|Enacted by the||
91st United States Congress
|Effective||October 27, 1970|
|Public Law||Pub.L. 91–513|
|Stat.||84 Stat. 1242|
|Hillory J. Farias and Samantha Reid Date-Rape Prevention Act of 2000|
|United States Supreme Court cases|
|Gonzales v. Raich
United States v. Oakland Cannabis Buyers' Cooperative
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. The CSA is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain substances is regulated. 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 substance to be included in each. Two federal agencies, the Drug Enforcement Administration and the Food and Drug Administration, determine which substances are added to or removed from the various schedules, though the statute passed by Congress created the initial listing, and Congress has sometimes scheduled other substances through legislation such as the Hillory J. Farias and Samantha Reid Date-Rape Prevention Act of 2000, which placed gamma hydroxybutyrate in Schedule I. Classification decisions are required to be made on criteria including potential for abuse (an undefined term), currently accepted medical use in treatment in the United States, and international treaties.
|Regulation of therapeutic goods in the United States|
The nation first outlawed addictive drugs in the early 1900s and the International Opium Convention helped lead international agreements regulating trade. The Food and Drugs Act of 1906 was the beginning of over 200 laws concerning public health and consumer protections. Others were the Federal Food, Drug, and Cosmetic Act (1938), and the Kefauver Harris Amendment of 1962.
In 1969, President Richard Nixon announced that the Attorney General, John N. Mitchell, was preparing a comprehensive new measure to more effectively meet the narcotic and dangerous drug problems at the federal level by combining all existing federal laws into a single new statute. The CSA did not merely combine existing federal drug laws but changed the nature of federal drug law and policy, expanded the scope of federal drug laws and expanded federal police power enormously.
Part F of the Comprehensive Drug Abuse Prevention and Control Act of 1970 established the National Commission on Marijuana and Drug Abuse-known as the Shafer Commission after its chairman, Raymond P. Shafer-to study marijuana abuse in the United States. During his presentation of the commission's First Report to Congress, Shafer recommended the decriminalization of marijuana in small amounts, saying,
[T]he criminal law is too harsh a tool to apply to personal possession even in the effort to discourage use. It implies an overwhelming indictment of the behavior which we believe is not appropriate. The actual and potential harm of use of the drug is not great enough to justify intrusion by the criminal law into private behavior, a step which our society takes only with the greatest reluctance.
Rufus King notes that this stratagem was similar to that used by Harry Anslinger when he consolidated the previous anti-drug treaties into the Single Convention and took the opportunity to add new provisions that otherwise might have been unpalatable to the international community. According to David T. Courtwright, "the Act was part of an omnibus reform package designed to rationalize, and in some respects to liberalize, American drug policy." (Courtwright noted that the Act became, not libertarian, but instead repressionistic to the point of tyrannical, in its intent.) It eliminated mandatory minimum sentences and provided support for drug treatment and research. King notes that the rehabilitation clauses were added as a compromise to Senator Jim Hughes, who favored a moderate approach. The bill, as introduced by Senator Everett Dirksen, ran to 91 pages. While it was being drafted, the Uniform Controlled Substances Act, to be passed by state legislatures, was also being drafted by the Department of Justice; its wording closely mirrored the Controlled Substances Act.
Since its enactment in 1970, the Act has been amended several times:
The Drug Enforcement Administration was established in 1973, combining the Bureau of Narcotics and Dangerous Drugs (BNDD) and Customs’ drug agents. Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the 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 laboratories, state and local law enforcement and regulatory agencies, or other sources of information. Once the DEA has collected the necessary data, the Deputy Administrator of DEA, 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, judicial review.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. Unlike ordinary scheduling proceedings, such temporary orders are not subject to
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.
The Congressional findings in 21 USC §§ , , and state that a major purpose of the CSA is to "enable the United States to meet all of its obligations" under international treaties. 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.
The domestic and international legal nature of these treaty obligations must be considered in light of the supremacy of the United States Constitution over treaties or acts and the equality of treaties and Congressional acts. In Reid v. Covert the Supreme Court of the United States addressed both these issues directly and clearly holding:
According to the Cato Institute, these treaties only bind (legally obligate) the United States to comply with them as long as that nation agrees to remain a state party to these treaties. The U.S. Congress and the President of the United States have the absolute sovereign right to withdraw from or abrogate at any time these two instruments, in accordance with said nation's Constitution, at which point these treaties will cease to bind that nation in any way, shape, or form.
A provision for automatic compliance with treaty obligations is found at, 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 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:
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, were the United States not to exercise its sovereign right to withdraw from and/or abrogate the Single Convention on Narcotic Drugs and/or the 1971 Convention on Psychotropic Substances prior to repealing the Controlled Substances Act. 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".
Placing a drug or other substance in a certain Schedule or removing it from a certain Schedule is primarily based on 21 USC §§ , , , , , and . Every schedule otherwise requires finding and specifying the "potential for abuse" before a substance can be placed in that schedule. The specific classification of any given drug or other substance is usually a source of controversy, as is the purpose and effectiveness of the entire regulatory scheme.
"The term 'controlled substance' means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986." wine which is sacramentally used by many major religious denominations in the United States.Some have argued that this is an important exemption, since alcohol and tobacco are the two most widely used drugs in the United States. Also of significance, the exclusion of alcohol includes
Schedule I substances are those that have the following findings:
- The drug or other substance has a high potential for abuse.
- The drug or other substance has no currently accepted medical use in treatment in the United States.
- 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.)
[W]hen 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. Sentences for violent offenders are much higher.
Drugs in this schedule include:
Schedule II substances are those that have the following findings:
- The drug or other substances have a high potential for abuse
- The drug or other substances have currently accepted medical use in treatment in the United States, or currently accepted medical use with severe restrictions
- Abuse of the drug or other substances may lead to severe psychological or physical dependence.
Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), may be dispensed without the written prescription of a practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act (21 USC 353 (b)). Prescriptions shall be retained in conformity with the requirements of section 827 of this title. No prescription for a controlled substance in schedule II may be refilled. Notably no emergency situation provisions exist outside the Controlled Substances Act's "closed system" although this closed system may be unavailable or nonfunctioning in the event of accidents in remote areas or disasters such as hurricanes and earthquakes. Acts which would widely be considered morally imperative remain offenses subject to heavy penalties.
These drugs vary in potency: for example fentanyl is about 80 times as potent as morphine (heroin is roughly four times as potent). More significantly, they vary in nature. Pharmacology and CSA scheduling have a weak relationship.
Schedule II substances are typically only given once a month. Federal law does not allow refills to be given. If the doctor thinks it's necessary he/she can write three separate 30-day prescriptions to the patient.
Drugs in this schedule include:
Schedule III substances are those that have the following findings:
Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule III or IV, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), may be dispensed without a written or oral prescription in conformity with section 503(b) of that Act (21 USC 353 (b)). Such prescriptions may not be filled or refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner. Control of wholesale distribution is somewhat less stringent than Schedule II drugs. Provisions for emergency situations are less restrictive within the "closed system" of the Controlled Substances Act than for Schedule II though no schedule has provisions to address circumstances where the closed system is unavailable, nonfunctioning or otherwise inadequate.
Drugs in this schedule include:
"Placement on schedules; findings required Schedule IV substances are those that have the following findings:
- The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III
- The drug or other substance has a currently accepted medical use in treatment in the United States
- 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 in this schedule include:
Schedule V substances are those that have the following findings:
- The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV
- The drug or other substance has a currently accepted medical use in treatment in the United States
- 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.
No controlled substance in schedule V which is a drug may be distributed or dispensed other than for a medical purpose.
Drugs in this schedule include:
Due to pseudoephedrine and ephedrine being widely used in the manufacture of methamphetamine, the U.S. 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 customer signature of a "log-book" and presentation of valid photo ID to purchase of pseudoephedrine (PSE) containing products from all retailers.
The law restricts an individual to the retail sale of such products to no more than three packages or no more than 3.6 grams in a single transaction. Additionally, there is a limit of no more than 9 grams in one month. 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, Colorado, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, New Mexico, New Jersey, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington, 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 and Safety Code sections 11100 and 11106 specify the new restrictions regarding over the counter (OTC) sale of ephedrine or pseudoephedrine containing products (PSE).
Recently, in a report published in the journal The Lancet, researchers have introduced an alternative method for drug classification in the UK. This new system uses a "nine category matrix of harm, with an expert Delphic procedure, to assess the harms of a range of illicit drugs in an evidence-based fashion." The new classification system suggested that alcohol and tobacco were in the mid-range of harm, while cannabis, LSD, and MDMA were all less harmful than the two legal drugs. This research is in line with a House of Commons of the United Kingdom report Drug classification: making a hash of it?
There has been a lot of criticism against the schedule classifications of the listed drugs and subtances in the CSA, citing undefined terms.
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