Comment from Anonymous

As a registered nurse and future advanced practice registered nurse, I appreciate the FDA's creation of a transparent and systematic process for evaluating and identifying bulk drug substances that compounding pharmacies can legally use to compound medications. Compounding pharmacies fill critical gaps in our healthcare system by offering flexibility, customization, and continuity of care when commercial drugs are backordered or discontinued. GLP-1 receptor agonists are perhaps the most recent example of the benefits of compounded medications. Many patients have experienced notable health benefits from compounded versions of GLP-1's due to the ability to customize dosages to reduce side effects, resulting in improved adherence and long-term success. Additionally, compounded pharmacies have made these medications more accessible for patients when the commercial versions are either in shortage or not covered by insurance. Decisions to include or exclude various substances on the 503B list must be based on clinical need and safety data, which the FDA is doing by allowing stakeholders (clinicians, pharmacists, manufacturers, and the public) to provide their safety data for review. This ensures that only clinically justified, safe, and necessary substances are suitable for compounding, which can improve overall health outcomes. I encourage the FDA to maintain transparent, evidence-based criteria for evaluating these substances and to continue to seek input from real-world providers. I also urge the FDA to provide timely updates to the list to prevent treatment delays and ensure continuity of care.