Frequent Questions about the Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule

Question: How do these proposed regulations differ from the current hazardous waste generator regulations?

Answer: Under current requirements any facility that generates hazardous pharmaceutical waste is subject to the RCRA hazardous waste generator regulations. These regulations vary depending on the total amount and type of hazardous waste generated at the site in a calendar month. Many healthcare facilities are considered large quantity generators (LQGs) because they generate more than 1 kilogram (kg) of acute hazardous waste per month. Under the proposed management standards, generators of hazardous pharmaceutical wastes will manage their hazardous waste pharmaceuticals under subpart P of part 266 in title 40 of the Code of Federal Regulations (CFR), instead of the standard RCRA generator regulations found in part 262. Compared to the hazardous waste generator regulations, healthcare facilities operating under the new standards will have the following benefits:

  1. A healthcare facility will not become a LQG, with all the associated requirements, when it generates more than 1 kg of acute hazardous waste pharmaceuticals in a month;
  2. A healthcare facility will not have to comply with the satellite accumulation area regulations, which are a poor fit for healthcare facilities;
  3. The facility will not need to specify hazardous waste codes on manifests;
  4. The facility will be able to accumulate hazardous waste pharmaceuticals on site without a RCRA permit for 365 days, an increase of 275 days over the current generator regulations; and
  5. The facility will have basic training requirements.

Additionally, the proposed standards are tailored to how pharmaceutical reverse distributors operate and will replace the standard generator regulations for the accumulation and management of hazardous waste pharmaceuticals at pharmaceutical reverse distributors.

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