CONTROLLED SUBSTANCE ACT (CSA)
The Comprehensive Drug Abuse Prevention and Control Act of 1970, or the Controlled Substance Act (CSA), regulates phar- maceutical and illicit controlled substances in the United States (DEA, 2010b). The CSA requires registration, outlines specific rules about dispensing pharmaceutical controlled substances, and determines the legality of these substances (DEA, 2018a). The U.S. Drug Enforcement Agency (DEA) was formed in 1973 to enforce the CSA. For pharmaceutical controlled substances, the DEA is responsible for preventing the diversion and abuse of controlled drug substances. The agency also ensures that an adequate and uninterrupted supply of pharmaceutical controlled
substances is available to meet legitimate medical, scientific, and research needs. Along with state and other federal agencies, the DEA regulates the registration of manufacturers, distributors, and dispensers of controlled pharmaceutical substances and the im- port and export of these substances. The DEA prosecutes anyone who violates this law (DEA, 2020a). Evidence-Based Practice: The U.S. federal agencies involved in scheduling controlled substances include the Drug Enforce- ment Agency (DEA), the Food and Drug Administration (FDA), and the Department of Health and Human Services (HHS).
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. at- torney general may add, remove, or change the controlled sub- stance schedule of a given compound. In addition, by the au- thority of the U.S. attorney general, the DEA may add or transfer substances between programs by rule (i.e., it does not require a change in statute). Other substances deemed to have the poten- tial 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 substance, the attorney general must re- quest 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 rec- ommendations are considered binding, and the DEA must follow them. The following factors are considered when deciding how to schedule a pharmaceutical product or substance: ● 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 sub- stance already on the controlled substance list. (DEA, 2018b) The DEA ultimately decides whether to initiate rulemaking pro- ceedings 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 gen- eral may place the immediate precursor in the same or any other schedule with a higher designation. Additionally, the DEA may, without regard to standard proce- dures, assign a drug or substance temporary Schedule I status if it has determined an imminent hazard to public safety. When Schedules of controlled substances A complete list of the scheduled controlled substances is pub- lished 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 con- trolled substance analog even though it is not included on these lists. Final rules are found in the Federal Register before the pub-
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 sec - retary 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 safe- ty for substances identified as controlled substance analogs. A controlled substance analog intended for human consumption is structurally or pharmacologically substantially similar to a Sched- ule I or Schedule II substance. It is not an FDA-approved medica- tion 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, particular- ly 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 emer - gency 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. 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 sepa- rate registration from the DEA to conduct research with Schedule I substances (DEA, 2020b). Such research is essential to deter- mine if a given substance offers any medical benefit and to iden - tify other safety factors, such as drug interactions and possible adverse effects.
lication 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 super- vision, and have a high level of abuse (DEA, 2018b).
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Book Code: RPUS3024
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