FDA Publishes Final Rule on Combination Products
The U.S. Food and Drug Administration (FDA) has issued a long-awaited final rule concerning current good manufacturing practice (CGMP) requirements for combination products.
The rule, which was published in the Jan. 22 Federal Register, is designed to clarify what CGMP requirements apply to products made of a combination of drugs, devices, and/or biologics. As the agency notes, it is “largely identical” to a proposed rule on the topic issued in September 2009.
For those products whose constituent parts are separately manufactured and marketed, the respective CGMP requirements for each part would apply, the rule states. The situation has proven murkier for single-entity and copackaged products, so the final rule discusses how manufacturers of these items may demonstrate compliance with CGMP requirements. For example, manufacturers of drug-device combinations may do one of the following:
- Show compliance with all drug CGMP requirements and the quality system (QS) regulation
- Show compliance with drug CGMP requirements and certain provisions of the QS regulation
- Show compliance with the QS regulation and certain provisions of the drug CGMP requirements
The rule also addresses the 25 comments the FDA received on the 2009 proposed rule, including ones suggesting that the rule should apply only to new products, not existing ones. The agency rejected this idea, noting it isn’t trying to change existing CGMP requirements, but merely explaining how to apply them to combination products.
Although one commenter argued the rule would stifle innovation, the agency disagreed, adding that manufacturers should already be in compliance with CGMP requirements for each part of their combination products. The final rule merely “clarifies and codifies this view,” the regulator notes.
The agency estimates that roughly 300 manufacturers will be affected by the final rule. However, they “should benefit from the greater clarity provided regarding what regulatory provisions apply to their products and how they may comply with them,” the rule notes.
The rule takes effect July 22, 2013. Click here to read the Federal Register notice.
AAMI is forming a new working group on Combination Products (AAMI/CP) to begin work on a new AAMI TIR, Quality Management System (QMS) requirements comparison for combination products (link here to the NWIP). AAMI is looking for interested parties to participate on the new working group. If you would like to participate or have nominations, please send them to Hillary Woehrle (hwoehrle@aami.org).
Posted: January 23, 2013