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EPA Releases Updated Pharmaceutical Waste Blueprint

APTIM representatives are experts in hazardous waste regulation. We are here to assist you in preparing, reviewing, or modifying your programs for compliance security.

On October 20, 2022, the Environmental Protection Agency published a revised guidance document entitled “A 10-step Blueprint for Managing Pharmaceutical Waste in U.S. Healthcare Facilities.” This is a revision to their earlier versions first created in 2006 and amended in 2008.  The document has been recently updated in light of regulatory changes made with the adoption of Final Rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine (Pharmaceutical Rule), which was instated on February 22, 2019.

The blueprint, which was primarily written by industry professionals with government input, is intended to help affected businesses understand the new regulatory requirements and apply that nuanced understanding into building an effective compliance program. Broadly speaking, the steps are divided into two subcategories:

  • Regulatory overview encompasses the first three steps, focusing primarily on regulatory specifications and business applicability.
  • Program implementation outlines the remaining six steps and walks companies through the main leverage points (e.g., leadership, vendor selection, and team management) and highlights considerations for implementing a compliant pharmaceutical waste program. This section also contains decision-tree diagrams, flow charts, and tables to help organize and optimize such programs.

If you are interested in learning more about this effort, download a PDF of the 58-page guidance document here.

Whether you have already developed a program or are looking to start or update a new pharmaceutical waste management system, having a guidance document approved by regulators at your disposal is critical to assuring your compliance with regulatory standards.  Above and beyond this resource, APTIM representatives are experts in hazardous waste regulation, and we are here to assist you in preparing, reviewing, or modifying your programs as an additional layer of compliance security. We maintain working relationships with regulators at all levels (federal, state, and local) and understand not only their regulations but the motivations and driving forces behind them.

APTIM assists numerous clients with managing their hazardous material and waste programs, and we look forward to partnering with you for your pharmaceutical and other hazardous material and waste program needs.

Contact

Brian Mullen
Environmental Science Specialist, Permitting and Compliance
Brian.Mullen@APTIM.com

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