Under FDA part C, drugs that require a prescription are categorized into what two parts?

The correct categorization under FDA part C for drugs that require a prescription distinguishes between those that have a prescription requirement (Rx) and those that may be available for over-the-counter (OTC) sale. In this context, also noting the presence of the PR (Prescription Required) designation emphasizes that some medications cannot be legally obtained without a prescription from a qualified healthcare provider.

The option specifying "Rx required, PR printed on package" accurately reflects the FDA's classification system. Drugs that fall under this classification must have the prescription requirement clearly noted to inform both consumers and healthcare professionals about the regulatory requirements for their use. This is crucial for patient safety and ensuring that potentially dangerous medications are only used under medical supervision.

In comparison to the other options, those that mention PR only or suggest that prescriptions are optional do not accurately capture the true regulatory requirements. Prescription medications must have a clear distinction from those that are available OTC, which is not conveyed in options suggesting limited or incorrect categorizations. This clarity helps ensure that patients receive the appropriate medications safely and responsibly.