Prior to initial dispensing of investigational drugs within an institution, which information must be maintained?

• A. Complete info regarding these drugs and their disposition
• B. Drug monograph only
• C. Signed patient consent only
• D. None

Answer: (A)

Investigational drugs require strict accountability and documentation. Before the first dispensing, there must be a complete record of the drug and how it will be used and handled. This means knowing the drug’s identity, source, lot numbers, expiration, and storage requirements, along with the specific protocol, dosing plan, monitoring, and labeling. Equally important is documenting the disposition of the drug—how much is dispensed, to whom, and what happens to unused or returned material (destruction or return to the sponsor). This enables precise traceability, patient safety, and regulatory compliance, and it supports audits or inspections. While obtaining patient consent is essential for participation, it does not replace the need for thorough drug information and disposition records.