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FDA Releases New Rule Directing the Application of Current Good Manufacturing Practices for Combination Products

January 30, 2013

On January 22, 2013, the United States Food and Drug Administration (FDA) released a final rule clarifying which current good manufacturing practices (CGMPs) are applicable to "combination products." 78 Fed. Reg. 4307 (Jan. 22, 2013). The rule establishes 21 C.F.R. Part 4 – Regulation of Combination Products.

Manufacturers of combination products – those that combine constituent parts from two or more product classes – have struggled without a framework to guide compliance with competing, and sometimes redundant, CGMP requirements for drugs, biologics, and medical devices. The new rule aims to resolve confusion and eliminate unnecessary redundancy in the operating systems used to comply with CGMP.

The new rule breaks down into two parts. The first is straightforward, and addresses constituent parts that are manufactured or marketed separately. Not surprisingly, such parts of a combination product are each subject only to the CGMP regulations applicable to that type of constituent part. Thus, drug constituents are subject to CGMPs set forth in 21 C.F.R. Parts 210 and 211; device constituents are subject to CGMPs set forth in Part 820 (Quality System (QS) regulations); and biological constituents are subject to CGMPs in Parts 600 through 680.

The second part of the rule addresses single-entity and co-packaged combination products. In those instances, FDA directs manufacturers to comply with a CGMP regime applicable to one constituent part, and then specifies those provisions from other CGMP regimes with which the manufacturer must also comply with for other constituent parts. Thus, the manufacturer of a single-entity product with drug and device constituents may comply with the drug CGMPs (21 C.F.R. Parts 210 and 211) in their entirety, as well as the following QS regulations: Sections 820.20 (management responsibility); 820.30 (design controls); 820.50 (purchasing controls); 820.100 (corrective and preventive action); 820.170 (installation); and 820.200 (servicing). Likewise, the new rule specifies those provisions of the drug CGMPs with which a manufacturer must also comply with if it satisfies the QS regulations in their entirety.

FDA also plans to publish guidance along with the final rule. This guidance will provide further clarity in the post-approval change requirements and consistency in the type of post-market submission needed for a change to a combination product that was previously approved. Comments on the draft guidance, docket number FDA-2012-D-1240, are due by April 22.

The new rule on "combination products" will become effective on July 22, 2013. 

For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.

John Fuson
Partner – Washington, D.C.
Phone: +1.202.624.2910