Opioid manufacturing quotas cut for 2019

The U.S. Attorney’s Office for the Northern District of Florida sent out a press release on the DEA’s proposal to reduce manufacturing quotas for the most six frequently misused opioids for 2019 by an average 10 percent as compared to the 2018 amount. The Notice of Proposed Rulemaking (NPRM) marks the third straight year of proposed reductions, which help reduce the amount of drugs potentially diverted for trafficking and used to facilitate addiction.

“Northern Florida communities and our neighbors across the country have suffered from the abuse of these highly addictive drugs, which can quickly destroy lives, families, friends, and career,” said U.S. Attorney Christopher P. Canova in the release. “The U.S. Attorney’s Office is committed to supporting strategies that fight the epidemic. Some of these strategies include: limiting the production and prescription of opioids, prosecuting drug trafficking organizations and medical professionals who illegally divert controlled substances, raising public awareness especially among young people, and strengthening law enforcement and public health agency partnerships to use every available resource to monitor and combat the opioid crisis.”

On July 11, the Justice Department announced that DEA was issuing a final rule amending its regulations to improve the agency’s ability to consider the likelihood of whether a drug can be diverted for abuse when it sets annual opioid production limits. The final rule also promotes greater involvement from state attorneys general

The DEA has proposed to reduce more commonly prescribed schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl.The agency believes that the revised limits will encourage vigilance on the part of opioid manufacturers, help DEA respond to the changing drug threat environment, and protect the American people from potential addictive drugs while ensuring that the country has enough opioids for legitimate medical, scientific, research, and industrial needs.

“The opioid epidemic that we are facing today is the worst drug crisis in American history,” Attorney General Jeff Sessions said. “Cutting opioid production quotas by an average of ten percent next year will help us continue that progress and make it harder to divert these drugs for abuse. These smarter limits bring us one big step closer to President Trump’s goal of finally ending this unprecedented crisis.”

“We’ve lost too many lives to the opioid epidemic and families and communities suffer tragic consequences every day,” said DEA Acting Administrator Uttam Dhillon. “This significant drop in prescriptions by doctors and DEA’s production quota adjustment will continue to reduce the amount of drugs available for illicit diversion and abuse while ensuring that patients will continue to have access to proper medicine.”

Once the aggregate quota is set, DEA allocates individual manufacturing and procurement quotas to those manufacturers that apply for them. DEA may revise a company’s quota at any time during the year if change is warranted due to increased or decreased sales or exports, new manufacturers entering the market, new product development, or product recalls.

When Congress passed the Controlled Substances Act, the quota system was intended to reduce or eliminate diversion from “legitimate channels of trade” by controlling the quantities of the basic ingredients needed for the manufacture of controlled substances.

Next year, the aggregate manufacturing quota for commonly prescribed schedule II opioids will be 44 percent less than the 2016 quota, going from 303.3 million to 169.9 million grams. See chart.