Drug schedules are categories of drugs regulated by the U.S. government. The Drug Enforcement Administration classifies drugs based on several factors. A drug’s schedule influences how the drug can be legally manufactured, imported, distributed, possessed or used in the United States.
Drug schedules were created when President Richard Nixon signed the Controlled Substances Act of 1970. The law immediately classified substances that were already regulated by federal law, and it authorized the Drug Enforcement Administration and the Food and Drug Administration to add, remove or reclassify new substances.
Substances are classified based on their potential for abuse, potential to cause dependence and their accepted medical use. Federal agencies use the following criteria to schedule controlled substances:
Schedule I Controlled Substances
Schedule II Controlled Substances
Schedule III Controlled Substances
Schedule IV Controlled Substances
Schedule V Controlled Substances
The classification criteria have one exception. A drug must be categorized in a schedule that meets the criteria of any international treaty, protocol or convention that the United States has agreed to.
For example, the United States signed the Single Convention on Narcotic Drugs in 1961. The treaty puts strict limitations on the production and distribution of cannabis, and the only way the United States can adhere to the requirements of the treaty is to classify cannabis in Schedule I or Schedule II.
Examples of Drugs
Examples of Drugs
Examples of Drugs
Examples of Drugs
Examples of Drugs
Because there is no medically accepted use for Schedule I substances, the drugs can’t be legally possessed or distributed in the United States without permission from the federal government. The DEA does permit the production, distribution and possession of some Schedule I substances for research purposes.
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Controlled substances that aren’t in Schedule I can be legally manufactured, distributed and possessed in the United States if they’re used for approved research or to treat appropriate medical conditions. Drug companies, pharmaceutical distributors and pharmacies have to follow FDA and DEA regulations to adhere to the law.
Most people don’t interact with drug companies or distributors. They interact with doctors and pharmacists who also have to follow special rules to write and distribute prescriptions. Prescribers have to register with the DEA before they can legally write a prescription. When they write prescriptions, they have to include specific information, including:
Prescribers must sign the prescription in ink on the date that it’s issued, and the details of the prescription must be written in ink or typewritten. Prescribers typically include physicians, dentists, veterinarians, mid-level practitioners and other professionals registered with the DEA.
Several states and insurance providers limit the length of prescriptions for Schedule II controlled substances to 30 days, but there are no federal limits. Prescriptions can be issued verbally in emergency situations only. Otherwise, they must be written.
Prescriptions for Schedule II drugs cannot be refilled. Patients must visit the doctor and receive a new prescription if it’s necessary. However, prescribers can issue multiple prescriptions totaling a 90-day supply under certain circumstances.
Prescribers should issue multiple prescriptions only if there is a necessary medical purpose, there is no additional risk for diversion or prescription drug abuse and there is no state law forbidding multiple prescriptions.
Schedule III, IV and V controlled substances can be prescribed in writing or via verbal communication with a pharmacist. Prescribers can authorize a refill in writing or over the phone. However, the drug can be refilled only up to five times in the six months after the date that the prescription was issued.
The DEA can change or remove a controlled substance from a schedule if it receives evidence that a substance is in an inappropriate schedule. The change must be initiated by the Department of Health and Human Services, the DEA or an interested party, such as:
When a change is requested, the DEA gathers information about the substance from a variety of sources. The agency evaluates the information to determine:
The DEA also must take into account treaties requiring the United States to control a substance in a specific way. The most well-known schedule change request may be for marijuana, which the DEA declined to reschedule in 2016.
However, the DEA has rescheduled drugs based on public requests in the past. In 2014, the DEA rescheduled hydrocodone combination products from Schedule III to Schedule II based on the petitions of public interest groups such as the Steve Rummler Hope Foundation and new evidence of how the drugs were being abused.
Under the Controlled Substances Act, the attorney general has the authority to temporarily place a substance in Schedule I if he or she finds it is necessary to avoid an imminent hazard to public safety and the substance is not already scheduled. The attorney general has since delegated that authority to the administrator of the DEA.
Prior to issuing an order for the temporary scheduling, the administrator must inform the secretary of the Department of Health and Human Services. The attorney general must also place a notice in the Federal Register announcing the intention to temporarily schedule the drug and the reasoning for scheduling the drug. The order can be issued no sooner than 30 days from the date these actions are completed.
The temporary scheduling lasts for up to two years, but the attorney general can extend the temporary scheduling for one additional year. The temporary scheduling is vacated if the DEA determines how to permanently schedule the substance or if it determines that the drug does not meet the criteria for any schedule.
Anabolic steroids are classified as schedule III drugs, but the DEA administrator may temporarily add a substance to the definition of anabolic steroids if he or she determines that the substance meets the criteria to be considered an anabolic steroid or if he or she determines that adding the substance to the definition will prevent abuse or misuse of the substance.
The DEA regularly uses its authority to temporarily schedule new substances that are similar in chemical structure to illicit drugs. Illegal drug manufacturers often tweak the chemical structures of drugs such as synthetic cannabinoids to create new over-the-counter products such as Spice or K2. Temporary scheduling allows law enforcement to keep up with the illicit chemists.
The agency also uses the authority to regulate known substances if new trends of abuse emerge. In August 2016, the DEA issued a notice of intent to temporarily schedule kratom in Schedule I. The plant can cause effects similar to opioids, which are Schedule II drugs, and kratom has been increasingly used as an opioid substitute.
Kratom was involved in 660 poison control calls during a six-year period, leading the DEA to believe it could cause a public health threat. However, after receiving input from the public and scientific community, the DEA temporarily withdrew its notice of intent to schedule kratom in October 2016. The agency announced it would accept public comment until December 2016, and then it would determine how to regulate kratom.
The DEA schedules controlled substances to protect the public from abuse, dependency and other dangerous side effects. Drug scheduling also helps regulate how drug companies, pharmacies and prescribers manufacture and distribute controlled substances. The DEA can add, remove or change the schedules of drugs based on scientific evidence, but drug schedules must adhere to international treaties.