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These branded-product labels do not establish that a compounded formulation has an identical safety profile

Panfili E et al

Context: Thus, the prohibitions set forth in ANVISAs (Brazilian FDA) Rule #67/2007 , which governs Good Manufacturing Practices for Compounding Pharmacies, should also be applicable to these clinics. Decisions to make: timeline to implement vs transition window. Next steps: run a focused gap assessment