Food and Drug Administration

  • 21 CFR Part 4
  • [Docket No. FDA–2009–N–0435]

Current Good Manufacturing Practice Requirements for Combination Products

  • AGENCY: Food and Drug Administration, HHS.
  • ACTION: Final rule.


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. 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. 

DATES: This rule is effective July 22, 2013.

Download Final Rule in PDF

Download “cGMP for Combination Products” 2013-01068.pdf – Downloaded 364 times – 256 KB

FDA Guidance

Last Updated: 2016-05-19