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Section 503A permits compounding of drug products as customized therapies for identified individual patients whose medical needs cannot be met by commercially available drug products. 503B compounding , on the other hand, is performed at outsourcing facilities, which are subject to stricter FDA oversight, including cGMP requirements, a requirement to register with FDA, periodic FDA inspections and an obligation to submit adverse event reports and other product-specific information to FDA

But adoption is expected to accelerate as innovation and regulatory activity in the space drive down prices

The ACR Convergence 2025 data, the Sjogren case report, the CRP reduction data from STEP and SELECT trials

Yin et al., 2024)

This personalized approach is a cornerstone of their success, as seen in Jacklyns journey

They add to the bacteria already in your GI tract, helping to balance out the microbiome