FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. The rule clarifies which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. For certain types of combination products the application of CGMP requirements is straightforward – the constituent parts of a combination product are each subject only to the CGMP requirements applicable to that type of constituent part if the parts are manufactured and marketed separately. In other words, where parts of a combination product are separately manufactured and marketed, they remain separate for the purposes of applying CGMP regulations. The application of CGMP requirements to “single-entity” and “co-packaged” combination products is more complex. Thus, the final rule also sets forth a transparent and streamlined regulatory framework for manufacturers to use when demonstrating compliance with CGMP requirements for such products. Specifically, manufacturers may demonstrate compliance with CGMPs for “single-entity” and “co-packaged” combination products in one of two ways: (1) by demonstrating compliance with the specifics of all CGMP requirements applicable to each of the constituent parts included in the combination product; or (2) if the combination product contains both a drug and a device, demonstrating compliance with either drug CGMPs or quality system regulations for devices, in addition to other requirements set forth in the final rule. “Single-entity” combination products are products comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single-entity. “Co-packaged” combination products are two or more separate products packaged together in a single package or as a unit and comprised two regulated components. The rule becomes effective on July 22, 2013.