DEA rolled out its proposed aggregate production quotas for 2021 earlier this week, the same day, in fact, that it proposed adjustments to its 2020 quotas. Let’s start off by looking at the Big Five, at least as far as the SUPPORT Act is concerned: fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone.
manufacturing
DEA Proposes Decreasing Opioid Quotas for 2020
Quota Reductions
DEA is out with its proposed 2020 aggregate production quotas for Schedule I and II controlled substances, and they have been reduced dramatically from 2019’s numbers. From the press release:
DEA proposes to reduce the amount of fentanyl produced by 31 percent, hydrocodone by 19 percent, hydromorphone by 25 percent, oxycodone by nine percent and oxymorphone by 55 percent. Combined with morphine, the proposed quota would be a 53 percent decrease in the amount of allowable production of these opioids since 2016.”
How’d They Get There?
Why the size of the decrease? Aside from the obvious political pressures attendant to legitimate concern over the proliferation of the opioid crisis and, perhaps, some less-legitimate political posturing, the DEA cites the usual factors and a significant new one. As always, DEA consults “many sources, including estimates of the legitimate medical need from the Food and Drug Administration; estimates of retail consumption based on prescriptions dispensed; manufacturer’s disposition history and forecasts; data from DEA’s internal system for tracking controlled substance transactions; and past quota histories.”
DEA Slashes Opioid Manufacturing Quotas for 2019
In a joint statement by the U.S. Department of Justice and the Drug Enforcement Administration, the government announced continued efforts to tackle the opioid crisis by reducing the quantity of controlled substances permitted to be manufactured next year. The proposal decreases the 2019 Aggregate Production Quotas (APQ) for six of the most frequently misused…
DEA Finalizes Rule to Schedule Tramadol
Possibly in the hopes of catching everyone before they leave for their 4th of July holiday, the DEA published its Final Rule in the Federal Register on July 2nd placing tramadol into Schedule IV effective August 18, 2014. (Tramadol is a centrally acting opioid analgesic first approved for use in the U.S. in 1995 under…
Obtaining DEA Quota to Manufacture Controlled Substances
DEA Quota Season is Upon Us This is the first of several discussions we will have regarding the DEA quota process and the adverse impact DEA’s handling of the quota process can have on the availability of controlled substances for the legitimate medical needs of the United States. Some context and background is required to…