The US Environmental Protection Agency’s (EPA) final rule prohibiting healthcare facilities and reverse distributors from disposing of unused hazardous waste pharmaceuticals into the sewer system took effect on August 21. Such disposal was previously acceptable under the domestic sewage exclusion in the Resource Conservation and Recovery Act (RCRA).
In addition, the final rule eliminates the dual regulation of hazardous waste pharmaceuticals that are also classified as controlled substances by the Drug Enforcement Administration (DEA) and such drugs are now regulated solely by the DEA, eliminating the difficulty of complying with both DEA and EPA regulations. The dual regulation had inadvertently encouraged hazardous waste pharmaceuticals that are also DEA controlled substances to be disposed in the sewer in order to avoid the costs of DEA-compliant incineration. Such drugs are.
The final rule also protects “drug take-back” programs by making hazardous waste pharmaceuticals brought to such events exempt from RCRA hazardous waste disposal regulations.
In response to this new rule, many providers, distributors and pharmacies will be required to change their protocol and processes or risk potential penalties and enforcement action.