The Drug Enforcement Administration has issued a final rule that, effective Aug. 15, will strengthen controls over the diversion of controlled substances and make other improvements in the quota management regulatory system for the production, manufacturing, and procurement of controlled substances. The DEA states that the current regulations need to be updated to reflect changes in the manufacture of controlled substances, changing patterns of substance abuse and markets in illicit drugs, and the challenges presented by the current national crisis of controlled substance abuse.

This rule makes two additions to the list of factors that must regularly be considered in setting aggregate production quotas; i.e., the total quantity of each basic class of controlled substance listed in schedule I or II needed in a calendar year for U.S. medical, scientific, research, and industrial needs, for lawful export, and for the establishment and maintenance of reserve stocks. These additions are (1) the extent of any diversion of the controlled substance in the class and (2) relevant information from the Department of Health and Human Services and its components, including the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services, as well as relevant information obtained from the states.

This rule also (1) clarifies that the DEA administrator may require additional information from quota applicants that may help to detect or prevent diversion, including customer identities and amounts of the controlled substance sold to each customer, and (2) authorizes the administrator to, at any time, increase or reduce the aggregate production quotas for basic classes of controlled substances.

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