Wisconsin MPJE (Pharmacy Jurisprudence) Practice Exam

Which one of the following was NOT a change introduced by the FDA Modernization Act of 1997?

1. Changed long legend to "Rx only"

2. Encouraged NDAs for new uses

3. Expedited the approval process for generic drugs

4. Removed habit-forming wording

The correct answer is: Changed long legend to "Rx only"

The FDA Modernization Act of 1997 made several important changes to the regulation of drugs and medical devices. One of these changes was the removal of the "Caution Federal law prohibits dispensing without a prescription" statement, also known as the long legend, on prescription drug labels. This was replaced with the simpler "Rx only" statement. Therefore, A is incorrect and the other options are correct. B encouraged drug companies to submit New Drug Applications (NDAs) for new uses of already approved drugs. C expedited the approval process for generic drugs by allowing generic companies to rely on safety and efficacy data from the brand name drug. D removed habit-forming wording from drug labels in an effort to better inform patients about the potential risks and side effects of their medications.