Opinion: FDA’s overreach will harm compounding pharmacies and the patients they serve
Compounding pharmacies — and the patients they serve — benefit from a strong regulatory framework. But it needs to be a practical one that assures that patients have access to…
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
