What does 21 CFR 207 regulate?

21 CFR 207 specifically regulates the registration of producers of drugs and the listing of drugs that are in commercial distribution. This section of the Code of Federal Regulations outlines the requirements for establishments involved in the manufacturing, repacking, or relabeling of drugs for human use. It mandates that these entities properly register with the FDA and ensure that their products are listed accurately. The registration process helps the FDA track drug manufacturers and the drugs in circulation, facilitating regulatory oversight, safety monitoring, and enforcement actions when necessary.

This regulation is critical for maintaining an up-to-date inventory of medical products available in the market, which supports the FDA's mission to protect public health. The focus on registration and listing rather than other areas, such as the approval process, clinical trials management, or device premarket processes, distinguishes 21 CFR 207’s specific regulatory intent and scope.