US FDA Approves Four Peptides for Compounding Amid Generic Drug Tariff Debate

President Trump announced on Truth Social a plan to impose a 100% tariff on all generic drugs starting in August 2028, rising to 200% the following year. Generics fill roughly 90% of U.S. prescriptions and are largely produced overseas, especially in India. Analysts warn the move could backfire, raising drug costs for cash‑strapped patients, noting that “generic drugmakers lack the operational flexibility of large branded pharmaceutical companies.”

Meanwhile, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted to add four peptide bulk drug substances—BPC‑157, KPV, TB500 and MOTS‑c—to the 503A Category 1 list, allowing their use in compounding. The panel split 8‑6‑1 on three substances and 7‑5‑2 on the fourth, despite the FDA’s own scientific review team recommending against inclusion. The approvals signal a regulatory shift toward broader peptide access for compounding pharmacies.