Registration Rule Gets Early Response From Compounders

Posted on January 10, 2014

Two years ago, compounding pharmacies were in the spotlight after an outbreak of fungal meningitis claimed the lives of 64 people and sickened hundreds more.  Officials were able to trace the contamination back to the Framingham, Massachusetts-based New England Compounding Center.

The issue brought to light a serious problem with compounders, pharmacies that formulate medications in ways that satisfy the unique needs of specific individuals.  But as such facilities expanded from their traditional local-centric role to shipping products across the country instead, they entered a regulatory gray area where neither the state or the federal level (as represented by the Food and Drug Administration) was sure that they had authority over the compounders.

This incident has prompted lawmakers to issue sweeping new regulations that would seek to keep dangerous outbreaks related to compounders from happening again.  One such rule would see compounders needing to register with the FDA if they want to ship products in bulk.  This allows them to be classified as an outsourcing facility, and with that status comes regular inspections, adversity reporting, safety benchmarks, and a fee that must be paid to the FDA.

A new report in Reuters relates this new rule and notes that 11 compounders have already registered in this manner.  If a compounder chooses not to take this step, there will be certain limits placed on them and they will exist within the scope of state regulators.

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