[Federal Register Volume 59, Number 202 (Thursday, October 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25947]
[[Page Unknown]]
[Federal Register: October 20, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled Substances: Established Initial 1995 Aggregate
Production Quotas
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of aggregate production quotas for 1995.
-----------------------------------------------------------------------
SUMMARY: This notice establishes initial 1995 aggregate production
quotas for some controlled substances in Schedules I and II of the
Controlled Substances Act (CSA).
EFFECTIVE DATE: This order is effective upon October 20, 1994.
FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug &
Chemical Evaluation Section, Drug Enforcement Administration, Drug
Enforcement Administration, Washington, D.C. 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 Sec. 0.100 of title 28 of the Code of Federal
Regulations. The Administrator, in turn, has redelegated this function
to the Deputy Administrtor pursuant to 59 FR 23637 (May 6, 1994).
On August 4, 1994, a notice of the proposed initial 1995 aggregate
production quotas for certain controlled substances in Schedules I and
II was published in the Federal Register (59 FR 39790). All interested
persons were invited to comment on or before September 6, 1994. The
following comments were received.
Two companies commented that the proposed 1995 initial aggregate
production quota for amphetamine is insufficient to provide for the
estimated medical, scientific, research and industrial needs of the
United States, for export requirements and the maintenance of reserve
stocks. Based on current 1994 manufacturing quotas, the 1995 FDA
estimate of medical need, and export requirements, the DEA increased
the 1995 initial aggregate production quota for amphetamine.
A company commented that the proposed initial 1995 aggregate
production quota for levo-desoxyephedrine is insufficient to provide
for the estimated medical, scientific, research and industrial needs of
the United States, for export requirements and the maintenance of
reserve stocks. After a review of the 1994 manufacturing quota, the
1995 FDA estimate of medical need and other data, the DEA has
determined that no adjustment is necessary at this time.
Two companies commented that the proposed 1995 initial aggregate
production quota for methylphenidate is insufficient to meet the
estimated medical, scientific, research and industrial needs of the
United States and for the maintenance of reserve stocks. Based on 1994
manufacturing quotas, 1993 year-end inventories, the 1995 FDA estimate
of medical need and research and development requirements, the DEA
adjusted the initial 1995 aggregate production quota for
methylphenidate accordingly.
Pertaining to Sufentanil, one company commented that the proposed
1995 initial aggregate production quota is insufficient to meet the
estimated medical, scientific, research and industrial needs of the
United States. The DEA reviewed all available information and adjusted
the initial 1995 aggregate production quota for Sufentanil.
Another company commented that the proposed initial 1995 aggregate
production quotas for hydromorphone, oxymorphone and oxycodone (for
conversion) are insufficient to meet the estimated medical, scientific,
research and industrial needs of the United States. After a review of
1994 manufacturing quotas and research and product development
requirements, the DEA has determined that increases are necessary to
meet medical, scientific, research and industrial needs of the United
States.
The Office of Management and Budget has determined that notices of
aggregate production quotas are not subject to centralized review under
Executive Order 12866. 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 implications to warrant the preparation of a Federalism
Assessment.
The Deputy Administrator hereby certifies that this action will
have no significant impact upon small entities whose interest must be
considered under the Regulatory Flexibility Act, 5 U.S.C. 601, et seq.
The establishment of annual 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 Deputy Administrator
has determined that this actions 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 1970 (21 U.S.C. 826),
delegated to the Administrator of the DEA by Sec. 0.100 of title 28 of
the Code of Federal Regulations, and redelegated to the Deputy
Administrator, pursuant to 59 FR 23637 (May 6, 1994), the Deputy
Administrator hereby orders that the 1995 initial aggregate production
quotas, expressed in grams of anhydrous acid or base, be established as
follows.
------------------------------------------------------------------------
Established
initial 1995
Basic class quotas (in
grams)
------------------------------------------------------------------------
Schedule I:
Acetylmethadol........................................ 2
Aminorex.............................................. 2
Bufotenine............................................ 10
Cathinone............................................. 4
Difenoxin............................................. 14,000
2,5-
Dimethoxy-amphetamine............................... 15,650,000
Dimethylamphetamine................................... 2
N-Ethylamphetamine.................................... 4
Lysergic acid diethylamide............................ 41
Mescaline............................................. 2
Methaqualone.......................................... 2
Methcathinone......................................... 9
4-Methoxyamphetamine.................................. 12
4-Methylaminorex...................................... 2
3-Methylfentanyl...................................... 12
3,4-
Methylenediox-yamphetamine.......................... 12
3,4-Methylenedioxy-N-ethylamphetamine................. 2
3,4-..................................................
Methylenedioxy-methamphetamine...................... 12
Normorphine........................................... 2
Tetrahydrocannabinols................................. 35,000
Thiophene Analog of Phencyclidine..................... 10
Schedule II:
Alfentanil............................................ 7,000
Amobarbital........................................... 5
Amphetamine........................................... 1,026,100
Cocaine............................................... 550,000
Codeine (for sale).................................... 67,312,000
Codeine (for conversion).............................. 16,181,000
Desoxyephedrine....................................... \1\900,020
Dextropropoxyphene.................................... 124,012,000
Dihydrocodeine........................................ 202,000
Diphenoxylate......................................... 688,000
Ecgonine (for conversion)............................. 650,000
Fentanyl.............................................. 76,000
Hydrocodone........................................... 8,474,000
Hydromorphone......................................... 404,000
Levo-alpha-acetylmethadol............................. 200,000
Levorphanol........................................... 8,000
Meperidine............................................ 8,637,000
Methadone............................................. 3,779,000
Methadone (for conversion)............................ 364,000
Methadone Intermediate (for sale)..................... 300,000
Methadone Intermediate (for conversion)............... 4,393,000
Methylphenidate....................................... 8,886,000
Morphine (for sale)................................... 7,612,000
Morphine (for conversion)............................. 78,105,000
Noroxymorphone (for sale)............................. 21,000
Noroxymorphone (for conversion)....................... 3,500,000
Opium................................................. 1,118,000
Oxycodone (for sale).................................. 3,613,000
Oxycodone (for conversion)............................ 23,000
Oxymorphone........................................... 9,200
Pentobarbital......................................... 15,706,000
Phencyclidine......................................... 52
Phenylacetone (for conversion)........................ 3,528,000
Secobarbital.......................................... 480,000
Sufentanil............................................ 1,600
Thebaine.............................................. 9,383,000
------------------------------------------------------------------------
\1\900,000 grams of levo-desoxyephedrine for use in a non-controlled,
non-prescription product and 20 grams for methamphetamine.
Dated: October 12, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-25947 Filed 10-19-94; 8:45 am]
BILLING CODE 4410-09-M
