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Self-funded employer plans, common at larger companies, choose their own benefits, and a self-funded exclusion can be written broadly enough to bar the drug under any indication

Bacteriostatic water is preferred for multi-dose vials because benzyl alcohol inhibits contamination between draws

Enforcement Discretion: The FDA announced a transition period (60 days for 503A, 90 days for 503B) to allow facilities to wind down operations