The Drug Enforcement Administration today announced proposed regulations to improve DEA’s ability to oversee the production of dangerous drugs at the height of the national opioid crisis. This proposed regulation would further limit excess quantities of medications that might be vulnerable to diversion for illicit distribution and use.
The proposal published today in the Federal Register incorporates important and necessary changes to DEA’s quota regulations resulting from comprehensive legislation passed by Congress last year to address the nation’s deadliest drug epidemic in history, the Substance Use-Disorder Prevention that Promotes Opioid Recovery Treatment for Patients and Communities Act, or SUPPORT Act. The SUPPORT Act requires that appropriate quota reductions be made after estimating potential for diversion. This estimate is based on rates of overdose deaths and abuse, the overall public health impact related to specific controlled substances and may include other factors as appropriate.
Today’s proposal amends the manner in which DEA grants quotas to manufacturers for maintaining inventories. These proposed levels align with current manufacturing standards aimed at promoting quality and efficiency, while also ensuring that the country has sufficient quantities of Schedule II substances necessary for the medical, scientific, research and industrial needs of patients nationwide.
The proposal also introduces several new types of quotas that DEA would grant to certain DEA-registered manufacturers. These use-specific quotas include quantities of controlled substances for use in commercial sales, product development, packaging/repackaging and labeling/relabeling, or replacement for quantities destroyed. These use-specific quotas will greatly improve the timeliness of DEA’s responses to applications filed by manufacturers while simultaneously improving DEA’s ability to respond quickly to drug shortages.
This regulation builds on important regulatory changes finalized in 2018 which gave a role to state attorneys general and certain federal partners – including the Department of Health and Human Services, Food and Drug Administration, the Centers for Disease Control and the Centers for Medicare and Medicaid Services – in setting the aggregate production quotas for Schedule I and II controlled substances.
The full text of the proposal may be found on the Federal Register site. The public has 60 days to review and comment on this proposal, which DEA must then consider before drafting final regulations.