Ensuring Accuracy in Drug Applications: A Guide to Composition Statements & Labeling

In April 2024, FDA released a new draft guidance on the Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs. Every detail matters, and the composition statements and labeling sections require meticulous attention to detail to meet regulatory standards. Let's delve into the key points of this guidance and understand its significance for your submissions. 

Understanding the Guidance 

The FDA's guidance aims to assist NDA and ANDA applicants in submitting accurate and complete composition statements and corresponding statements of ingredients in labeling. It provides recommendations for minimizing assessment cycles and ensuring FDA-approved labeling contains the required qualitative and quantitative ingredient information. Following these recommendations, Amicus assist applicants in streamlining the approval process by ensuring compliance with regulatory requirements. 

Importance of Composition Statements 

Composition statements play a vital role in drug applications, providing detailed information about the components of a drug product. According to FDA regulations, NDAs must include a full list of articles used as components and a statement of the composition of the drug. Similarly, ANDAs must list all components used in manufacturing the drug product and provide a statement of its composition. These statements serve as the foundation for assessing the safety, efficacy, and quality of the drug product. 

Ensuring Consistency 

One of the key principles emphasized in the FDA guidance is the importance of consistency. Composition statements submitted in applications must align with the corresponding statements of ingredients in FDA-approved labeling and across all sections of the submission. This alignment ensures that the information provided to the FDA remains consistent throughout the application process, minimizing the risk of discrepancies and facilitating efficient assessment. 

Clarity in Inactive Ingredient Information 

Inactive ingredients are an essential aspect of drug formulations, and their accurate identification is crucial for assessing safety and efficacy. The FDA guidance emphasizes the need for clear identification of inactive ingredient function, hydration state, and amount. Standardized terminology and precise descriptions enhance clarity and understanding, enabling accurate reporting in composition statements and labeling. 

Updating Composition Statements 

Post-approval, applicants are required to update composition statements as necessary. Any changes beyond minor editorial adjustments must be submitted to the FDA for review and approval. This ensures that the information provided remains accurate and up-to-date throughout the lifecycle of the drug product. 

Conclusion 

In conclusion, adherence to FDA guidance on composition statements and labeling is essential for successful NDA and ANDA submissions. By following these recommendations, Amicus helps applicants navigate the regulatory process with confidence by providing comprehensive services in drafting and reviewing the content and format of composition statements and corresponding statements of ingredients in labeling. The Amicus Team remains committed to supporting the pharmaceutical industry in its efforts to bring innovative and lifesaving treatments to market, and consulting on composition statements and labeling is just one example of its dedication to this mission.