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There is no Therapeutic Use Exemption pathway because BPC-157 has no approved therapeutic indication in any major jurisdiction
For example, synovial macrophages from patients with ACPA-negative RA exhibit reprogramming of multiple amino acid metabolic pathways, and this metabolic phenotype is closely linked to disease progression (86)
If courts determine that adding niacinamide or other ingredients does not create a sufficiently "different" product, compounding pharmacies may face existential challenges in this market
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