As reported by the U.S.-based Waste Business Journal (www.wastebusinessjournal.com), the U.S. Environmental Protection Agency (EPA) is now considering healthcare facility-specific regulations for managing hazardous pharmaceutical waste rather than regulate them under its universal waste program as proposed in December 2008.
The action follows criticism from states and the healthcare industry that EPA’s original approach would fail to address improper disposal of the waste.
EPA's 2008 proposed rule aimed to facilitate better management of pharmaceutical wastes by streamlining generator requirements and encouraging generators of hazardous pharmaceutical wastes to manage them under the provisions of the Universal Waste Rule, which is generally less stringent than federal rules for hazardous waste.
The proposed rule was intended to facilitate take-back programs by removing Resource Conservation & Recovery Act (RCRA) barriers, according to the rule's preamble.
The Environmental Council of the States, representing state environmental regulators, wrote that EPA's proposed rule was unlikely to divert pharmaceuticals from sewer systems because of the U.S. Drug Enforcement Administration’s (DEA's) witnessed destruction requirements and because reverse distributors cannot accept most pharmaceutical wastes generated outside the pharmacy.
States want the agency to take a more holistic approach to dealing with pharmaceutical waste by working with other federal agencies, like the DEA and the U.S. Food and Drug Administration (FDA), on the issue.