Quotas

The DEA limits the quantity of Schedule I and II controlled substances which may be produced in the United States in any given calendar year. By utilizing available data on sales and inventories of these controlled substances, and taking into account estimates of drug usage provided by the FDA, the DEA establishes annual aggregate production quotas for Schedule I and II controlled substances. The aggregate production quota is allocated among the various manufacturers who are registered to manufacture the specific drug. The DEA also allocates the amount of bulk drug that may be procured by those companies which prepare the drug into dosage units.