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A New England Compounding Center meningitis outbreak that began in September 2012 sickened 798 individuals and resulted in the deaths of more than 100 people. [2] [3] [4] In September 2012, the Centers for Disease Control and Prevention, in collaboration with state and local health departments and the Food and Drug Administration (FDA), began investigating a multistate outbreak of fungal ...
New England Compounding Center (NECC) is a compounding pharmacy founded in 1998, along with its sister companies Ameridose, Medical Sales Management Inc, and Alaunus Pharmaceutical LLC. Based in Framingham, Massachusetts , the New England Compounding Center was founded by brothers-in-law Greg Conigliaro and Barry Cadden.
On July 9, 2013, Sánchez, in response to a nationwide outbreak of fungal meningitis stemming from a compounding pharmacy in Framingham, released legislation reforming state oversight of the pharmaceutical compounding industry of Massachusetts. His legislation has been hailed as a "national model" by several industry experts and academics.
For anticipatory compounding a pharmacy may compound: “limited quantities before the receipt of a valid prescription order for such individual patient” if: 1. The compounding is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the human drug product; and 2.
The law established that pharmacies compounding only "patient-specific" preparations made in response to a prescription (503A pharmacies) cannot be required to obtain FDA approval for such products, as they will remain exclusively under state-level pharmacy regulation.
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