Pharmaceutical Waste Management in US Healthcare Facilities: US Environmental Protection Agency Funds 10-Step Plan (2022 Edition) | Mitchell, Williams, Selig, Gates & Woodyard, LLC

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The U.S. Environmental Protection Agency (“EPA”) funded a recently released document titled:

A 10-Step Blueprint for Pharmaceutical Waste Management in U.S. Healthcare Facilities (2022 Edition) (“Blueprint”)

The lead author of the Blueprint is Charlotte Smith of GreatWorks, LLC.

Blueprint’s 2022 edition is a later version of the document published in 2006.

The document describes its main purpose as follows:

. . . provide a guide to help healthcare facilities including hospitals, surgery centers and urgent care facilities understand applicable regulations so they can develop a compliant, holistic and cost-effective pharmaceutical waste management program .

Therefore, the blueprint focuses primarily on EPA Subtitle C hazardous waste regulations as they apply to pharmaceuticals treated as hazardous waste. This issue became relevant due to the EPA’s revision of the Resource Conservation and Recovery Act (“RCRA”) regulations in 2019 by issuing the final rule titled:

Pharmaceutical Hazardous Waste Management Standards and PO75 List Amendment for Nicotine (see Federal Register Volume 84 February 2019) (“Drugs Rule”)

The Pharmaceuticals Rule added Subpart P to the RCRA Subtitle C regulations found in 40 CFR Part 266. In addition, it provided an exemption for OCT nicotine patches, gum and lozenges.

Pharmaceutical hazardous waste management is somewhat unique in that the facilities (such as pharmacies, hospitals, nursing homes, etc.) needed to meet these requirements have had relatively little exposure to the waste management system. dangerous RCRA from cradle to grave. This is markedly different from industrial and commercial facilities that have been subject to various RCRA Subtitle C requirements since the mid-1980s. Therefore, documents such as the Master Plan have been deemed essential to educate the regulated community. concerned.

The 10 steps (i.e. components) of the Blueprint include:

  • Step One: Understand which pharmaceuticals are regulated as hazardous pharmaceutical waste when discarded
  • Step two: review of standards for healthcare facilities operating under the hazardous pharmaceutical waste rule
  • Step Three: Determine Which Facilities Should Operate Under Subpart P
  • Step Four: Leadership and Current Program Review
  • Step Five: Choose the Right Suppliers
  • Step Six: Implement a Pharmaceutical Waste Management Program in the Pharmacy
  • Step Seven: Implementing a Pharmaceutical Waste Management Program in the Nursing Unit and Other Patient Care Areas
  • Step Eight: Management Responsibilities: Team Management, Developing Policies and Procedures, and Improving Processes
  • Step Nine: Training Programs – Program Relaunch and Online Training
  • Step Ten: RCRA Generator Category for Facilities Operating Under Subpart P

Annexes to the Master Plan include:

  • Appendix A. Links to Code of Federal Regulations (40 CFR) for Subpart P
  • Appendix B. Common Acronyms
  • Appendix C. Quick Start Guide: Pharmaceutical Hazardous Waste Management — Over-the-Counter Nicotine Exemption and Subpart P
  • Appendix D. How to Assess the Toxic Characteristic Using Total Constituent Analysis Instead of TCLP—Case Study: Thimerosa
  • Appendix E. NIOSH Hazardous Drug List
  • Annex F. Step-by-step guide to notifying under Subpart P
  • Appendix G. Categories of RCRA Hazardous Waste Generators

A copy of the Blueprint can be downloaded here.

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