Hi all, just wanted to give my quick input as well as condolences for N2K, he will be deeply missed. The quota for controls has nothing to do with the FDA and is handled by the DEA, the biggest issue as everyone is seeing with teh shortages was that the DEA adjusted annual quotas down for the past 2-3 years because of the opioid abuse, now you are seeing the repercussions, they are going to be hesitant to increase it as now everyone is watching things under a magnifying glass and pointing fingers. The entire blame for all of this mess is the DEA but no one can go after them, untouchable.
Elite has to file Form 250 by April 1 asking for 2024 quota based on historical sales and previous quotas and can usually add 10% to previous years. So in theory Elite already has all of 2023 quota approved, Lannett not so much if they got any at all. Yes Lannett needs to file as a new company and will not get a large amount as they have no manufacturing history nor quota history for this compound, this is if the DEA even gives them quota as there is a shortage. We have seen them deny quota to new companies when the demand is this bad. Just wanted to give everyone a little context. Hope all is well with everyone. Russ
Deadlines
Annual applications for quotas must be filed on or before the date indicated of the year preceding the calendar year for which the quota is being applied.
DEA Form 189 for Manufacture Quotas must be filed on or before May 1.
DEA Form 250 for Procurement Quotas must be filed on or before April 1.
DEA Form 488 for Import Quotas must be filed on or before April 1.
