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Evaluation of P-Listed Pharmaceutical Residues in Empty Pharmaceutical Containers
Tolaymat, T. AND A. El Badawy. Evaluation of P-Listed Pharmaceutical Residues in Empty Pharmaceutical Containers. U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-14/167, 2015.
The primary purpose of this study is to evaluate if simply removing the drug (specifically nicotine, coumadin and physostigmine) from its container is equivalent to triple rinsing the container. The secondary purpose of this study was to determine whether the active pharmaceutical ingredient is present in the residues remaining in the containers. The U.S. Environmental Protection Agency (EPA) Office of Solid Waste and Emergency Response (OSWER) plans to address the issue of rendering these pharmaceutical packages RCRA empty through a rulemaking. The objectives of this study were achieved as follows: (a) Measure the amount of total residuals in pharmaceutical containers containing warfarin, physostigmine and nicotine medications after removing the drugs; (b) Calculate the "maximum possible weight of residual drug/total residual/container" for each compound and packaging combination. This calculated result may be used to infer an upper limit for the amount of active pharmaceutical compound in the total residue remaining in the container; (c) Use thermal gravimetric analysis (TGA) technique to qualitatively evaluate the presence of active pharmaceutical ingredient in the residuals after removing the drug from the rinsed pharmaceutical containers.
Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have struggled with RCRA's empty container requirements when it comes to disposing of visually empty warfarin and nicotine containers, and this issue is in need of investigation. For example, nicotine gums, patches and lozenges are hazardous wastes because nicotine and its salts are listed as P075, and Coumadin (also known as warfarin) is hazardous because warfarin and its salts are listed as P001 (when warfarin is present at concentrations greater than 0.3%). Therefore, when unused nicotine-based smoking cessation products (e.g., patches, gum and lozenges) and Coumadin are discarded, they are acute hazardous wastes and must be managed in accordance with all applicable RCRA regulations. Furthermore, due to additional management requirements for P-listed wastes, any acute hazardous water residues remaining in containers (and therefore the container itself) must be managed as hazardous unless the container has been rendered "RCRA empty" either by triple-rinsing with an appropriate solvent or by another method proven to achieve equivalent removal.