DEA Congressional Testimony
March 11, 1999

Terrance Woodworth, Deputy Director
Office of Diversion Control
Drug Enforcement Administration
United States Department of Justice

Before the:

House Commerce Committee Subcommittee on Oversight and Investigations

Date:

March 11, 1999

Note: This document may not reflect changes made in actual delivery.

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CONTENTS


Gamma-hydroxybutyrate (GHB)

Flunitrazepam

Ketamine

Conclusion

 

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Mr. Chairman, distinguished members of the Committee, I want to thank you for the opportunity to address you today on behalf of the Drug Enforcement Administration (DEA) Administrator, Thomas A. Constantine. I will provide you with some specific data on three drugs, gamma-hydroxybutyrate (GHB), flunitrazepam and ketamine. Additionally, I will discuss the GHB precursor, gamma-butyrolactone (GBL). While each of these drugs has a unique chemical structure and specific pharmacological properties, as drugs of abuse, they share a number of similarities. Before I talk about each of these drugs individually, I would like to take a few moments and comment about some of the things they have in common.

Collectively, these three substances are referred to as "party" drugs because of their availability and distribution at bars, night clubs and all-night dance parties called raves or techno parties. Gamma-hydroxybutyrate (GHB, Goop), flunitrazepam (Roofies) and ketamine (Special K) are new additions to a long list of substances that have often been encountered in these settings. In the 1980s we saw the abuse and trafficking of psychedelics like MDMA (Ecstasy) and its analogues and the depressant, methaqualone (Ludes). Other drugs that are also encountered in these settings include LSD (Acid), PCP (Angel Dust), amphetamine, cocaine and marijuana. As their street names imply, these drugs are touted to be fun. They have a wide range of pharmacological effects and are often taken in combination with each other or with alcohol. A disturbing factor is that these three substances are primarily being abused by teens and young adults.

While the illicit trafficking and abuse of these substances are DEA's primary considerations with regard to Federal control measures, we are aware and concerned about the use of these substances to facilitate the commission of sexual assault. As such, these three substances are referred to as "date rape" drugs implying this more sinister aspect of their illicit use. Individuals intent on sexual assault are aware of the availability of these substances, especially at bars and night clubs, and of their pharmacological profiles, both of which provide some insight into why they might find these drugs so appealing.

Each of these substances has gained popularity among drug abusers in recent years. Since their emergence as drugs of abuse, the DEA has been collecting data on their illicit manufacturing, distribution, trafficking and abuse. I will provide you with a summary of that data. Based on that data, the DEA now views these substances as having significant abuse potential. There is evidence that individuals are taking these substances in a manner and amounts sufficient to create a hazard to their health or to the health and/or safety of others. There is significant clandestine production of GHB and significant diversion of the pharmaceutical products containing flunitrazepam and ketamine. Large quantities of flunitrazepam have been illicitly smuggled into the U.S. and ketamine has been diverted from legitimate veterinary supplies within the U.S. Individuals are taking these substances on their own initiative rather than on the advice of a medical practitioner. Actually, only ketamine is approved for medical use in the U.S. - neither GHB nor flunitrazepam has been approved for marketing as a medicine by the Food and Drug Administration (FDA). In addition, these substances share many of the same pharmacological properties of drugs that have been identified as having serious abuse potential and are already controlled in the Controlled Substances Act (CSA). This data indicates that each of these drugs should be placed under control in the CSA. At this time, however, only flunitrazepam is controlled at the Federal level.

Although Congress has passed legislation that expedites the scheduling of drugs and other substances under the CSA, the temporary or emergency scheduling provision of the CSA could not be used for any one of these three substances. Emergency scheduling action is not possible when a substance is (1) being evaluated as part of a DHHS approved research program as is the case with GHB; (2) already a controlled substance as is the case with flunitrazepam; or (3) already marketed in the United States as is the case with ketamine. As a consequence, all three of these drugs have proven to be a challenge with regard to more effectively controlling their abuse. Action to curb the trafficking and diversion of these drugs has been difficult and time consuming. Prior to changing the control status or placing any new substance under control using administrative or traditional scheduling process of the CSA, the DEA must gather the necessary data, forward that information to the Department of Health and Human Services (DHHS) and request, receive and consider a scientific and medical evaluation from the DHHS. In addition, the CSA requires specific findings for each of the five schedules that must be based on scientifically valid and legally defensible data (See Attachment). Scheduling actions must be substantiated by the available evidence. From the time the DEA identifies a new drug of abuse to the time that substance is finally placed under control in the CSA, if warranted, a significant amount of time may elapse when the administrative scheduling process is utilized.

Gamma-hydroxybutyrate (GHB)

GHB is a central nervous system depressant which is abused for its ability to produce euphoric states and its alleged role as a growth hormone releasing agent to stimulate muscle growth. Although GHB gained early favor with health enthusiasts as a safe and "natural" food supplement sold in health food stores in the late 1980s, the medical community soon became aware of overdoses and related problems caused by its abuse. In 1990, the FDA issued an advisory declaring GHB unsafe and illicit, except under FDA-approved, physician-supervised, study protocols. GHB has not been approved by the FDA for marketing. Doctors do not prescribe it, pharmacists do not sell it and patients do not use it. However, it is currently under investigation for use in treating narcolepsy under the FDA's Orphan Drug program.

Although its importation, distribution and use as a drug are not allowed in the U.S., the abuse of GHB has increased. As a drug of abuse, GHB is generally ingested orally after being mixed in a liquid. The onset of action is rapid and in overdose, unconsciousness can occur in as little as 15 minutes and profound coma can occur within 30 to 40 minutes. GHB produces dose-dependent drowsiness, dizziness, nausea, amnesia, visual hallucinations, reduced blood pressure, decreased heart rate, hypnotic effects resembling petit mal epilepsy, convulsions, severe respiratory depression and coma. Overdose frequently requires emergency room care, including intensive care for respiratory depression and coma. Most individuals regain consciousness within two to four hours. However, since 1995, Medical Examiners have reported 32 fatalities in which GHB was detected in the decedent. Many of these deaths involved the use of GHB in combination with alcohol which potentiates the depressant effect of GHB. Of these 32 cases, GHB was found to be the sole cause of death in eight cases.

Since 1993, more than 3,500 GHB-related cases of abuse, overdose, possession, illegal manufacturing, illicit diversion and trafficking have been documented by Federal, state and local officials. This data has been obtained from DEA case files, state and local law enforcement case files, state and Federal forensic laboratory reports, the Drug Abuse Warning Network (DAWN) data, the FDA Office of Criminal Investigations and poison control center data bases. This data shows that GHB is frequently taken in combination with other drugs that often heighten its effects, and it is frequently found at bars, night clubs, rave parties and gyms. The primary users are teenagers and young adults. The populations abusing this drug fall into three major groups:

(1) users who take GHB as an intoxicant or euphoriant or for its alleged hallucinogenic effects;

(2) bodybuilders who abuse GHB for its alleged utility as an anabolic agent or as a sleep aid; and

(3) individuals who use GHB to commit sexual assault. These categories are not mutually exclusive and an abuser may use the drug illicitly to produce several effects.

The number of cases in which GHB has been used facilitate sexual assault is impossible to determine; many such cases may go unreported or unsubstantiated due to the difficulty of detecting its use. GHB is quickly eliminated from the body making detection in the body fluids unlikely. In addition, GHB's fast onset of depressant effects and its amnesiac effect render victims unable to recall the details of the attack. Nonetheless, DEA is aware of 13 sexual assault cases involving 22 victims under the influence of GHB since 1996. These assaults occurred in California, Florida, Louisiana, Maryland, Massachusetts, Michigan, Texas, and Wisconsin.

GHB is illicitly produced in clandestine laboratories. Since 1997, the DEA is aware of at least 100 cases involving GHB illicit laboratories and over 200 submissions to DEA and state and local forensic laboratories. GHB has been encountered in every region of the United States and both small (personal use amounts) and large (intended for distribution) clandestine laboratories have been encountered. It is marketed as a "legal high" or a substitute for MDMA (Ecstasy) and is sold in solid and liquid forms.

The clandestine synthesis involves the use of two common, non-regulated chemicals: gamma-butyrolactone (GBL), the primary precursor chemical, and sodium hydroxide (lye). The synthesis is a simple one-pot method requiring no special chemical expertise. GBL is a solvent with a wide range of industrial uses. Tens of thousands of metric tons are produced annually and it is readily available from chemical supply companies. In addition, kits for making GHB containing GBL and sodium hydroxide are being sold on the Internet. GBL, once absorbed from the gastrointestinal tract after oral administration, is readily converted to GHB in the body and produces the same profile of physiological and behavioral effects as GHB.

The DEA is reviewing various control measures for GBL. If GHB is placed under Schedule I or II of the CSA, GBL could be treated as an analogue for the purposes of criminal prosecution if it is being distributed for human use outside of an FDA approved Investigational New Drug (IND). As there are no regulatory controls imposed on handlers of analogues, the licit industrial or pharmaceutical use of GBL would be unencumbered by this method of control. Alternatively, if GHB is controlled in any schedule of the CSA, GBL can be controlled as an immediate precursor in the same or lower schedule as GHB. The full range of CSA drug control measures would then apply to GBL. Another method of controlling GBL distribution and use by clandestine manufacturers would be to make GBL a listed chemical with a level of control commensurate with its current industrial use. Both of these last two measures (immediate precursor and listed chemical) could be taken by the DEA following a notice and comment rulemaking process. In October 1998, the DEA published a Federal Register notice seeking information about the industrial uses and handling of GBL. The DEA is currently evaluating this information.

The abuse of GHB is associated with significant adverse effects to the abuser and health risk to the general public. The DAWN estimated that there were 54 GHB emergency room mentions in 1994 compared to 764 in 1997. In 62 percent of these episodes, recreational use was cited as the reason for taking this drug. Alcohol, which intensifies the depressant and psychoactive effects of GHB, was reported in 86 percent of the mentions. Poison control centers reported over 600 GHB incidents in 1996 and over 900 GHB incidents in 1997. GHB is repeatedly detected in driving under the influence (DUI) cases indicating the public health and safety hazards associated with its abuse. As previously mentioned, there have been 32 GHB-related deaths since 1995 and 22 GHB- related sexual assaults reported to DEA since 1996.

Despite data indicating that the continued, uncontrolled clandestine manufacture, distribution and abuse of GHB is an imminent hazard to the public health and safety, the DEA cannot place GHB under temporary control because it has an active IND exemption. As a consequence, the DEA is pursuing measures to administratively schedule GHB. In September 1997, the DEA forwarded its scheduling review to the Department of Health and Human Services (DHHS) and requested their scientific and medical evaluation and a scheduling recommendation. The DEA continues to document law enforcement encounters and GHB-related abuse cases and, as required by law, awaits a response from the DHHS before proceeding with any proposed scheduling action. The DEA has also conducted an informal field survey on GHB. Forty-one states and the District of Columbia reported incidents involving GHB. Most of the incidents reported in the survey occurred between January 1996 and March 1998. Reports were received from hospitals, poison control centers, coroners, police and sheriffs departments, public health department laboratories, security departments of colleges and universities and drug rehabilitation centers. Georgia, California and Texas reported the highest number of incidents with 312, 237 and 223 reports, respectively.

Twenty states have already controlled GHB. Alabama, Delaware, Georgia, Hawaii, Idaho, Illinois, Michigan, Nebraska, Nevada, Oklahoma, Rhode Island, and Wisconsin have placed GHB in Schedule I. California, Florida, Indiana, Louisiana and New Hampshire have placed it in Schedule II and Alaska, North Carolina, and Tennessee have controlled GHB in Schedule IV. In addition, New Jersey and Texas have criminalized the sale and possession of GHB and placed it in the same penalty group as LSD and marijuana.

Flunitrazepam

Flunitrazepam, commonly known as Rohypnol, belongs to the benzodiazepine class of drugs. Like other benzodiazepines (such as Valium, Librium, Xanax and Halcion), flunitrazepam's pharmacological effects include sedation, muscle relaxation, reduction in anxiety and prevention of convulsions. With respect to its sedative effects, flunitrazepam is approximately 7 to 10 times more potent than diazepam (Valium). The effects of flunitrazepam appear approximately 15 to 20 minutes after oral administration, and last approximately 4 to 6 hours. Some residual effects can be found 12 hours or more after administration. Although it is in Schedule IV of the CSA along with other benzodiazepines (due to compliance with the Psychotropic Convention), flunitrazepam has never been approved for medical use in the United States. Doctors cannot prescribe it and pharmacists cannot sell it. However, flunitrazepam is legally prescribed in over 50 other countries, and is widely available in Mexico, Colombia and Europe where it is used for the treatment of insomnia and as a preanesthetic medication.

Flunitrazepam is abused by a wide variety of individuals including high school students, college students, street gang members, rave party attendees and heroin and cocaine abusers. It is abused to produce profound intoxication, to boost the high of heroin, and to modulate the effects of cocaine. Flunitrazepam is primarily abused orally and frequently in combination with alcohol. To a much lesser extent, it is also abused by crushing the tablets and snorting the powder.

Flunitrazepam causes anterograde amnesia in which individuals are unable to remember certain events that they experienced while under the influence of the drug. This anterograde amnesia is particularly problematic when flunitrazepam is used to aid in the commission of sexual assault; victims may not be able to clearly recall the assault, the assailant, or the events surrounding the assault. Since 1994, at least nine individuals have been convicted of sexual assault in five state court cases in which there was evidence that they used flunitrazepam to incapacitate the victim. The DEA is aware of 17 other sexual assault cases from 1994 to 1998 in which there is evidence to suggest that flunitrazepam was used to facilitate the assault.

For a variety of reasons, it is difficult to estimate just how large a problem flunitrazepam-facilitated sexual assault is across the country. One problem is the documentation of the use of flunitrazepam in sexual assault cases. Very often in these cases, biological samples are taken at a time when the effects of the drug have already passed and only residual amounts remain in the body fluids. These residual amounts are difficult, if not impossible, to detect using standard screening tests available in the United States. If flunitrazepam exposure is to be detected at all, urine samples must be collected within 72 hours of ingestion and subjected to sensitive analytical tests. The problem is compounded by the onset of amnesia after ingestion, a factor on which the assailant relies to conceal the facts surrounding the rape. This amnesiac effect may lead to critical delays in reporting the assault, making it difficult or impossible to obtain appropriate biological samples for toxicology testing.

The abuse of flunitrazepam, like other controlled substances, is associated with clear risk to the abuser and to the safety of the surrounding community. Flunitrazepam abuse causes a number of adverse effects in the abuser, including drowsiness, dizziness, loss of motor control, lack of coordination, slurred speech, confusion, and gastrointestinal disturbances, which may last for 12 or more hours. Higher doses produce respiratory depression. Chronic use of flunitrazepam can result in physical dependence and the appearance of a withdrawal syndrome when the drug is discontinued. Flunitrazepam impairs cognitive and psychomotor function which affect reaction time and driving skill. The use of flunitrazepam in combination with alcohol is a particular concern because they both potentiate each other's toxic effects. There were 167 flunitrazepam emergency room episodes reported in DAWN from January 1994 through December 1997. Nearly half of the episodes involved males under the age of 20. In nearly 50 percent of the episodes drug dependence was reported as the motive for taking the drug. Eighty percent of the episodes involved other drugs, including alcohol (59%), marijuana (44%) and cocaine (35%).

The increased popularity of flunitrazepam has led to smuggling and illegal distribution of flunitrazepam into various parts of the United States. Flunitrazepam has most often been smuggled into the U.S. from Mexico, primarily at border crossings located in Texas, Arizona and California. In addition, approximately 25 other countries have been identified from which flunitrazepam has been directly smuggled into the U.S.

Since 1985, the DEA has documented approximately 4,500 Federal, state and local law enforcement cases involving the illegal distribution and/or possession of flunitrazepam in 38 states. The largest number of cases in the past has been concentrated in Texas (1,600) and Florida (1,500). Significant numbers of cases also occurred in Louisiana, Oklahoma and Arizona with the majority of these cases occurring between January 1994 and December 1996.

An examination of both DEA case files and the DEA System to Retrieve Information from Drug Evidence reveals 212 cases involving over 544,000 flunitrazepam tablets for the period of January 1, 1985 to February 28, 1999. Most of these investigations were conducted in Texas and Florida. There were 34,000 tablets of flunitrazepam seized in 1994, 227,199 tables seized in 1995, 155,000 tablets in 1996; and 35,000 seized in 1997. However, during 1998, the number of tablets seized increased over the previous year with 56,000 tablets being seized. The vast majority of these tablets were either the one milligram (mg) pharmaceutical (Rohypnol) tablet or counterfeit two mg tablets which contain flunitrazepam and are designed to look like the pharmaceutical Rohypnol tablet.

The two mg pharmaceutical tablet, until recently, has been the most frequently encountered form of flunitrazepam seized by law enforcement officials. However, the manufacturer, Hoffman La Roche has discontinued production of the two mg tablet. As a result, there was a significant reduction in law enforcement encounters with the pharmaceutical two mg tablets. This was followed quickly by increases in encounters with the one mg pharmaceutical tablets and with counterfeit tablets containing two mgs of flunitrazepam. Counterfeit tablets demonstrate that there is an established illicit market in the U.S.

Flunitrazepam was placed into Schedule IV of the Controlled Substances Act (CSA) in 1984 due to international treaty obligations. At that time there was no known abuse of flunitrazepam in the United States. However, over the last several years, DEA has been concerned with the problem of flunitrazepam abuse and approximately four years ago, began to consider the merits of transferring flunitrazepam to a different schedule. While the abuse and trafficking of flunitrazepam are considered to be an imminent hazard to the public safety, the DEA could not take immediate steps to curb this abuse by using the temporary scheduling provision of the CSA because this drug was already a controlled substance. As a consequence, the DEA proceeded with the administrative scheduling process and, as required under the CSA, the DEA submitted its data on the abuse and trafficking of flunitrazepam to the DHHS in April, 1996. Along with DEA's document was a request to the DHHS for a scientific and medical evaluation and a scheduling recommendation. In January, 1997, after the appropriate scientific and medical review, the DHHS provided its scheduling recommendation to the DEA which stated that flunitrazepam has no accepted medical use in the United States (consistent with Schedule I placement) but that its abuse potential was no different than other benzodiazepines, a finding which is consistent with Schedule IV control. The DHHS recommended that flunitrazepam remain in Schedule IV. After careful analysis of the relevant data and in consideration of the DHHS recommendation, the DEA concluded that sufficient grounds did not exist to administratively reschedule flunitrazepam. Several states, however, have determined that the existing controls were inadequate to address the abuse and trafficking of flunitrazepam within their jurisdictions and have rescheduled flunitrazepam through their state administrative process or by state legislation. Florida, Idaho, Minnesota, New Hampshire, New Mexico, North Dakota, Oklahoma, and Pennsylvania have rescheduled flunitrazepam into Schedule I and some states have increased the penalties for illegal distribution.

Even though the control status of flunitrazepam has not changed, other actions have been taken. Congress passed The Drug-Induced Rape Prevention and Punishment Act of 1996 which made it a crime to give any unconsenting individual a controlled substance with the intent of committing a violent act, including rape, against that individual. In addition, the law established stricter Federal penalties for the possession and distribution of flunitrazepam without changing the schedule of the drug. In implementing these new penalty provisions, the United States Sentencing Commission established sentencing guidelines for flunitrazepam that were above those generally applicable to Schedule I and II depressant drugs. These guidelines became effective on November 1, 1997. Also, since March 5, 1996, the U.S. Customs Service has been seizing personal use amounts of flunitrazepam encountered at border points of entry. This action was taken in response to the growing abuse and trafficking problem and the fact that it is not approved for use in this country.

Ketamine

The final drug I would like to discuss is ketamine. It is the only one of the three which has been approved for marketing in the United States although its primary use is in veterinary medicine. It is a rapidly acting, general anesthetic whose pharmacological profile is essentially the same as phencyclidine (PCP). Like PCP, individuals anesthetized with ketamine feel detached or disconnected from their pain and environment. In addition, ketamine has both analgesic (pain relief) and amnesic (memory loss) properties. The use of ketamine as a general anesthetic for humans has been quite limited due to its adverse effects including the delirium and hallucinations which some experience after awakening from anesthesia. However, it does have some utility for emergency surgery in humans and surgery of short duration in children and the elderly, groups which experience delirium and hallucinations less frequently.

As a drug of abuse, ketamine (street name "Special K") has become common at dance parties or "raves." It produces a dose-related progression of effects from a state of dreamy intoxication to delirium accompanied by the inability to move, feel pain or remember what has occurred while under the drug's influence. The "Special K" trip is similar to that of LSD or PCP but lasts only 30 to 60 minutes as opposed to several hours. Ketamine is less potent than PCP: 25 mg of PCP can produce a full psychedelic experience whereas it would require at least 100 mg of ketamine (depending on body size) for a similar effect.

"Special K" is prepared by evaporating the liquid from the legitimate pharmaceutical injectable product and grinding the residue into a powder. Ketamine is difficult to synthesize and there have been no reports of its clandestine manufacture. All of the ketamine encountered by law enforcement to date has been diverted from licit sources, primarily distributors and veterinarians. The "Special K" powder is snorted like cocaine or to a lesser extent smoked on tobacco or marijuana. In addition, the liquid form has been added to drinks. A typical dose would be 20 mgs snorted in each nostril, repeated at 5 to 10 minute intervals (usually 3 or 4 times) until the desired effect is achieved. It is distributed as powder in small bottles, ziplock bags, capsules, paper, glassine or aluminum "folds", or as a liquid in small vials or bottles.

Prior to 1993, there were few documented law enforcement encounters, emergency room mentions, or reported thefts of ketamine. However, since 1993, the frequency of law enforcement encounters as well as emergency room and medical examiner's reports has increased, indicating the increased abuse of ketamine. Abuse of ketamine is indicated in the 145 emergency room episodes reported to DAWN during the period 1993 to 1997. Alcohol, cocaine and marijuana were the most frequently reported substances identified in the DAWN reports as being used in combination with ketamine. This drug can be used by individuals intent on committing sexual assault due to its effect on victims who become extremely compliant and later may not be able to remember what happened. However, the DEA is aware of only one documented case in which it was demonstrated that ketamine was used to facilitate a rape. Of course, the same factors which could lead to the under-reporting of the use of flunitrazepam and GHB in sexual assault apply to ketamine as well.

The DHHS has, on two occasions, in 1981 and 1986, recommended that ketamine be placed in Schedule III of the Controlled Substances Act (CSA) based on a scientific and medical review. These recommendations were based largely on the pharmacological profile of the drug. On each occasion, the DEA determined that the incidence of actual abuse, along with its status as a prescription drug with limited distribution, did not provide sufficient cause to place ketamine under CSA control. Ketamine's recent emergence as a drug of abuse has prompted the DEA to reevaluate its placement in the CSA. The DEA requested a new scientific and medical evaluation and scheduling recommendation from DHHS in April 1998. The DHHS conducted an expeditious review and responded to our request in December 1998. The DHHS again recommended Schedule III placement. The Federal control of ketamine is proceeding and a notice of proposed scheduling should be published within 60 days.

Eighteen states have already controlled ketamine: California, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, New Hampshire, New Jersey, New Mexico, New York, Oklahoma, and Wisconsin have placed it in Schedule III; Missouri and Tennessee have placed it in Schedule IV; and Massachusetts has placed ketamine under the same penalty category as LSD and PCP.

Conclusion:

GHB, flunitrazepam and ketamine are three recent drugs of abuse. Their continued illegal distribution and abuse pose serious risks to the American public health and safety. In reviewing the data presented here today, it is clear that GHB and ketamine should be placed under control in the CSA and that the actions taken to deter flunitrazepam smuggling and illegal distribution and abuse must be continued. The DEA applauds the actions taken by various states authorities to quickly address the abuse, diversion and trafficking of these substances in their areas. Such actions are also part of the evaluation process for Federal control of these drugs when warranted. Emergency scheduling action to increase the regulatory controls and curb the illicit availability and abuse of certain substances is not possible when those substances are: (1) already controlled [flunitrazepam]; (2) already marketed in the U.S.[ketamine]; or (3) are being evaluated as part of a DHHS approved research program [GHB]. We are working within the Executive Branch with DHHS to examine alternatives to current procedures.

The continued abuse and trafficking of GHB are of grave concern to the DEA. Congress may legislatively place any of these substances under the CSA and the DEA would not be apposed to Congress taking this action especially in regard to GHB. Congress has taken similar action in the past. It directed that methaqualone be moved from Schedule II to Schedule I in 1984 and it added anabolic steroids to Schedule III in 1990.

Mr. Chairman, in closing, I would like to thank you and the Committee for providing me with the opportunity to offer the DEA's position and comments on the very serious problem of abuse of GHB, flunitrazepam and ketamine. I will be happy to answer any questions you may have.

 

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Findings required to Place a Substance in Schedules I - V as set out in 21 U.S.C. 812(b)
Schedule I:

(A) The drug or other substance has a high potential for abuse.

(B) The drug or other substance has no currently accepted medical use in treatment in the United States.

(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.

Schedule II:

(A) The drug or other substance has a high potential for abuse.

(B) The drug or other substance has a currently accepted use in treatment in the United States or a currently accepted medical use with severe restrictions.

(C) Abuse of the drug or other substance may lead to severe psychological or physical dependence.

Schedule III:

(A) The drug or other substance has a potential for abuse less than the drugs or other substances on schedules I and II.

(B) The drug or other substance has a currently accepted medical use in treatment in the United States.

(C) Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.

Schedule IV:

(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.

(B) The drug or other substance has a currently accepted medical use in treatment in the United States.

(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.

Schedule V:

(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.

(B) The drug or other substance has a currently accepted medical use in treatment in the United States

(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.