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“Obtaining DEA Quota to Manufacture Controlled Substances”

DEA Chronicles By Larry P. Cote

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 better understand the issue(s). DEA requires registered manufacturers seeking Procurement Quota (“PQ”) to submit an application for PQ “on or before April 1 of the year preceding the calendar year for which the procurement quota is being applied.” Likewise, “bulk manufacturers” seeking Individual Manufacturing Quota (“IMQ”) are required by DEA’s regulations to submit an application for IMQ “on or before May 1 of the year preceding the calendar year for which the manufacturing quota is being applied.” The Controlled Substances Act and the DEA’s own regulations impose certain deadlines on the Agency with respect to its quota obligations. DEA isrequired to publish the Aggregate Production Quota (“APQ”) and the Annual Assessment of Needs (“AAN”) in the Federal Register on or before May 1. That deadline has come and gone and no such notice was published by the DEA in the Federal Register. In fact, DEA has failed to meet the deadline for establishing the APQ going back at least to 1998 and the AAN since the requirement was imposed on the Agency in 2006 (see chart below).It stands to reason that DEA’s repeated failure to meet the initial deadlines for filing APQ and AAN necessarily results in the Agency’s failure to issue IMQ and PQ on a timely basis. While there may very well be valid reasons for the DEA’s untimely issuance of quota, it nonetheless presents significant challenges to manufacturers of controlled substances. In future posts, we will discuss why the timely issuance of quotas is important. Stay tuned…

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