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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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Two-Decade Old US Interstate Compounding Provision Stayed For More Comments

Responding to court ruling, US FDA will explore what it will cost compounding pharmacies to submit to increased state restrictions and oversight of out-of-state compounding quality under a standard MOU that Congress required decades ago.

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.

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