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Category 2 is where compounds go when the FDA has determined they cannot be used in compounding typically because the agency has identified safety signals, insufficient data, or both

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Insulin glulisine compared to insulin aspart and to insulin lispro administered by continuous subcutaneous insulin infusion in patients with type 1 diabetes: a randomized controlled trial

Diabetes Obes Metab 20:22382245 Reigner BG, Williams PE, Patel IH, Steimer JL, Peck C, Van Brummelen P (1997) An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development