Which of the following statements is true about the Medication Guide program?

The Medication Guide program was established by the FDA to ensure that patients receive essential information about specific medications that carry serious risks. The program applies only to a limited number of prescription drugs that are deemed to have specific safety concerns, including potential adverse effects or other issues that require enhanced communication to patients.

The correct answer highlights that the program is not universal across all prescription drugs, but rather targeted towards those medications that warrant additional patient guidance. This allows healthcare providers to better educate their patients about the medications they are using, ensuring safety and minimizing the risk of adverse events.

The other statements do not accurately depict the scope or requirements of the Medication Guide program. For instance, the program is mandatory for certain drugs, not optional for manufacturers, indicating that manufacturers must comply with the guidelines for those specific medications. Additionally, it does not apply to over-the-counter drugs, as the program primarily focuses on prescription medications that have been identified as needing a Medication Guide for safe usage. Thus, the emphasis on a limited group of drugs underscores the specific nature of the program.