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GGD-95-52R 1 (1995-01-18)

handle is hein.gao/gaobacksy0001 and id is 1 raw text is: United States General Accounting Office Washington, D.C. 20548 General Government Division B-259550 January 18, 1995 The Honorable F. James Sensenbrenner, Jr. House of Representatives Dear Mr. Sensenbrenner: This correspondence responds to your request for information on how certain controlled substances are regulated, particularly methylphenidate--a central nervous system stimulant approved for the treatment of attention deficit disorder and narcolepsy. The Controlled Substances Act of 19701 requires the Attorney General to establish annual production quotas for schedules I and II controlled substances such as methylphenidate to avoid their overproduction and diversion to illegitimate channels while ensuring that legitimate needs are satisfied. Authority for setting these quotas has been delegated to the Deputy Administrator of the Department of Justice's (DOJ) Drug Enforcement Administration (DEA). The Controlled Substances Act of 1970 established five controlled substance schedules, with schedule I substances being the most strictly regulated. Schedule II controlled substances are considered to have an acceptable medical use in the United States as well as a high potential for abuse that may lead to severe psychological or physical dependence. The controlled substances in these schedules are subject to yearly quota limitations. There are various quotas for controlled substances, including aggregate production quotas and manufacturing quotas. Aggregate production quotas are the total quantity of a substance that may be produced during a calendar year and are to be proposed and established through Federal Register notices.2 Manufacturing quotas are the quantity of a substance that a company can manufacture in a calendar year. Each manufacturer is to be notified in writing of its 'P.L. 91-513 (1970). 2Before February 1994, these notices had to be reviewed and approved by DOJ's Office of Policy Development (OPD) and the Office of Management and Budget (OMB) prior to publication. GAO/GGD-95-52R Controlled Substance Quotas

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