Date="10/14/92" Citation="57 FR 47120" Group="legal" Type="NOTICE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE" Subject="Controlled Substances: Established 1992 Aggregate Production Quota"

DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled Substances: Established 1992 Aggregate Production Quota AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of established 1992 aggregate production quotas.

DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled Substances: Established 1992 Aggregate Production Quota AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of established 1992 aggregate production quotas. ------------------------------------------------------------ SUMMARY: This notice establishes revised 1992 aggregate production quotas for controlled substances in Schedules I and II as required under the Controlled Substances Act of 1970. DATES: This order is effective October 14, 1992. 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 that the Attorney General establish aggregate production quotas for all 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 July 27, 1992, a notice of the proposed revised 1992 aggregate production quotas for certain controlled substances in Schedules I and II was published in the Federal Register (57 FR 33214). All interested parties were invited to comment on or object to these proposed aggregate production quotas on or by (August 26, 1992). Mallinckrodt Specialty Chemicals Company commented that the proposed revised 1992 aggregate production quotas for codeine (for sale), dihydrocodeine, hydromorphone, morphine (for sale), oxycodone (for conversion), oxycodone (for sale) and morphine (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. Mallinckrodt's comments were based on their initial 1992 manufacturing quotas, 1991 year-end inventories and actual and projected 1992 sales. At this time, the DEA has determined that no increases are necessary for the established 1992 aggregate production quotas for codeine (for sale), dihydrocodeine, hydromorphone, morphine (for sale), oxycodone (for conversion), oxycodone (for sale) and morphine (for conversion). Mallinckrodt Specialty Chemicals Company also commented that the proposed revised 1992 aggregate production quotas for hydrocodone, codeine (for conversion), and diphenoxylate 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' 1991 year-end inventories, initial 1992 manufacturing quotas and projected 1992 sales, the final 1992 aggregate production quotas of hydrocodone, codeine (for conversion) and diphenoxylate were adjusted by the DEA to meet the medical, scientific, research and industrial needs of the United States. Relative to dextropropoxyphene, Mallinckrodt Specialty Chemicals Company and Abbott Laboratories commented that the proposed revised 1992 aggregate production quota is 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. Mallinckrodt and Abbott's comments were based on their initial 1992 manufacturing quotas, 1991 year-end inventories and actual and projected 1992 sales. The DEA has reviewed the involved companies' 1991 year-end inventories, their initial 1992 manufacturing quotas and their actual and projected 1992 sales and has adjusted the revised 1992 aggregate production quota for dextropropoxyphene to meet the medical, scientific, research and industrial needs of the United States. Relative to methylphenidate, MD Pharmaceutical, Inc. commented that the proposed revised 1992 aggregate production quota is insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States and for the establishment and maintenance of reserved stocks. MD Pharmaceutical, Inc.'s comment was based on their initial 1992 manufacturing quota, 1991 year-end inventory and actual and projected 1992 sales. The DEA has reviewed the involved companies' 1991 year-end inventory, their initial 1992 manufacturing quota and their 1992 actual and projected sales and has adjusted the revised 1992 aggregate production quota for methylphenidate to meet the medical, scientific, research and industrial needs of the United States. Subsequent to the Federal Register publication regarding the 1992 aggregate production quotas, Arenol Chemical Corporation and The Upjohn Company requested an increase in the 1992 aggregate production quota for methamphetamine (for conversion). The Upjohn Company will close a manufacturing facility in 1993 and will be manufacturing their 1993 procurement quota during 1992. As the bulk manufacturer of methamphetamine, Arenol Chemical Corporation's 1992 manufacturing quota will have to be increased. Because of the time require to change the 1992 aggregate production quota and the economic impact in delaying the establishment of the revised 1992 aggregate production quotas, the DEA has determined that the 1992 aggregate production quota for methamphetamine (for conversion) will be revised to accommodate Arenol Chemical Corporation and The Upjohn Company's request. Regarding amphetamine, SmithKline Beecham Pharmaceuticals commented on the proposed revised 1992 aggregate production quota. SmithKline Beecham will transfer the manufacture of a capsule formulation to another facility and estimate Food and Drug Administration's approval of their new drug application in June 1994. SmithKline Beecham feels that the proposed increase of the 1992 aggregate production quota of amphetamine does not recognize their request to manufacture enough of the capsule formulation to meet the medical needs of the United States and lawful export requirements during this time of transfer and approval. The DEA has taken into consideration the projected sales of the capsule formulation for 1993 through 1995, the export requirements for 1993 through 1995, and the 1991 year-end inventory and has adjusted the 1992 aggregate production quota for amphetamine to allow Smithkline Beecham to manufacture enough of the capsule formulation to meet the medical needs of the United States during the transfer of their operations. Pursuant to sections (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. This action has 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 implication to warrant the preparation of a Federalism Assessment. The Administrator hereby certifies that this matter will have no significant impact upon small entities within the meaning and intent of 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 international commitments of the United States. Such quotas impact predominantly upon major manufacturers of the affected controlled substances. Therefore, under the authority vested in the Attorney General by section 306 of the Controlled Substances Act of 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 1992 revised aggregate production quotas for Schedules I and II controlled substances, expressed as grams of anhydrous acid or base, be established as follows: --------------------------------------------------------------+--------------- | Established | revised | 1992 | aggregate | production | quota | (grams) --------------------------------------------------------------+--------------- | Schedule I: | 2,5-Dimethoxyamphetamine ................................... | 13,600,000 Schedule II: | Alfentanil ................................................. | 7,400 Amobarbital ................................................ | 108,000 Amphetamine ................................................ | 626,000 Cocaine .................................................... | 356,000 Codeine (for sale) ......................................... | 61,171,000 Codeine (for conversion) ................................... | 8,168,000 Desoxyephedrine ............................................ | 1,065,000 Levodesoxyephedrine ........................................ | 1,042,000 Methamphetamine ............................................ | 23,000 Dextropropoxyphene ......................................... | 99,774,000 Dihydrocodeine ............................................. | 375,000 Diphenoxylate .............................................. | 797,000 Hydrocodone ................................................ | 5,757,000 Hydromorphone .............................................. | 253,000 Levorphanol ................................................ | 6,800 Meperidine ................................................. | 8,714,000 Methadone .................................................. | 2,264,000 Methadone Intermediate (4-cyano-2-dimethylamino-4,4- | 2,830,000 diphenylbutane). | Methamphetamine (for conversion) ........................... | 1,327,000 Methylphenidate ............................................ | 3,708,000 Morphine (for sale) ........................................ | 5,991,000 Morphine (for conversion ................................... | 75,353,000 Opium (tinctures, extracts, etc. expressed in terms of USP | 982,000 powdered opium). | Oxycodone (for sale) ....................................... | 3,128,000 Oxycodone (for conversion) ................................. | 241,300 Pentobarbital .............................................. | 15,019,000 Phenylacetone .............................................. | 2,504,000 Secobarbital ............................................... | 471,000 Sufentanil ................................................. | 610 --------------------------------------------------------------+--------------- Dated: September 14, 1992. Robert C. Bonner, Administrator, Drug Enforcement Administration. [FR Doc. 92-24852 Filed 10-13-92; 8:45 am] BILLING CODE 4410-09-M