What type of drugs is subject to the Drug Product Safety and Effectiveness provisions of the FDA?

Prescription and over-the-counter medications are both subject to the Drug Product Safety and Effectiveness provisions of the FDA. This comprehensive regulatory framework is designed to ensure that all marketed drugs, regardless of their classification, meet specific safety and efficacy standards before they can be sold to the public. The provisions are critical for consumer protection, ensuring that both prescription medications, which require a healthcare provider's supervision, and over-the-counter medications, which are available for public purchase without a prescription, are thoroughly evaluated for their intended use and any potential side effects.

This regulatory oversight covers a wide range of pharmaceuticals to ensure that they are safe for consumption, effective for their intended uses, and properly labeled to inform users about potential risks and benefits. In practice, this means that both types of medications must undergo rigorous testing and review processes before they can be marketed, ensuring public health and safety as a primary concern of the FDA.