[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