in charge Yes / No 1 pt
  20. Accuracy of the perpetual inventory Rating
    • All counts match and reconciliations are current 5 pts
    • Counts match but reconciliations are late 3 pts
    • Unexplained discrepancies 1 pt

3. Receiving 19 items

  1. Totes containing controlled substances are handed to pharmacy staff, not left at the front-store receiving door Yes / No 1 pt
  2. Tote seals are checked for tampering before the driver's delivery record is signed Yes / No 1 pt
  3. Seal numbers on controlled substance totes match the delivery manifest Yes / No 1 pt
  4. Controlled substance totes are opened on the day of delivery, before other freight Yes / No 1 pt
  5. A pharmacist, or the person local regulation designates, checks each controlled substance line against the invoice for drug, strength and quantity Yes / No 1 pt
  6. Manufacturer seals on the bottles received are intact Yes / No 1 pt
  7. The order record is completed with the quantity and date received, as local regulation requires Yes / No 1 pt
  8. Quantities received are added to the perpetual inventory on the day of delivery Yes / No 1 pt
  9. Stock is placed in the safe or its storage location as soon as it is checked in Yes / No 1 pt
  10. Shortages and damaged bottles are reported to the wholesaler on the day of delivery Yes / No 1 pt
  11. Controlled substance invoices are signed and dated by the pharmacist who received the order Yes / No 1 pt
  12. Controlled substance invoices are filed separately from other invoices Yes / No 1 pt
  13. Orders are placed only by pharmacists authorized to order controlled substances Yes / No 1 pt
  14. Ordering passwords or digital certificates are not shared between pharmacists Yes / No 1 pt
  15. Blank paper order forms are kept locked, where paper forms are used Yes / No 1 pt
  16. Controlled substances are ordered for the quantity needed until the next delivery, within the maximum set by company policy Yes / No 1 pt
  17. Transfers of controlled substances between stores are documented at both the sending and the receiving store Yes / No 1 pt
  18. Controlled substance invoices checked during the visit Number
  19. Receiving of controlled substances Rating
    • Checked in by a pharmacist the same day and recorded 5 pts
    • Checked in late or by other staff 3 pts
    • Not verified against the invoice 1 pt

4. Dispensing checks 18 items

  1. The prescription monitoring program is consulted before dispensing where local regulation or company policy requires it Yes / No 1 pt
  2. The consultation of the prescription monitoring program is documented on the prescription record Yes / No 1 pt
  3. Refills and transfers on the controlled substance prescriptions sampled stay within what local regulation allows Yes / No 1 pt
  4. Controlled substance prescriptions sampled carry every element local regulation requires Yes / No 1 pt
  5. Paper prescriptions are examined for alterations and for the security features of the prescription pad Yes / No 1 pt
  6. Controlled substance prescriptions are filled only within the validity period that local regulation sets from the date written Yes / No 1 pt
  7. Early refill requests are refused or carry a documented authorization from the prescriber Yes / No 1 pt
  8. Calls to a prescriber to verify a prescription are noted with the date and the person spoken to Yes / No 1 pt
  9. The quantity of each controlled substance fill is counted twice Yes / No 1 pt
  10. The person who double counted initials the label or record Yes / No 1 pt
  11. Partial fills are recorded with the quantity remaining and the date by which it must be collected Yes / No 1 pt
  12. Refusals to fill are recorded in a log or on the patient profile Yes / No 1 pt
  13. Photo identification of the person collecting is recorded where local regulation or company policy requires it Yes / No 1 pt
  14. An emergency verbal prescription is followed by the written prescription within the time local regulation allows Yes / No 1 pt
  15. Naloxone is offered with opioid prescriptions that meet the criteria in company policy Yes / No 1 pt
  16. The stock bottle is taken from the safe for one prescription at a time and put back before the next fill Yes / No 1 pt
  17. Controlled substance prescriptions sampled Number
  18. Checks before dispensing controlled substances Rating
    • Monitoring program, prescription and count verified each time 5 pts
    • Verified with gaps in documentation 3 pts
    • Checks skipped 1 pt

5. Disposal 18 items

  1. Expired controlled substances are removed from active stock at least once a month Yes / No 1 pt
  2. Each item removed is listed with its drug, strength and quantity Yes / No 1 pt
  3. Controlled substances awaiting destruction stay on the inventory records until they leave the pharmacy Yes / No 1 pt
  4. Expired controlled substances are sent to an authorized reverse distributor or destroyed at the frequency set by company policy Yes / No 1 pt
  5. Date of the last shipment or destruction of expired controlled substances Date
  6. The transfer documents and the receipt from the reverse distributor are on file for the last shipment Yes / No 1 pt
  7. Destruction on site is done only where local regulation allows it Yes / No 1 pt
  8. Each destruction record is signed by two authorized people Yes / No 1 pt
  9. Broken or spilled controlled substances are recorded with a witness signature Yes / No 1 pt
  10. Medication returned by patients is never placed in the pharmacy's stock Yes / No 1 pt
  11. Expired controlled substances held in the marked container are counted at each full reconciliation Yes / No 1 pt
  12. The take-back kiosk is locked Yes / No 1 pt
  13. The quantities on the reverse distributor's receipt match the pharmacy's list for the last shipment Yes / No 1 pt
  14. Reconstituted or compounded controlled substances never collected are recorded as waste with a witness signature Yes / No 1 pt
  15. Sealed liners from the take-back kiosk are kept locked, apart from the pharmacy's own expired stock Yes / No 1 pt
  16. Controlled substance prescriptions never collected are added back to the perpetual inventory by a pharmacist Yes / No 1 pt
  17. Expired controlled substance items awaiting disposal Number
  18. Disposal of controlled substances Rating
    • Segregated, documented and witnessed 5 pts
    • Segregated with incomplete documents 3 pts
    • Expired stock mixed with active stock or undocumented 1 pt

6. Records 18 items

  1. Controlled substance prescriptions are filed so that they can be retrieved separately, as local regulation requires Yes / No 1 pt
  2. 5 controlled substance prescriptions selected from the dispensing report were retrieved within 10 minutes Yes / No 1 pt
  3. Records are kept at the pharmacy for the period local regulation requires Yes / No 1 pt
  4. The daily controlled substance dispensing report is signed by the pharmacist where local regulation requires it Yes / No 1 pt
  5. Dispensing data is transmitted to the prescription monitoring program on schedule Yes / No 1 pt
  6. Transmission errors returned by the prescription monitoring program are corrected and resent Yes / No 1 pt
  7. Thefts and significant losses were reported to the regulator within the required time Yes / No 1 pt
  8. Theft or loss reports filed in the last 12 months Number
  9. The pharmacy's controlled substance registration or license is current Yes / No 1 pt
  10. Expiry date of the controlled substance registration or license Date
  11. Authorizations to order controlled substances name only pharmacists currently employed at the store Yes / No 1 pt
  12. The list of people with access to the safe matches the current staff roster Yes / No 1 pt
  13. Each pharmacy employee has a controlled substance handling training record dated within the last 12 months Yes / No 1 pt
  14. Findings of the last regulatory inspection or internal audit have been corrected Yes / No 1 pt
  15. Date of the last internal audit of controlled substances Date
  16. Name of the pharmacist in charge Short text
  17. Overall control of controlled substances Rating
    • Stock locked, counts matching and records complete 5 pts
    • Stock locked and counts matching, with late or incomplete records 3 pts
    • Unexplained count differences or stock left unsecured 1 pt
  18. Corrective actions required Comments

About this template

This checklist is part of the Bindy template library. Yes / No checks score 1 point when met; ratings score the points shown for each option. The overall score is the percentage of points earned, with N/A answers excluded. In Bindy you can add photos, assign corrective actions, require sign-off and compare results across sites.

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