Sometimes consistency is a bad thing…

On September 9, 2013, the DEA published the 2014 Aggregate Production Quota (APQ) and Annual Assessment of Needs (AAN).  This is noteworthy because it continues the DEA’s streak of failing 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.  We discussed this is a previous posting and provided a helpful chart to document the unfortunate streak.

The untimely issuance of quota can have a detrimental impact on the availability of controlled substances for the legitimate medical and scientific needs of the United States.  The manufacturing process – whether for controlled or non-controlled substances – requires advanced planning and coordination.  A manufacturer cannot simply stop making one drug one day and start producing a different drug on the next day.  Advanced planning and preparation is required to clean, sterilize, test and prepare production lines for manufacturing, a process that can take weeks.

Knowing the APQ and AAN, as well as the amount of quota assigned well in advance of the quota year provides the manufacturer with the ability to optimize production lines and ensure that all customer needs are met in a timely manner.  Presumably Congress had this in mind when they required the DEA to issue quota to manufacturers several months in advance of the quota year.