January 19, 2023

Ten-Step Blueprint for Managing Hazardous Waste Pharmaceuticals

In response to problems with mismanagement of hazardous waste pharmaceuticals, EPA finalized the pharmaceuticals rule in Part 266, Subpart P, on February 22, 2019. [84 FR 5816] EPA recently published A 10-Step Blueprint for Managing Pharmaceutical Waste in US Healthcare Facilities, which provides a guide for healthcare facilities subject to the regulations in Part 266, Subpart P. This 58-page document details how these regulations work at various types of facilities, such as pharmacies, nursing units, and hospitals, so these entities can develop compliant and effective pharmaceutical waste management programs.

Step 1 discusses how to determine which pharmaceuticals are regulated as hazardous waste when disposed of, essentially reviewing how to complete an accurate hazardous waste determination. EPA recommends a healthcare facility designate someone to complete the hazardous waste determinations and ensure they have the proper training. Other recommendations include taking the conservative approach and managing all waste pharmaceuticals under Subpart P or hiring a company that specializes in identifying hazardous waste pharmaceuticals.

Step 2 reviews the general requirements under Subpart P and other provisions in the final rule. Managing non-creditable versus creditable hazardous waste pharmaceuticals is explained, as is reverse distribution. Also discussed are some miscellaneous provisions of the rule, like the sewering ban and the exemption from the P075 nicotine listing for over-the-counter nicotine replacement therapies, lozenges, gums, and patches.

Step 3 focuses on determining which facilities must operate under Subpart P. Overall, if a healthcare facility is an SQG or LQG when counting hazardous wastes generated, including hazardous waste pharmaceuticals, the facility must operate under Subpart P and notify EPA using Site ID form 8700-12.

Step 4 discusses building a new program and reviewing current programs. The guidance stresses the importance of involving pharmacy, nursing, and environmental services departments. Additional resources are provided on evaluating the pros and cons of sorting hazardous waste pharmaceuticals and non-hazardous waste pharmaceuticals and on sorting models.

Steps 5, 6, and 7 review strategies for choosing appropriate vendors, implementing programs in pharmacies, and implementing programs in nursing units, respectively.

Step 8 addresses management responsibilities, primarily team management, policy and procedure development, and process improvement. Management responsibilities should include conducting monthly pharmaceutical waste audits and walkthroughs, reassessing current pharmaceutical waste management practices, and ensuring training materials are up to date and in compliance.

Step 9 details training program recommendations. The blueprint explains the importance of developing separate training programs for each department. Management should also ensure all Subpart P training requirements are met as well as RCRA generator, OSHA, and DOT training requirements.

Step 10 emphasizes the importance of complying with the RCRA generator requirements for very small quantity generators, small quantity generators, and large quantity generators and the applicable requirements for each generator category.

The 10-Step Blueprint also includes additional resources in a list of appendices that address notification requirements under Subpart P, the nicotine exemption, and hazardous waste determinations, among other things.

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Disclaimer

Considerable care has been exercised in preparing this document; however, McCoy and Associates, Inc. makes no representation, warranty, or guarantee in connection with the publication of this information. McCoy and Associates, Inc. expressly disclaims any liability or responsibility for loss or damage resulting from its use or for the violation of any federal, state, or municipal law or regulation with which this information may conflict. McCoy and Associates, Inc. does not undertake any duty to ensure the continued accuracy of this information.

This document addresses issues of a general nature related to the federal RCRA regulations. Persons evaluating specific circumstances dealing with the RCRA regulations should review state and local laws and regulations, which may be more stringent than federal requirements. In addition, the assistance of a qualified professional should be enlisted to address any site-specific circumstances.