On January 22, 2013, the FDA published its final cGMP rule for combination products in the Federal Register. According to the rule’s summary, “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. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for “single-entity” and “co-packaged” combination products.”
According to the FDA, the final rule is “largely identical” to the proposed rule published in the Federal Register on September 23, 2009. The rule takes effect on July 22, 2013.
