Which of the following best describes the regulatory goal of ensuring drug establishments and products are registered and listed?

• A. To ensure that drug establishments and products are registered and listed with the FDA
• B. To set drug prices
• C. To regulate only device manufacturers
• D. To oversee dietary supplements

Answer: (D)

Registration and listing of drug establishments and products with the FDA creates a current, official registry that the agency uses to know who manufactures drugs and what products are on the market. This foundation enables crucial regulatory actions—inspections, recalls, safety communications, and adverse-event monitoring—by providing precise, up-to-date information about each facility and product. It is a prerequisite for marketing many drug products and helps maintain accountability across the supply chain.

Prices, device regulation, and dietary supplements fall outside this specific registration-and-listing framework. Pricing is set through other mechanisms, devices are regulated under a separate track, and dietary supplements are governed by different rules under DSHEA, not the drug establishment registration and listing system.