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Compliance Audit · Pro

Pharmacy DEA Compliance Audit Checklist Form

Streamline your pharmacy's DEA compliance audits with a structured checklist covering controlled substance storage, security, and access controls.

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formbuilder.ai/f/pharmacy-controlled-substance-handling-dea-compliance-audit-checklist

Pharmacy Controlled Substance Handling & DEA Compliance Audit Checklist

Pharmacy Name

· · ·

Pharmacy License Number

· · ·

DEA Registration Number

· · ·

Submit

The Pharmacy Controlled Substance Handling & DEA Compliance Audit Checklist is a comprehensive form designed to help pharmacies systematically evaluate their adherence to federal regulations governing Schedule II–V controlled substances. It captures essential pharmacy and auditor details, DEA registration information, and a thorough review of physical security measures, storage compliance, and access controls as required by 21 CFR 1301.71–1301.76.

This template is ideal for pharmacy compliance officers, DEA auditors, state board inspectors, and pharmacy managers who need a reliable, repeatable process for conducting internal or external audits. It ensures every critical checkpoint—from locked cabinet requirements to 24/7 alarm monitoring and camera coverage—is documented and accounted for in a single organized form.

By using this digital checklist, pharmacies can reduce compliance risk, maintain accurate audit trails, and quickly identify and document security deficiencies before they become regulatory violations. Customize the form to match your pharmacy's specific operational needs and keep your DEA compliance program audit-ready at all times.

4 Pages

42 Questions

~14min To complete

Free No credit card needed

Field types Yes / No ×22 Date ×4 Short Text ×3 Long Text ×3 Dropdown ×2 Address Full Name Email Phone Star Rating File Upload termsandconditions Signature

Questions in this template

Free template

The exact questions included — customize any of them to fit your needs.

Page 1 Pharmacy & Auditor Information 10 questions

Pharmacy & Auditor Information

1 Pharmacy Name * Short Text

2 Pharmacy License Number * Short Text

3 DEA Registration Number * Short Text

4 DEA Registration Expiration Date * Date

5 Pharmacy Address * Address

6 Lead Auditor Name * Full Name

7 Auditor Email * Email

8 Auditor Phone Number Phone

9 Audit Date * Date

10 Audit Type * Dropdown

Page 2 Storage, Security & Access Controls 10 questions

Storage, Security & Access Controls

Evaluate all physical security measures, storage compliance, and access controls for Schedule II–V controlled substances per 21 CFR 1301.71–1301.76.

1 Are Schedule II substances stored in a securely locked, substantially constructed cabinet or vault? * Yes / No

2 Are Schedule III–V substances stored in a locked cabinet or dispersed throughout non-controlled inventory per DEA guidelines? * Yes / No

3 Is access to controlled substance storage limited to authorized personnel only? * Yes / No

4 Are keys, combinations, or electronic access credentials restricted and accounted for? * Yes / No

5 Are security cameras operational and covering all controlled substance storage areas? * Yes / No

6 Is the pharmacy equipped with a functioning alarm system monitored 24/7? * Yes / No

7 Describe any identified storage or security deficiencies Long Text

Access Log & Personnel Verification

8 Is a current list of all employees authorized to handle controlled substances maintained on-site? * Yes / No

9 Are background checks completed for all personnel with controlled substance access? * Yes / No

10 Are access logs reviewed regularly for unusual or unauthorized entries? * Yes / No

Page 3 Inventory, Recordkeeping & Dispensing Compliance 11 questions

Inventory Management & Perpetual Recordkeeping

1 Is a biennial inventory of all controlled substances completed and on file? * Yes / No

2 Date of Last Biennial Inventory * Date

3 Is a perpetual inventory system maintained for Schedule II substances? * Yes / No

4 Are all inventory discrepancies investigated and documented within 72 hours? * Yes / No

5 Are incoming controlled substance orders verified against invoices and logged immediately upon receipt? * Yes / No

Prescription Dispensing & Documentation

6 Are all Schedule II prescriptions verified for valid prescriber DEA number, patient information, and proper format? * Yes / No

7 Are controlled substance prescriptions filed separately or readily retrievable per DEA requirements? * Yes / No

8 Are records of controlled substance dispensing retained for a minimum of 2 years (or per state requirement)? * Yes / No

9 Is the pharmacy utilizing a state Prescription Drug Monitoring Program (PDMP) as required? * Yes / No

10 Are partial fills of Schedule II substances documented and tracked per DEA policy? * Yes / No

11 Note any recordkeeping or dispensing compliance gaps observed Long Text

Page 4 Loss Prevention, Reporting & Final Assessment 11 questions

Theft, Loss & Diversion Prevention

1 Is there a written policy for reporting controlled substance theft or significant loss to the DEA (Form 106)? * Yes / No

2 Have all instances of theft or significant loss been reported via DEA Form 106 within required timeframes? * Yes / No

3 Are expired or damaged controlled substances reverse-distributed through a DEA-authorized reverse distributor? * Yes / No

4 Is there an active diversion detection and prevention program in place? * Yes / No

Overall Compliance Assessment

5 Overall DEA Compliance Rating * Star Rating

6 Audit Outcome * Dropdown

7 Summary of Findings & Recommended Corrective Actions * Long Text

8 Upload Supporting Documentation (photos, logs, incident reports) File Upload

9 I certify that this audit was conducted thoroughly and the findings documented herein are accurate to the best of my knowledge. * termsandconditions

10 Auditor Signature * Signature

11 Date of Signature * Date

How to use this template

Click "Use This Template Free" to open it in the FormBuilder editor. From there you can add, remove, or reorder fields with drag-and-drop, switch themes for instant restyling, add your logo, configure email notifications, and set your success message. When ready, publish with a unique link and start collecting responses immediately.