Controlled Substances in the United States

At the Federal level, controlled substances are listed within a system of five schedules in the Controlled Substances Act. These Schedules are described in Table 1.2. Schedule I contains the most strongly controlled substances, while Schedule V includes the most moderately controlled. Those drugs contained in Schedules II to V may be prescribed, while those in Schedule I may not. The data in the table illustrate a point which requires to be addressed, particularly at cross-border (International, State or County) levels, that is, one of nomenclature. In the United Kingdom, heroin is taken to mean the mixture of products resulting from the synthesis of diamorphine from morphine. Both compounds are listed separately in UK legislation, although heroin is not. However, in the United States, heroin can sometimes be taken to mean diamorphine and the two are sometimes used interchangeably. 

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Codeine is a controlled substance in the United States. Its manufacture and distribution are controlled by... 

Table 1.2 Federal scheduling of controlled substances in the United States of America...

Pemoline (Cylert, others) is structurally dissimilar to methylphenidate but elicits similar changes in CNS function with minimal effects on the cardiovascular system. It is a schedule IV controlled substance in the United States and is employed in treating ADHD. It can be given once daily because of its long half-life. Clinical improvement may require treatment for 3 to 4 weeks. Use of pemoline has been associated with severe hepatic failure. 

Human chorionic gonadotrophin is now considered an anabolic steroid and, as such, requires a license for ordering as a controlled substance in the United States. Although the Ml6 and M2 culture media are listed as being stable for only 2 weeks, we have found they can be used for at least 2 months without diminution of success in transgenic mouse production. The reason for this is that embryos are maintained in these media for only a short time. 

Stimulants related to amphetamine, particularly methamphetamine, have nearly supplanted cocaine as the second most abused controlled substance in the United States. Methamphetamine is highly addictive and easy to make from readily available materials, a combination that has proven hard to defeat or control. Clan-... 

It is a dangerously addictive drug, a Schedule II controlled substance in the United States and a Class-A drug in the United Kingdom. 

Cathinone and cathine are controlled under the United Nations Convention on Psychotropic Substances. In the United States, Canada, Switzerland, Scandinavia, and most of the Middle East, excluding Yemen, the leaf itself is banned. The khat plant is not controlled under domestic law in the United Kingdom. 

As industrial chemicals, FWAs are regulated by national laws such as the Toxic Substance Control Act in the United States and the relevant classification, packaging, and labeling directives in the European Community. For specific applications such as food packaging, the national regulatory requirements must be complied with. 

Because of the abuse potential of amphetamines, the Drug Enforcement Agency has strictly controlled the manufacture, distribution, and use of these substances in the United States. 

Toxic Substances Control Act of 1976 (TSCA)—federal legislation intended to protect human health and the environment, and to regulate commerce by requiring testing and imposing restrictions on certain chemical substances. The TSCA applies to all manufacturers, exporters, importers, processors, distributors, and disposers of chemical substances in the United States. 

In the United States, the Clean Air Act of 1990 requires plants to reduce emissions of 189 toxic and carcinogenic substances such as chlorine, chloroform, and 2,3,7,8-TCDD (dioxin) by 90% over the 1990s. The U.S. Environmental Protection Agency is working to develop standards based on maximum achievable control technologies and the industry has invested bUHons of doUars in capital investments to retrofit or rebuUd plant equipment to meet these measures. 

Both butanals are on the United States Toxic Substances Control Act (TSCA) Inventory, a prerequisite for the manufacture or importation for commercial sale of any chemical substance or mixture in quantities greater than one thousand pounds (455 kg). Additionally, the manufacture and distribution of the butanals in the United States are regulated under the Superfund Amendments and Reauthorization Act (SARA), Section 313, which requires that anyone handling at least ten thousand pounds (4550 kg) a year of a chemical substance report to both the EPA and the state any release of that substance to the environment. 

The Toxic Substances Control Act (TSCA) was enacted in 1976 to identify and control toxic chemical ha2ards to human health and the environment. One of the main provisions of TSCA was to estabUsh and maintain an inventory of all chemicals in commerce in the United States for the purpose of regulating any of the chemicals that might pose an unreasonable risk to human health or the environment. An initial inventory of chemicals was estabhshed by requiring companies to report to the United States Environmental Protection Agency (USEPA) all substances that were imported, manufactured, processed, distributed, or disposed of in the United States. Over 50,000 chemical substances were reported. PoUowing this initial inventory, introduction of all new chemical substances requires a Premanufacturing Notification (PMN) process. To be included in the PMN are the identity of the new chemical, the estimated first year and maximum production volume, manufacture and process information, a description of proposed use, potential release to the environment, possible human exposure to the new substance, and any health or environmental test data available at the time of submission. In the 10 years that TSCA has been in effect, the USEPA has received over 10,000 PMNs and up to 10% of the submissions each year are for dyes (382)... 

Many laws have been enacted over the last century that affect drug distribution and administration. Those included here are the Pure Food and Drug Act Harrison Narcotic Act Pure Food, Drug, and Cosmetic Act and the Comprehensive Drug Abuse Prevention and Control Act. These laws control the use of the three categories of drugs in the United States (prescription, nonprescription, and controlled substances). 

GHB has been used both for legitimate clinical and chnical research purposes and for a range of iUicit purposes. It was marketed legally in the United States until 1990, when the U.S. Food and Drug Administration (FDA) banned its sale to consumers. Except for the one indication described later in this section, GHB is a Schedule I controlled substance without other FDA-approved indications. The FDA has also declared y-butyrolactone (GBL) as a List I chemical and 1,4-butanediol (1,4-BD) as a Class I health hazard, practically designating these GHB precursors, which are also industrial solvents, as illicit and unapproved new drugs (National Institute on Drug Abuse 2000). 

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