CONTROLLED SUBSTANCE SCHEDULES
The CSA categorizes medications into five schedules based on medical benefits, relative abuse potential, and the likelihood of causing dependence when abused (DEA, 2018b). The U.S. attorney general may add, remove, or change the controlled substance schedule of a given compound. In addition, by the authority of the U.S. attorney general, the DEA may add or transfer substances between schedules by rule (i.e., doing so does not require a change in statute). Other substances deemed to have the potential for abuse may be removed from the plan if they do not meet the requirements for inclusion in any schedule (DEA, 2020b). Before adding, removing, or changing the controlled substance schedule of a drug or other substance, the attorney general must request a medical and scientific evaluation and recommendation from the secretary of the HHS. The FDA, which reports to the secretary of the HHS, usually performs this evaluation. These recommendations are considered binding, and the DEA must follow them. The following factors are considered when deciding how to schedule a pharmaceutical product or other substance (DEA, 2018b): ● Its actual or relative potential for abuse. ● Scientific evidence of its pharmaceutical effect, if known. ● The state of current scientific knowledge regarding the drug or other substance. ● Its history and current pattern of abuse. ● The scope, duration, and significance of abuse. ● What, if any, risk there is to public health. ● Its psychic or physiological dependence liability. ● Whether the substance is an immediate precursor of a substance already on the controlled substance list. The DEA ultimately decides whether to initiate rulemaking proceedings to reschedule a controlled substance. However, there are circumstances in which the DEA is not required to follow the above procedures. First, suppose a substance is an immediate precursor of a substance already on the list. In that case, the attorney general may place the immediate precursor in the same or any other schedule with a higher designation. Additionally, the DEA may, without regard to standard procedures, assign a drug or substance temporary Schedule I status if it has determined there is an imminent hazard to public safety. When issuing an order for temporary Schedule I status, A complete list of the scheduled controlled substances is published annually in the DEA regulations (Title 21 of the Code of Federal Regulations (CFR) , Sections 1308.11 through 1308.15). These lists describe the primary or parent compound and do not include the salts, esters, or salts of isomers that Schedule I controlled substances Substances in this class have no accepted medical use within the U.S., lack appropriate safety levels under medical supervision, and have a high level of abuse (DEA, 2018b). Examples include: ● Heroin. ● Marijuana (cannabis). ● Peyotes. ● Methylene-dimethoxy-methamphetamine (MDMA [ecstasy]). ● Lysergic acid diethylamide (LSD). Schedule II/IIN controlled substances Substances in this class have a high potential for abuse that may lead to severe psychological or physical dependence, and they also have accepted medical use (DEA, 2018b). Examples of Schedule II narcotics include: ● Codeine. ● Hydrocodone (Vicodin, Zohydro ER). ● Hydromorphone (Dilaudid).
the attorney general is only required to consider the history and pattern of abuse; the scope, duration, and significance of abuse; the risk to public safety; actual abuse; a diversion from legitimate channels; and clandestine importation, manufacture, or distribution. The DEA must issue a notice in the Federal Register of the intention to issue the temporary Schedule I status, and the temporary status will become official 30 days after the publication of the notice in the Federal Register . The temporary status remains in effect for two years, with a potential extension of one additional year. Human clinical trials may determine whether the substance produces adverse effects sufficient to provide an imminent hazard to public safety. Once the DEA receives scientific and medical evaluation from the secretary of the HHS, an interim final rule is issued, which becomes effective immediately (DEA, 2018c). Recently, the DEA has invoked the right to assign a substance Schedule I status based on an imminent hazard to public safety for substances identified as controlled substance analogs. A controlled substance analog intended for human consumption is structurally or pharmacologically substantially similar to a Schedule I or Schedule II substance. It is not an FDA-approved medication in the U.S. (DEA, 2018b). Under federal law, any controlled substance analog is considered a Schedule I controlled substance (DEA, 2022a). Common controlled substance analogs include synthetic cannabinoids and synthetic opioids, particularly fentanyl. In addition, there are substances found in illicit substances of abuse such as K2, or “spice” (i.e., synthetic cannabinoids), heroin (i.e., synthetic fentanyl compounds), “bath salts,” and other new psychoactive substances (e.g., synthetic cathinones). Abuse of these synthetic compounds has increased significantly, leading to clinical management challenges for first responders and emergency medicine clinicians. Healthcare Consideration: Healthcare providers must be able to differentiate between the various controlled substance schedules and know the types of drugs in each schedule on a federal and a state level. This allows nurse practitioners to adhere to legal mandates and appropriately control and monitor the distribution of such drugs and their effects on patients.
SCHEDULES OF CONTROLLED SUBSTANCES
may be controlled substances. Therefore, a substance may be regulated as a controlled substance analog even though it is not included in these lists. Final rules are found in the Federal Register before the publication of the next CFR (DEA, 2018c).
The CSA allows medical research on Schedule I substances if the researcher is certified by the FDA and the research protocol is approved. Researchers who meet these criteria must obtain separate registration from the DEA to conduct research with Schedule I substances (DEA, 2020b). Such research is essential to determine if a given substance offers any medical benefit and to identify other safety factors, such as drug interactions and possible adverse effects.
● Opium. ● Oxycodone (Roxicodone, OxyContin, Percocet). ● Fentanyl (Sublimaze, Duragesic). Examples of Schedule IIN non-narcotics include: ● Amobarbital. ● Amphetamine (Dexedrine, Adderall). ● Nabilone (Cesamet). ● Methamphetamine (Desoxyn). ● Methylphenidate (Ritalin). ● Pentobarbital.
● Methadone (Dolophine). ● Meperidine (Demerol). ● Morphine (MSContin, Roxanol).
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