The Drug Enforcement Administration has announced proposed regulations that it says will improve the agency’s ability to oversee the production of dangerous drugs at the height of the “national opioid crisis”.

The goal is to further limit excess quantities of medications that might be vulnerable to diversion for illicit distribution and use.

Here are the proposed regulations:

The proposal published in the Federal Register proposes 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.

While the comment period has only been open for a couple of days, already the opposition is being generated from persons one would assume are chronic pain patients.

Here’s what Christy Alford said:

“Why, why, why do you all keep taking meds from people? You are hurting the pain patients who need this medication. Start taking the drugs off the streets not from our doctor’s.”

Comments received so far:

The public comment period is open until December 23rd of this year.

Today’s proposal how 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 enough 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 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.

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