South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What does the FDA Modernization Act of 1997 require to be labeled on prescription drugs?

1. Prescription only

2. Rx only

3. Only by a licensed pharmacist

4. Over-the-counter use

The correct answer is: Rx only

The FDA Modernization Act of 1997 brought significant changes to the regulation of prescription drugs, specifically concerning their labeling. One of the key requirements established by this legislation is the use of "Rx only" on prescription medications. This designation is crucial as it clearly indicates that the product is intended for use only under a licensed healthcare provider's supervision. Using "Rx only" instead of phrases like "Prescription only" is a more streamlined approach and is now the standard that aligns with the need for clarity and brevity in drug labeling. This change was made to reduce confusion and to provide a clear indication of the drug's status which helps ensure patients understand that these medications require a prescription. In contrast, options referring to specifications such as indicating a licensed pharmacist's involvement or categorizing a drug for over-the-counter use do not align with the specific requirements outlined in the FDA Modernization Act related to the labeling of prescription medications.