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DEA Federal Register Entry
U.S. Federal register
Date="12/16/92" Citation="57 FR 59845" Group="legal" Type="NOTICE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE" Subject="Quotas for Controlled Substances in Schedules I and II"
------------------------------------------------------------ Drug Enforcement Administration Quotas for Controlled Substances in Schedules I and II AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of Established 1993 aggregate production quotas.
------------------------------------------------------------ Drug Enforcement Administration Quotas for Controlled Substances in Schedules I and II AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of Established 1993 aggregate production quotas. ------------------------------------------------------------ SUMMARY: This notice establishes initial 1993 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act. DATES: This order is effective upon publication. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug & Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183. SUPPLEMENTARY INFORMATION: Section 306 of the Controlled Substances Act (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas for controlled substances in Schedules I and II each year. This responsibility has been delegated to the Administrator of the DEA pursuant to sec0.100 of title 28 of the Code of Federal Regulations. On September 22, 1992, a notice of the proposed initial 1993 aggregate production quotas for certain controlled substances in Schedules I and II was published in the Federal Register (57 FR 43751). All interested parties were invited to comment on or object to these proposed aggregate production quotas on or before October 22, 1992. Three comments were received. Mallinckrodt Specialty Chemicals Company commented that the proposed initial 1993 aggregate production quotas for thebaine, codeine (for sale), hydromorphone and opium were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States, estimated export requirements, and for the establishment and maintenance of reserve stocks. Mallinckrodt's comments were based on their forecasted 1993 domestic sales, forecasted 1993 exports and trends in the aggregate production quotas from 1986 to 1993. After reviewing the relevant information, the DEA has determined that no increases are necessary for the initial 1993 aggregate production quotas for thebaine, codeine (for sale), hydromorphone and opium at this time. Mallinckrodt Specialty Chemicals Company also commented that the proposed initial 1993 aggregate production quotas for oxycodone, morphine (for conversion), hydrocodone, diphenoxylate and codeine (for conversion) were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States and for the establishment and maintenance of reserve stocks. Taking into consideration the involved companies' current and projected sales and inventories and the Food and Drug Administration's (FDA) estimates of medical need for 1993, the initial 1993 aggregate production quotas for oxycodone, morphine (for conversion), hydrocodone, diphenoxylate and codeine (for conversion) were adjusted by the DEA. Polaroid Corporation commented that the proposed initial 1993 aggregate production quota for 2,5-dimethoxyamphetamine was insufficient to provide for the estimated industrial needs of the United States and for the establishment and maintenance of reserve stocks. The DEA has reviewed Polaroid's request and has adjusted the initial 1993 aggregate production quota for 2,5-dimethoxyamphetamine. SmithKline Beecham Pharmaceuticals commented that the proposed initial 1993 aggregate production quota for amphetamine was insufficient to meet their revised production requirements. The DEA has taken this into consideration and has adjusted the 1993 aggregate production quota for amphetamine accordingly. A manufacturer has advised the DEA that the initial 1993 aggregate production quota for alfentanil may not be sufficient for 1993. The DEA has reviewed and adjusted the initial 1993 aggregate production quota of alfentanil. The adjustment was based on revised 1992 and projected 1993 sales and the FDA's estimates of medical need for 1993. The DEA has added an initial 1993 aggregate production quota for methadone (for conversion). This quota is to be used for the manufacture of methadone solely for conversion to levo-alpha- acetylmethadol. This quota will be reviewed again during 1993 and will be adjusted if necessary. Pursuant to section 3(c)(3) and 3(e)(2)(C) of Executive Order 12291, the Director of the Office of Management and Budget has been consulted with respect to these proceedings. These actions have been analyzed in accordance with the principles and criteria contained in Executive Order 12612, and it has been determined that this matter does not have sufficient Federalism implications to warrant the preparation of a Federalism Assessment. The Administrator hereby certifies that this action will have no significant impact upon small entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The establishment of aggregate production quotas for Schedules I and II controlled substances is mandated by law and by international treaty obligations.While aggregate production quotas are of primary importance to large manufacturers, their impact upon small entities is neither negative nor beneficial. Accordingly, the Administrator has determined that this action does not require a regulatory flexibility analysis. Therefore, under the authority vested in the Attorney General by section 306 of the Controlled Substances Act of the 1970 (21 U.S.C. 826) and delegated to the Administrator of the DEA by sec0.100 of title 28 of the Code of Federal Regulations, the Administrator of the DEA hereby orders that the 1993 initial aggregate production quotas, expressed in grams of anhydrous acid or base, be established as follows: -------------------------------------------------------------+---------------- | Established Basic class | initial 1993 | quotas (in | grams) -------------------------------------------------------------+---------------- | Schedule I: | 2,5-Dimethoxyamphetamine .................................. | 15,000,000 Lysergic acid diethylamide ................................ | 9 3,4-Methylenedioxyamphetamine ............................. | 2 3,4-Methylenedioxymethamphetamine ......................... | 2 Tetrahydrocannabinols ..................................... | 35,000 Psilocyn .................................................. | 5 Psilocybin ................................................ | 5 4-Methylaminorex .......................................... | 2 Methaqualone .............................................. | 2 Mescaline ................................................. | 2 Methcathinone ............................................. | 2 N-Hydroxy-3,4-methylenedioxyamphetamine ................... | 0 Dimethylamphetamine ....................................... | 0 levo-alpha-acetylmethadol ................................. | 150,000 Schedule II: | Alfentanil ................................................ | 8,790 Amobarbital ............................................... | 5 Amphetamine ............................................... | 446,000 Cocaine ................................................... | 586,000 Codeine (for sale) ........................................ | 63,613,000 Codeine (for conversion) .................................. | 9,297,000 Desoxyephedrine ........................................... | 1,161,000 1,140,000 grams of levodesoxyephedrine for use in a noncontrolled, nonprescription product and 21,000 grams for methamphetamine. | Dextropropoxyphene ........................................ 107,296,000 Dihydrocodeine ............................................ 579,000 Diphenoxylate ............................................. 832,000 Ecgonine (for conversion) ................................. 650,000 Fentanyl .................................................. 50,900 Glutethimide .............................................. 0 Hydrocodone ............................................... 6,137,000 Hydromorphone ............................................. 261,000 Levorphanol ............................................... 7,500 Meperidine ................................................ 8,325,000 Methadone (for sale) ...................................... 2,604,000 Methadone (for conversion) ................................ 220,000 Methadone Intermediate (4-Cyano-2-dimethylamino-4,4- 3,255,000 diphenylbutane). Methamphetamine (for conversion) .......................... 603,000 Methylphenidate ........................................... 3,411,000 Mixed Alkaloids of Opium .................................. 800 Morphine (for sale) ....................................... 6,378,000 Morphine (for conversion) ................................. 78,650,000 Opium (tinctures, extracts, etc. expressed in terms of USP 662,000 powdered opium). Oxycodone (for sale) ...................................... 3,262,000 Oxycodone (for conversion) ................................ 6,300 Oxymorphone ............................................... 2,500 Pentobarbital ............................................. 12,912,000 Phencyclidine ............................................. 15 Phenylacetone (for conversion) ............................ 320,000 Secobarbital .............................................. 587,000 Sufentanil ................................................ 620 Thebaine .................................................. 7,155,000 ------------------------------------------------------------------------------ Dated: November 25, 1992. Robert C. Bonner, Administrator of Drug Enforcement. [FR Doc. 92-30497 Filed 12-15-92; 8:45 am] BILLING CODE 4410-09-M
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