Schedules of Controlled Substances; Placement of 2,5-Dimethoxy-4-(n)-propylthiophenethylamine and N-Benzylpiperazine Into Schedule I of the Controlled Substances Act

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Final rule.

SUMMARY:

This final rulemaking is issued by the Acting Deputy Administrator of the Drug Enforcement Administration (DEA) to place 2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) and N-benzylpiperazine (BZP) into Schedule I of the Controlled Substances Act (CSA). This action by the DEA Acting Deputy Administrator is based on a scheduling recommendation by the Department of Health and Human Services (DHHS) and a DEA review indicating that 2C-T-7 and BZP meet the criteria for placement in Schedule I of the CSA. This final rule will continue to impose the regulatory controls and criminal sanctions of Schedule I substances on the manufacture, distribution, and possession of 2C-T-7 and BZP.

EFFECTIVE DATE:

March 18, 2004.

FOR FURTHER INFORMATION CONTACT:

Christine A. Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone (202) 307-7183.

SUPPLEMENTARY INFORMATION:

On September 20, 2002, the Deputy Administrator of the DEA published two separate final rules in the Federal Register (67 FR 59161 and 67 FR 59163) amending § 1308.11(g) of Title 21 of the Code of Federal Regulations to temporarily place 2C-T-7, BZP and TFMPP (1-(3-trifluromethylphenyl)piperazine into Schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). These final rules, which became effective on the date of publication, were based on findings by the Deputy Administrator that the temporary scheduling of BZP, TFMPP and 2C-T-7 was necessary to avoid an imminent hazard to the public safety. Section 201(h)(2) of the CSA (21 U.S.C. 811(h)(2)) requires that the temporary scheduling of a substance expires at the end of one year from the effective date of the order. However, if proceedings to schedule a substance pursuant to 21 U.S.C 811(a)(1) have been initiated and are pending, the temporary scheduling of a substance may be extended for up to six months. On September 8, 2003, the Administrator published a notice of proposed rulemaking in the Federal Register (68 FR 52872) to place BZP, TFMPP and 2C-T-7 into Schedule I of the CSA on a permanent basis. The temporary scheduling of BZP, TFMPP and 2C-T-7 which would have expired on September 19, 2003, was extended to March 19, 2004 (68 FR 53289). One comment was received regarding the proposed placement of these substances in Schedule I of the CSA.

The DEA has gathered and reviewed the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse and the relative potential for abuse for 2C-T-7, BZP and TFMPP. The Administrator has submitted these data to the Assistant Secretary for Health, Department of Health and Human Services (DHHS). In accordance with 21 U.S.C. 811(b), the Administrator also requested a scientific and medical evaluation and a scheduling recommendation for 2C-T-7, BZP and TFMPP from the Assistant Secretary of DHHS. On March 10, 2004, the Acting Assistant Secretary for Health recommended that 2C-T-7 and BZP be permanently controlled in Schedule I of the CSA. However, under recommendation of the Food and Drug Administration (FDA) and a scientific evaluation of the National Institute on Drug Abuse (NIDA), the DHHS did not recommend control of TFMPP. Accordingly, TFMPP will no longer be controlled under the CSA after March 19, 2004.

BZP is a piperazine derivative. This substance has not been evaluated or approved for medical use in the U.S. The available scientific evidence suggests that the pharmacological effects of BZP are substantially similar to amphetamine.

BZP is self-administered by monkeys maintained on cocaine and fully generalizes to amphetamine's discriminative stimulus in monkeys. The effects of BZP in amphetamine-trained monkeys strongly suggest that BZP will produce amphetamine-like effects in humans. BZP acts as a stimulant in humans and produces euphoria and cardiovascular changes including increases in heart rate and systolic blood pressure. BZP is about 20 times more potent than amphetamine in producing these effects. However, in subjects with a history of amphetamine dependence, BZP was found to be about 10 times more potent than amphetamine. The risks to the public health associated with amphetamine abuse are well known and documented. BZP is likely to share these same public health risks.

The abuse of BZP was first reported in late 1996 in California. Since that time, the DEA, state and local law enforcement agencies have encountered BZP in California, Connecticut, Florida, Illinois, Indiana, Iowa, Louisiana, Minnesota, Missouri, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington, DC, and Wisconsin. Since 2000, there have been 83 cases involving the seizure of nearly 18,000 BZP tablets and over 600,000 grams of BZP powder. Seizures involving the combination of TFMPP and BZP include over 55,000 tablets and over 80 grams of powder.

BZP has increasingly been found in similar venues as the popular club drug MDMA (also known as Ecstasy). BZP, often in combination with TFMPP, is sold as MDMA, promoted as an alternative to MDMA and is targeted to the youth population. BZP (alone or in combination with TFMPP) has been encountered in powder and tablet form and sold on the Internet.

2C-T-7 is the sulfur analogue of 4-bromo-2,5-dimethoxyphenethylamine (2CB) and shares structural similarity with other Schedule I phenethylamine hallucinogens including 2,5-dimethoxy-4-methylamphetamine (DOM) and 1-(4-bromo-2,5-dimethoxyphenyl)-2-aminopropane (DOB). Based on its structural similarity to 2CB, one would expect 2C-T-7's pharmacological profile to be qualitatively similar to 2CB.

2C-T-7 is abused for its action on the central nervous system (CNS), and for its ability to produce euphoria with 2CB-like hallucinations. 2C-T-7 has not been approved for medical use in the United States by the FDA and the safety of this substance for use in humans has never been demonstrated.

Drug discrimination studies in animals indicate that 2C-T-7 is a psychoactive substance capable of producing hallucinogenic-like discriminative stimulus effects (i.e., subjective effects). 2C-T-7's subjective effects were shown to share some commonality with LSD; it partially substituted for LSD up to doses that severely disrupted performance in rats trained to discriminate LSD. In rats trained to discriminate DOM, 2C-T-7 fully substituted for DOM and was slightly less potent than 2CB in eliciting DOM-like effects. The ability of 2C-T-7 to function as a discriminative stimulus has been evaluated in rats trained to discriminative 1.0 mg/kg of 2C-T-7 from saline. After stimulus control was established, 2C-T-7, 2CB (0.6, 1.0, and 2.0 mg/Kg) and LSD (0.1 mg/kg) were substituted for 2C-T-7. Results suggest that both 2CB and LSD share 2C-T-7-like discriminative stimulus effects. 2CB generalized to the 2C-T-7 stimulus cue; 96 percent 2C-T-7-appropriate responding was observed. LSD elicited 95 percent 2C-T-7-appropriate responding.

The subjective effects of 2C-T-7, like those of 2CB and DOM, appear to be mediated through central serotonin receptors. 2C-T-7 selectively binds to the 5-HT receptor system. Users indicate that the hallucinogenic effects of 2C-T-7 are comparable to those of 2CB and mescaline.

The abuse of stimulant/hallucinogenic substances in popular all night dance parties (raves) and in other venues has been a major problem in Europe since the 1990s. In the past several years, this activity has spread to the United States. MDMA and its analogues, are the most popular drugs abused at these raves. Their abuse has been associated with both acute and long-term public health and safety problems. These raves have also become venues for the trafficking and abuse of other controlled substances. 2C-T-7 has been encountered at raves in Wisconsin, California, and Georgia.

The abuse of 2C-T-7 by young adults in the United States began to spread in the year 2000. Since that time, 2C-T-7 has been encountered by law enforcement agencies in Wisconsin, Texas, Tennessee, Washington, Oklahoma, Georgia, and California. 2C-T-7 has been purchased in powder form over the Internet and distributed as such. In the United States, capsules containing 2C-T-7 powder have been encountered.

2C-T-7 can produce sensory distortions and impaired judgment can lead to serious consequences for both the user and the general public. To date, three deaths have been associated with the consumption of 2C-T-7 alone or in combination with MDMA. The first death occurred in Oklahoma during April of 2000; a young healthy male overdosed on 2C-T-7 following intranasal administration. The other two 2C-T-7 related deaths occurred in April 2001 and resulted from the co-abuse of 2C-T-7 with MDMA. One young man died in Tennessee while another man died in the state of Washington.

In 2002, law enforcement data identified an Internet site that sold 2C-T-7. This site was traced to an individual in Indiana who had been selling large quantities of this substance since January 2000. Sales through this Internet site were thought to be the major source of this drug in the U.S. After further investigation, one clandestine laboratory was identified in Las Vegas, Nevada who was the supplier of 2-C-T-7 for the individual in Indiana.

The DEA received one comment from an organization in response to the proposed placement of 2C-T-7, BZP and TFMPP into Schedule I of the CSA. This organization did not support the proposed placement of these drugs into Schedule I on the following basis: (1) They felt insufficient data exists to support placement into Schedule I as the mere use of these substances was not abuse and (2) Prohibiting the possession of these substances is a substantial infringement of the fundamental right of adults to freedom of thought. Both the DEA and the DHHS have found that sufficient scientific, trafficking and abuse data, as summarized herein, does exist to place 2C-T-7 and BZP in Schedule I of the CSA on a permanent basis. As these substances have no legitimate medical use in the U.S., the trafficking in, and use by individuals for the psychoactive effects they produce, is considered abuse. In addition, the control of these substances in Schedule I of the CSA does not violate any legally protected right.

Based on all the available information gathered and reviewed by the DEA and in consideration of the scientific and medical evaluation and scheduling recommendation by the Assistant Secretary of the DHHS, the Acting Deputy Administrator has determined that sufficient data exist to support the placement of 2C-T-7 and BZP into Schedule I of the CSA pursuant to 21 U.S.C. 811(a). The Acting Deputy Administrator finds:

(1) 2C-T-7 and BZP have a high potential for abuse.

(2) 2C-T-7 and BZP have no currently accepted medical use in treatment in the United States.

(3) 2C-T-7 and BZP lack accepted medical safety for use under medical supervision.

In accordance with 21 U.S.C. 811(h)(5), the Acting Deputy Administrator hereby vacates the orders temporarily placing 2C-T-7, BZP and TFMPP into Schedule I of the CSA published in the Federal Register on September 20, 2002.

The Acting Deputy Administrator of the DEA hereby certifies that the placement of 2C-T-7 and BZP into Schedule I of the CSA will have no significant impact upon entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This action involves the control of two substances with no currently accepted medical use in the United States.

This final rule is not a significant regulatory action for the purposes of Executive Order (E.O.) 12866 of September 30, 1993. Drug Scheduling matters are not subject to review by the Office of Management and Budget (OMB) pursuant to provisions of E.O. 12866, section 3(d)(1).

This action has been analyzed in accordance with the principles and criteria in E.O. 13132, and it has been determined that this rulemaking does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

Regulatory Requirements

With the issuance of this final order, 2C-T-7 and BZP continue to be subject to regulatory controls and administrative, civil and criminal sanctions applicable to the manufacture, distribution, dispensing, importing and exporting of a Schedule I controlled substance, including the following:

1. Registration. Any person who manufactures, distributes, dispenses, imports or exports 2C-T-7 and BZP or who engages in research or conducts instructional activities with respect to 2C-T-7 and BZP or who proposes to engage in such activities must submit an application for Schedule I registration in accordance with part 1301 of Title 21 of the Code of Federal Regulations (CFR).

2. Security. 2C-T-7 and BZP are subject to Schedule I security requirements and must be manufactured, distributed and stored in accordance with §§ 1301.71, 1301.72(a), (c), and (d), 1301.73, 1301.74, 1301.75 (a) and (c) and 1301.76 of Title 21 of the Code of Federal Regulations.

3. Labeling and Packaging. All labels and labeling for commercial containers of 2C-T-7 and BZP which are distributed on or after April 19, 2004, shall comply with requirements of §§ 1302.03-1302.07 of Title 21 of the Code of Federal Regulations.

4. Quotas. Quotas for 2C-T-7 and BZP are established pursuant to Part 1303 of Title 21 of the Code of Federal Regulations.

5. Inventory. Every registrant required to keep records and who possesses any quantity of 2C-T-7 and BZP is required to keep an inventory of all stocks of the substances on hand pursuant to §§ 1304.03, 1304.04 and 1304.11 of Title 21 of the Code of Federal Regulations. Every registrant who desires registration in Schedule I for 2C-T-7 and BZP shall conduct an inventory of all stocks of 2C-T-7 and BZP.

6. Records. All registrants are required to keep records pursuant to §§ 1304.03, 1304.04 and §§ 1304.21-1304.23 of Title 21 of the Code of Federal Regulations.

7. Reports. All registrants required to submit reports in accordance with § 1304.31 through § 1304.33 of Title 21 of the Code of Federal Regulations shall do so regarding 2C-T-7 and BZP.

8. Order Forms. All registrants involved in the distribution of 2C-T-7 and BZP must comply with the order form requirements of part 1305 of Title 21 of the Code of Federal Regulations

9. Importation and Exportation. All importation and exportation of 2C-T-7 and BZP must be in compliance with part 1312 of Title 21 of the Code of Federal Regulations.

10. Criminal Liability. Any activity with 2C-T-7 and BZP not authorized by, or in violation of, the Controlled Substances Act or the Controlled Substances Import and Export Act occurring on or after March 18, 2004, will continue to be unlawful.

List of Subjects in 21 CFR Part 1308

• Administrative practice and procedure
• Drug traffic control
• Reporting and recordkeeping requirements

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 re-delegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Acting Deputy Administrator amends 21 CFR Part 1308 as follows:

PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES

1. The authority citation for Part 1308 continues to read as follows:

Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.

2. Section 1308.11 is amended by:

A. Removing paragraphs (g)(3), (4) and (5) and redesignating paragraphs (g)(6) and (7) as (g)(3) and (4) respectively;

B. Redesignating existing paragraphs (d)(6) through (d)(31) as paragraphs (d)(7) through (d)(32) respectively;

C. Adding a new paragraph (d)(6),

D. Redesignating existing paragraphs (f)(2) through (f)(7) as paragraphs (f)(3) through (f)(8) respectively; and

E. Adding a new paragraph (f)(2) to read as follows: