What Is a Combination Product?
As innovation merges drugs, biologics, and devices into single therapies, traditional regulatory boundaries continue to blur. While combination products improve patient convenience—such as enabling at-home self-administration—they also introduce greater regulatory complexity because each constituent part retains its individual regulatory status after combination.
The Three Types of Combination Products
- Single-Entity Combination Products – Two or more regulated components are physically, chemically, or otherwise combined and produced as one unit.
- Co-Packaged Combination Products – Two or more separate products packaged together in a single package or sold as a unit.
- Cross-Labeled Combination Products – A drug, device, or biologic packaged separately but intended for use only with another specifically identified product.
