Rx-360 summary of the FDA proposed rule for combination products

The proposed rule would harmonize the requirements for prescription and nonprescription products.

On 23 December 2015, FDA issued the proposed rule on “Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph”.

FDA is proposing to revise its regulations on prescription fixed-combination drugs 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. These products must meet specific evidentiary requirements for approval. The proposed rule would harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing Agency policy.

Comments on the proposed rule must be submitted by 22 March 2016.