FDA Releases cGMP Draft Guidance For Combination Products

The U.S. Food and Drug Administration recently issued draft guidance outlining current good manufacturing practice (cGMP) requirements for combination products. The draft guidance intends to clarify cGMP requirements for combination products and provides hypothetical scenarios illustrating compliance considerations for certain types of combination products. In the draft guidance, the FDA defines a combination product as a product that comprises any combination of drugs, device, or biologics, referred to as its constituent parts (Section II). These may be further classified into single-entity, co-packaged, and cross-labeled combination products. The draft guidance reiterates that the preamble to the final rule states that "the cGMP requirements for constituent parts of cross-labeled combination products that are manufactured separately and not co-packaged are the same as those that would apply if these constituent parts were not part of a combination product."