The Food and Drug Administration (FDA) and state regulators will discuss the role pharmaceutical manufacturing can play in the country’s pharmaceutical manufacturing process, as a federal law requires.
The agency will review the impact of drug manufacturing on the production and distribution of drugs, including potential impact on quality and availability of drugs and the environment.
The agency also will explore whether the drug-manufacturing process can be reformed to reduce environmental and health risks, and how those risks can be mitigated.
A draft regulatory proposal released by the agency on Friday is based on a study by the University of California-Irvine, which analyzed chemicals used to manufacture more than a dozen pharmaceutical products and found that manufacturing processes were responsible for the deaths of at least 3,000 people across the country since 1998.
In addition to the chemical chemicals used in manufacturing pharmaceuticals, the study also examined the chemicals used for packaging and testing, including polyethylene glycol and polyethylenimine.
The study also found that the production of polyethylenes and polypropylene polyester was the most dangerous, with more than 1,000 deaths in the United States each year, while the production for biotechnology products was the second most deadly, with nearly 800 deaths.
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