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Tkalcevic VI, et al

Vials last multiple weeks, making the twenty-eight day bacteriostatic protection essential

We also received several comments about making ASM a voluntary model instead of mandatory

If any signs of injection site infection develop (increasing redness, warmth, swelling, or pain), discontinue use and consult a healthcare provider

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The 2026 regulatory changes opened a path toward licensed compounding access in the United States, but the FDA's Pharmacy Compounding Advisory Committee decision in July 2026 will determine whether that path expands or narrows