The Drug Enforcement Administration (DEA) reversed a January 2024 regulation that would have unintended consequences on the supply of morphine, other opioids, and Schedule II controlled substances.

DEA dictates the quantity of controlled substances drug manufacturers are allowed to make through a quota system. However, DEA found that some manufacturers were not using the full amount of their annual quota, instead hoarding their quotas, and therefore finalized a rule that would set quarterly quotas for drug companies to prevent shortages of medications.

Unfortunately, the policy had the unintended consequence of delaying the delivery of quota allocations to manufacturers, causing delayed production, and limited manufacturers from planning the production of Schedule II products.

Many LeadingAge member providers, especially those in the hospice space who use Schedule II drugs to support comfort at the end of life, have noticed reduced access to critical drugs. In DEA’s reversal, the quota system for injectable Schedule II drugs will revert back to an annual allocation while all other Schedule II drugs’ allocations will be made semi-annually. This immediate change will hopefully reduce drug supply chain issues and create a greater supply of necessary drugs.