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The Controlled Substances Act (CSA) was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 USC 13). The CSA is the legal basis by which the manufacture, importation, possession, and distribution of certain drugs are regulated by the federal government of the United States. The Act also served as the national implementing legislation for the Single Convention on Narcotic Drugs.

The legislation created five Schedules (classifications), with varying qualifications for a drug to be included in each. Two federal departments, the Department of Justice and the Department of Health and Human Services (which includes the Food and Drug Administration) determine which drugs are added or removed from the various schedules; though the statute passed by Congress created the initial listing. Classification decisions are required to be made on the criteria of potential for abuse, accepted medical use in the United States, and potential for addiction.

The Department of Justice is also the executive agency in charge of federal law enforcement (i.e. it is the federal police force). State governments also regulate certain drugs.

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:

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) 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*. 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 of the CSA, that authority is the Secretary of Health and Human Services (HHS). Under Article 3 of the Single Convention and Article 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 (flunitrazepam) 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*:

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 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 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"[http://www.fuoriluogo.it/arretrati/2003/apr_17_en.htm" target="_blank" >*.

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"*.

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). However, 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

The below lists include examples only. For a complete and up-to-date list of controlled substances, see DEA Drug Scheduling Reference.

21 U.S.C. §812(b) specifies the findings that the government must make in order to classify a drug in a certain schedule. The specific classification of any given drug is usually a source of controversy, as is the purpose and effectiveness of the entire regulatory scheme.

Schedule I drugs

Findings required:

(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.

Tobacco, beer, wine, and spirits are explicitly exempt from the Controlled Substances Act.

No prescriptions may be written for Schedule I substances, and such substances are subject to production quotas by the DEA.

Under the DEA's interpretation of the CSA, a drug does not necessarily have to have the same abuse potential as heroin or cocaine to merit placement in Schedule I (in fact, cocaine is currently a Schedule II drug) *:

When it comes to a drug that is currently listed in schedule I, if it is undisputed that such drug has no currently accepted medical use in treatment in the United States and a lack of accepted safety for use under medical supervision, and it is further undisputed that the drug has at least some potential for abuse sufficient to warrant control under the CSA, the drug must remain in schedule I. In such circumstances, placement of the drug in schedules II through V would conflict with the CSA since such drug would not meet the criterion of "a currently accepted medical use in treatment in the United States." 21 USC 812(b).

Sentences for first-time, non-violent 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, 433 F.3d 738 (10th Cir. 2006) (55 years for three sales of marijuana). Sentences for violent offenders are much higher.

Drugs on this schedule include:

Schedule II drugs

Findings required:

(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.
(C) Abuse of the drug or other substances may lead to severe psychological or physical dependence.

These drugs are only available by prescription, and distribution is carefully controlled and monitored by the DEA. Oral prescriptions are not allowed except in emergencies, and no refills are allowed. Also, Schedule II drugs are subject to production quotas set by the DEA.

Drugs on this schedule include:

  • Cocaine (used as a topical anaesthetic);

  • Amphetamine was originally placed in Schedule III, but was moved to Schedule II in 1971. Injectable methamphetamine has always been in Schedule II;

Schedule III drugs

Findings required:

(A) The drug or other substance has a potential for abuse less than the drugs or other substances in 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.

These drugs are available only by prescription, though control of wholesale distribution is somewhat less stringent than Schedule II drugs.

Drugs on this schedule include:

  • Ketamine, a drug that was originally developed as a milder substitute for PCP (primarily to be used as a human anesthetic) but has since become popular as a veterinary anesthetic;

  • Xyrem, a preparation of GHB used to treat narcolepsy. Xyrem is in Schedule III but with a restricted distribution system;

  • Rohypnol (Flunitrazepam). Flunitrazepam was placed in Schedule IV in 1984 and moved to Schedule III in 1995, but the DEA is considering moving it into Schedule I because of widespread non-medical use, and the fact that flunitrazepam is not approved by the FDA. It is best known as a date rape drug but is also fairly widely used in recreational ways. Flunitrazepam is already classified as a Schedule I drug in several states.

Schedule IV drugs

Findings required:

(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.

Control measures are similar to Schedule III.

Drugs on this schedule include:

  • Certain non-amphetamine stimulants, including pemoline and the pseudostimulant Modafinil.

Schedule V drugs

Findings required:

(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.

Schedule V drugs are sometimes available without a prescription.

Drugs on this schedule include:

  • Cough suppressants containing small amounts of codeine;

  • Preparations containing small amounts of opium or Diphenoxylate (used to treat diarrhea);

  • Pregabalin, an anticonvulsant and pain modulator.

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.

Due to pseudoephedrine being widely used in the manufacture of methamphetamine, the state of Oregon now requires a prescription for pharmacies to dispense any cold remedy containing pseudoephedrine. Likewise, the states of Illinois, Indiana, Iowa, Kansas, Michigan, New Mexico, North Carolina, Oklahoma, Minnesota, Tennessee, Virginia and Wyoming restrict sales of pseudoephedrine-containing products to licensed pharmacies and requires customers to show photo ID and sign a log book. California and Maine have also enacted degrees of controlled access to over the counter drugs that contain pseudoephedrine. This affects many preparations which were previously available over-the-counter without restriction, such as Sudafed, Actifed, their generic equivalents, etc. California Health & Safety Code sections 11100 and 11106 specify the new restrictions regarding over the counter (OTC) sale of ephedrine or pseudoephedrine containing products. The law restricts an individual to the retail sale of such products to no more than three packages or no more than nine grams in a single transaction (9 gram is equivalent to 300 standard 30mg tablets of Sudafed nasal decongestant). A violation of this statute constitutes a misdemeanor.

Pharmaceuticals that require a prescription to be dispensed often are not covered under the Controlled Substances Act. This category includes medicines which should only be taken under a doctor's care, or which may have harmful interactions with other substances, but which are not known to be addictive and which are not used recreationally. These medications are used to treat a wide variety of medical conditions and to manage chronic conditions.

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

1970 in law | United States federal controlled substances legislation

規制物質法 | Controlled Substances Act

 

This article is licensed under the GNU Free Documentation License. It uses material from the "Controlled Substances Act".

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