FDA Current 21 CFR Part 4 Good Manufacturing Practice Requirements for Combination Products

FDA Current 21 CFR Part 4 Good Manufacturing Practice Requirements for Combination Products

Final Regulation

The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP)requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products.