Procurement of Controlled Substances – Standard Operating Procedure

1) Purpose

To establish guidelines for the procurement of controlled substances in compliance with regulatory requirements, ensuring secure handling and proper documentation within the pharmaceutical purchase department.

2) Scope

This SOP applies to all procurement activities involving controlled substances, including order placement, receipt, storage, and documentation.

3) Responsibilities

Procurement Manager: Responsible for overseeing the procurement process and ensuring compliance with regulations.
Procurement Team: Responsible for executing procurement activities and maintaining accurate records of controlled substances.

4) Procedure

4.1) Supplier Qualification:
4.1.1) Select suppliers authorized to handle and distribute controlled substances.
4.1.2) Verify supplier compliance with relevant regulatory requirements, such as DEA or local regulations.

4.2) Order Placement:
4.2.1) Ensure purchase orders for controlled substances are placed with approved suppliers.
4.2.2) Include necessary documentation and authorization with each order, as required by regulations.

4.3) Receipt of Controlled Substances:
4.3.1) Verify the accuracy of delivered controlled substances against the purchase order and accompanying documentation.
4.3.2) Record the receipt in a controlled substances log, including quantities, batch numbers, and storage locations.

4.4) Storage and Security:
4.4.1) Store controlled substances in secure, locked facilities with restricted access.
4.4.2) Implement security measures, such as surveillance systems and access controls, to prevent unauthorized access.

4.5) Documentation and Record Keeping:
4.5.1) Maintain detailed records of all transactions involving controlled substances, including orders, receipts, and usage.
4.5.2) Ensure records are complete, accurate, and readily available for regulatory inspections.

4.6) Compliance and Audits:
4.6.1) Conduct regular audits to verify compliance with regulatory requirements and internal procedures.
4.6.2) Address any discrepancies or non-compliance issues promptly and implement corrective actions.

4.7) Disposal of Controlled Substances:
4.7.1) Follow regulatory guidelines for the disposal of expired, unused, or excess controlled substances.
4.7.2) Document the disposal process, including quantities and methods used, in accordance with regulatory requirements.

5) Abbreviations, if any

• DEA: Drug Enforcement Administration

6) Documents, if any

• Purchase Orders
• Controlled Substances Log
• Supplier Compliance Certificates
• Audit Reports
• Disposal Records

7) Reference, if any

Regulatory Guidelines: DEA regulations, FDA CFR Part 1300
Industry Standards: ISO 13485:2016

8) SOP Version

Version 1.0