Controlled Substance Quotas

GGD-95-52R: Published: Jan 18, 1995. Publicly Released: Feb 14, 1995.

Additional Materials:


Office of Public Affairs
(202) 512-4800

Pursuant to a congressional request, GAO provided information on how the Drug Enforcement Administration (DEA) establishes aggregate production and manufacturing quotas for methylphenidate and other schedule II controlled substances. GAO noted that: (1) DEA establishes quotas for schedule II controlled substances by analyzing past sales, inventory, anticipated need, and market trend data; (2) although quotas are set on an annual basis, they can be updated and are published for public comment; (3) pharmaceutical companies are notified of their manufacturing quotas and can request quota adjustments by providing DEA with updated medical-use and sales data information; (4) although DEA does not track the extent to which initial and revised quotas match, quotas for many schedule II controlled substances are revised each year; (5) although its 1986 methylphenidate quota failed to provide for legitimate medical needs, DEA recalculated the quota and allowed pharmaceutical companies to produce those amounts; (6) although DEA has no authority to bypass the notice and comment requirements, it can issue interim rules that make quotas effective upon publication; (7) the 2-month delay in publishing the revised 1993 quotas for several controlled substances has caused concern of an impending methylphenidate shortage; and (8) although DEA officials have monitored the possibility of a methylphenidate shortage, they do not believe the matter warrants the use of the interim rule to establish quotas.

Sep 26, 2018

Sep 5, 2018

Jul 18, 2018

Jul 16, 2018

Jun 27, 2018

May 31, 2018

May 17, 2018

Apr 18, 2018

Apr 12, 2018

Looking for more? Browse all our products here