The United States Environmental Protection Agency (“EPA”) regulates pharmaceutical hazardous waste. Under the EPA, unused and disposed of pharmaceuticals are evaluated, managed and disposed of as potential “hazardous waste” under the Resource Conservation and Recovery Act (RCRA) Regulations. The RCRA establishes procedures and standards for hazardous and solid waste material management and disposal. Under the RCRA, solid waste includes “solids, liquids and gases and must be discarded to be considered waste.”[i]
The False Claims Act (“FCA” or “Act”) is a federal anti-fraud statute that protects against persons and companies defrauding the government. The Act has been dubbed the government’s “primary litigation tool for recovering losses resulting from fraud.” The FCA imposes civil liability on any one who “knowingly presents…a false or fraudulent claim for payment or approval” to the federal government. It is used extensively to protect against fraud in healthcare.
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