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.
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.