Jump to content

Controlled Substances Act

From Wikipedia, the free encyclopedia

This is an old revision of this page, as edited by 209.149.113.52 (talk) at 11:11, 12 June 2007 (→‎Schedule II drugs). The present address (URL) is a permanent link to this revision, which may differ significantly from the current revision.

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.[1] 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. State governments also regulate certain drugs not controlled at the federal level.

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 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 HHS. Then, 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 DEA 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
Unexpected use of template {{21}} - see Template:21 for details. 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]. 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.

A provision for automatic compliance with treaty obligations is found at 21 U.S.C. § 811(d), which also 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 U.S.C. § 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 United Nations 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[2]:

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 United States into conflict with international law[3]. 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 and 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"[4].

Constitutional Disputes

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].

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.[2] 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.[3]

Drug Schedules

The below lists include examples only. For a complete and up-to-date list of controlled substances, see [6]

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

Tobacco, beer, wine, and spirits are explicitly exempt from the Controlled Substances Act. Some have argued that this is an important omission, since alcohol and tobacco are the two most widely abused drugs in the United States [7] [8], and have no accepted medical uses. Caffeine is also not on the list, although it is a psychoactive drug and it technically meets the requirements for schedule IV or V: it is often abused and it can lead to limited physical dependence.

Dextromethorphan (DXM), a drug found in many OTC cough medications, is also explicitly exempt from scheduling under the original 1970 version of the CSA. However, the DEA has noted DXM to be abused recreationally as a dissociative anaesthetic similar to PCP or ketamine. DXM is therefore listed as a 'chemical of concern' and is being considered for possible evaluation for scheduling.

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.

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 due to limited medical use) [9]:

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.[4] Sentences for violent offenders are much higher.

Drugs on this schedule include:

  • GHB (Gamma-hydroxybutyrate), which 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. Uniquely, this drug is also listed in Schedule III for limited uses, under the trademark Xyrem;
  • 12-Methoxyibogamine (Ibogaine), which has been used in opiate addiction treatment and psychotherapy.
  • Cannabis (includes tetrahydrocannibinols found in marijuana, hashish, and hashish oil). Cannabis has legal medical uses in some states in the U.S. Consequently, extreme controversy exists about its placement in Schedule I. Main article: Cannabis rescheduling in the United States.
  • Dimethyltryptamine (DMT)
  • Heroin (Diacetylmorphine), which is used in much of Europe as a potent pain reliever in terminal cancer patients. (It is about twice as potent, by weight, as morphine.)
  • MDMA (3,4-methylenedioxymethamphetamine,Ecstasy), which continues to be used medically, notably in the treatment of post-traumatic stress disorder (PTSD).The medical community originally agreed upon placing it as a Schedule 3 substance. The government denied this suggestion from the medical community, without any discussion.[citation needed] The FDA approved this PTSD use in 2001.
  • Psilocybin, the active ingredient in psychedelic mushrooms
  • 5-MeO-DIPT (Foxy / Foxy Methoxy / 5-methoxy-n,n-diisopropyltryptamine)
  • Lysergic acid diethylamide (LSD / Acid), which has historically been used to treat alcoholism and other addictions, helped to stop cluster headaches, and has been shown to be useful in treating schizophrenia, bi-polar, and other psychological disorders.
  • Peyote, one of the few plants specifically scheduled, which has a narrow exception to its illegal status for religious use by members of the Native American Church;
  • Mescaline, the main psychoactive ingredients of the peyote cactus;
  • Methaqualone (Quaalude, Sopor, Mandrax); It was previously used for similar purposes as used for barbiturates, until it was rescheduled.
  • 2,5-dimethoxy-4-methylamphetamine (STP / DOM)
  • THG an anabolic progestegenic androgen
  • 2C-T-7 (Blue Mystic / T7)
  • 2C-B (Nexus / Bees / Venus / Bromo Mescaline)
  • Cathinone (β-ketoamphetamine) is a monoamine alkaloid found in the shrub Catha edulis (Khat).
  • AMT (alpha-methyltryptamine)
  • Bufotenin (5-OH-DMT)[5]
  • Controlled Substance Analogs intended for human consumption (as defined by the Federal Analog Act)

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 allowed, except that the prescription is limited to 30 days worth of doses, although exceptions are made for cancer patients, burn victims, etc. and oral prescriptions for schedule II drugs must be confirmed in writing within 3 days. No refills are allowed. Also, Schedule II drugs are subject to production quotas set by the DEA.

Drugs on this schedule include

  • Amphetamines were originally placed on Schedule III, but were moved to Schedule II in 1971. Injectable methamphetamine has always been on 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. Prescriptions for Schedule III drugs may be refilled up to five times within a six month period.

Drugs on this schedule include

  • Ketamine, a drug originally developed as a milder substitute for PCP (mainly to use 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. All other forms of GHB are in Schedule I;

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. Prescriptions for Schedule IV drugs may be refilled up to five times within a six month period.

Drugs on this schedule include:

  • As listed on the US Customs web site under discussion of Khat, see cathine and its listing based on relative freshness. See [10]

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;

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.

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).

Federal Regulation of Pseudoephedrine

Due to pseudoephedrine being widely used in the manufacture of methamphetamine (see also: pseudoephedrine, "Misuse and illicit use"), Congress passed the Methamphetamine Precursor Control Act which places restrictions on the sale of any medicine containing pseudoephedrine. That bill was then superseded by the Combat Methamphetamine Epidemic Act of 2005, which was passed as an amendment to the Patriot Act renewal and included wider and more comprehensive restrictions on the sale of pseudoephedrine containing products. This law requires[11] customer signature of a "log-book" and presentation of valid photo ID to purchase of pseudoephedrine (PSE) containing products from all retailers (see also [12].

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 grams is equivalent to 300 standard 30mg tablets of Sudafed nasal decongestant). A violation of this statute constitutes a misdemeanor. In states where OTC medications which contain pseudoephedrine are not regulated, many retailers, notably Target and Wal-Mart have restricted their purchase by requiring it to be sold behind the pharmacy or service counter and/or placing an age restriction on purchase. Additionally, pharmacies such as CVS and Walgreens also require photo ID and log-book signatures for sales of PSE containing products in compliance with Federal law.

Prior to this, the state of Oregon passed a law requiring a prescription for pharmacies to dispense any cold remedy containing pseudoephedrine. Likewise, the states of Alabama, Arizona, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, South Carolina, New Mexico, New Jersey, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin and Wyoming restrict sales of pseudoephedrine-containing products to licensed pharmacies and require customers to show photo ID and sign a log book. California, Maryland, 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 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 (PSE).

Notes

  1. ^ Pub. L. No. 91-513, 84 Stat. 1236 (Oct. 27, 1970), codified at 21 U.S.C. § 801 et. seq.
  2. ^ 352 F.3d 1222 (9th Cir. 2003).
  3. ^ 545 U.S. 1 (2005).
  4. ^ See United States v. Angelos, 433 F.3d 738 (10th Cir. 2006) (55 years for three sales of marijuana).
  5. ^ Drug Scheduling. DEA. Accessed on May 7, 2007.

See also

External links

Retrieved from "https://en.wikipedia.org/w/index.php?title=Controlled_Substances_Act&oldid=137656409"