Protocol for Handling Returned and Expired Drugs in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedures for the proper handling, documentation, and disposal of returned, expired, or unused investigational drugs used in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all study personnel involved in the receipt, storage, distribution, and disposal of investigational drugs, including Investigators, Study Coordinators, Pharmacists, and Clinical Research Associates (CRAs).

Responsibilities

• The Investigator is responsible for ensuring the safe storage, handling, and disposal of investigational drugs in accordance with study protocols, regulatory requirements, and sponsor agreements.
• The Study Coordinator is responsible for coordinating the return and destruction of investigational drugs, documenting drug disposition, and maintaining drug accountability records.
• The Pharmacist is responsible for verifying the accuracy of drug returns, ensuring proper storage conditions, and overseeing drug destruction activities in compliance with pharmacy regulations.
• The Clinical Research Associate (CRA) is responsible for monitoring drug accountability, documenting drug returns and destruction, and verifying compliance with study protocols and regulatory requirements.

Procedure

1. Receive returned investigational drugs from study participants, study sites, or other authorized personnel according to established procedures and timelines.
2. Verify the accuracy and integrity of returned drug supplies, including batch numbers, expiry dates, and packaging condition, against study records and drug shipment documentation.
3. Document all returned drug transactions, including quantities returned, reasons for return, and disposition of returned drugs, in drug accountability logs and study documentation.
4. Store returned investigational drugs securely in designated storage areas with appropriate temperature and security controls to prevent unauthorized access or tampering.
5. Dispose of expired, unused, or surplus investigational drugs according to study protocols, sponsor instructions, and applicable regulatory requirements.
6. Destroy investigational drugs using approved methods, such as incineration, chemical decomposition, or other secure destruction processes, in compliance with environmental and safety regulations.
7. Document the destruction of investigational drugs, including the method of destruction, quantities destroyed, and witness signatures, in drug destruction records and study documentation.
8. Ensure that all drug destruction activities are conducted by authorized personnel and witnessed by at least one independent observer to verify the accuracy and completeness of drug destruction.
9. Report drug returns, destruction, and disposal activities to the sponsor, Institutional Review Board (IRB), and regulatory authorities as required by study protocols and regulatory guidelines.
10. Review and reconcile drug accountability records regularly to ensure accuracy and completeness of drug inventory and disposition records throughout the study conduct.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRA – Clinical Research Associate
• IRB – Institutional Review Board

Documents

• Drug Accountability Log
• Drug Return Documentation
• Drug Destruction Records
• Communication Log

Reference

International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for handling investigational drugs in clinical research.

SOP Version

Version 1.0