Healthcare

Mitigating a crisis for the compounding pharmacy industry

Challenge

The nation’s premier advocacy group for compounding pharmacists approached Roberti Global for assistance after several hundred patients were infected, some fatally, with meningitis from contaminated products sold by a non-member pharmacy.

Action

Engaged lawmakers serving on key House and Senate committees by explaining how the organization had no affiliation with the offending pharmacy and, more importantly, how the actions of that pharmacy were in complete contravention of the standards and practices of both the organization and industry. As the committees worked on crafting legislation, we educated them on compounding pharmacy practices and ensured that the organization not only had a seat at the table, but that its views and concerns were both effectively conveyed and incorporated throughout the entire process.

Results

Through Roberti Global’s efforts, a legislative proposal that would have imposed several onerous mandatory legal and regulatory requirements on the industry was averted. Instead, the legislation passed by Congress emphasized the enforcement of existing laws, provided a “safe harbor” for traditional pharmacy compounding, and created a new, voluntary program for large scale compounders that required adherence to cGMPs – but exempted products from FDA approval and labeling requirements.

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