Sustainable Solutions: Amendment to Management of Pharmaceuticals


On 2/22/19, EPA has published the final rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine. This rule was initially proposed in 2015 and is scheduled to go into effect August 21, 2019.

Goals for this rule include EPA’s efforts to establish cost-savings and streamlined standards for hazardous waste pharmaceutical (HWP) management in order to accommodate healthcare operations and maintain human health and environmental protection.  The rule also eliminates intentional sewer disposal or discharge of hazardous waste pharmaceuticals, reduces overlapping regulations (DEA, FDA, etc.), provides regulatory clarity and consistency on how RCRA applies to reverse distribution and reverse logistics, and allows pharmaceutical distributors, healthcare facilities, and other site that manage these wastes to exclude HWP from RCRA regulation standards.  This also excludes some FDA nicotine therapy products from regulation.

Below is a brief list of notable takeaways:
  • Divides HWP into “creditable” and “non-creditable” categories, which require generators to manage onsite storage and shipping differently.
  • Excludes HWP from affecting generator status.
  • Explicit prohibition of drain disposal or discharge into public sewer system.
  • Generators must meet requirements in order to qualify for exclusion.
    • Employees who handle & accumulate these wastes must be trained.
    • Hazardous waste determinations are required.
    • New accumulation & time limit rules apply.
    • New Labeling requirements apply for certain HWP containers.
    • Containers must be stored away from public access.
    • Reporting, recordkeeping & release response standards apply.
    • Land Disposal Restriction (LDR) notification is required for certain HWP.
    • Manifests are required for certain off-site shipments.
The new regulation covers most health care entities that manage pharmaceutical products and waste including Hospitals, Pharmacies, Dentists, nursing facilities, long-term care facilities (LTCFs), clinics and reverse distributors.  The new regulation does not cover pharmaceutical manufacturers (unless they act as reverse distributors) or production facilities.

To help industry understand these changes and how it would affect them, EPA has a webinar that goes over important changes and new requirements. If you have any additional questions your local Enviroexpert is ready and available to chat.

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