DEA Compliance at Registered Hospital/Clinic (Checklist)
DEA Compliance and Controlled Substance Records
- All records are readily retrievable and stored securely.
- Records include accurate inventory, receipts, dispensing logs, and destruction documentation.
- Separate records for Schedule II substances.
- Records maintained for at least 2 years, per DEA requirements.
DEA Form Documentation
- Copy of the DEA certificate
- Copy of the State License
- Initial and/or Biennial Inventory
- DEA Form 222 used for Schedule II transfers and properly filed.
- DEA Form 41 completed for destruction of controlled substances.
- DEA Form 106 filed for theft or loss incidents, to include the 24 hour notice.
- Schedule III-V Invoices
- Power of Attorneys
- Dispensing or Administering Records
Compounding & Stock Use
- Documentation supports compounding for stock use.
- Registration type matches compounding activity (e.g., not just hospital/clinic).
- If compounding based on a patient order the hospital/clinic registration is permitted
- If compounding non-patient specific you must be registered as a manufacturer.
Destruction Protocols
- Destruction methods render substances non-retrievable.
- Witness documentation and logs are complete.
- Reverse distributor records are maintained.
Distributions
- Controlled substances are not shipped to unregistered locations.
Patient-Owned Medications
- Policies in place for handling and storing patient-owned controlled substances.
- Are patient own medications stored in the pharmacy
- Are all controlled substances brought into the hospital by patients turned over to the police or local DEA office.
Security & Access
- Access to controlled substance records is restricted to authorized personnel.
- All controlled substances secured in a substantially constructed securely locked cabinet.
- Security team procedures align with DEA guidelines for possession and destruction.
Audit & Review
- Regular internal audits of controlled substance records.
- Staff training on DEA recordkeeping requirements.
Other Records (Consult and Attorney before providing)
- List of persons who have access to controlled substances
- Floor plan of the pharmacy
