● Whether the substance is an immediate precursor of a substance already on the controlled substance list. (DEA, 2018b) The DEA ultimately decides whether to initiate rulemaking proceedings to reschedule a controlled substance. However, there are circumstances where the DEA is not required to follow these 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 an imminent hazard to public safety. When issuing an order for provisional Schedule I status, 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; the temporary status will become official 30 days after the publication of the notice in the Federal Register . The temporary status is in effect for 2 years, with a potential extension of 1 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 Schedules of controlled substances 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 may be controlled substances. Therefore, a substance may be regulated as a controlled substance analog even though it is not included on these lists. Final rules are found in the Federal Register before the publication of the next CFR (DEA, 2018c). Schedule I Controlled Substances Substances in this class have no accepted medical use within the United States, 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). 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. 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: ● Codeine. ● Hydrocodone (Vicodin, Zohydro ER).
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 United States (DEA, 2018b). Under federal law, any controlled substance analog is considered a Schedule I controlled substance (DEA, 2022a). Commonly controlled substance analogs include synthetic cannabinoids and synthetic opioids, particularly fentanyl. In addition, substances found in illicit substances of abuse, such as K2 or “spice” (i.e., synthetic cannabinoids), heroin (i.e., synthetic fentanyl compounds), “bath salts,” or 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: Prescribers must be able to differentiate between the various controlled substance schedules and know the types of drugs in each schedule on a federal and 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. ● Hydromorphone (Dilaudid). ● Methadone (Dolophine). ● Meperidine (Demerol). ● Morphine (MSContin, Roxanol). ● Opium. ● Oxycodone (Roxicodone, OxyContin, Percocet). ● Fentanyl (Sublimaze, Duragesic). Examples of Schedule IIN non-narcotics: ● Amobarbital. ● Amphetamine (Dexedrine, Adderall). ● Nabilone (Cesamet). ● Methamphetamine (Desoxyn). ● Methylphenidate (Ritalin). ● Pentobarbital. Schedule III/IIIN Controlled Substances Substances in this schedule have less of a potential for abuse than substances in Schedules I and II, and abuse may lead to low to moderate physical dependence and high psychological dependence (DEA, 2018b). Examples of Schedule III narcotics: ● Products containing no more than 90 mg of codeine (Tylenol with Codeine). ● Buprenorphine (Suboxone). Examples of Schedule IIIN non-narcotics: ● Benzphetamine (Didrex). ● Butalbital (Fiorinal). ● Dronabinol (Marinol). ● Ketamine. ● Anabolic steroids. ● Testosterone (Androderm). Schedule IV Controlled Substances Substances in this schedule have a low potential for abuse relative to substances in Schedule III (DEA, 2018b). Examples of Schedule IV controlled substances:
● Alprazolam (Xanax). ● Carisoprodol (Soma).
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