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Final Rule Management for Hazardous Waste

October 5, 2021

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Final Rule Management Standards for Hazardous Waste Pharmaceuticals

Final Rule Management for Hazardous Waste. As of August 21, 2019, the U.S. Federal government made changes to the standards for pharmaceutical hazardous wastes for classification and disposal which is detailed under the RCRA (Resource Conservation and Recovery Act). Prior to this date, certain pharmaceuticals were not listed as “hazardous” and any facility licensed to handle these medications were allowed to dispose of them by flushing them into the water/sewer system or placing them in landfills without the use of standard medical waste disposal methods. The updated rules reorganize the EPAs previous policy on the status of regulations of nonprescription pharmaceuticals going through reverse logistics.

The new standards apply to all healthcare facilities for humans as we as animals as well as reverse distributors. While they prohibit the disposal of pharmaceuticals that are considered to be hazardous waste by dumping down a drain, the ruling does exempt pharmaceuticals that are collected during the pharmaceutical take-back events and programs, as long as they are ensured for proper disposal.

One of the most notable changes is the decision made by the EPA (Environmental Protection Agency) of excluding certain over-the-counter NRTs (nicotine replacement therapies) and salts from consideration as hazardous waste, and creating a policy of regulatory status of unsold retail items that are not considered to be pharmaceuticals.

Pharmaceutical Hazardous Waste

Final Rule Management for Hazardous Waste. Certain pharmaceuticals fall into the categories of hazardous waste when they contain commercial chemical products. The properties of these ingredients can include toxicity, reactivity, corrosivity, and ignitability. While hazardous wastes are divided into (1) listed wastes and (2) characteristic wastes, listed wastes have four subcategories: F, K, P, and U, and hazardous pharmaceuticals fall into both the “P” and “U” subcategories.

The P-list primary criteria for a drug includes any medication that is acutely hazardous with an oral lethal dose of 50 mh/kg (LD50) or less. LD50 is the amount of medication that would be given all at once which could cause death in 50% of tested animals. Eight chemicals are included on the P-list, with the waste code: Arsenic trioxide P012, Phentermine (CIV) P046, Epinephrine base P042, Physostigmine P204, Nicotine P075, Physostigmine salicylate P188, Nitroglycerin P081, and Warfarin >0.3% P001.

The updated rulings excludes certain nicotine replacement therapies (NRT) that are over-the-counter from the hazardous waste category.

The U-list primary criteria for a drug includes any medication that contains chemicals that are listed primarily for their toxicity. There are twenty one drugs that currently fall into the U-list category that include the following with their waste code: Chloral hydrate (CIV) U034, Paraldehyde (CIV) U182, Chlorambucil U035, Phenol U188, Cyclophosphamide U058, Reserpine U200, Daunomycin U059, Resorcinol U201, Dichlorodifluoromethane U075, Saccharin U202, Diethylstilbestrol U089, Selenium sulfide U205, Hexachlorophene U132, Streptozotocin U206, Lindane U129, Trichloromonofluromethane U121, Melphalan U150, Uracil mustard U237, Mercury U151, Warfarin, and Mytomycin C U010.

Healthcare Facilities deal with a variety of pharmaceutical types that can be considered as waste: tablets, lozenges, gums, transdermal patches, creams, and liquid that could be delivered via IV tubing (intravenous), nebulizers, and syringes. Since many facilities have small quantities of hazardous pharmaceuticals based on the needs of individual patients. The new guidelines are design to make it easier for staff to try to determine when and how the pharmaceuticals are to be disposed.

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