The Environmental Protection Agency (EPA) recently issued a pre-publication Proposed Rule (40 C.F.R. part 266, subpart P) regulating the management and disposal of drugs deemed “hazardous waste pharmaceuticals” by healthcare providers. One of the EPA’s principal objectives in promulgating the Proposed Rule is to curtail the environmental impact of pharmaceuticals on lakes and rivers by reducing the number of drugs being disposed of “down the drain,” a practice common to healthcare providers in many states.

The Proposed Rule also largely eliminates the Resource Conservation and Recovery Act (RCRA) hazardous waste exemption for long term care providers. Providers that are conditionally exempt small quantity generators (CESQGs) under the RCRA will maintain their conditional exemption from many of the RCRA’s requirements and will not be subject to most aspects of the Proposed Rule. In addition, some healthcare providers may become CESQGs as they will no longer be required to count the hazardous waste pharmaceuticals that they generate in determining their RCRA generator category. A shift in generator category would allow a provider to manage its non-pharmaceutical hazardous waste according to the reduced generator category requirements.

“Pharmaceutical”

The Proposed Rule defines “pharmaceutical” as:

Any chemical or biological product that is intended for use in the diagnosis, cure, mitigation, care, treatment, or prevention of disease or injury of a human or other animal; or any chemical or biological product that is intended to affect the structure or function of the body of a human or other animal.

The definition includes dietary supplements defined by the Federal Food, Drug and Cosmetic Act; prescription drugs; over-the-counter drugs; residues of pharmaceuticals remaining in containers (including delivery devices such as dispensing bottles, IV bags and tubing, vials, unit dose packages, and delivery devices, such as syringes and patches); personal protective equipment contaminated with residues of pharmaceuticals; and clean-up material from the spills of pharmaceuticals, including loose tablets accumulated during pharmacy floor sweepings.

Sharps, such as needles or syringes with needles, are excluded from the proposed definition because they are separately regulated. Residue of hazardous waste pharmaceuticals remaining in fully dispensed syringes and certain unit dose containers are also conditionally excluded under the Proposed Rule. However, if syringe residue is discharged onto a gauze pad, then the residue must be managed as a hazardous waste.

“Hazardous Waste Pharmaceutical"

The drug waste covered by the Proposed Rule is more limited and covers only pharmaceuticals regulated as hazardous waste under the RCRA when discarded. A pharmaceutical is considered a hazardous waste under the RCRA in one of two ways:

  • The pharmaceutical is a commercial chemical product that is on the RCRA’s P- or U-list (and has not been used for its intended purpose). P-listed waste includes arsenic trioxide, smoking cessation products with nicotine as the sole active ingredient, and Coumadin pharmaceuticals with greater than 0.3 percent warfarin (and salts) as the sole active ingredient; U-listed waste includes cyclophosphamide, mitomycin C, streptozotocin and warfarin and salts (≤ 0.3 percent) as the sole active ingredient.
  • The pharmaceutical does not appear on the RCRA’s P- or U- list but exhibits certain hazardous waste characteristics (e.g., it is ignitable, corrosive, reactive, or toxic).

The Regulatory Impact Analysis for the Proposed Rule includes a non-exhaustive list of pharmaceuticals that the EPA considers hazardous waste. The agency has developed an informational Hazardous Waste Pharmaceuticals Wiki to assist providers in determining whether the pharmaceuticals they discard meet the RCRA hazardous waste definition.

Disposal of Controlled Substances

Drug Enforcement Administration (DEA) regulations currently prohibit “down the drain disposal” of controlled substances in most cases because drain disposal does not meet the DEA’s “non-retrievable” destruction standard. To address the overlap between the RCRA hazardous waste and DEA controlled substances regulations, the Proposed Rule exempts hazardous waste pharmaceuticals that are also DEA controlled substances provided such pharmaceuticals are combusted in a proper hazardous or municipal solid waste incinerator.

Dual Waste Disposal

In instances where a hazardous waste pharmaceutical also constitutes a biological hazard (commonly referred to as a “dual waste”), the Proposed Rule directs providers to manage the waste in accordance with the RCRA and state and/or local medical waste regulations. Autoclaving is not an acceptable method of treating dual waste, according to the EPA.

Disposal of Creditable Hazardous Waste Pharmaceuticals

The Proposed Rule allows providers to continue sending hazardous waste pharmaceuticals, for which they may receive a manufacturer’s credit, to pharmaceutical reverse distributors for processing manufacturers’ credit. To be considered creditable, the pharmaceutical must be unused, or un-administered and unexpired, or less than one year past the expiration date. The Proposed Rule also provides standards to ensure the proper delivery of creditable hazardous waste pharmaceuticals to reverse distributors. Notably, the EPA opted not to impose specific management standards for the accumulation of containers with potentially creditable hazardous waste pharmaceuticals, nor did it address labeling standards or the length of time for which such containers may accumulate.

Disposal of Non-Creditable Hazardous Waste Pharmaceuticals

The EPA provides a number of management standards applicable to non-creditable hazardous waste pharmaceuticals (i.e., those ineligible to receive a manufacturer's credit) in the Proposed Rule, including:

  • A one-time notification to the EPA of non-CESQG “healthcare facility” status (regardless of whether the facility has an EPA identification number and ongoing reporting requirements)
  • Personnel training requirements for the generation and/or management of such waste
  • Container standards that include labeling requirements and time limits for accumulation
  • Land disposal restrictions
  • Off-site shipment, record keeping, and accidental release requirements
  • Requirements applicable to a provider’s acceptance of hazardous waste pharmaceuticals from off-site CESQGs

The Proposed Rule is scheduled for publication in the Federal Register on September 25, 2015. Providers may submit comments to the EPA for a period of 60 days after the Proposed Rule is published.