Richard Sieg, Regulatory Counsel, Inmar
The Environmental Protection Agency (EPA) remains determined to finalize its “Management Standards for Hazardous Waste Pharmaceuticals” regulation. The gatekeeper for federal agency regulations, the Office of Management and Budget’s (OMB’s) Office of Information and Regulatory Affairs (OIRA), informed the agencies that they have until this summer to complete and submit their priority regulations, if they expect those regulations to be published prior to President Obama’s departure from office. In a recent CSPA conference, Robert “Drew” Lausch stated that EPA is working through the stakeholder comments to meet its goal to get the rule finalized as scheduled.
The fear in the industry is that EPA does not have enough time to review and thoughtfully consider the hundreds of stakeholders’ comments and then make the changes to the rule necessary to make the rule feasible. Among other things, the final rule should:
- Expressly allow wholesale distributors to manage drugs under new, less stringent requirements;
- Embrace existing standard industry practices to manage the processing of drugs for credit, including aging;
- Remove critical ambiguities in the rule such as the definitions for potentially creditable pharmaceutical and non-creditable pharmaceutical, which would lead to significant uncertainties for healthcare facilities (including retailers); and,
- Rely upon other agency regulations for the management of drug products and not create conflicting and overbroad waste regulations.
The industry should work to understand these new rules when they are published. During this process, EPA must make some critical decisions regarding the management of pharmaceuticals in the healthcare and retail settings and these decisions could have very significant impacts on the entire supply chain.
Meanwhile, President Obama signed the “Ensuring Patient Access and Effective Drug Enforcement Act (S. 483) into law. HDMA’s President and CEO, John M. Gray, proclaimed:
“Today’s enactment is a victory for not only supply chain stakeholders and regulators, who share a common goal in mitigating the scourge of prescription drug abuse in this country, but the many individuals who rely on life-enhancing pain medicines every day. The changes brought forth through this law strike the appropriate balance of further protecting the supply chain against drug diversion, while allowing continuing patient access to critical medicines — and it does so in a way that promotes collaboration between the healthcare supply chain and those who regulate it.”
HDMA will continue to work with its members, the DEA and supply chain partners to best ensure the efficient and effective implementation of this law. For those interested in a bit more detail about this new law, an excerpt from https://www.congress.gov/bill/114th-congress/senate-bill/483 is provided below:
“This law amends the Controlled Substances Act to define: (1) “factors as may be relevant to and consistent with the public health and safety,’ for purposes of the Attorney General’s determination of whether registering an applicant to manufacture or distribute a controlled substance in schedules I or II is in the public interest, as factors that are relevant to and consistent with the findings of such Act; and (2) “imminent danger to the public health or safety,’ for purposes of the suspension of such a registration, to mean that in the absence of an immediate suspension order, controlled substances will continue to be distributed or dispensed by a registrant who knows or should know, through fulfilling the obligations of the registrant under such Act, that the dispensing is outside the usual course of professional practice, that the distribution or dispensing poses a present or foreseeable risk of adverse health consequences or death due to the abuse or misuse of the controlled substances, or that the controlled substances will continue to be diverted outside of legitimate distribution channels.”
As HDMA states, collaboration is important – not only for the new law and its implementation, but for other actions being considered, finalized and implemented by the government and its agencies.