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Controlled Substances Act

The Controlled Substances Act (CSA), Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, is the legal foundation of the United States government's fight against the abuse of drugs and other substances. This law is a consolidation of numerous laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances.

The CSA places all substances that are regulated under existing federal law into one of five schedules. This placement is based upon the substance's medicinal value, harmfulness, and potential for abuse or addiction. Schedule I is supposed to be reserved for the most dangerous drugs that have no recognized medical use, while Schedule V is the classification used for the least dangerous drugs. The act also provides a mechanism for substances to be controlled, added to a schedule, decontrolled, removed from control, rescheduled, or transferred from one schedule to another.

In 2003, the Ninth Circuit Court of Appeals ruled the CSA illegal as it applied to the use of medical marijuana in the case Raich v. Ashcroft. The case has currently been appealed to the Supreme Court by the federal government.

Contents

1 Enforcement authority 2 Drug Schedules 2.1 Schedule I drugs 2.2 Schedule II drugs 2.3 Schedule III drugs 2.4 Schedule IV drugs 2.5 Schedule V drugs 2.6 Other provisions 3 References 4 External links

Enforcement authority

Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the Drug Enforcement Administration (DEA), the Department of Health and Human Services (HHS), or by petition from any interested party, including the manufacturer of a drug, a medical society or association, a pharmacy association, a public interest group concerned with drug abuse, a state or local government agency, or an individual citizen. When a petition is received by the DEA, the agency begins its own investigation of the drug.

The DEA also may begin an investigation of a drug at any time based upon information received from law enforcement laboratories, state and local law enforcement and regulatory agencies, or other sources of information.

Once the DEA has collected the necessary data, the DEA Administrator, by authority of the Attorney General, requests from the HHS a scientific and medical evaluation and recommendation as to whether the drug or other substance should be controlled or removed from control. This request is sent to the Assistant Secretary of Health of the HHS. Then, the HHS solicits information from the Commissioner of the Food and Drug Administration and evaluations and recommendations from the National Institute on Drug Abuse, and on occasion, from the scientific and medical community at large. The Assistant Secretary, by authority of the Secretary, compiles the information and transmits back to the DEA a medical and scientific evaluation regarding the drug or other substance, a recommendation as to whether the drug should be controlled, and in what schedule it should be placed.

The medical and scientific evaluations are binding to the DEA with respect to scientific and medical matters. The recommendation on scheduling is binding only to the extent that if HHS recommends that the substance not be controlled, the DEA may not control the substance.

Once the DEA has received the scientific and medical evaluation from HHS, the Administrator will evaluate all available data and make a final decision whether to propose that a drug or other substance be controlled and into which schedule it should be placed.

The CSA also creates a closed system of distribution for those authorized to handle controlled substances. The cornerstone of this system is the registration of all those authorized by the DEA to handle controlled substances. All individuals and firms that are registered are required to maintain complete and accurate inventories and records of all transactions involving controlled substances, as well as security for the storage of controlled substances.

Drug Schedules

Schedule I drugs

Schedule I drugs are defined as those considered to have high potential for abuse, with no recognized medical use in treatment in the US. It includes, among others, 5-MeO-DIPT; GHB; MDA; MDMA/Ecstasy; heroin; ibogaine; LSD; marijuana; mescaline; peyote; psilocybin:

• GHB (Gamma-hydroxybutyrate) has been used as a general anestetic with minimal side-effects and controlled action but a limited safe dosage range. It was placed in Schedule I in March 2000 after widespread recreational use.

• Ibogaine has potential medical uses in the treatment of drug and alcohol addiction and is regarded as an experimental, rather than illegal, drug in some countries.

• Strict application of the "no recognized medical use" requirement would exclude marijuana from this schedule and place it in Schedule II, since it does have recognised medical uses in the US, notably to control nausea in those undergoing chemotherapy; see medical marijuana. In 1988, the DEA's own adminstrative law judge, Francis Young, proposed moving marijuana into Schedule II, on the basis that marijuana is "one of the safest therapeutically active drugs known to man" ¹ and that a respectible minority of physicians supported its medical uses. The DEA refused to honor Young's ruling, and subsequent petitions to reschedule have been denied.

• MDMA continues to be used medically, notably in the treatment of post-traumatic stress disorder (PTSD). The FDA approved this PTSD use in 2001. Medical recommendations were that because of its medical use it be placed in Schedule III, not Schedule I.

• Psilocybin was studied in an FDA-approved study for its potential use in the treatment of obsessive-compulsive disorder.

• Rohypnol (Flunitrazepam) was placed in Schedule IV in 1984, but the DEA is considering moving it into Schedule I because of widespread non-medical use, and the fact that Rohypnol is not approved by the FDA. It is best known as a date-rape drug but is also fairly widely used in recreational ways.

The medical uses illustrate the dominance of recreational use as the primary qualifying factor for Schedule I, even when there are medical uses which in theory disqualify them from being eligible for Schedule I.

Schedule II drugs

Schedule II drugs are those with a high potential for abuse, but recognized medical use; and a high incidence of physical or psychological dependence. These are available only by prescription, and distribution is carefully controlled and monitored by the DEA. It includes, among others, cocaine; methylphenidate (Ritalin); most pure opioid agonists: Demerol, fentanyl, opium, oxycodone, morphine; short-acting barbiturates such as secobarbital; methamphetamine; amphetamine:

• PCP was originally in Schedule IV and used for both human and veterinary anaestesia but was discontinued from human use because of hallucinations following treatment and because of its undesirably long half-life. It was moved to Schedule II in 1978.

• Amphetamine was originally placed in Schedule III, but was moved to Schedule II in 1971.

• Methamphetamine, except when in an injectable form, was originally in Schedule III, but was moved to Schedule II in 1971. Injectable methamphetamine has always been in Schedule II.

Schedule III drugs

Schedule III drugs are those deemed to have less potential for abuse than Schedules I and II; recognized medical uses; and a moderate to low incidence of physical or psychological dependence. These are available only by prescription, though control of wholesale distribution is somewhat less stringent than Schedule II drugs.

• includes, among others, anabolic steroids; intermediate-acting barbiturates such as talbutal; preparations that combine codeine or hydrocodone with aspirin or acetaminophen; ketamine; and paregoric.

Schedule IV drugs

Schedule IV drugs are those deemed to have a low potential for abuse relative to drugs in Schedule III; recognized medical uses; and a low risk of dependence relative to drugs in Schedule III. These are controlled similarly to Schedule III drugs.

• includes, among others, benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (librium), diazepam (Valium) ; long-acting barbiturates such as phenobarbital; some partial agonist opioid analgesics, such as propoxyphene (Darvon) and pentazocine (Talwin); and certain non-amphetamine stimulants, including pemoline and Modafinil.

Schedule V drugs

Schedule V drugs are deemed to have a lower potential for abuse relative to drugs in Schedule IV and a small incidence of physical or psychological dependence. These are sometimes available without a prescription and includes, among others, cough suppressants containing small amounts of codeine and preparations containing small amounts of opium, used to treat diarrhea.

Other provisions

The federal law has only five schedules, but some states have added a "Schedule VI" to cover certain substances which are not "drugs" in the conventional sense, but are nonetheless abused recreationally; these include toluene (found in many types of paint, especially spray paint) and similar inhalants such as amyl nitrite (or poppers), butyl nitrite, and nitrous oxide (found in many types of aerosol cans). Many state and local governments enforce age limits on the sale of products containing these substances (in addition to its inhalant properties, the sale of spray paint is restricted in some localities in an effort to curtail the incidence of graffiti vandalism).

Drugs requiring prescriptions are sometimes also known as legend drugs because legislation requires labels with the legend, "Caution! Federal law prohibits dispensing without a prescription."

The term controlled drugs is sometimes used for scheduled drugs because of the additional controls placed on them (beyond the need for a prescription).

References

1. US Department of Justice (Drug Enforcement Agency), Marijuana Rescheduling Petition: Opinion and recommended ruling, findings of fact, conclusions of law and decision of administrative law judge, 6 September 1988, Section VIII, Part 16 [1] (http://www.angeljustice.org/downloads/Marijuana%20Rescheduling%20Petition%20Doc%20No%2086%2022.pdf)

External links

• Controlled Substances Act - U.S. Drug Enforcement Administration (http://www.usdoj.gov/dea/agency/csa.htm)

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