The United States Environmental Protection Agency (EPA) has extended until March 4, 2009, the deadline for public comments on its proposal to include hazardous pharmaceutical waste in the Universal Waste Rule. The proposal is intended by EPA to make it easier for health care facilities to collect and properly dispose of these items as hazardous waste. Presently, if you generate hazardous pharmaceutical wastes, you are subject to Resource Conservation and Recovery Act (RCRA) generator requirements. Under the proposed regulation, you will have the option of managing these wastes as "universal wastes," with the benefit of an increased (i) accumulation threshold; (ii) on-site accumulation quantity limit; (iii) storage time limit; and (iv) no manifest requirement. The EPA expects the proposed rule to significantly reduce disposal costs, while reducing the improper disposal of pharmaceutical wastes down drains.

The Universal Waste Rule (UWR), 40 C.F.R. part 273, enacted in 1995, modified RCRA's hazardous waste regulations, establishing more streamlined requirements for the collection of certain widely dispersed hazardous wastes called "universal wastes." The current proposal adds hazardous pharmaceutical wastes to the list of universal wastes. Under the proposal, you could elect to have such waste remain regulated under the current RCRA generator regulations as set forth in 40 C.F.R. part 262, or could choose to manage your hazardous pharmaceutical wastes under the UWR.

Under the proposed rule, a "pharmaceutical" is defined as any chemical product, vaccine or allergenic (including any product with the primary purpose of dispensing or delivering the same), not containing a radioactive component, that is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or injury in people or animals, or any such product that is intended to affect the structure or function of the human body or animals. This does not include sharps, infectious or bio-hazardous "red-bag" wastes, scrubs, gowns or gloves. "Pharmaceutical universal waste" means a pharmaceutical that is a hazardous waste as defined in 40 C.F.R. Sec. 261.3 and containers (e.g., pill bottles, vials, IV bags, and tubes of ointment/gel/cream, etc.) that have held any hazardous pharmaceutical waste and that would be classified as a hazardous waste under 40 C.F.R. Sec. 261.7.

Currently, as a generator of pharmaceutical waste, you must determine if your pharmaceutical waste is subject to hazardous waste regulations under RCRA. EPA has said that many health care facilities are unaware of the applicability of these RCRA hazardous waste regulations to their hazardous pharmaceutical wastes and may be sending their pharmaceuticals to a regulated medical waste incinerator, rather than a RCRA-permitted incinerator, or disposing of them down the drain. Segregating the RCRA regulated pharmaceutical wastes from the non-hazardous pharmaceutical wastes can be difficult, and separately collecting small volumes of hazardous waste from multiple locations in a facility can be complicated and burdensome.

The proposed new rule is intended by EPA to simplify the process by providing, but not requiring, the opportunity for all pharmaceutical waste, hazardous or not, to be managed as a single waste stream. That is, if you choose to manage both your RCRA and non-RCRA pharmaceutical wastes as universal wastes, you would no longer need to identify and separate hazardous from non-hazardous pharmaceutical waste.

Further, the increased accumulation and storage time limits are intended to allow facilities to accumulate enough waste to make shipment through a hazardous waste hauler more cost-effective. The UWR also allows the transport of such materials with a common carrier that abides by subpart D of the UWR, rather than a hazardous waste transporter, and, generally, would no longer require a handler to manifest waste to disposal facilities. EPA anticipates that including pharmaceutical wastes in the UWR will result in the management of non-RCRA pharmaceuticals in the same manner. Lastly, wastes managed as universal wastes do not count toward your hazardous waste generator status. See 40 C.F.R. 261.5; 262.10.
 
It must be noted, however, that the proposed inclusion of hazardous pharmaceutical wastes in the UWR will not amend other laws and regulations Thus, you would still need to comply with state-required disposal regulations and the Controlled Substances Act and DEA regulations (21 C.F.R. parts 1300-1316) for the handling of Schedule II through V drugs and the HIPAA standards in 45 C.F.R. parts 160, 162 and 164. Further, the proposal does not seek to change any of the existing requirements for responding to releases of hazardous pharmaceutical wastes.