In an effort to address the national opioid crisis, the Drug Enforcement Administration (DEA) recently announced proposed regulations to improve oversight of the production of dangerous drugs that might be vulnerable to diversion.
The DEA’s proposal amends the manner in which the DEA grants quotas to manufacturers for maintaining inventories and introduces several new types of quotas that DEA would grant to certain DEA-registered manufacturers.
The proposed regulations incorporate important changes to the DEA’s quota regulations resulting from the 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 regulation builds on important regulatory 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.
If you are a manufacturer in the pharmaceutical industry potentially affected by the proposed regulation, contact Frier Levitt today to make your voice heard during the 60-day review and comment period before the DEA issues final regulations.
The deadline to submit comments is 12/23/2019.