Pharmaceutical waste

• Knowledge on certain key definitions are crucial for understanding hazardous waste pharmaceuticals.

Hazardous waste pharmaceuticals are a sector-specific, waste-specific category of waste regulated under the Resource Conservation and Recovery Act (RCRA). Cited under 40 CFR 261.2, 40 CFR 262, and 40 CFR 266 Subpart P, some key definitions under the rule include the following.

• Evaluated hazardous waste pharmaceutical means a prescription hazardous waste pharmaceutical that has been evaluated by a reverse distributor and will not be sent to another reverse distributor for further evaluation or verification of manufacture credit.
• Hazardous waste pharmaceutical means a pharmaceutical that is a solid waste, as defined in 261.2, that exhibits one or more characteristics identified in part 261 subpart C, or is listed in part 261 subpart D. A pharmaceutical is not a solid waste, and therefore not a hazardous waste pharmaceutical, if it is legitimately used/reused (e.g., lawfully donated for its intended purpose) or reclaimed. An over-the-counter pharmaceutical, dietary supplement, or homeopathic drug is not a solid waste, and therefore not a hazardous waste pharmaceutical, if it has a reasonable expectation of being legitimately used/reused (e.g., lawfully redistributed for its intended purpose) or reclaimed.
• Non-creditable hazardous waste pharmaceutical means a prescription hazardous waste pharmaceutical that does not have a reasonable expectation to be eligible for manufacturer credit or a nonprescription hazardous waste pharmaceutical that does not have a reasonable expectation to be legitimately used/reused or reclaimed. This includes but is not limited to:
  • Investigational drugs;
  • Free samples of pharmaceuticals received by healthcare facilities;
  • Residues of pharmaceuticals remaining in empty containers;
  • Contaminated personal protective equipment;
  • Floor sweepings; and
  • Clean-up material from the spills of pharmaceuticals.
• Non-hazardous waste pharmaceutical means a pharmaceutical that is a solid waste, as defined in 261.2, and is not listed in 40 CFR part 261 subpart D, and does not exhibit a characteristic identified in 40 CFR part 261 subpart C.
• Pharmaceutical means any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system (e.g., electronic cigarette or vaping pen); or any liquid nicotine (e-liquid) packaged for retail sale for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials). This definition includes, but is not limited to:
  • Dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act; prescription drugs, as defined by 21 CFR 203.3(y);
  • Over-the-counter drugs;
  • Homeopathic drugs;
  • Compounded drugs;
  • Investigational new drugs;
  • Pharmaceuticals remaining in non-empty containers;
  • Personal protective equipment contaminated with pharmaceuticals; and
  • Clean-up material from spills of pharmaceuticals.

This definition does not include dental amalgam or sharps.

• Potentially creditable hazardous waste pharmaceutical means a prescription hazardous waste pharmaceutical that has a reasonable expectation to receive manufacturer credit and is:

1. In original manufacturer packaging (except pharmaceuticals that were subject to a recall);
2. Undispensed; and
3. Unexpired or less than one year past expiration date.

The term does not include evaluated hazardous waste pharmaceuticals or nonprescription pharmaceuticals including, but not limited to, over-the-counter drugs, homeopathic drugs, and dietary supplements.