Controlled substances Act - wikipedia Controlled substances Act Controlled Substances Act Long title An Act to amend the Public Health Service Act and other laws to provide increased research into, and prevention of, drug abuse and drug dependence ; to provide for treatment and rehabilitation of drug abusers and drug dependent persons ; and to strengthen existing law enforcement authority in the field of drug abuse. Acronyms ( colloquial ) CSA Enacted by the 91st United States Congress Effective May 1, 1971 Citations Public law 91 - 513 Statutes at Large 84 Stat. 1236 a.k.a. 84 Stat. 1242 Codification Titles amended 21 U.S.C. : Food and Drugs U.S.C. sections created 21 U.S.C. ch. 13 § 801 et seq. Legislative history Introduced in the House as H.R. 18583 by Harley O. Staggers ( D -- WV ) on September 10, 1970 Committee consideration by Interstate and Foreign Commerce Committee and Senate Judiciary Committee Passed the House on September 24, 1970 ( 342 -- 7 ) Passed the Senate on October 7, 1970 ( 54 -- 0 ) Reported by the joint conference committee on October 13, 1970 ; agreed to by the House on October 14, 1970 ( passed ) and by the Senate on October 14, 1970 ( passed ) Signed into law by President Richard Nixon on October 27, 1970 Major amendments 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 McFadden v. United States The Controlled Substances Act ( CSA ) is the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use, and distribution of certain substances is regulated. It was passed by the 91st United States Congress as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and signed into law by President Richard Nixon. 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 ( DEA ) and the Food and Drug Administration ( FDA ), determine which substances are added to or removed from the various schedules, although the statute passed by Congress created the initial listing. 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 and sodium oxybate in Schedule III. 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. Contents 1 History 1.1 Amendments, 1970 - 2010 2 Content 3 Enforcement authority 4 Treaty obligations 5 Schedules of controlled substances 5.1 Schedule I controlled substances 5.2 Schedule II controlled substances 5.3 Schedule III controlled substances 5.4 Schedule IV controlled substances 5.5 Schedule V controlled substances 6 Regulation of precursors 7 Criticism 8 See also 9 Notes 10 References 11 External links History Regulation of therapeutic goods in the United States Prescription drugs Over-the - counter drugs Law Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch - Waxman exemption Marihuana Tax Act Government agencies Department of Health and Human Services Food and Drug Administration Department of Justice Drug Enforcement Administration Process Drug discovery Drug design Drug development New drug application Investigational new drug Clinical trial ( Phase I, II, III, IV ) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off - label use International coordination International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs Non-governmental organizations Institute of Medicine Research on Adverse Drug events And Reports NORML 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. With the help of White House Counsel head John Dean, the Executive Director of the Shafer Commission Michael Sonnenreich, and the Director of the BNDD John Ingersoll creating and writing the legislation, Mitchell was able to present Nixon with an exceptional bill. The CSA not only combined existing federal drug laws and expanded their scope, but it also changed the nature of federal drug law policies and expanded Federal law enforcement pertaining to controlled substances. Title II, 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 cannabis abuse in the United States. During his presentation of the commission 's First Report to Congress, Sonnenreich and Shafer recommended the decriminalization of marijuana in small amounts, with Shafer stating, ( 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 ; it 's wording closely mirrored the Controlled Substances Act. Amendments, 1970 - 2010 Since its enactment in 1970, the Act has been amended numerous times : The 1976 Medical Device Regulation Act. The Psychotropic Substances Act of 1978 added provisions implementing the Convention on Psychotropic Substances. The Controlled Substances Penalties Amendments Act of 1984. The 1986 Federal Analog Act for chemicals `` substantially similar '' in Schedule I and II to be listed The 1988 Chemical Diversion and Trafficking Act ( implemented August 1, 1989 as Article 12 ) added provisions implementing the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances that went into force on November 11, 1990. 1990 The Anabolic Steroids Act, passed as part of the Crime Control Act of 1990, which placed anabolic steroids into Schedule III The 1993 Domestic Chemical Diversion and Control Act ( effective on April 16, 1994 ) in response to methamphetamine trafficking. The 2008 Ryan Haight Online Pharmacy Consumer Protection Act The 2010 Electronic Prescriptions for Controlled Substances ( EPCS ). Content The Controlled Substances Act consists of 2 subchapters. Subchapter I defines Schedules I-V, lists chemicals used in the manufacture of controlled substances, and differentiates lawful and unlawful manufacturing, distribution, and possession of controlled substances, including possession of Schedule I drugs for personal use ; this subchapter also specifies the dollar amounts of fines and durations of prison terms for violations. Subchapter II describes the laws for exportation and importation of controlled substances, again specifying fines and prison terms for violations. Enforcement authority The Food and Drug administration inspects packages for illegal drug shipments at an international mail facility in New York 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 HHS recommendation on scheduling is binding to the extent that if HHS recommends, based on its medical and scientific evaluation, that the substance not be controlled, then the DEA may not control the substance. Once the DEA has received the scientific and medical evaluation from HHS, the DEA Administrator evaluates all available data and makes 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. Unlike ordinary scheduling proceedings, such temporary orders are not subject to judicial review. 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. Treaty obligations The Congressional findings in 21 USC § § 801 ( 7 ), 801a ( 2 ), and 801a ( 3 ) 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 : ( N ) o agreement with a foreign nation can confer power on the Congress, or on any other branch of Government, which is free from the restraints of the Constitution. Article VI, the Supremacy Clause of the Constitution, declares : `` This Constitution, and the Laws of the United States which shall be made in Pursuance thereof, and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land ;... '' There is nothing in this language which intimates that treaties and laws enacted pursuant to them do not have to comply with the provisions of the Constitution. Nor is there anything in the debates which accompanied the drafting and ratification of the Constitution which even suggests such a result. These debates, as well as the history that surrounds the adoption of the treaty provision in Article VI, make it clear that the reason treaties were not limited to those made in `` pursuance '' of the Constitution was so that agreements made by the United States under the Articles of Confederation, including the important peace treaties which concluded the Revolutionary War, would remain in effect. It would be manifestly contrary to the objectives of those who created the Constitution, as well as those who were responsible for the Bill of Rights -- let alone alien to our entire constitutional history and tradition -- to construe Article VI as permitting the United States to exercise power under an international agreement without observing constitutional prohibitions. In effect, such construction would permit amendment of that document in a manner not sanctioned by Article V. The prohibitions of the Constitution were designed to apply to all branches of the National Government, and they can not be nullified by the Executive or by the Executive and the Senate combined. There is nothing new or unique about what we say here. This Court has regularly and uniformly recognized the supremacy of the Constitution over a treaty. For example, in Geofroy v. Riggs, 133 U.S. 258, 133 U.S. 267, it declared : `` The treaty power, as expressed in the Constitution, is in terms unlimited except by those restraints which are found in that instrument against the action of the government or of its departments, and those arising from the nature of the government itself and of that of the States. It would not be contended that it extends so far as to authorize what the Constitution forbids, or a change in the character of the government, or in that of one of the States, or a cession of any portion of the territory of the latter, without its consent. '' This Court has repeatedly taken the position that an Act of Congress, which must comply with the Constitution, is on a full parity with a treaty, and that, when a statute which is subsequent in time is inconsistent with a treaty, the statute to the extent of conflict renders the treaty null. It would be completely anomalous to say that a treaty need not comply with the Constitution when such an agreement can be overridden by a statute that must conform to that instrument. 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 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 : 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 ''. Schedules of controlled substances There are five different Schedules of controlled substances, numbered I -- V. The CSA describes the different Schedules based on three factors : Potential for abuse : How likely is this drug to be abused ? Accepted medical use : Is this drug used as a treatment in the United States ? Safety and potential for addiction : Is this drug safe ? How likely is this drug to cause addiction ? What kinds of addiction ? The following table gives a summary of the different Schedules. Potential for Abuse Accepted Medical Use ? Potential for Addiction Schedule I High None Drug is not safe to use, even under medical supervision Schedule II High Yes ; sometimes allowed only with `` severe restrictions '' Abusing the drug can cause severe physical and mental addiction Schedule III Medium Yes Abusing the drug can cause severe mental addiction, or moderate physical addiction Schedule IV Low Yes Abusing the drug may lead to mild mental or physical addiction Schedule V Lowest Yes Abusing the drug may lead to mild mental or physical addiction Placing a drug or other substance in a certain Schedule or removing it from a certain Schedule is primarily based on 21 USC § § 801, 801a, 802, 811, 812, 813, and 814. 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. -- 21 U.S.C. § 802 ( 6 ) Some have argued that this is an important exemption, since alcohol and tobacco are two of the most widely used drugs in the United States. Also of significance, the exclusion of alcohol includes wine which is sacramentally used by many major religious denominations in the United States. Schedule I controlled substances Main article : List of Schedule I drugs ( US ) Schedule I substances are described as 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 which the DEA imposes. Under the DEA 's interpretation of the CSA, a drug does not necessarily have to have the same `` high potential for abuse '' as heroin, for example, to merit placement in Schedule I : ( 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 ). ( emphasis added ) -- Drug Enforcement Administration, Notice of denial of petition to reschedule marijuana ( 2001 ) 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 listed in this control schedule include : αMT ( alpha - methyltryptamine ), a psychedelic, stimulant, and entactogen drug of the tryptamine class that was originally developed as an antidepressant by workers at Upjohn in the 1960s. BZP ( benzylpiperazine ), a synthetic stimulant once sold as a designer drug. It has been shown to be associated with an increase in seizures if taken alone. Although the effects of BZP are not as potent as MDMA, it can produce neuroadaptations that can cause an increase in the potential for abuse of this drug. Cathinone, an amphetamine - like stimulant found in the shrub Catha edulis ( khat ). DMT ( dimethyltryptamine ), a naturally occurring psychedelic drug that is widespread throughout the plant kingdom and endogenous to the human body. DMT is the main psychoactive constituent in the psychedelic South American brew, ayahuasca, for which the UDV are granted exemption from DMT 's schedule I status on the grounds of religious freedom. Etorphine, a semi-synthetic opioid possessing an analgesic potency approximately 1,000 -- 3,000 times that of morphine. GHB, a general anesthetic and treatment for narcolepsy - cataplexy and alcohol withdrawal with a limited safe dosage range and poor ability to control pain when used as an anesthetic ( severely limiting its usefulness ). It was placed in Schedule I in March 2000 after widespread recreational use led to increased emergency room visits, hospitalizations, and deaths. A specific formulation of this drug is also listed in Schedule III for limited uses, under the trademark Xyrem. Heroin ( diacetylmorphine ), which is used in some European countries as a potent pain reliever in terminal cancer patients, and as second option, after morphine ; it is about twice as potent, by weight, as morphine and, indeed, becomes morphine upon injection into the bloodstream. Ibogaine, a naturally occurring psychoactive substance found in plants in the Apocynaceae family. Some countries use ibogaine as an alternative medicine treatment for drug addiction. Ibogaine is also used for medicinal and ritual purposes within African spiritual traditions of the Bwiti. LSD ( lysergic acid diethylamide ), a semi-synthetic psychedelic drug famous for its involvement in the counterculture of the 1960s. Marijuana and its cannabinoids. Pure ( -- ) - trans - Δ9 - tetrahydrocannabinol is also listed in Schedule III for limited uses, under the trademark Marinol. Ballot measures in several states such as Colorado, Washington, California, Florida, Massachusetts, Oregon and others have made allowances for recreational and medical use of marijuana and / or have decriminalized possession of small amounts of marijuana -- such measures operate only on state laws, and have no effect on Federal law. Whether such users would actually be prosecuted under federal law is a separate question. MDMA ( `` ecstasy '' ), a stimulant, psychedelic, and entactogenic drug which initially garnered attention in psychedelic therapy as a treatment for post-traumatic stress disorder ( PTSD ). The medical community originally agreed upon placing it as a Schedule III substance, but the government denied this suggestion, despite two court rulings by the DEA 's administrative law judge that placing MDMA in Schedule I was illegal. It was temporarily unscheduled after the first administrative hearing from December 22, 1987 -- July 1, 1988. Mescaline, a naturally occurring psychedelic drug and the main psychoactive constituent of peyote ( Lophophora williamsii ), San Pedro cactus ( Echinopsis pachanoi ), and Peruvian torch cactus ( Echinopsis peruviana ). Methaqualone ( Quaalude, Sopor, Mandrax ), a sedative that was previously used for similar purposes as barbiturates, until it was rescheduled. Peyote ( Lophophora williamsii ), a cactus growing in nature primarily in northeastern Mexico ; one of the few plants specifically scheduled, with a narrow exception to its legal status for religious use in Native American churches. Psilocybin and psilocin, naturally occurring psychedelic drugs and the main psychoactive constituents of psilocybin mushrooms. Controlled substance analogs intended for human consumption, as defined by the Federal Analog Act. Schedule II controlled substances Main article : List of Schedule II drugs ( US ) 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 to an ultimate user by a practitioner other than a pharmacist, 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 ) ). With exceptions, an original prescription is always required even though faxing in a prescription in advance to a pharmacy by a prescriber is allowed. 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 two times as potent ). More significantly, they vary in nature. Pharmacology and CSA scheduling have a weak relationship. Because refills of prescriptions for Schedule II substances are not allowed, it can be burdensome to both the practitioner and the patient if the substances are to be used on a long - term basis. To provide relief, in 2007, 21 C.F.R. 1306.12 was amended ( at 72 FR 64921 ) to allow practitioners to write up to three prescriptions at once, to provide up to a 90 - day supply, specifying on each the earliest date on which it may be filled. Drugs in this schedule include : Amphetamine drugs including Adderall, Dextroamphetamine ( Dexedrine ), Lisdexamfetamine ( Vyvanse ) : treatment of ADHD, narcolepsy, severe obesity ( limited use, dextroamphetamine only ), binge eating disorder ( lisdexamfetamine only ). Originally placed in Schedule III, but moved to Schedule II in 1971. Barbiturates ( short - acting ), such as pentobarbital Cocaine : used as a topical anesthetic and to stop severe epistaxis Codeine ( pure ) and any drug for non-parenteral administration containing the equivalent of more than 90 mg of codeine per dosage unit ; Diphenoxylate ( pure ) Fentanyl and most other strong pure opioid agonists, i.e. levorphanol Hydrocodone in any formulation as of October 2014 ( Examples include Vicodin, Norco, Tussionex ). Prior to October 2014, formulations containing hydrocodone and over-the - counter analgesics such as Acetaminophen and Ibuprofen were Schedule III. Hydromorphone ( semi-synthetic opioid ; active ingredient in Dilaudid, Palladone ) Methadone : treatment of heroin addiction, extreme chronic pain Methamphetamine : treatment of ADHD ( rare ), severe obesity ( limited use ) Methylphenidate ( Ritalin, Concerta ), Dexmethylphenidate ( Focalin ) : treatment of ADHD, narcolepsy Morphine Nabilone ( Cesamet ) -- A synthetic cannabinoid. An analogue to dronabinol ( Marinol ) which is a Schedule III drug. Opium tincture ( Laudanum ) : a potent antidiarrheal Oxycodone ( semi-synthetic opioid ; active ingredient in Percocet, OxyContin, and Percodan ) Oxymorphone ( semi-synthetic opioid ; active ingredient in Opana ) Nembutal ( Pentobarbital ) -- barbiturate medication originally developed for narcolepsy ; primarily used today for physician assisted suicide and euthanasia of animals. Pethidine ( USAN : Meperidine ; Demerol ) Phencyclidine ( PCP ) Secobarbital ( Seconal ) Tapentadol ( Nucynta ) -- A drug with mixed opioid agonist and norepinephrine re-uptake inhibitor activity. Schedule III controlled substances Main article : List of Schedule III drugs ( US ) Schedule III substances are those that have the following findings : The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II. 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 moderate or low physical dependence or high psychological dependence. 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. A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call - in. 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 : Anabolic steroids ( including prohormones such as androstenedione ) ; the specific end molecule testosterone in many of its forms ( Androderm, AndroGel, Testosterone Cypionate, and Testosterone Enanthate ) are labeled as scheduled III while low - dose testosterone when compounded with estrogen derivatives have been exempted ( from scheduling ) by the FDA Intermediate - acting barbiturates, such as talbutal or butalbital Buprenorphine ( semi-synthetic opioid ; active in Suboxone, Subutex ) Dihydrocodeine when compounded with other substances, to a certain dosage and concentration. Ketamine, a drug originally developed as a safer, shorter - acting replacement for PCP ( mainly for use as a human anesthetic ) but has since become popular as a veterinary and pediatric 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. Marinol, synthetically prepared tetrahydrocannabinol ( officially referred to by its INN, dronabinol ) used to treat nausea and vomiting caused by chemotherapy, as well as appetite loss caused by AIDS. Paregoric, an antidiarrheal and anti-tussive, which contains opium combined with camphor ( which makes it less addiction - prone than laudanum, which is in Schedule II ). Phendimetrazine Tartrate, a stimulant synthesized for use as an anorexiant. Benzphetamine HCl ( Didrex ), a stimulant designed for use as an anorexiant. Fast - acting barbiturates such as secobarbital ( Seconal ) and pentobarbital ( Nembutal ), when combined with one or more additional active ingredient ( s ) not in Schedule II ( e.g., Carbrital ( no longer marketed ), a combination of pentobarbital and carbromal ). Ergine ( lysergic acid amide ), listed as a sedative but considered by some to be psychedelic. An inefficient precursor to its N, N - diethyl analogue, LSD, ergine occurs naturally in the seeds of the common garden flowers Turbina corymbosa, Ipomoea tricolor, and Argyreia nervosa. Schedule IV controlled substances Main article : List of Schedule IV drugs ( US ) `` 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. A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call - in. Drugs in this schedule include : Benzodiazepines, such as alprazolam ( Xanax ), chlordiazepoxide ( Librium ), clonazepam ( Klonopin ), diazepam ( Valium ), and Lorazepam ( Ativan ), as well as : temazepam ( Restoril ) ( note that some states require specially coded prescriptions for temazepam ) flunitrazepam ( Rohypnol ) ( note that flunitrazepam is not used medically in the United States ) The benzodiazepine - like Z - drugs : zolpidem ( Ambien ), zopiclone ( Imovane ), eszopiclone ( Lunesta ), and zaleplon ( Sonata ) ( zopiclone is not commercially available in the U.S. ) Chloral hydrate, a sedative - hypnotic Long - acting barbiturates such as phenobarbital Some partial agonist opioid analgesics, such as pentazocine ( Talwin ) The eugeroic drug modafinil ( sold in the U.S. as Provigil ) as well as its ( R ) - enantiomer armodafinil ( sold in the U.S. as Nuvigil ) Difenoxin, an antidiarrheal drug, such as when combined with atropine ( Motofen ) ( difenoxin is 2 -- 3 times more potent than diphenoxylate, the active ingredient in Lomotil, which is in Schedule V ) Tramadol ( Ultram ) Carisoprodol ( Soma ) has become a Schedule IV medication as of 11 January 2012 Schedule V controlled substances Main article : List of Schedule V drugs ( US ) 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. A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call - in. Drugs in this schedule include : Cough suppressants containing small amounts of codeine ( e.g., promethazine + codeine ) ; Preparations containing small amounts of opium or diphenoxylate ( used to treat diarrhea ) ; Some anticonvulsants, such as pregabalin ( Lyrica ), lacosamide ( Vimpat ) and retigabine ( ezogabine ) ( Potiga / Trobalt ) ; Pyrovalerone ( used to treat chronic fatigue and as an appetite suppressant for weight loss ) ; Some centrally - acting antidiarrheals, such as diphenoxylate ( Lomotil ) when mixed with atropine ( to make it unpleasant for people to grind up, cook, and inject ). Difenoxin with atropine ( Motofen ) has been moved to Schedule IV. Without atropine, these drugs are in Schedule II. Regulation of precursors The Controlled Substances Act also provides for federal regulation of precursors used to manufacture some of the controlled substances. The DEA list of chemicals is actually modified when the United States Attorney General determines that illegal manufacturing processes have changed. In addition to the CSA, due to pseudoephedrine ( PSE ) 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 PSE - containing products. This law requires customer signature of a `` log - book '' and presentation of valid photo ID in order to purchase PSE - containing products from all retailers. Additionally, the law restricts an individual to the retail purchase of no more than three packages or 3.6 grams of such product per day per purchase -- and no more than 9 grams in a single month. A violation of this statute constitutes a misdemeanor. Retailers now commonly require PSE - containing products to be sold behind the pharmacy or service counter. This affects many preparations which were previously available over-the - counter without restriction, such as Actifed and its generic equivalents. Criticism There has been criticism against the schedule classifications of the listed drugs and substances in the CSA, citing undefined terms. Some criticism has arisen due to research that has found several substances on the list of Schedule I substances to have actual accepted medical uses and low abuse potential, despite the requirement for a Schedule I listing mandating that any substance so scheduled have both a high potential for abuse and no accepted medical use. One such example is the legalization of marijuana in some capacity in over 29 states. Further information : Removal of cannabis from Schedule I of the Controlled Substances Act See also Government of the United States portal Convention on Psychotropic Substances Drug - Free Workplace Act of 1988 Fair Sentencing Act Gonzales v. Raich Legality of the War on Drugs List of pharmaceutical companies Medical amnesty policy Regulation of therapeutic goods Single Convention on Narcotic Drugs ( 1961 ) Treaty Clause and Head Money Cases United States v. Oakland Cannabis Buyers ' Cooperative Federal drug policy of the United States Similar legislation outside of the United States : Controlled Drugs and Substances Act ( Canada ) Misuse of Drugs Act 1971 ( United Kingdom ) Notes Jump up ^ Less than the drugs in Schedule I and Schedule II Jump up ^ When compared with the drugs in Schedule III Jump up ^ When compared with the drugs in Schedule IV References Jump up ^ Pub. L. 91 -- 513, 84 Stat. 1236, enacted October 27, 1970, codified at 21 U.S.C. § 801 et. seq. Jump up ^ `` 2000 - Addition of Gamma - Hydroxybutyric Acid to Schedule I ''. US Department of Justice via the Federal Register. March 13, 2000. Jump up ^ `` William J. Clinton : Statement on Signing the Hillory J. Farias and Samantha Reid Date - Rape Drug Prohibition Act of 2000 ''. February 18, 2000. ^ Jump up to : Government Regulations Docket ID : DEA - 2009 - 0013 in BASIS FOR THE RECOMMENDATION TO CONTROL 5 - METHOXY - DIMETHYLTRYPTAMINE ( 5 - MeO - DMT ) IN SCHEDULE I OF THE CONTROLLED SUBSTANCES ACT The term `` abuse '' is not defined in the CSA. ^ Jump up to : `` ( D ) rug abuse may refer to any type of drug or chemical without regard to its pharmacologic actions. It is an eclectic concept having only one uniform connotation : societal disapproval... The Commission believes that the term drug abuse must be deleted from official pronouncements and public policy dialogue. The term has no functional utility and has become no more than an arbitrary codeword for that drug use which is presently considered wrong. '' -- Second Report of the National Commission on Marihuana and Drug Abuse ; Drug Use In America : Problem In Perspective ( March 1973 ), p. 13 Jump up ^ `` Illegal Drugs in America : A Modern History ''. DEA Museum & Visitors Center. Archived from the original on 4 December 2004. Jump up ^ `` The 1912 Hague International Opium Convention ''. Public Policy Options. Canadian Senate Special Committee on Illegal Drugs. 3. Schaffer Library of Drug Policy. Jump up ^ Musto, David F. `` History of Legislative Control Over Opium, Cocaine, and Their Derivatives ''. Schaffer Library of Drug Policy. Jump up ^ `` Legislation ''. U.S. Food and Drug Administration. 2 July 2015. Jump up ^ `` Medical Device Amendments ''. Rx - wiki. Parsons Printing Press. Retrieved 2012 - 12 - 30. Jump up ^ `` 50 Years : The Kefauver - Harris Amendment ''. FDA. Retrieved 7 July 2016. Jump up ^ Strength of the Pack : The Personalities, Politics and Espionage Intrigues. Google Books. Douglas Valentine. Retrieved 2018 - 05 - 13. Jump up ^ 91st United States Congress ( 1970 ), `` Part F -- Advisory Commission : Establishment of Commission on Marihuana and Drug Abuse '', An Act to amend the Public Health Service Act and other laws to provide increased research, into, and prevention of, drug abuse and drug dependence ; to provide for treatment and rehabilitation of drug abusers and drug dependent persons ; and to strengthen existing law enforcement authority in the field of drug abuse, U.S. Government Publishing Office, pp. 1280 -- 1281. Pub. L. 91 -- 513, 84 Stat. 1236, enacted October 27, 1970 Jump up ^ National Commission on Marihuana and Drug Abuse ( March 1973 ). Drug Use In America : Problem In Perspective, Second Report of the National Commission on Marihuana and Drug Abuse ( Report ). Jump up ^ `` NORML - Working to Reform Marijuana Laws ''. norml.org. Retrieved 2018 - 05 - 15. ^ Jump up to : King, Rufus. `` The 1970 Act : Do n't Sit There, Amend Something ''. The Drug Hang Up, America 's Fifty - Year Folly. Schaffer Library of Drug Policy. Jump up ^ Courtwright, David T. ( 5 October 2004 ). `` The Controlled Substances Act : how a `` big tent '' reform became a punitive drug law ``. Drug and Alcohol Dependence. 76 ( 1 ) : 9 -- 15. doi : 10.1016 / j. drugalcdep. 2004.04. 012. PMID 15380284. Jump up ^ `` S. 510 - An Act to amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes ''. Congress.Gov. Library of Congress. Retrieved 31 August 2016. Jump up ^ `` S. 2399 - Psychotropic Substances Act ''. Congress.Gov. Library of Congress. Retrieved 31 August 2016. Jump up ^ Steven B. Karch. Pathology, Toxicogenetics, and Criminalistics of Drug Abuse. CRC Press, 2007 ISBN 9781420054569 Jump up ^ Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Wikisource. 2009. Jump up ^ `` Title 21 United States Code ( USC ) Controlled Substances Act ''. Drug Enforcement Administration : Office of Diversion Control. United States Department of Justice. Jump up ^ `` State and Local Task Forces ''. Drug Enforcement Administration. United States Department of Justice. Retrieved 2012 - 12 - 30. Jump up ^ Drug Enforcement Administration ( 21 August 2009 ). `` Schedules of Controlled Substances : Placement of 5 - Methoxy - N, N - Dimethyltryptamine Into Schedule I of the Controlled Substances Act ''. Federal Register. 74 ( 161 ) : 42217 -- 42220. Under the authority vested in the Attorney General by section 201 ( a ) of the CSA ( 21 USC 811 ( a ) ), and delegated to the Administrator of DEA by Department of Justice regulations ( 28 CFR 0.100 ), and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104... 74 FR 42217 Jump up ^ `` Final Order : Temporary Placement of Five Synthetic Cannabinoids Into Schedule I ''. Drug Enforcement Administration : Office of Diversion Control. United States Department of Justice. Retrieved 2012 - 12 - 30. Jump up ^ Abood, Richard R. ( 21 November 2012 ). `` The Closed System of Controlled Substance Distribution ''. Pharmacy Practice and the Law. Jones & Bartlett. p. 184. ISBN 978 - 1 - 4496 - 8691 - 8. Retrieved 2012 - 12 - 30. Jump up ^ `` Reid v. Covert, 354 U.S. 1 at pp 17 -- 19 ''. Justia Law. Retrieved 30 October 2014. ^ Jump up to : `` The War on Drugs '' ( PDF ). Cato Handbook for Congress : Policy Recommendations for the 108th Congress. Cato Institute. 2003. pp. 171 -- 178. Retrieved 2012 - 10 - 20. Jump up ^ `` Date Rape '' Drugs Archived 2006 - 05 - 16 at the Wayback Machine. Jump up ^ fuoriluogo.it -- aprile 2003 Archived April 23, 2015, at the Wayback Machine. Jump up ^ Cite error : The named reference rx was invoked but never defined ( see the help page ). Jump up ^ 21 U.S.C. § 812 -- Schedules of controlled substances. Jump up ^ `` 21 U.S. Code Chapter 13 - Drug Abuse Prevention and Control ''. LII / Legal Information Institute. Jump up ^ `` 21 U.S. Code § 802 - Definitions ''. LII / Legal Information Institute. Jump up ^ `` Appendix C : Measurement of Dependence, Abuse, Treatment, and Treatment Need -- 2000 NHSDA -- Substance Dependence, Abuse, and Treatment ''. National Household Survey on Drug Abuse. SAMHSA, Office of Applied Studies. 2000. Archived from the original on 2013 - 02 - 21. Jump up ^ `` InfoFacts -- Cigarettes and Other Tobacco Products ''. Retrieved 30 October 2014. ^ Jump up to : 21 U.S.C. § 812 -- Schedules of controlled substances ^ Jump up to : Marshall, Donnie ( 20 March 2001 ). `` Notice of denial of petition to reschedule marijuana ''. Federal Register. Drug Enforcement Administration. 66 ( 75 ) : 20038 -- 20076. Retrieved 13 June 2013. ^ Jump up to : See United States v. Angelos, 433 F. 3d 738 ( 10th Cir. 2006 ) ( 55 years for three sales of marijuana ). Jump up ^ Gee, Paul ; Gilbert, Mark ; Richardson, Sandra ; Moore, Grant ; Paterson, Sharon ; Graham, Patrick ( 2008 ). `` Toxicity from the Recreational Use of 1 - benzylpiperazine ''. Clinical Toxicology. 46 ( 9 ) : 802 -- 07. doi : 10.1080 / 15563650802307602. PMID 18821145. Jump up ^ Brennan, K. ; Johnstone, A. ; Fitzmaurice, P. ; Lea, R. ; Schenk, S. ( 2007 ). `` Chronic Benzylpiperazine ( BZP ) Exposure Produces Behavioral Sensitization and Cross-sensitization to Methamphetamine ( MA ) ''. Drug and Alcohol Dependence. 88 ( 2 -- 3 ) : 204 -- 13. doi : 10.1016 / j. drugalcdep. 2006.10. 016. PMID 17125936. Jump up ^ Tunnicliff, G. ( 1997 ). `` Sites of action of gamma hydroxybutyrate ( GHB ) -- A neuroactive drug with abuse potential ''. Clinical Toxicology. 35 ( 6 ) : 581 -- 590. doi : 10.3109 / 15563659709001236. Jump up ^ Okun, M.S. ; Boothy, L.A. ; Bartfield, R.B. ; Doering, P.L. ( 2001 ). `` GHB : An important pharmacologic and clinical update ''. Journal of Pharmacy and Pharmacological Science. 4 ( = 2 ) : 167 -- 175. Jump up ^ `` MAPS Legal History of MDMA ''. Retrieved 30 October 2014. ^ Jump up to : `` Manuals -- Practitioner 's Manual -- SECTION V ''. Retrieved 2014 - 01 - 07 ^ Jump up to : `` 21 U.S. Code § 829 - Prescriptions ''. LII / Legal Information Institute. Jump up ^ `` 21 U.S. Code Part D - Offenses and Penalties ''. LII / Legal Information Institute. Jump up ^ `` Issuance of Multiple Prescriptions for Schedule II Controlled Substances ''. U.S. DEA, U.S. DOJ. November 2007. Retrieved 3 September 2014. Jump up ^ Federal Register / Vol. 79, No. 163 / Pgs. 49661 - 49682 / Aug 22, 2014 DEA - Final Rule, Effective October 6, 2014 Text ( 162 KB ) PDF ( 242 KB ) Jump up ^ Exempt Anabolic Steroids ( 21 CFR § 1308.33 and 21 CFR § 1308.34 ) 05 February 2015 Drug Enforcement Administration Office of Diversion Control Drug and Chemical Evaluation Section Jump up ^ Halpern, J.H. ( 2004 ). `` Hallucinogens and dissociative agents naturally growing in the United States ''. Pharmacology & Therapeutics. 102 : 131 -- 138. doi : 10.1016 / j. pharmthera. 2004.03. 003. PMID 15163594. Jump up ^ Schultes, R.E. and Hofmann, A., 1980. The botany and chemistry of hallucinogens, Charles C. Thomas, Springfield, IL. Jump up ^ ( Federal Register Volume 76, Number 238 ( Monday, December 12, 2011 ) ) ( Rules and Regulations ) ( Pages 77330 - 77360 ) Jump up ^ `` Federal Pseudoephedrine Law '' ( PDF ). doh.state.fl.us. Florida Department of Health, Division of Medical Quality Assurance. October 5, 2006. Archived from the original ( PDF ) on July 30, 2012. Retrieved 2012 - 10 - 20. Jump up ^ `` General Information Regarding the Combat Methamphetamine Epidemic Act 2005 ''. Drug Enforcement Administration, Office of Diversion Control. Retrieved October 20, 2012. Jump up ^ `` Drug Scheduling ''. Drug Enforcement Administration, United States Department of Justice. Jump up ^ Nutt, David J. ; King, Leslie A. ; Phillips, Lawrence D. ; Independent Scientific Committee on Drugs ( 6 November 2010 ). `` Drug harms in the UK : A multicriteria decision analysis ''. The Lancet. 376 ( 9752 ) : 1558 -- 1565. doi : 10.1016 / S0140 - 6736 ( 10 ) 61462 - 6. PMID 21036393. Jump up ^ `` DrugFacts : Is Marijuana Medicine ? ''. National Institute on Drug Abuse. National Institutes of Health ; U.S. Department of Health and Human Services. July 2015. Jump up ^ `` State Marijuana Laws in 2018 Map ''. www.governing.com. External links Full text of Controlled Substances Act hide Regulation of therapeutic goods Americas Brazil Canada United States ( drug schedules : I - II - III - IV - V ) Eurasia European Union Germany India Japan Netherlands Norway Portugal Singapore Soviet Union Switzerland Thailand United Kingdom Oceania Australia Retrieved from `` https://en.wikipedia.org/w/index.php?title=Controlled_Substances_Act&oldid=844955530 '' Categories : Controlled Substances Act Drug Enforcement Administration History of drug control 1970 in American politics United States federal criminal legislation 1970 in cannabis Cannabis law in the United States Hidden categories : Pages with reference errors Webarchive template wayback links Pages with broken reference names All articles with unsourced statements Articles with unsourced statements from March 2014 Talk Contents About Wikipedia Español 日本 語 Polski Simple English Edit links This page was last edited on 8 June 2018, at 10 : 05. 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Question: who has the ability to add delete or reschedule a drug as more information becomes available
Answer: Two federal agencies, the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA)