DEA Form 222 & CSOS e222: Ordering Schedule II Controlled Substances
A comprehensive guide to ordering, documenting, and managing Schedule II controlled substances using paper DEA Form 222 and electronic CSOS e222 systems.
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For additional resources to support pharmacy controlled substance ordering and inventory compliance click HERE.
FULL ARTICLE
Ordering Schedule II controlled substances requires strict adherence to federal regulations to ensure security, traceability, and accountability. Pharmacies must properly manage both paper DEA Form 222 and its electronic equivalent, CSOS e222, to maintain compliance and prevent diversion.
This guide outlines how to request, complete, store, and manage these order forms, along with best practices for maintaining accurate and audit-ready records.
Authorized Use & Access
Only properly registered pharmacies may order Schedule II controlled substances using DEA Form 222 or CSOS e222.
- Access is limited to authorized personnel, typically those granted Power of Attorney (POA)
- Authorization should be clearly documented and periodically reviewed
- Unauthorized staff must not handle or execute controlled substance orders
DEA Form 222 (Paper Order Forms)
Requesting & Managing Forms
- DEA Form 222 is obtained during DEA registration or ordered online for additional forms
- Upon receipt, forms should be:
- Verified for correct pharmacy information--contact the local DEA office if errors are present
- Checked for sequential numbering
- Stored securely (e.g., locked cabinet or safe)
- Missing or stolen forms must be reported immediately to the DEA
- Pharmacies should maintain a DEA Form 222 Manifest for documenting all DEA Form 222 actions (e.g. activated, voided, returned to the DEA, etc.).
Completing DEA Form 222
To ensure validity:
- Forms must be completed using permanent methods (pen, printer, or typewriter)
- Each form allows:
- One drug per line
- Accurate entry of package size, quantity, and drug name
- Required elements include:
- Purchaser name, signature, and date
- Supplier information (name, address, DEA number)
- Only one supplier per form
- Last line completed
- Once signed, the form is valid for 60 days
Processing & Receiving Orders
After completion:
- The pharmacy retains a copy (paper) and sends the original to the supplier for fulfillment
- Upon receipt of the order:
- Record quantities received and date on the form copy
- Reconcile against the wholesaler invoice
- Annotate invoice (check, sign, and date)
- Store documents together in a readily retrievable format separate from all other records
- Records must be maintained for at least 2 years
Errors, Voids, & Corrections
- Errors must not be altered or erased
- Incorrect forms should be:
- Marked “VOID”
- Documented and retained
- Replaced with a new form
Rejected or Cancelled Orders
- Suppliers may reject incomplete or altered forms
- Rejected forms must be retained with documentation explaining the reason
- Orders may be partially or fully canceled in writing
- Suppliers must document cancellations on the original form
Lost or Stolen Forms
If forms are stolen:
- Notify the DEA immediately with serial numbers (if available)
- Maintain documentation of the incident
If an order is lost:
- Issue a replacement form
- Provide a statement confirming the original was not fulfilled
If DEA registration is terminated, all unused forms must be returned
CSOS e222 (Electronic Ordering System)
CSOS allows electronic ordering of Schedule II substances, offering improved efficiency and digital recordkeeping.
Enrollment & Access
- Pharmacies must enroll in CSOS and designate a CSOS Coordinator
- Orders must be signed using a DEA-issued digital certificate
Required Order Information
Each e222 must include:
- Unique tracking number (specific format required)
- Pharmacy DEA number
- Supplier name, address, and DEA number
- Date of order
- Drug name, strength, and NDC
- Package size and quantity ordered
Recordkeeping Requirements
- Original signed electronic orders must be retained
- Records must be:
- Electronically linked
- Readily retrievable
- Maintained for at least 2 years
- Best practice includes:
- Downloading and saving a PDF copy
- Using consistent file naming conventions
- Storing in secure, organized folders (e.g., cloud or local systems)
Receiving & Reconciling CSOS Orders
Upon receiving shipments:
- Access the order in the wholesaler system
- Mark the order as “received” and record the date
- Confirm receipt (attestation)
- Download and store finalized records
- Reconcile the order with the invoice:
- Verify quantities
- Annotate, sign, and date the invoice
- Store with the corresponding e222 record
Additional Considerations
- Electronic orders must follow the same rules for:
- Rejection
- Cancellation
- Loss or discrepancies
- All activities must align with Controlled Substances Act (CSA) requirements
Proper management of DEA Form 222 and CSOS e222 orders is essential for maintaining compliance, ensuring accurate controlled substance tracking, and preventing diversion. By implementing structured processes, securing documentation, and routinely reviewing records, pharmacies can remain audit-ready and operate with confidence.
Disclaimer: These tools and templates are intended for general informational purposes and are provided by Montana Family Pharmacies as a service to pharmacies. While we try to keep the information timely and accurate, we make no guarantees. These tools and templates are not a substitute for legal, regulatory, or professional advice.
Policies and procedure, templates, checklists, and other tools should be customized to fit the specific needs and regulatory requirements of your pharmacy.
Montana Family Pharmacies disclaims any liability for any damages, losses, or other consequences arising from the use or reliance on the tools or policy templates.