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A 503B outsourcing facility is a larger, cGMP-compliant, FDA-registered facility that can compound bulk batches without patient-specific prescriptions for use in healthcare settings at the cost of heavier federal oversight and product reporting

Cutting the pill at the center may also reduce the dose of each side by half

So the market for it is black, or at least severely grey, with shady overseas companies exploiting a legal loophole to get around regulatory barriers

Conclusion Autoimmune conditions are complex and demand a multifaceted approach

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Cell Biochem Funct 2002