The Drug Enforcement Administration (DEA) within the Department of Justice is seeking public comment on a proposed rule to strengthen controls over diversion of controlled substances and make other improvements in the quota management regulatory system for the production, manufacturing, and procurement of controlled substances.
Provisions of the Controlled Substances Act, 21 U.S.C. 801 et seq., authorize the Attorney General to issue rules and regulations relating to registration and control of the manufacture, distribution, and dispensing of controlled substances and listed chemicals. 21 U.S.C. 821. Pursuant to this authority, the Attorney General, through the Drug DEA, has issued and administers regulations setting aggregate production quotas for each basic class of controlled substances in schedules I and II, manufacturing quotas for individual manufacturers, and procurement quotas for manufacturers to produce other controlled substances or to convert the substances into dosage form. See 21 CFR part 1303.
The current regulations, issued initially in 1971, 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 proposed rule modifies the regulations to strengthen controls over diversion—that is, the redirection of controlled substances which may have lawful uses into illicit channels—and makes other improvements in the controlled substance regulatory quota system.
The quota process, in general terms, is a critical element of the Controlled Substances Act's regulatory system that seeks to prevent or limit diversion by preventing the accumulation of controlled substances in amounts exceeding legitimate need. The measures the proposed rule adopts to strengthen the system include authorizing the requisition from quota applicants of additional information helpful in detecting and preventing diversion, and ensuring that DEA's determinations regarding the appropriate quotas are adequately informed by input from other federal agencies, from the states, and from quota applicants.