Health care facilities that provide a host of health care-related services or distribute, sell or dispense pharmaceuticals, and reverse distributors of pharmaceuticals will need to learn a whole new set of regulations recently finalized by the Environmental Protection Agency (EPA) under the Resource Conservation and Recovery Act (RCRA), or risk being assessed steep penalties. The new rule, revising management standards for hazardous waste pharmaceuticals (HWPs), will take effect six months following publication in the Federal Register. Although EPA has released the final pre-publication version of the rule, actual publication was delayed during the government shutdown but is expected shortly (barring another government shutdown). Health care facilities are well advised to begin their efforts now to understand the requirements, draft and implement effective policies and procedures, develop a staff training program and enter into such contractual relationships as may be necessary to ensure compliance.
The final rule revises some of the regulations and management standards for HWPs currently existing under RCRA and sets them apart in a separate section of the RCRA regulations, to be codified at 40 C.F.R. Part 266, Subpart P (“Subpart P”). Subpart P will be applicable specifically to health care facilities and reverse distributors. The new standards will be mandatory for all RCRA Hazardous Waste Small Quantity Generators and Large Quantity Generators, regardless of the amount of HWPs that are generated, and optional for Very Small Quantity Generators.
Among the many changes in the RCRA regulations, the following are especially significant: (1) “long-term care facilities,” other than assisted living, group homes and independent living facilities, will now be subject to RCRA requirements for all hazardous wastes, not just for pharmaceutical wastes; (2) HWPs that are to be sent offsite to reverse distributors must be managed as RCRA hazardous wastes while still at the health care facility; and (3) HWPs will be banned from being disposed of down a drain or flushed in a toilet. Other revisions will be made to the accumulation, notification, training, container, labeling, shipping, reporting and recordkeeping requirements. Facilities in the health care industry will have to evaluate what is considered a “health care facility,” a “pharmaceutical,” a “hazardous waste pharmaceutical,” a “non-creditable hazardous waste pharmaceutical” and other definitions in the final rule to determine if they are subject to the new requirements, and if so, which ones. Moreover, because the federal rule (other than the sewering ban) will not be immediately binding in states with their own authorized programs, facilities will also have to compare a state’s hazardous waste requirements to the new federal ones; state requirements will be different until the state agency adopts the federal regulations or if the state decides to retain its own more stringent requirements.
Some of the components of the final rule will relieve the existing burdens on generators of HWPs while other components may make the management of HWPs more onerous, at least initially. The complexity of the rule and coordination with the requirements of other federal agencies, such as the Department of Transportation and the Drug Enforcement Agency, will require careful analysis and planning.
For more information, please contact Brooke F. Dickerson or Jennifer L. Hilliard