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News January 22, 2013

Combination products ruling in Federal Register

FDA issues rule on current Good Manufacturing Practice requirements applicable to combination products.
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A Final Rule on current Good Manufacturing Practice Requirements for Combination Products was published in the Federal Register Jan. 22, 2013.

The summary states, “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.”

FDA received 25 sets of comments from regulated entities, trade associations, and individuals that are listed in the Federal Register, The Daily Journal of the U.S. Government.

A Linkedin discussion from the Combination Products Coalition notes, “I think the industry is very glad to have the GMP rule published. Among other things, it means we can start talking more freely with FDA now. Ever since the proposed rule came out, and indeed even before then, FDA was reluctant to talk because they were in a rulemaking mode. As a result, it was very tough to get specific guidance on how GMPs are applied to combination products. Now that the final rule is out, we hope that there’s no impediment to such discussions.”

Combination products represents a newer subcommittee within the Institute of Packaging Professionals’ Medical Device Packaging Technical Committee and is looking for professional input. Contact this author for more information at

For more information on combination products, visit FDA’s Web site.

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