This opinion piece by IACP’s Scott Brunner appeared in STAT News on June 19, 2019.
The deaths of 64 people and sickening of nearly 800 due to criminal negligence by employees of the New England Compounding Center in 2012 marked a profound failure of state and federal regulatory enforcement.
That horrific episode led to Congress including in the Drug Quality and Security Act of 2013 provisions to create a more robust regulatory framework for compounding pharmacies — both small, local compounding pharmacies and larger distributors.
The legislation instructed the FDA to create regulations within parameters set by Congress that would assure patient safety while permitting local compounders to continue to meet patient needs by providing customized compounded medications using FDA-approved substances.
But the FDA has overreached in implementing the provisions, all but halting common compounding practices that have been safely performed for years and on which patients with legitimate needs for compounded medications rely. Not only that, but the FDA has done so by circumventing the federal Administrative Procedure Act, issuing “guidance documents” to implement policies rather than following the statutory rule-making process that requires stakeholder input regarding proposed regulations.