FDA Reopens Comment Period for Proposed Rule Regarding Regulation of Fixed-Combination Drugs


On December 23, 2015, the FDA announced a proposed rule regarding the regulation of fixed-combination drugs.  In its announcement, FDA proposed that its requirements for prescription fixed-combination drugs be modified “to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter (OTC) monograph.”

The proposed rule is part of FDA’s effort to “harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing Agency policy.”  Furthermore, the Agency stated that the rule would mandate applicable products to meet specific evidentiary requirements for approval.

When the proposed rule was initially announced, FDA asked for feedback, opening the comment period until March 22, 2016.  On April, 18th, shortly after its closing, FDA announced that the comment period would be reopening to allow additional time for interested people to submit comments.  FDA will be accepting comments until May 18th and is asking interested parties to provide feedback as soon as possible.

Are you in the process of developing a prescription or OTC fixed-combination or co-packaged product that may be effected by this regulation? Do you already have one on the market? We can help ensure that you are compliant with all applicable regulation. To learn more about our services and how we can help you, contact us today.