Must Read: Custom-drug makers to come under voluntary oversight; Regulators from Idaho, Minnesota, Nevada, Texas, Virginia and other states said they want to see their state lawmakers adopt similar definitions for outsourcing facilities and allow states to inspect the facilities along with federal regulators.

Michelle Ye Hee Lee, The Republic | azcentral.com 9:56 p.m. MST May 27, 2014

Complex, custom-made medications produced in factorylike pharmacies, including several in Arizona, are distributed to hospitals across the country with almost no state or federal oversight — a loophole dramatized by a deadly 2012 meningitis outbreak linked to tainted steroids from one of those facilities in New England.
That outbreak could just as easily have happened in Arizona or anywhere else. Illnesses and deaths linked to it spread across 20 states.
There is no accurate count of how many of these facilities — in effect, large-scale custom drugmakers that ship to hospitals and doctors offices — exist in the U.S. because they are totally unregulated. And because nobody tracks them, it is unclear how many are in each state or the destinations of their shipments.

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