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A Lesson on Outsourcing: The NECC Fungal Meningitis Outbreak

This article was originally published in The Gold Sheet

Executive Summary

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FDA Again Proposes To Advance Outsourcing Sector With Center Of Excellence

The US FDA’s FY 2020 budget request calls for funding to help advance the emerging drug compounding outsourcing sector, as did the FY 2019 request. The money would bring more training, specially tailored GMP requirements and a center of excellence.

Regulatory Updates in Brief

EU issues GMP Annex 16 on qualified persons; New ISO-9001 standard released; FDA extends comments for “established conditions” guidance; USP to revise General Chapter <797> on pharmaceutical compounding for sterile preparations; and FDA issues guidance on adverse event reporting for 503(b) outsourcing facilities.

Government’s RICO Case Against NECC is Unprecedented

A 131-count indictment unsealed last month that includes murder and racketeering allegations against New England Compounding Center pharmacists for violations of the FD&C Act is unprecedented and signals that the federal government is using more aggressive legal tools in prosecuting individuals whose products harm or kill consumers.

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