South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which act enacted in 1997 modernized regulations governing pharmaceutical manufacturing and marketing?

1. Food, Drug, and Cosmetic Act

2. Federal Anti-Tampering Act

3. FDA Modernization Act

4. Dietary Supplement Health and Education Act

The correct answer is: FDA Modernization Act

The FDA Modernization Act, enacted in 1997, was specifically designed to update and modernize the various regulatory processes governing drug and medical device approval, as well as the marketing of pharmaceuticals. It aimed to streamline the process for introducing new drugs and encouraged innovation in the pharmaceutical industry. Key provisions of the act included eliminating certain requirements that were seen as outdated, such as the necessity for health claims on dietary supplements to be pre-approved by the FDA. It also made significant changes to the drug approval process, allowing for a more flexible and expedited pathway for the introduction of new medications. Furthermore, the act aimed to enhance patient access to information regarding treatment options and to facilitate faster patient access to new drugs through the reduction of the time frame for reviews and approvals. This modernization ultimately aimed to balance the need for effective oversight of drug manufacturing and marketing with the recognition of the rapid advancements in pharmaceutical science and public health needs. The other acts listed either do not pertain specifically to the modernization of pharmaceutical regulations or are focused on different areas of public health and safety.