The Controlled Substances Act (CSA or the act) is the statutory framework through which the federal government regulates the lawful production, possession, and distribution of controlled substances. The CSA places various plants, drugs, and chemicals (such as narcotics, stimulants, depressants, hallucinogens, and anabolic steroids) into one of five schedules based on the substance's medical use, potential for abuse, and safety or dependence liability. Further, the act requires persons who handle controlled substances or listed chemicals (such as drug manufacturers, wholesale distributors, doctors, hospitals, pharmacies, and scientific researchers) to register with the Drug Enforcement Administration (DEA) in the U.S. Department of Justice, which administers and enforces the CSA. Controlled Substances Analogues

Controlled substance analogues are substances that are not controlled but are structurally or pharmacologically similar to substances found in Schedule I or II and have no accepted medical use. All registrants are required by the CSA to maintain complete and accurate inventories and records of all regulated transactions involving controlled substances and listed chemicals, as well as provide adequate security controls to prevent their diversion. Registration

The CSA defines who must register with the DEA in order to handle controlled substances. Certain DEA regulations implementing the CSA also apply to listed chemicals. Because controlled substances classified as Schedule I drugs are deemed to have no accepted medical purpose in the United States, they may only be used for research, and they may not be dispensed to patients. Under the CSA, only licensed medical practitioners are authorized to prescribe controlled substances listed in Schedules II-V to patients. Only with respect to this provision of the Controlled Substances Act, a "valid prescription" means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least one medical evaluation of the patient in the physical presence of the practitioner. By regulation, the Administrator must consider the following factors in making his quota determinations: (i) the total disposal of the controlled substance during the current and two preceding years; (ii) trends in the national rate of new disposal of the controlled substance; (iii) total inventories (actual or estimated) of "the class and all substances manufactured from the class [of controlled substances listed in Schedule I or II];" (iv) projected demand for a particular controlled substance; and (v) other relevant factors affecting the use of controlled substances including, changes in the currently accepted medical use of a controlled substance, the economic and physical availability of the raw materials necessary to produce a controlled substance, and recent unforeseen emergencies (i.e., natural disasters). Penalties

While the criminal provisions of the CSA focus mainly on the illicit possession, manufacture, and distribution of controlled substances, there are a few noteworthy penalty provisions applicable to persons registered with the DEA. The CSA sets forth certain offenses involving listed chemicals, DEA registration, and other prohibited acts related to registrants who manufacture, distribute and dispense controlled substances.
This report highlights certain non-criminal regulatory requirements of the Controlled Substances Act (CSA). The CSA and its implementing regulations establish a framework through which the federal government regulates the use of controlled substances for legitimate medical, scientific, research, and industrial purposes, and prevents these substances from being diverted for illegal purposes. The CSA assigns various plants, drugs, and chemicals (such as narcotics, stimulants, depressants, hallucinogens, and anabolic steroids) to one of five schedules based on the substance's medical use, potential for abuse, and safety or dependence liability. Schedule I contains substances that have no currently accepted medical use and cannot safely be made available to the public under a prescription, while Schedules II, III, IV, and V include substances that have recognized medical uses and may be manufactured, distributed, and used in accordance with the CSA. The order of the schedules reflects substances that are progressively less dangerous and addictive. To restrict access to chemicals used in the illicit manufacture of certain controlled substances, the CSA also regulates 40 "listed chemicals." Furthermore, the CSA regulates controlled substance "analogues," which are substances that are not controlled but are structurally or pharmacologically similar to substances found in Schedule I or II and have no accepted medical use.
Unless specifically exempted by the CSA, any person who handles controlled substances or listed chemicals (such as drug manufacturers, wholesale distributors, doctors, hospitals, pharmacies, and scientific researchers) must register with the Drug Enforcement Administration (DEA) in the U.S. Department of Justice, which administers and enforces the CSA. Registrants must keep accurate and complete records of all transactions involving controlled substances, maintain detailed inventories of the substances in their possession, and periodically file reports with the DEA, as well as ensure that controlled substances are securely stored and safeguarded in accordance with DEA regulations.
Between 10%-11% of all drug prescriptions written in the United States are for pharmaceutical controlled substances. Only licensed medical practitioners (who are registered with the DEA) are authorized to prescribe controlled substances listed in Schedules II-V to patients; such prescriptions may only be issued by a practitioner who is "acting in the usual course of his professional practice," and for a "legitimate medical purpose." The CSA authorizes the DEA Administrator to suspend or revoke a physician's prescription privileges upon a finding that he has "committed such acts as would render his registration ... inconsistent with the public interest."
While the CSA provides criminal sanctions for illicit possession, manufacture, or distribution of controlled substances, the statute also contains a few noteworthy penalty provisions that are specifically applicable to persons who are authorized by the DEA to handle controlled substances lawfully. The CSA sets forth certain offenses involving listed chemicals and DEA registration and other prohibited acts relating to registrants who manufacture, distribute, and dispense controlled substances.