DEA Cuts Oxycodone Supply, But Raises Production of Morphine in Surprise Move

By Pat Anson

The Drug Enforcement Administration is moving ahead with its plan to reduce the supply of oxycodone by over 6% in 2026, while at the same time significantly raising its production quota for morphine. There will be small reductions in the supply of hydrocodone, codeine and other Schedule II opioids this year.

The move to increase the supply of morphine by 10.5% is surprising, as the agency proposed cutting morphine production by over half a percent a little over a month ago. 

The DEA officially announced its plans January 5 in the Federal Register, 35 days after a December 1 deadline set for the agency in the Controlled Substances Act (CSA). Under the CSA, the DEA has broad legal authority to set annual aggregate production quotas (APQs) for opioids and other controlled substances. 

The December 1 deadline is important because it gives the pharmaceutical industry time to prepare for the coming year by adjusting drug manufacturing and distribution schedules. The DEA’s chronic failure to meet that deadline in previous years has contributed to shortages, according to drug makers.

Over 5,000 public comments were received by the DEA in response to the agency’s initial APQs for 2026. Most comments pleaded with the agency not to make any further cuts in the supply of opioids, many of which are already in short supply at pharmacies and hospitals. 

“I oppose cutting production for controlled medications at this time as there is already a shortage for many of these medications and patients are often not able to obtain their prescriptions. Cutting production during a shortage will only exacerbate the problem and increase patient suffering,” Hannah Khalil wrote in a public comment echoed by many others. 

The DEA, however, was dismissive of claims about opioid shortages, saying it was not responsible for them.

“Drug shortages may occur due to factors outside of DEA's control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations,” the DEA said. “Currently, FDA has not listed on its Drug Shortage website any nationwide shortages of oxycodone and hydrocodone products.”

While it is true the FDA does not currently have oxycodone or hydrocodone on its shortage list, the American Society of Health-System Pharmacists (ASHP) has listed both opioids on its shortage list since 2023. Limited supplies of oxycodone and hydrocodone are available from some manufacturers, according to the ASHP, while others have the medications on back order.

The difference between the FDA and ASHP shortage lists is that the FDA relies on drug manufacturers to report shortages, while the ASHP proactively surveys both pharmacies and drug makers about their inventories. That arguably makes it superior to the FDA’s methodology.

Ironically, the DEA itself has challenged the reliability of the FDA’s drug shortage list.

“DEA has made it clear it does not trust FDA’s information, as it does not consider many of the shortages that FDA verifies to be legitimate,” the General Accountability Office (GAO) said in a 2015 audit report. “They do not believe FDA appropriately validates or investigates the shortages.”

Increased Morphine Production

The DEA offered no explanation for the increase in morphine production. The production quota for morphine is 10.55% higher than last year's quota and the highest amount since 2021.

One likely reason for the DEA’s decision is that the FDA recently added morphine tablets and injectable morphine solutions to its shortage list, due to discontinuations and short supplies. The ASHP has listed morphine in shortage for several months. 

Morphine solutions and other injectable opioids are an important resource in hospitals, emergency rooms and surgery centers, where they are used in post-op care, sedation and anesthesia.

Morphine tablets are most often used to treat severe chronic pain.

“I fear there will be continued shortages resulting in many patients suffering from the DEA’s quota decisions.”

— Dr. Lynn Webster, pain management expert

“In 2025, there were major shortages of morphine immediate release (15-mg, 30-mg tablets) and morphine extended release (mostly 30-mg tablets) that lasted 3-4 months and were disruptive to care. I mentioned morphine in my personal, submitted comments (to the Federal Register),” said Chad Kollas, MD, a palliative care physician in Florida.

“I suspect that others also complained about last year’s morphine shortages, which may have led to the increase in production of morphine in 2026. It is also the cheapest of the traditional opioids, which may have played a role in the decision. I’m disappointed that they held the line on the oxycodone reduction.”

“I don't know why the DEA would reduce oxycodone while increasing the morphine quota. It seems illogical since there are reports that both are in shortage at the clinical level,” says Lynn Webster, MD, a pain management expert and former president of the American Academy of Pain Medicine. “I fear there will be continued shortages resulting in many patients suffering from the DEAs quota decisions.  

“They know patients are struggling to get access to both medications but they may think oxycodone is more likely to be abused than morphine. It appears they are trying to tell providers what they should prescribe. Yet they are not supposed to be involved in determining how medicine is practiced. Whether intentional or not, that is exactly what they are doing.”

Even with this year’s increase in morphine production, DEA has reduced the supply of morphine by over 63% since 2015. Steep declines have also been made in quotas for hydrocodone (-73%), oxycodone (-71%), and codeine (-70%) over the past decade.  

The DEA began cutting the opioid supply in response to pressure from Congress and anti-opioid activists, who claimed that prescription opioids were responsible for soaring overdose rates. While that claim has been largely debunked, opioid prescribing has continued to fall, as doctors became fearful of being accused of “overprescribing.”

The DEA says the “medical usage” of opioids fell by 10.5% in 2024 alone. The agency expects  that trend to continue, while dismissing claims that its shrinking opioid production quotas have interfered with the practice of medicine. 

“DEA's regulations do not impose restrictions on the amount and the type of medication that licensed practitioners can prescribe. DEA has consistently emphasized and supported the authority of individual practitioners under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards,” DEA said. 

DEA Missed Deadline for Opioid Production Quotas. Will It Worsen Shortages?

By Pat Anson

In recent years, hundreds of physicians have been prosecuted by the U.S. Justice Department for violations of the Controlled Substances Act (CSA).

In many cases, the doctors were accused of prescribing opioid pain medication without “a legitimate medical purpose” – a vague term in the CSA that was meant to prevent drug abuse, but in practice put the DOJ in charge of deciding whether healthcare decisions involving controlled substances are legal. 

The CSA is rigidly enforced when federal prosecutors believe opioids are prescribed excessively. But when it comes to enforcing another provision in the CSA, the DOJ and Drug Enforcement Administration have routinely ignored deadlines for setting aggregate production quotas (APQs) for opioids and other Schedule I and II controlled substances:

“On or before December 1 of each year, upon application therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled substances in schedules I and II.”

The December 1 deadline is important because it gives the pharmaceutical industry a small window to prepare for the coming year by acquiring raw materials for drugs, setting manufacturing schedules, and distributing medications to hospitals and pharmacies – a process that can take as long as six months. . 

But Attorney General Pam Bondi and acting DEA Administrator Terry Cole didn't publish their proposed quotas for 2026 in the Federal Register until November 28, which call for a 6% cut in the supply of oxycodone.

Allowing for a shortened public comment period that ends December 15, and time to review thousands of comments and make changes in the quota allotments, that means the final APQs for next year will likely not be ready until after January 1.

The last time production quotas were that late was in 2024, when the final APQs were not published until January 3. Drug shortages spiked to record levels in the first few months of that year, including many medications that are covered under the quota system. 

Missing the deadline again this year threatens to worsen chronic shortages of oxycodone, hydrocodone, fentanyl, hydromorphone, morphine and amphetamine-based stimulants that are vital to millions of patients who live with pain or attention deficit disorder (ADHD).

The DOJ and DEA did not respond to multiple requests from PNN to explain why the CSA deadline was missed again.

This is not a new problem. Late quotas and drug shortages have persisted for years, as the DOJ and DEA have focused on going after doctors who prescribe opioids – at times using “flimsy evidence” – rather than ensuring that essential medications are available on time. 

That mindset of being a law enforcement agency first – with maintaining the drug supply an afterthought – may have cost some patients their lives. 

“We talk a lot about opioid misuse, but almost never about the quiet suffering caused when essential pain medicines simply aren't available,” says Lynn Webster, MD, a pain management expert and former president of the American Academy of Pain Medicine. “Chronic delay and rigidity in quota decisions make patients with serious illness feel like collateral damage in a war on drugs that has lost sight of its humanitarian obligations.

“Quotas were meant to curb diversion, not to create a permanent state of scarcity for people in pain. By keeping quotas tight and decisions late, the DEA has turned an already fragile supply chain into a game of musical chairs where patients lose their seats.”

Late Quotas Worsened Drug Shortages

As far back as 2015, the General Accountability Office (GAO) warned in an audit report that the DEA “has not effectively administered the quota process.” Although a decade old, many of the problems cited by the GAO still exist today.

“Each year, manufacturers apply to DEA for quota needed to make their drugs. DEA, however, has not responded to them within the time frames required by its regulations for any year from 2001 through 2014,” the GAO said.

“Manufacturers who reported quota-related shortages cited late quota decisions as causing or exacerbating shortages of their drugs.”

The report found that drugs containing Schedule II controlled substances accounted for over half the shortages between 2001 and 2013. Several manufacturers complained to the FDA the shortages were caused by the DEA’s mishandling of the quota system.

But the DEA denied any responsibility for the shortages, while blaming the missed deadlines on  “inadequate staffing” and an “increasing workload” in its Quota Unit.

“DEA is confident that its administration of the quota process did not affect a shortage during the period of review because drug product shortages are not limited to products that contain Schedule II controlled. substances,” Joseph Rannazzisi, then-DEA Deputy Assistant Administrator, wrote in the agency’s response to the GAO report.

Rannazzisi would later emerge as a “whistleblower” on 60 Minutes, who blamed the opioid crisis on lax policies at the FDA that favored that drug industry.

The relationship between DEA and FDA, at least in 2015, was not one of trust. The FDA advised the DEA about medical demand for Schedule II drugs and any shortages that may exist, but the DEA didn’t always listen.

“DEA and FDA are not able to effectively collaborate due to fundamental disagreement over whether any given shortage exists. DEA has made it clear it does not trust FDA’s information, as it does not consider many of the shortages that FDA verifies to be legitimate,” the GAO said. “They do not believe FDA appropriately validates or investigates the shortages.” 

The GAO concluded that problems in DEA’s Quota Unit run deeper than any petty rivalries with the FDA. 

“Our work shows that DEA’s lack of internal controls, such as controls to ensure data reliability, performance measures, and monitoring of performance, may hinder the agency’s ability to ensure an adequate and uninterrupted supply of controlled substances,” the 2015 report found. “This approach to the management of an important process is untenable and poses a risk to public health.”

New Deadline

The GAO’s critique came at a time when the DEA’s deadline for final APQs was October 1 – a deadline the agency consistently failed to meet. 

To buy itself more time to work on quotas, the DEA lobbied Congress to change the annual deadline to December 1 in the 2018 Support Act, a bill intended to reduce opioid diversion. The DEA also reduced the amount of inventory drug manufacturers are allowed to keep of controlled substances, and agreed to base its quotas on dosages, not the raw supply of drugs.

How has that worked out? Poorly.

The DEA has not only been unable to meet the December 1 deadline, but the smaller inventories have worsened the ability of drug manufacturers to respond to late quotas and emerging drug shortages. 

The pharmaceutical industry warned the DEA that reducing inventories would only worsen shortages and do little to prevent diversion.

“We believe that risks associated with this proposal, including the increased likelihood for drug shortages and market outages, greatly outweigh the negligible benefit this provision will provide,” Larry Cote, an attorney representing a drug manufacturer, wrote to the agency in 2019.

“Given the timing of procurement quota issuance, it will become more imperative to carry increased levels of inventory at year end in order to ensure continued drug supply, as opposed to decreased levels.”

The DEA ignored those warnings and reduced inventories anyway. As a result, analgesic medications needed for surgery and post-op care, such as injectable fentanyl and hydromorphone, have been on the FDA shortage list for years, in part due to low inventories. The two drugs are rarely diverted.

‘Vulnerable to Supply Shocks’

Two pharmacists recently criticized the DEA for its “outdated system” for APQs.

“The current one-size-fits-all system for setting APQs is ineffective and Congress recognized this back in 2018, passing the SUPPORT Act to modernize the APQ setting process and require quota allocations based on dosage form. Yet seven years later, the DEA has failed to implement this law, leaving manufacturers constrained, patients underserved, and the nation vulnerable to supply shocks,” Soumi Saha, PharmD, and Justin Schneider, PharmD, wrote in a recent op/ed published in the Pharmacy Times.   

Saha and Schneider believe many of the quota problems could be addressed if the DEA were to hire a Chief Pharmacy Officer who is familiar with the drug supply system and is put in charge of the quota system.

“It is time to elevate the agency’s clinical responsibility by establishing a Chief Pharmacy Officer (CPO) within the DEA - a role dedicated to ensuring that patient access is not an afterthought, but a core priority,” they said. “A strong CPO would not only modernize quota systems but also bring agility, accountability and patient advocacy to the heart of DEA decision-making.”

To be clear, the DEA is not solely at fault for persistent shortages of opioids and other controlled substances. A 2021 opioid litigation settlement with three drug distributors essentially rationed the supply of opioids at many pharmacies and made pharmacists even more wary of filling new prescriptions. 

In a 2023 PNN survey of over 2,800 patients, 90% said they experienced delays or problems getting their opioid prescriptions filled, mostly because their pharmacy was out of stock. Nearly one in five were unable to get their pain medication, even after contacting multiple pharmacies.

Some generic drug manufacturers have stopped making opioids because of low profit margins and because of concerns they could be targeted by plaintiff law firms in opioid lawsuits that could cost them billions of dollars. 

Bad weather and a heavy reliance on foreign drug manufacturers have also made the supply chain less reliable and contributed to shortages.  

But the DEA’s chronic failure to meet quota deadlines – a problem dating back decades – and its slow-walking of efforts at reforming the quota system, have made a fragile drug supply chain even more vulnerable to disruptions. And it is patients who pay the ultimate price for the DEA’s negligence.

“When DEA repeatedly misses its own deadlines for setting opioid production quotas, that uncertainty reverberates all the way to the bedside,” says Dr. Webster. “Manufacturers pull back, pharmacies ration, and it's the patients – people with cancer, sickle cell disease, or severe chronic pain – who are left wondering if their next prescription will even be filled.” 

Should the DEA hire a Chief Pharmacy Officer? Should deciding what is or isn’t “a legitimate medical purpose” be left to the DEA and DOJ? Only a few days are left to comment on the DEA’s proposed APQs for 2026. You can leave a public comment by clicking here.

DEA Plans Further Cuts in Oxycodone Supply

By Pat Anson

The Drug Enforcement Administration is planning to cut the supply of oxycodone by over 6% in 2026, along with marginal reductions in the supply of hydrocodone, morphine and other Schedule II opioids. 

If the DEA’s plans are finalized after a short public comment period, it would be the 10th consecutive year the opioid supply has been reduced in the United States.

The DEA announced its plans Friday in the Federal Register. Under the Controlled Substances Act (CSA), the agency has broad legal authority to set annual aggregate production quotas (APQs) for drug makers – in effect telling them the amount of Schedule I and Schedule II chemicals and medications they can produce. 

The DEA is planning another round of cuts in the Schedule II opioid supply because it continues to see declines in the “medical usage” of opioids – an average decrease of 10.5% in 2024 alone. 

It’s important to note that medical usage is different from “medical need.” Doctors simply aren’t prescribing as many opioids as they used to, so while the need for pain relief hasn’t changed and may have even increased due a spike in rates of chronic pain, the number of prescriptions written for opioids has declined. 

DEA expects that trend to continue, based in part on data from IQVIA, a private company that tracks prescription drug use. The agency is also seeing fewer requests from drug manufacturers to make oxycodone.

“DEA projects that the medical usage of these controlled substances will continue to decline in 2026 based on a review of domestic usage data from IQVIA,” DEA said in its Federal Register notice. “Additionally, DEA has observed a significant decline in requests for product development quotas to support manufacturing towards FDA approval of drug products containing oxycodone.” 

DEA Opioid Production Cuts Planned for 2026

• Oxycodone          6.24% decrease

• Morphine             0.559% decrease

• Hydrocodone       0.529% decrease

• Hydromorphone  0.109% decrease

• Fentanyl              0.014% decrease

• Codeine               0.002% decrease

From year-to-year, the cuts may not appear significant. But over the past decade, there has been an historic decline in the nation’s opioid supply. If its current plan is adopted, DEA will have cut the supply of hydrocodone by 72.9% and oxycodone by 70.6% since 2014.

Some of the decline in “medical usage” is driven by scarcity. For example, Endo Pharmaceuticals recently informed the FDA it discontinued production of 2.5, 5, 7.5 and 10 mg Percocet (oxycodone/acetaminophen) tablets. Major Pharmaceuticals stopped making oxycodone/acetaminophen tablets a few months ago. And Teva Pharmaceuticals, a large generic drug maker, stopped making immediate-release oxycodone in 2023.  

The FDA does not currently list oxycodone products on its drug shortage database, but the American Society of Health-System Pharmacists (ASHP) has since 2023. Limited supplies of oxycodone are available from some manufacturers, according to ASHP, while others have the medications on back order.

Hydrocodone/acetaminophen tablets have also been on the ASHP’s shortage list (but not on the FDA’s) since 2023. Major and Camber Pharmaceuticals have both stopped making them.

Health Canada reported a nationwide shortage of oxycodone/acetaminophen combinations over the summer, a shortage that persists today but is expected to resolve soon.

Why would the DEA be reducing production quotas for opioids that are already in short supply?

DEA sets its APQs after consulting with states willing to share their prescription drug data, as well as federal agencies like Health and Human Services and the Food and Drug Administration. 

DEA also asked for input from the Centers for Disease Control and Prevention, an agency in turmoil after several months of layoffs, budget cuts and leadership changes. A response to that request “was inadvertently delayed” at CDC, but DEA says it will take it under consideration when or if it ever arrives. 

“DEA remains committed to monitoring drug shortages, limiting their impact, and resolving them as quickly as possible. DEA continues to seek additional information that will assist in accurately forecasting domestic medical usage and export requirements of schedule I or II substances,” DEA said.

Unlike previous years, when there was a 30-day period for public comments on the DEA’s quota proposal, the agency is only allowing about two weeks. You can leave a comment here, but it must be posted no later than December 15. DEA did not explain why it was reducing the amount of time the public can comment.