What you need to know about the EPA’s Hazardous Waste Pharmaceuticals Rule

Healthcare facilities are facing several changes when it comes to the management of pharmaceuticals considered to be hazardous waste under the Resource Conservation and Recovery Act (RCRA). These facilities include hospitals, medical practices, surgery centers, pharmacies, dentists, veterinary, nursing and long-term care (LTC) facilities, as well as, clinics, reverse distributors and more.

The Environmental Protection Agency (EPA) has finalized new management standards for hazardous waste pharmaceuticals to establish cost- savings and streamline standards for handling hazardous waste pharmaceuticals to better fit the operations of the healthcare sector while maintaining protection of human health and the environment.

The “Final Rule: Management Standards for Hazardous Waste Pharmaceuticals (HWP) and Amendment to the P075 Listing for Nicotine” released by the EPA will go into effect on August 21, 2019. States will be required to adopt the rule but will have the ability to make changes, therefore, the effective dates may vary per state.

Highlights of the rule:

  • Goes into effect August 21, 2019;
  • States that are authorized to implement the RCRA program must adopt the more stringent portions of the rule, which become effective in that state upon adoption;
  • Pharmaceutical waste (including P-listed wastes) will not count toward generator status;
  • Prohibits flushing/sewering of hazardous waste pharmaceuticals down the drain;
  • Exempts FDA-approved, over-the-counter (OTC) nicotine replacement therapies from regulation by removing such products from the P075 hazardous waste listing. This means that OTC nicotine patches, gums, and lozenges will not be treated as hazardous waste when discarded;
  • Allows very small quantity generators (VSQGs) to send hazardous waste to a large quantity generator (LQG) that is under the control of the same person and consolidate it there before sending it on to management at a RCRA-designated facility, provided certain conditions are met;
  • VSQG or a small quantity generator (SQG) will maintain its existing generator category in the case of an event in which the VSQG or SQG generates a quantity of hazardous waste in a calendar month that would otherwise bump the generator into a more stringent generator regulatory category. Under this provision, generators that satisfy the listed conditions do not have to comply with the more stringent generator standards when an unusual event such as a cleanout or an act of nature causes its generator category to temporarily increase;
  • Small and Large Quantity Generators (SQG and LQGs) that meet the EPA’s new definition of a healthcare facility or reverse distributor must manage their hazardous pharmaceutical waste under new subpart P.

More information on the categories of hazardous waste generators and their requirements can be found on the EPA’s website.

Healthcare facilities nationwide will need to be prepared to comply with the EPA Final Rule on August 2019. In the vast majority of states, however, state-level implementation must occur before the remaining provisions of the Final Rule go into effect.  Healthcare facilities in these states should closely monitor implementation of the HWP Rule, particularly since these states are free to implement more stringent requirements. Healthcare facilities located in multiple states should consider state-level advocacy that seeks to achieve, to the fullest extent possible, consistent regulatory obligations in the states where they operate. Finally, healthcare companies that outsource waste services should consider reviewing contracts with waste management service providers to ensure that contract terms sufficiently address compliance with the Final Rule.

Our team is happy to address all questions or concerns any healthcare facility has regarding this new EPA standard via phone (855) 228-1715 or email [email protected]