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Pure tides therapy is not a compounding pharmacy or compounding facility as defined under Section 503A of the Federal Food, Drug, and Cosmetic Act, nor is it an outsourcing facility as defined under Section 503B of the same Act

Those with a higher metabolism may see quicker progress, while others may require more time

Recent developments include CMS unveiling its BALANCE model, a voluntary Medicare and Medicaid coverage pathway that includes price negotiations and supplemental lifestyle support, with coverage beginning in 2026 for Medicaid and 2027 for Medicare Part D [2]

However, these uses are still under research, and no conclusive clinical recommendations exist for routine use

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Schmidt-Mende, J