Which act is associated with expanded oversight of OTC drugs and the requirement to label inactive ingredients?

Which act is associated with expanded oversight of OTC drugs and the requirement to label inactive ingredients?

• A. Kefauver-Harris Amendment
• B. Durham-Humphrey Amendment
• C. FDA Modernization Act of 1997
• D. DESI program

Answer: (C)

The key idea is how regulatory actions shape how OTC drugs are overseen and what must appear on their labels. The FDA Modernization Act of 1997 expanded the FDA’s authority to modernize and streamline oversight of over-the-counter drugs, and it specifically moved toward more complete labeling practices, including requiring that inactive ingredients be listed on labeling. This helps consumers, especially those with allergies or sensitivities, know exactly what’s in an OTC product. The Kefauver-Harris Amendment focused on proving drug safety and efficacy before approval and on related manufacturing and advertising controls, but it predates the modernization push for OTC labeling. The Durham-Humphrey Amendment established prescription versus OTC status and general labeling directions, rather than broad oversight expansion or inactive-ingredient labeling. The DESI program evaluated older, preexisting drugs to determine efficacy, rather than addressing current labeling requirements.

The key idea is how regulatory actions shape how OTC drugs are overseen and what must appear on their labels. The FDA Modernization Act of 1997 expanded the FDA’s authority to modernize and streamline oversight of over-the-counter drugs, and it specifically moved toward more complete labeling practices, including requiring that inactive ingredients be listed on labeling. This helps consumers, especially those with allergies or sensitivities, know exactly what’s in an OTC product.

The Kefauver-Harris Amendment focused on proving drug safety and efficacy before approval and on related manufacturing and advertising controls, but it predates the modernization push for OTC labeling. The Durham-Humphrey Amendment established prescription versus OTC status and general labeling directions, rather than broad oversight expansion or inactive-ingredient labeling. The DESI program evaluated older, preexisting drugs to determine efficacy, rather than addressing current labeling requirements.