DE.pdf

The Pharmaceutical Rule, effective January 2021, regulates hazardous waste pharmaceuticals in Delaware, aiming to assist sites in making accurate hazardous waste determinations, streamlining management, avoiding dual requirements, and eliminating disposal down the drain. The rule applies to healthcare facilities and reverse distributors that generate hazardous waste pharmaceuticals, with specific definitions for these terms. Healthcare facilities include hospitals, clinics, pharmacies, and retailers of pharmaceuticals, while reverse distributors manage prescription pharmaceuticals for manufacturer credit. The rule clarifies the management of nicotine-containing products, with FDA-approved OTC nicotine replacement therapies exempt from hazardous waste regulation, while nicotine e-juices and e-cigarettes remain subject to the P075 listing. To determine if Subpart P is applicable, a pharmaceutical must be evaluated as a waste, and a hazardous waste determination is required, considering exclusions, exemptions, and listed hazardous wastes.