Which of the following statements is true concerning a product that has a Risk Evaluation and Mitigation Strategy REMS program?

While the REMS program may include specific guidelines for safe handling or administration, it does not necessarily dictate compounding instructions. Compounding is typically governed by separate regulations and standards, and not all REMS programs include compounding directives.

Although REMS programs are implemented to manage risks, the existence of a REMS does not inherently mean that misuse or diversion is more likely. Instead, it indicates that the product has specific safety concerns that need to be monitored, rather than suggesting a higher incidence of misuse.

Adherence to REMS program guidelines is not subject to pharmacist discretion; it is a regulatory requirement. Pharmacists must follow the guidelines as part of their professional responsibility to ensure patient safety and compliance with FDA regulations.