Which of the following is NOT a component of REMS programs?

• A. MedGuides
• B. Package insert
• C. Public health advisory
• D. Patient registries

Answer: (C)

RemS programs are designed to reduce serious risks by embedding safeguards and information directly into how a drug is prescribed, dispensed, and used. They commonly include MedGuides that educate patients about key risks, changes to labeling that appear in the package insert to communicate REMS-related safety information to clinicians, and patient registries that collect real-world safety data to monitor outcomes. A public health advisory, while an FDA safety communication about drug risks in general, operates outside the REMS framework and does not constitute a drug‑specific risk‑mitigation element. So the item that isn’t part of a RemS program is the public health advisory.