Richard Sieg, Inmar Regulatory Counsel
The end of a year is a good time to reflect on the regulatory changes that occurred in 2014. No summary would be complete without mentioning the Sept. 9, 2014 Final Rule for the Disposal of Controlled Substances. DEA is trying to create a better solution to patients’ historical management of drugs in the home, seeking to use retail pharmacies and others as a vehicle for collecting these drugs from homes.
This kind of take-back program is a good cause, but it still has some hurdles to overcome. The EPA reasonably appears to be leaning on the household hazardous waste exclusion from the federal EPA regulations as it accommodates the DEA rules. How the individual states will respond to adapt their regulations to the initiative is still ambiguous, but it’s likely to bring challenges to the implementation of the DEA rules. On December 10, during the Connecticut Department of Energy and Environmental Protection (DEEP) Stakeholders Recommended Framework for Universal Pharmaceutical Waste Regulations Workgroup meeting, it was announced that the State of Connecticut has decided that “drop off” boxes in pharmacies would not be allowed. Whether police stations will be the only take-back option in Connecticut remains to be seen.
In a prior article I discussed the impacts of the rescheduling of hydrocodone combination products from Schedule III to Schedule II. This Final Rule published in August 2014 significantly impacts retailers and reverse distributors who must adjust to the new requirements. The Tramadol rescheduling raised a few eyebrows as well. While we reflect on these changes, we need to prepare for what is ahead in 2015.
It appears now that the Universal Waste Proposed Rule for the Management of Pharmaceuticals is expected for publishing in June 2015. This long awaited rule could have significant positive impact on the management of waste pharmaceuticals. The EPA appears to be embracing reverse distribution as a necessary part of the solution of safely, securely managing waste pharmaceuticals. EPA states in it published regulatory agenda, “The revisions are also intended to clarify regulation of a major mechanism used by healthcare facilities for management of unused and/or expired pharmaceuticals, known as reverse distribution.” That document indicates the agency is considering modifications to federal hazardous waste regulations in the form of “healthcare facility-specific regulations for the management of hazardous waste pharmaceuticals in order to provide a regulatory scheme that is adapted to the unique issues that hospitals, pharmacies and other healthcare-related facilities face.”
In 1980, in the face of the aftermath of Love Canal and all that came with it along the lines of hazardous waste regulation, EPA published a one-size-fits-all regulation for the management of the nation’s waste problems. In doing so, it acknowledged that a one-size fits all approach may not work for all situations and the agency would reconsider the regulations when appropriate.
The agency is following through on its statement in the original rule in this round of seeking to create regulations that are a good fit for healthcare settings in pharmacies, hospitals, etc., but EPA cannot do it alone. It is important for the regulated community to participate in the rule-making process. EPA needs stakeholders such as Inmar and our clients to provide the information sufficient for the agency to have a clear picture of the unique challenges of managing drugs as waste. Inmar will comment on the proposed rule, when it is published, and we hope you will as well.
Stay tuned – it should be a very interesting 2015 as things develop.
Read more about this proposal in the EPA’s online published agenda.