The legislation created five Schedules (classifications), with varying qualifications for a drug to be included in each. Two federal departments, the Department of Justice (which includes the Drug Enforcement Administration and the Federal Bureau of Investigation) 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 dependence.
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.
Also during this time, Nixon commissioned 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 findings 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." Nixon buried this commission's findings and went on to sign the Controlled Substances Act.
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 1970 Controlled Substances Act was part of an omnibus reform package designed to rationalize, and in some respects to liberalize, American drug policy." 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 Hughes, who favored a moderate approach. The bill, as introduced by Senator Dirksen, ran 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 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 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, 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.
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 :
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 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"
The findings that the government must make in order to classify a drug in a certain schedule are specified at . 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 used drugs in the United States. Caffeine is also not on the list.
Recently, in a report published in The Lancet Journal, 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 Ecstasy were all below the two legal drugs in harmfulness. This research is in line with a British House Of Commons report Drug Classification: Making A Hash Of It.
The placement of some drugs is paradoxical: both morphine and fentanyl are on Schedule II, and heroin is on Schedule I. Fentanyl is approximately 80 times the potency of morphine, and heroin is somewhere between morphine and fentanyl. Morphine has been used by physicians for over 150 years. It is very addictive, but it is very effective for severe pain, so it is licensed for careful medical use. Heroin was introduced in the late 19th century and licensed the same way until it was banned in 1924. Fentanyl has been used for less than 50 years and has always been carefully restricted.
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.
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):
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 on this schedule include
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. The Drug Enforcement Administration (DEA) is finalizing a Notice of Proposed Rulemaking published on September 6, 2006 (71 FR 52724). In that document, DEA proposed to amend its regulations to allow practitioners to provide individual patients with multiple prescriptions, to be filled sequentially, for the same schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90- day supply of that controlled substance. This went in to effect December 19, 2007. Also, Schedule II drugs are subject to production quotas set by the DEA. Some of these drugs (notably Fentanyl in non-transdermal form) are never given to patients for home use, but are administered only by a physician. Fentanyl can be given to patients for home use in Duragesic transdermal therapeutic system patch form. The prescription must be hand delivered within 7 days to the pharmacy and the prescription is limited to 30 days worth of doses.
Drugs on this schedule include:
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:
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:
Schedule V drugs are only available for a medical purpose.
Drugs on this schedule include:
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 formerly required labels with the legend, "Caution! Federal law prohibits dispensing without a prescription."; the current requirement has been simplified to the legend "Rx only".
The term controlled drugs is sometimes used for scheduled drugs because of the additional controls placed on them (beyond the need for a prescription).
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 customer signature of a "log-book" and presentation of valid photo ID to purchase of pseudoephedrine (PSE) containing products from all retailers (see also ).
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 30 mg 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, 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 & Safety Code sections 11100 and 11106 specify the new restrictions regarding over the counter (OTC) sale of ephedrine or pseudoephedrine containing products (PSE).