Standard Operating Procedure for Handling of Controlled Drugs and Substances

Purpose

The purpose of this SOP is to establish procedures for the secure and compliant handling, storage, and distribution of controlled drugs and substances, ensuring adherence to regulatory requirements and minimizing the risk of diversion or misuse.

Scope

This SOP applies to all personnel involved in the handling of controlled drugs and substances within the pharmaceutical distribution facility, including receipt, storage, dispensing, and documentation.

Responsibilities

• The Controlled Substances Coordinator is responsible for overseeing the handling of controlled drugs and substances and ensuring compliance with regulatory requirements.
• The Pharmacy Manager is responsible for maintaining accurate records of controlled substances transactions and monitoring inventory levels.
• The Security Officer is responsible for implementing security measures to prevent unauthorized access to controlled substances and monitoring surveillance systems.

Procedure

1. Receipt of Controlled Substances:
   • Receive controlled substances shipments in a designated receiving area under supervision.
   • Verify shipment documentation and reconcile received quantities with purchase orders.
2. Storage and Security:
   • Store controlled substances in secure storage areas with limited access and adequate physical security measures.
   • Implement access controls, such as key cards, biometric systems, or locked cabinets, to restrict access to authorized personnel only.
3. Dispensing and Administration:
   • Dispense controlled substances only to authorized personnel with valid prescriptions or requisitions.
   • Document all dispensing activities, including patient information, dosage, and quantity dispensed.
4. Inventory Management:
   • Maintain accurate records of controlled substances inventory, including initial counts, receipts, dispenses, and adjustments.
   • Conduct regular inventory reconciliations and physical counts to identify discrepancies and ensure accountability.
5. Documentation and Reporting:
   • Document all transactions involving controlled substances, including receipts, dispensing, waste disposal, and transfers.
   • Report any discrepancies, losses, or thefts of controlled substances to the appropriate authorities as per regulatory requirements.
6. Training and Education:
   • Provide training to personnel involved in the handling of controlled substances on proper procedures, security protocols, and regulatory requirements.
   • Ensure ongoing education and awareness programs to promote compliance and minimize risks associated with controlled substances handling.

Abbreviations

• SOP – Standard Operating Procedure

Documents

Reference documents related to the handling of controlled drugs and substances may include:

• Controlled substances inventory logs
• Dispensing records
• Incident reports
• Security protocols and access control policies

Reference

Applicable regulatory guidelines for handling controlled substances

SOP Version

Version 1.0