|Schedules of Controlled Substances: Placement of Ketamine into Schedule III. AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule.|
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
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.
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
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
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
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
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
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
Based on these findings, the Deputy Administrator of the DEA concludes
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:
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,
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
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.
(5) Ketamine, its salts, isomers, and salts of isomers......... 7285 [Some other names for ketamine: (<plus-minus>)-2-(2-chlorophenyl)-2-(methylamino)-cyclohexanone]..............
Dated: July 7, 1999.
|Página electrónica propiedad del Dr. Luis Federico Higgins Guerra. Derechos de autor para Anestesiología Mexicana en Internet® (www.anestesia.com.mx) y logo. Las afirmaciones y opiniones expresadas en esta página electrónica reflejan única y exclusivamente el enfoque del(los) autor(es).|