DEA to Slash Opioid Production

September 13, 2019

Fentanyl, oxymorphone, and hydrocodone face greatest cuts.

The DEA is proposing to reduce the amount of five Schedule II opioid controlled substances that can be manufactured in the U.S.

In its Notice of Proposed Rulemaking, DEA proposes to reduce the amount of oxymorphone (Opana) produced by 55%, fentanyl by 31%, hydrocodone (Vicodin) by 19%, hydromorphone (Dilaudid) by 25%, and oxycodone (Oxycontin) by 9%.

Combined with morphine, the proposed quota would be a 53% decrease in the amount of allowable production of these opioids since 2016.

Trending: Generics and Biosimilars Facing Formulary Difficulties

“The aggregate production quota set by DEA each calendar year ensures that patients have the medicines they need while also reducing excess production of controlled prescription drugs that can be diverted and misused,” said Acting Administrator Uttam Dhillon in a statement

The five opioids that are being cut were subject to special scrutiny after the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act was enacted last year, the agency said. SUPPORT requires DEA to “estimate the amount of diversion of the covered substance that occurs in the United States” and “make appropriate quota reductions.”

While it is cutting opioid production, DEA is proposing to increase the amount of marijuana that can be produced for research from 2,450 kilograms to 3,200 kilograms-almost triple the amount produced in 2018. 

Read More: The Redefinition of Pharmacy Jobs

The Proposed Aggregate Production Quotas and Assessment of Annual Needs addresses more than 250 Schedule I and II controlled substances and three List I chemicals, which include ephedrine, pseudoephedrine, and phenylpropanolamine. “This reflects the total amount of substances needed to meet the country’s legitimate medical, scientific, research, industrial, and export needs for the year and for the maintenance of reserve stocks. DEA endeavors to set production limits at a level required to meet these needs, without resulting in an excessive amount of these potentially harmful substances,” the agency said.

Individuals can submit public comments on the proposed APQ until 11:59 p.m. on October 10, following the instructions in the Notice. After taking the comments into account, DEA will publish another notice later in the year informing the public of the established APQ.

download issueDownload Issue : Drug Topics October 2019