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“Our drug approval system for medicines manufactured by the pharmaceutical industry and regulated through the Food Drug and Cosmetic Act is the one of the strongest and safest in the world. However, for the last 20 years the rapidly evolving compounding pharmacies industry has been successful in thwarting regulations at every opportunity.
“Compounding pharmacies—where medicines are altered to fit particular needs of patients—are not subject to the same level of oversight and scrutiny as pharmaceutical companies. Under the banner of compounding, these pharmacies do not conduct rigorous testing and research, nor do they adhere to safe manufacturing processes that pharmaceutical companies keep to. In particular, this has made last fall’s fungal meningitis outbreak, killing 53 and sickening over 700 people across the country, an inevitable tragedy.
“To allow the FDA to better protect the health and safety of the American people from unsafe compounded drugs in the marketplace, Congress must enact legislation that puts in place more complete public health regulations and safeguards. We must never repeat the avoidable tragedy of having contaminated and unsafe drugs on the market again.”
Tools & Resources
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