[T]he release of the guidance just days after the signing of the legislation marks an unusual—perhaps even unprecedented—speed for the agency, which can sometimes take years to release guidance. The agency has been clamoring for more authority with which to confront the compounders since an October 2011 outbreak of fungal meningitis from a Massachusetts-based compounding pharmacy, the New England Compounding Center (NECC), and the speed may reflect its desire to move forward as quickly as possible.
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