Ordering & Receiving Controlled Substances in Pharmacies
A practical guide to safely ordering, receiving, and documenting Schedule II–V controlled substances while maintaining compliance and preventing diversion.
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Pharmacies must maintain a secure and well-documented process for ordering and receiving controlled substances. These processes are essential to prevent diversion, ensure accurate inventory, and comply with federal and state regulations.
This guide outlines best practices for ordering Schedule II–V controlled substances, verifying shipments, and maintaining proper documentation.
Licensing & Wholesaler Requirements
Before ordering controlled substances, pharmacies must meet key regulatory requirements:
- Maintain an active DEA registration and all applicable state licenses
- Ensure all licenses are current and submitted to wholesalers as required
- Only order from licensed and registered wholesalers
Pharmacy leadership should periodically verify that all wholesaler credentials remain active and compliant.
Ordering Schedule II Controlled Substances
Schedule II medications require stricter controls and must be ordered using:
- DEA Form 222 (paper) or
- CSOS e222 (electronic system)
Authorized Personnel Only
- Only staff with proper authorization (e.g., Power of Attorney) may place Schedule II orders
Ordering Best Practices
- Orders should reflect legitimate patient need and historical usage
- Avoid excessive quantities
- Carefully review all orders before submission to ensure accuracy and necessity
Receiving Schedule II Controlled Substances
Upon delivery:
If Ordered via DEA Form 222:
- Record quantities received and date on the 222 form copy
- Reconcile with the wholesaler invoice
- Annotate invoice (check/initial line items, sign, date)
- Store documentation together in a readily retrievable format for at least 2 years
If Ordered via CSOS (e222):
- Access the order in the wholesaler system
- Verify accuracy and mark as “received”
- Record the date of receipt and confirm shipment
- Download and store the finalized e222 record
- Print a copy if required by workflow
- Reconcile and annotate the invoice
- Store all records together for at least 2 years
Handling Discrepancies
- Any mismatch between order, invoice, and received product must be reported to the wholesaler immediately
- Document the issue and resolution, and retain with the order records
Ordering & Receiving Schedule III–V Controlled Substances
These schedules follow a standard wholesaler ordering process but still require careful controls.
Ordering Guidelines
- Order only quantities consistent with expected patient demand
- Review orders before submission for accuracy and appropriateness
Receiving Process
- Reconcile received items with the invoice
- Annotate invoice (check/initial, sign, date)
- Store invoices separately and in a readily retrievable format for at least 2 years
Discrepancies
- Report and document any discrepancies immediately
- Retain all related documentation with the original invoice
Receiving & Unpacking Shipments
Proper receiving procedures are critical to maintaining security and preventing diversion.
Upon Delivery:
- Verify the number of totes against the delivery manifest
- Confirm all expected containers are present
- If items are missing, notify the driver and wholesaler immediately and refuse delivery if necessary
Inspection & Security:
- Ensure all totes and tamper-evident packaging are intact
- Secure shipments in a designated area before unpacking
Unpacking Process:
- Open and inspect contents promptly
- Verify:
- Products are in original containers
- Manufacturer seals are intact
- No signs of tampering, damage, or leakage
Issue Resolution:
- Contact the wholesaler immediately if any issues are identified
- Document findings and resolutions
- Store documentation with the corresponding invoice
Documentation & Record Retention
For all controlled substance orders:
- Maintain complete, accurate, and organized records
- Store documentation in a readily retrievable format
- Retain records for at least 2 years (or longer if required by state law)
Proper documentation supports audits, investigations, and ongoing compliance.
Maintaining a secure and consistent process for ordering and receiving controlled substances is essential for preventing diversion and ensuring regulatory compliance. By following structured procedures, verifying all shipments, and keeping thorough records, pharmacies can protect their inventory, staff, and patients while remaining audit-ready.
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.