Which organization has a policy on IRB and investigational use of drugs that supports pharmacists in managing control and distribution of drugs used in research?

• A. FDA
• B. NIH
• C. ASHP
• D. DEA

Answer: (C)

Pharmacists working with research drugs rely on formal guidance about how to handle investigational products within study protocols and IRB oversight. The American Society of Health-System Pharmacists provides policy statements and standards specifically about investigational drug services, including how to coordinate with IRBs, manage storage, dispensing, labeling, documentation, and accountability of investigational agents in hospital and health-system settings. This guidance directly supports pharmacists in controlling and distributing drugs used in research while complying with regulatory requirements and protecting patient safety.

While the FDA sets the regulatory framework for investigational drugs (like INDs and IRB approvals), its role is regulatory, not a practice policy for pharmacists' day-to-day management. NIH offers research guidance and funding policies, not pharmacy-specific policies for investigational drug handling. DEA focuses on controlled substances and enforcement, not the broader policy framework for research drug management in clinical settings.