FDA Issues Final Rule Regarding CGMPs for Combination Products


On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or “the Agency”) published a final rule regarding Current Good Manufacturing Practice Requirements for Combination Products. 78 Fed. Reg. 4307 (Jan. 22, 2013). FDA intends to clarify which current good manufacturing practice (CGMP) requirements apply to combination products, that is, products that combine drugs, medical devices, biological products, and/or human cell and tissue products (HCT/Ps). The final rule provides guidelines for the creation of a streamlined CGMP operating system for facilities that manufacture single entity or co-packaged combination products. The final rule will become effective on July 22, 2013.

History of the Rule -

FDA first attempted to address the CGMP requirements for combination products via a draft guidance document entitled “Current Good Manufacturing Practices for Combination Products” in October 2004. After receiving comments on the draft guidance, the Agency determined that the issue was best addressed through rulemaking and issued a proposed rule on September 23, 2009. In addition, FDA co-sponsored a stakeholder workshop in January 2010 to identify areas for potential comment on the proposed rule. FDA received 25 sets of comments from industry, trade associations, and individuals about the proposed rule and considered them when drafting the final rule.

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