Safety advocates and lawmakers have grown concerned about a potential loophole in the law that leaves a grey zone in the regulation of compounding pharmacies. Last year, over 700 people became ill and 50 died because they were exposed to contaminated steroid injections from a compounder. To make sure such an incident never happens again, a bill was drafted that would bolster the Food and Drug Administration’s ability to oversee such institutions. Now, that measure has received the unanimous approval of the Senate Health, Education, Labor, and Pension Committee. As the bill currently stands, compounders would have to register and report adversity to the FDA. They would also be privy to inspections, the costs of which would be offset with a fee paid by the compounder itself.
For more about this initial approval, click here.