Scheduling Actions - 1999[Federal Register: July 13, 1999 (Volume 64,
Number 133)] 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. 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; 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 EquinePractitioners (AAEP) and a practicing veterinarian. The AAHA, which represents 16,000 veterinary care providers, commented that the movement of ketamine into ScheduleIII 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 [21U.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 theinvestigations 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:
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:
[[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]
§ 1308.13 Schedule III. *
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* * (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, [FR Doc. 99-17803 Filed
7-12-99; 8:45 am]
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