Today, the FDA has published a new draft guidance titled Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDA (here) that describes the FDA’s current thinking on consistency of composition statements in NDAs and ANDAs.  It provides a clear and unambiguous requirement to list both the qualitative and quantitative formulation in the components and composition statements of applications as well as requirements for labeling of oral and nonoral products.  This promotes consistency within various sections of applications and also addresses the qualitative (Q1) and quantitative (Q2) labeling requirements for certain products.

The guidance states that “[A]pplicants of nonoral use drugs must disclose the names of all inactive ingredients and, for certain drug products, the quantities in the labeling.  In addition, qualitative information required by 21 CFR 201.100(b)(5), such as the identity and effect of tonicity agents or pH adjusters, must be listed in the approved labeling.”  In addition, the “FDA recommends including the name of inactive ingredients in the labeling of oral drug products.  The established name of the inactive ingredients is required on the labels and labeling of drug products.  See section 502(e)(1)(A)(iii) of the FD&C Act.  Although 21 CFR 201.100(b) does not require the names of inactive ingredients for oral drug products, from a safety perspective, listing inactive ingredients allows for identification of ingredients that may potentially cause sensitivities or hypersensitivity reactions in some patients.”

This guidance covers the following topics:

  • Consistency Between the Composition Statement in NDAs and ANDAs and the Statement of Ingredients in the Approved Labeling
  • Consistency in Compositions Identified Within the Same Application
  • Information on Inactive Ingredient Function, Hydration State, and Amount
  • Drug Product Compositions in Annual Reports

In addition, examples are provided relating to common problems encountered during application review.  The document also includes appendices that provide clear guidance on composition statements as well as examples of appropriate labeling for products that require Q1and Q2 labeling.

The FDA has been pursuing a means of providing Q1/Q2 labeling information for specific products for years.  This new draft guidance appears to be the first real indication that the Agency is ready to enforce the statute and regulations in a manner that provides this quantitative information on labeling for nonoral products.  This new process will allow for this information to be provided to ANDA applicants seeking to develop generic copies of certain nonoral products with Q1 Q2 formulations.

The comment period will be open for sixty days.  It will be very interesting to see what comments are submitted and by whom!