Controlled Substances Act
|
|
The Controlled Substances Act (CSA), 21 U.S.C. § 801 et. seq., 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.
| Contents |
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.
Under certain circumstances, the Government may temporarily schedule a drug without following the normal procedure. An example is when international treaties require control of a substance. In addition, 21 U.S.C. § 811(h) allows the Attorney General to temporarily place a substance in Schedule I "to avoid an imminent hazard to the public safety". Thirty days' notice is required before the order can be issued, and the scheduling expires after a year; however, the period may be extended six months if rulemaking proceedings to permanently schedule the drug are in progress. In any case, once these proceedings are complete, the temporary order is automatically vacated.
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.
History
Since its enactment in 1970, the Act has been amended several times:
- The Psychotropic Substances Act of 1978 added provisions implementing the Convention on Psychotropic Substances.
- The Chemical Diversion and Trafficking Act of 1988 added provisions implementing the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.
- The Domestic Chemical Diversion and Control Act of 1993.
- The Federal Analog Act.
International law
The Congressional findings in 21 U.S.C. § 801(7), 21 U.S.C. § 801(a)(2), and 21 U.S.C. § 801(a)(3) clearly state that a major purpose of the CSA is to "enable the United States to meet all of its obligations" under international treaties - specifically, the 1961 Single Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances[1] (http://www.usdoj.gov/dea/agency/csa.htm). The CSA bears many resemblances to these Conventions. Both the CSA and the treaties set out a system for classifying controlled substances in several Schedules in accordance with the binding scientific and medical findings of a public health authority. Under 21 U.S.C. § 811 (http://www.usdoj.gov/dea/pubs/csa/811.htm) of the CSA, that authority is the Secretary of Health and Human Services (HHS). Under Article 3 (http://www.incb.org/e/conv/1961/articles.htm#3) of the Single Convention and Article 2 (http://www.incb.org/e/conv/1971/articles.htm#2) of the Convention on Psychotropic Substances, the World Health Organization is that authority.
21 U.S.C. § 811(d) provides for automatic compliance with treaty obligations and establishes mechanisms for amending international drug control regulations to correspond with HHS findings on scientific and medical issues. If control of a substance is mandated by the Single Convention, the Attorney General is required to "issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations," without regard to the normal scheduling procedure or the findings of the HHS Secretary. However, the Secretary has great influence over any drug scheduling proposal under the Single Convention, because 21 USC § 811(d)(2)(B) requires the Secretary the power to "evaluate the proposal and furnish a recommendation to the Secretary of State which shall be binding on the representative of the United States in discussions and negotiations relating to the proposal."
Similarly, if the UN Commission on Narcotic Drugs adds or transfers a substance to a Schedule established by the Convention on Psychotropic Substances, so that current U.S. regulations on the drug do not meet the treaty's requirements, the Secretary is required to issue a recommendation on how the substance should be scheduled under the CSA. If the Secretary agrees with the Commission's scheduling decision, he can recommend that the Attorney General initiate proceedings to reschedule the drug accordingly. If the HHS Secretary disagrees with the UN controls, however, the Attorney General must temporarily place the drug in Schedule IV or V (whichever meets the minimum requirements of the treaty) and exclude the substance from any regulations not mandated by the treaty, while the Secretary is required to request that the Secretary of State take action, through the Commission or the UN Economic and Social Council, to remove the drug from international control or transfer it to a different Schedule under the Convention. The temporary scheduling expires as soon as control is no longer needed to meet international treaty obligations.
This provision was invoked in 1984 to place rohypnol in Schedule IV. The drug did not then meet the Controlled Substances Act's criteria for scheduling; however, control was required by the Convention on Psychotropic Substances. In 1999, an FDA official explained to Congress[2] (http://www.hhs.gov/asl/testify/t990311b.html):
- Rohypnol is not approved or available for medical use in the United States, but it is temporarily controlled in Schedule IV pursuant to a treaty obligation under the 1971 Convention on Psychotropic Substances. At the time flunitrazepam was placed temporarily in Schedule IV (November 5, 1984), there was no evidence of abuse or trafficking of the drug in the United States.
The Cato Institute's Handbook for Congress calls for repealing the CSA, an action that would likely bring the U.S. into conflict with international law[3] (http://www.cato.org/pubs/handbook/hb108/hb108-17.pdf). The exception would be if the U.S. were to claim that the treaty obligations violate the United States Constitution. Many articles in these treaties - such as Article 35 (http://www.incb.org/e/conv/1961/articles_II.htm?#35) and Article 36 (http://www.incb.org/e/conv/1961/articles_II.htm?#36) of the Single Convention - are prefaced with phrases such as "Having due regard to their constitutional, legal and administrative systems, the Parties shall . . ." or "Subject to its constitutional limitations, each Party shall . . ." According to former United Nations Drug Control Programme Chief of Demand Reduction Cindy Fazey, "This has been used by the USA not to implement part of article 3 of the 1988 Convention, which prevents inciting others to use narcotic or psychotropic drugs, on the basis that this would be in contravention of their constitutional amendment guaranteeing freedom of speech"[4] (http://www.fuoriluogo.it/arretrati/2003/apr_17_en.htm).
Constitutional issues
Most of the Congressional findings and declarations in 21 U.S.C. § 801 are devoted to establishing the statute's constitutionality. Using similar language to Article I, Section 8 of the U.S. Constitution, the CSA cites the impact of intrastate drug offences on "interstate commerce" and the "general welfare" of the American people. However, David Boaz, executive director of the Cato Institute, claims that "The Tenth Amendment reserves to the states or the people all powers not granted to the federal government. At least the advocates of alcohol Prohibition had enough respect for the Constitution to seek a constitutional amendment to impose Prohibition, but Congress never asked the American people for the constitutional power to impose drug prohibition"[5] (http://www.cato.org/dailys/3-03-97.html).
In 2003, the United States Court of Appeals for the Ninth Circuit ruled the CSA illegal as it applied to the use of medical marijuana in the case Raich v. Ashcroft, 352 F.3d 1222 (9th Cir. 2003). The case was appealed to the Supreme Court by the federal government, and in 2005, the Supreme Court ruled in favor of the federal government.
Drug Schedules
Schedule I drugs
Schedule I drugs are defined as those considered to have high potential for abuse, with no recognized medical use. The medical uses illustrate the dominance of recreational potential 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.
- GHB (Gamma-hydroxybutyrate) has been used as a general anaesthetic 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 cannabis from this schedule and place it in Schedule II, since it does have recognised medical uses in the U.S., notably to control nausea in those undergoing chemotherapy; see medical marijuana. In 1988, the DEA's own administrative 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 respectable minority of physicians supported its medical uses. The DEA refused to honor Young's ruling, and subsequent petitions to reschedule have been denied. See cannabis rescheduling in the United States.
- Heroin (Diacetylmorphine) is used in much of Europe as a potent pain reliever in terminal cancer patients. (It is about twice as strong, by weight, as morphine.) Some argue that the taboo surrounding heroin is what is keeping it in the CI category.
- Ecstasy (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.
Other include 5-MeO-DIPT; MDA (3,4-methylenedioxyamphetamine); LSD; mescaline; and peyote.
Sentences for first-time nonviolent offenders convicted of trafficking in Schedule I drugs can easily turn into de facto life sentences when multiple sales are prosecuted in one proceeding. See United States v. Angelos, 345 F. Supp. 2d 1227 (D. Utah 2004) (55 years for three sales of marijuana). Sentences for violent offenders, of course, are much higher.
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: Pethidine (INN) or meperidine (USAN), 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 anaesthesia 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.
- Amphetamines, except for injectable methamphetamine, were originally placed 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. Schedule III drugs include, among others:
- anabolic steroids
- intermediate-acting barbiturates such as talbutal
- preparations that combine codeine or hydrocodone with aspirin or acetaminophen
- ketamine
- paregoric
- Xyrem, a preparation of GHB used to treat narcolepsy, is in Schedule III but with a restricted distribution system.
- Marinol, a synthetic cannabinoid used to treat nausea and vomiting caused by chemotherapy, as well as appetite loss caused by AIDS.
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.
- 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.
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 diarrhoea.
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
- Cato Handbook for Congress (http://www.cato.org/pubs/handbook/hb108/hb108-17.pdf).
- Convention on Psychotropic Substances 1971 (http://www.incb.org/e/conv/1971/cover.htm), International Narcotics Control Board.
- Fazey, Cindy: The UN Drug Policies and the Prospect for Change (http://www.fuoriluogo.it/arretrati/2003/apr_17_en.htm), Apr. 2003.
- Single Convention on Narcotic Drugs 1961 (http://www.incb.org/e/conv/1961/), International Narcotics Control Board.
- Statement on "Date Rape" Drugs by Nicholas Reuter, M.P.H. (http://www.hhs.gov/asl/testify/t990311b.html), Mar. 11, 1999.
- US Department of Justice (Drug Enforcement Administration), 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 [6] (http://www.angeljustice.org/downloads/Marijuana%20Rescheduling%20Petition%20Doc%20No%2086%2022.pdf)
External links
- Boaz, David: Drug Prohibition Has Failed (http://www.cato.org/dailys/3-03-97.html), Mar. 3, 1997.
- Controlled Substances Act - U.S. Drug Enforcement Administration (http://www.usdoj.gov/dea/agency/csa.htm)
- DEA Drug Scheduling Reference (http://www.usdoj.gov/dea/pubs/scheduling.html)pl:Controlled Substances Act