By Richard Sieg
Inmar Regulatory Counsel
Looking ahead in 2015, change appears on the horizon for the management of hazardous waste pharmaceuticals. As discussed in prior articles, the Environmental Protection Agency (EPA) is attempting for the second time to push through a universal waste regulatory scheme for the management of hazardous waste pharmaceuticals. An effort in 2008 lost traction because of stakeholder concerns related to tracking and notification. On its website, EPA states that the concerns that stopped the progress of the 2008 proposal are addressed in its reinitiated efforts. In its current Regulatory Agenda,http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201410&RIN=2050-AG39, EPA states that the revisions are intended to “clarify regulation of a major mechanism used by healthcare facilities for management of unused and/or expired pharmaceuticals, known as reverse distribution.” EPA states that it is addressing the unique challenges that are especially difficult in the healthcare environment, which includes “hospitals, pharmacies and other healthcare-related facilities.” The current Regulatory Agenda for EPA estimates the issuance of the Second Notice of Proposed Rulemaking in June 2015.
Meanwhile, Connecticut is in its deliberative process of developing similar universal waste regulations for pharmaceuticals. Connecticut formed a Stakeholder Group to provide input to the Connecticut Department of Energy and Environmental Protection (DEEP) so that it may consider the various perspectives related to: (1) the challenges in the healthcare sector associated with the management of hazardous waste pharmaceuticals; and, (2) the proper regulatory framework for a universal waste regulation for the management of these pharmaceuticals. As a participant in this process, I can say that the various stakeholders within the healthcare industry were represented and the discourse was healthy and vigorous. The Stakeholder group is no longer active as the Agency representatives are in the rule-drafting stage. During this stage, these officials will consider the various stakeholder comments over the many months and draft its proposal for completion of the rulemaking process.
So, in 2015, we see the federal EPA and at least one state looking for an alternate approach for the management of hazardous waste pharmaceuticals. These rules are likely to receive many public comments, but I hope their efforts do not lose traction this time around. Through their rulemaking, the agencies can find a way to better align the management requirements for hazardous waste pharmaceuticals with the actual risks associated with their management. Professionals (e.g., nurses, doctors and pharmacists, etc.) have difficult challenges that well-tailored regulations can simplify without the agency creating public health and environmental problems. Looking forward to 2015, I am ever hopeful that these proposals will enjoy great momentum.
These regulations potentially could streamline the efficient and effective management of waste pharmaceuticals. Whatever happens with these regulations, we know from experience that drug schedule changes and other changes from the Drug Enforcement Agency (DEA) may also require all of us to make adjustments in our processes. We also need to keep our eyes open to how the state hazardous waste programs will adjust to the DEA’s Final Rule on the Takeback of Controlled Substances. Will states adopt interpretations of their hazardous waste regulations that will allow consumers to return these unwanted drugs to retail pharmacies, etc.? Or, will individual state agencies adopt interpretations that essentially block the takeback of controlled substances? What we can expect is that the states will vary in their approaches and we will have to navigate a state patchwork of regulations. Inmar looks forward to working with our partners in 2015 to manage the ever-changing requirements for the management of waste pharmaceuticals.
ContactRichard Sieg with any questions or comments.