What federal regulations govern the recall of pharmaceuticals?

The recall of pharmaceuticals is primarily governed by Title 21 of the Code of Federal Regulations (CFR), which outlines the regulations enforced by the Food and Drug Administration (FDA). This part of the CFR includes comprehensive guidelines regarding the approval, monitoring, and recall processes for pharmaceuticals and medical devices. Specifically, it details the responsibilities of manufacturers in maintaining safety and efficacy and the procedures that must be followed if a product is found to be unsafe or defective after being on the market.

The FDA has established clear protocols for product recalls, which are critical in protecting public health. These protocols ensure that when a pharmaceutical product poses a risk, appropriate actions are taken to remove it from the market swiftly, inform healthcare professionals and the public, and mitigate any potential health risks associated with its use. Therefore, Title 21 of the CFR is the authoritative source when it comes to understanding the federal framework governing pharmaceutical recalls.