When is a warning statement required on a prescription?

A warning statement is required on prescriptions specifically for controlled substances classified as C2 (Schedule II), C3 (Schedule III), and C4 (Schedule IV) drugs. This requirement is in place to ensure that patients and their caregivers are made aware of the potential risks associated with these medications, which include a higher likelihood of abuse and dependence compared to other classes of drugs. By providing this warning, healthcare providers can promote responsible use and adherence to safety protocols, thereby reducing instances of misuse.

The other provided options do not align with the specific regulatory requirements governing warning statements. While all prescription medications do come with specific instructions and information, not all require a distinct warning statement. Additionally, over-the-counter medications have their own labeling guidelines that differ from prescriptions, and herbal supplements do not typically fall under the same regulatory requirements as controlled substances. Therefore, the focus on C2-C4 drugs underscores the heightened concern regarding safety and misuse pertinent to these categories.