[Federal Register Volume 64, Number 133 (Tuesday, July 13, 1999)]
[Rules and Regulations]
[Pages 37673-37675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17803]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA-183F]
21 CFR Part 1308
Schedules of Controlled Substances: Placement of Ketamine into
Schedule III
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: With the issuance of this final rule, the Deputy Administrator
of the Drug Enforcement Administration (DEA) places the substance
ketamine, including its salts, isomers, and salts of isomers, into
schedule III of the Controlled Substances Act (CSA) (21 U.S.C. 801 et
seq.). As a result of this rule, the regulatory controls and criminal
sanctions of schedule III will be applicable to the manufacture,
distribution, dispensing, importation and exportation of ketamine and
products containing ketamine.
EFFECTIVE DATE: August 12, 1999.
FOR FURTHER INFORMATION CONTACT:
Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Drug
Enforcement Administration, Washington, DC 20537; Telephone: (202) 307-
7183.
SUPPLEMENTARY INFORMATION:
Background
Ketamine hydrochloride is marketed in the United States as a
general anesthetic for use in human medicine under the trade name
Ketalar. It is also marketed as a veterinary product under
various names including Ketajet, Ketaset, and
Vetalar. Since 1992, more than 775 reports of ketamine
diversion or abuse have been received by the DEA. More than 568 law
enforcement reports described encounters of individuals who sold the
drug, who had it in their possession and/or were under its influence.
Veterinary clinic burglaries which were directed at ketamine were
described also. The balance of the reports were of ketamine abuse
related hospital emergency department visits.
The wide geographic distribution and prevalence of diversion and/or
abuse of ketamine, the spreading notoriety of ketamine as a party drug,
Special `K' or `K', and the involvement of teenagers and young adults
caused the DEA to submit to the Department of Health and Human Services
(DHHS) information related to each of the eight factors which are
determinative of control under the CSA. The DHHS responded by letter,
recommending that ketamine be added to schedule III.
The pharmacological and behavioral effects of ketamine are similar,
but somewhat less intense and shorter in duration, to those of the
schedule II substance, phencyclidine (PCP). Low dose intoxication with
ketamine results in impaired attention, learning, and memory functions.
Higher doses may result in ataxia, dizziness, elevated blood pressure,
mental confusion, hyperexcitability, catalepsy (the inability to move),
amnesia, convulsions, a delusional dream-like state, hallucinations,
and psychosis. Long-term use of ketamine is associated with
hallucinatory flashbacks, an inability to concentrate, psychological
dependence, and tolerance. Reports of ketamine abuse leading to
physical or psychological dependence consistent with schedule III
criteria have been published.
Diversion of ketamine pharmaceutical products from practitioners
has been the most frequently documented source of the drug, with the
primary sources being veterinary clinics. The liquid pharmaceutical
product is injected or, more commonly, evaporated and the resultant
power inhaled (snorted). Clandestine manufacture of ketamine has not
been encountered. In contrast to that of PCP, the synthesis of ketamine
is difficult.
Notice of Proposed Rule Making
Relying on the scientific and medical evaluation and the
recommendation of the Assistant Secretary for Health in accordance with
section 201(b) of the CSA [21 U.S.C. 811(b)], and the independent
review of the DEA, the Deputy Administrator of the DEA, pursuant to
Sections 201(a) and 201(b) of the CSA [21 U.S.C. 811(a) and 811(b)
proposed the placement of ketamine, including its salts, isomers, and
salts of isomers, into schedule III of the CSA in an April 9, 1999,
Federal Register notice (64 FR 17299). The notice provided an
opportunity for all interested persons to submit their comments or
objections in writing on the proposed scheduling of ketamine on or
before June 8, 1999.
Comments
The DEA received five comments regarding the proposal. Comments in
support of the proposal were received from the American Animal Hospital
Association (AAHA), the American Veterinary Medical Association (AVMA),
the American Association of Equine Practitioners (AAEP) and a
practicing veterinarian. The AAHA, which represents 16,000 veterinary
care providers, commented that the movement of ketamine into Schedule
III was in the best interest of the veterinary industry and the general
public. The AVMA, on behalf of 62,000 members, stated that the security
and record keeping required of Schedule III controlled substances will
prevent diversion and unauthorized use of ketamine while providing a
reasonable mechanism for the continued, responsible use of ketamine for
legitimate purposes by members of the veterinary profession. The AAEP
which reaches 3.2 million horse owners through its more than 6,200
members world wide strongly supports the placement of ketamine into
Schedule III.
[[Page 37674]]
The group commented that anesthesia in the horse poses unique dangers
to both handlers and the horse; that ketamine has proven to be the
safest induction agent known and remains an important medication to the
equine practitioner; that the equine veterinary community is keenly
aware of the public health concerns associated with this drug; and that
many veterinary practices have already taken precautionary steps to
prevent its misuse by keeping the drug restricted and secured. A
veterinarian whose hospital in Pennsylvania was broken into by
individuals seeking ketamine strongly supports the placement of
ketamine into Schedule III and notes that publicity of the mandatory
security measures will discourage potential burglars.
The Phoenix Scientific, Inc., a supplier of generic veterinary
ketamine hydrochloride injection products, opposed the proposal. In
summary, the company posited that: 1. The Fort Dodge Animal Health
advocacy of the placement of ketamine into Schedule III might be an
attempt to limit the production and distribution of the generic
equivalent by reputable firms; 2. the problem of diversion of ketamine
is not a factor which needs to be addressed further at the
manufacturers' level; 3. compliance with the DEA requirements will
cause substantial price increases and not stop diversion; and 4. the
manufacturer(s) will be burdened with assisting law enforcement and
forensic labs throughout the country because a field test for the
identification of ketamine does not exist. Further, the company asked
that ``a reasonable amount of time'' be allowed for coming into
compliance with the regulatory requirements if the proposed action were
finalized.
In response, the Deputy Administrator finds that the comments do
not relate to the factors determinative of control of a substance [21
U.S.C. 811(c)] or the criteria for placement of a substance in a
particular schedule [21 U.S.C. 812(b)]. Therefore, he need not address
the objections. In relation to the commenter's request for the
allowance of sufficient time for coming into compliance with the
Schedule III regulatory requirements, the Deputy Administrator notes
that, as described below, the DEA will entertain any justified request
for an extension of time in the event that the regulations impose
special hardships.
Findings
The Deputy Administrator of the DEA, taking into consideration the
comments which were received in response to the publication of the
proposed rule, and based on the investigations and review conducted by
his staff and relying on the scientific and medical evaluation and the
recommendation of the Assistant Secretary for Health, received in
accordance with Section 201(b) of the Act [21 U.S.C. 811(b)], finds,
pursuant to Sections 201(a) and 201(b) of the Act [21 U.S.C. 811(a) and
811(b)], that:
(1) Ketamine has a potential for abuse less than the drugs or other
substances in Schedules I and II;
(2) Ketamine has currently accepted medical use in treatment in the
United States; and
(3) Abuse of ketamine may lead to moderate or low physical
dependence or high psychological dependence.
Scheduling Action
Based on these findings, the Deputy Administrator of the DEA
concludes that ketamine, including its salts and isomers, and salts of
isomers, warrants control in Schedule III in the CSA. The Schedule III
controls of ketamine will become effective on August 12, 1999. In the
event that the regulations impose special hardships on any registrant,
the DEA will entertain any justified request for an extension of time
to comply with the Schedule III regulations regarding ketamine. The
applicable regulations are as follows:
1. Registration. Any person who manufactures, distributes,
dispenses, imports or exports ketamine or who engages in research or
conducts instructional activities or chemical analysis with respect to
this substance, or who proposes to engage in such activities, must be
registered to conduct such activities in accordance with Part 1301 of
Title 21 of the Code of Federal Regulations on and after August 12,
1999. Any person who is currently lawfully engaged in any of the above
activities must submit an application for registration by August 12,
1999. Any such person may then continue their lawful activities until
the DEA has approved or denied that application.
2. Disposal of stocks. Any person who elects not to obtain a
Schedule III registration or is not entitled to such registration must
surrender all quantities of currently held ketamine in accordance with
procedures outlined in 21 CFR 1307.21 on or before August 12, 1999, or
may transfer all quantities of currently held ketamine to a person
registered under the CSA and authorized to possess Schedule III control
substances on or before August 12, 1999. Ketamine to be surrendered to
DEA must be listed on a DEA Form 41, ``Inventory of Controlled
Substances Surrendered for Destruction.'' DEA Form 41 and instructions
can be obtained from the nearest DEA office.
3. Security. Ketamine must be manufactured, distributed and stored
in accordance with Secs. 1301.71, 1301.72(b), (c), and (d), 1301.73,
1301.74, 1301.75(b) and (c) and 1301.76 of Title 21 of the Code of
Federal Regulations.
4. Labeling and packaging. All commercial containers of ketamine,
which are packaged on or after January 13, 2000, must have the
appropriate Schedule III labeling as required by Secs. 1302.03-1302.07
of Title 21 of the Code of Federal Regulations. Commercial containers
of ketamine packaged before January 13, 2000 and not meeting the
requirements specified in Secs. 1302.03-1302.07 of Title 21 of the Code
of Federal Regulations may be distributed until May 15, 2000. On and
after May 15, 2000 all commercial containers of ketamine must bear the
CIII labels as specified in Secs. 1302.03-1302.07 of Title 21 of the
Code of Federal Regulations.
5. Inventory. Registrants possessing ketamine are required to take
inventories pursuant to Secs. 1304.03, 1304.04 and 1304.11 of Title 21
of the Code of Federal Regulations.
6. Records. All registrants must keep records pursuant to
Secs. 1304.03, 1304.04 and 1304.21-1304.23 of Title 21 of the Code of
Federal Regulations.
7. Prescriptions. All prescriptions for ketamine are to be issued
pursuant to Secs. 1306.03-1306.06 and 1306.21-1306.26 of Title 21 of
the Code of Federal Regulations. All prescriptions for products
containing ketamine issued on or before September 13, 1999, if
authorized for refilling, shall as of that date be limited to five
refills and shall not be refilled after January 13, 2000.
8. Importation and Exportation. All importation and exportation of
ketamine shall be in compliance with Part 1312 of Title 21 of the Code
of Federal Regulations.
9. Criminal Liability. Any activity with ketamine not authorized
by, or in violation of, the CSA or the Controlled Substances Import and
Export Act shall be unlawful on or after August 12, 1999.
In accordance with the provisions of the CSA [21 U.S.C. 811(a)],
this action is a formal rulemaking ``on the record after opportunity
for a hearing.'' Such proceedings are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557 and, as such, are exempt from review
by the Office of Management and Budget pursuant to Executive Order
(E.O.) 12866, Section 3(d)(1). The Deputy Administrator, in accordance
with the Regulatory Flexibility Act [5 U.S.C. 605(b)], has reviewed
this rule and by
[[Page 37675]]
approving it, certifies that it will not have a significant economic
impact on a substantial number of small business entities. Ketamine
products are prescription drugs used as anesthetics in hospitals and
clinics. Handlers of ketamine are likely to handle other controlled
substances which are already subject to the regulatory requirements of
the CSA.
This rule will not result in the expenditure by State, local and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more in any one year, and it will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule, as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. This rule
will not result in an annual effect on the economy of $100,000,000 or
more; a major increase in costs or prices; or significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of the United States based companies to
compete with foreign-based companies in domestic and export markets.
This rule will not have substantial direct effects on the United
States, on the relationship between the national government and the
United States, or on the distribution of power and responsibilities
among the various levels of government. Therefore, in accordance with
E.O. 12612, it is determined that this rule does not have sufficient
federalism implications to warrant the preparation of a Federalism
Assessment.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Narcotics, Prescription drugs.
Under the authority vested in the Attorney General by Section
201(a) of the CSA [21 U.S.C. 811(a)], and delegated to the
Administrator of the DEA by the Department of Justice regulations (28
CFR 0.100) and redelegated to the Deputy Administrator pursuant to 28
CFR 0.104, the Deputy Administrator hereby amends 21 CFR part 1308 as
follows:
PART 1308--[AMENDED]
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.
2. Section 1308.13 is amended by redesignating the existing
paragraphs (c)(5) through (c)(11) as (c)(6) through (c)(12) and by
adding a new paragraph (c)(5) to read as follows:
Sec. 1308.13 Schedule III.
* * * * *
(c) * * *
(5) Ketamine, its salts, isomers, and salts of isomers......... 7285
[Some other names for ketamine: ()-2-(2-
chlorophenyl)-2-(methylamino)-cyclohexanone]..............
* * * * *
Dated: July 7, 1999.
Donnie R. Marshall,
Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 99-17803 Filed 7-12-99; 8:45 am]
BILLING CODE 4410-09-M
