From the Guidelines
A scheduled controlled substance is a medication regulated by the government due to its potential for abuse, addiction, or harm, categorized into five schedules (I-V) based on their medical use and abuse potential. In the United States, these medications are strictly controlled, affecting prescribing practices, refill limitations, and legal penalties for misuse. The scheduling of a medication is determined by its potential for abuse, with Schedule I drugs having no accepted medical use and high abuse potential, and Schedule V drugs having lower abuse potential 1.
Some common scheduled medications include:
- Opioid painkillers (oxycodone, hydrocodone)
- Stimulants (Adderall, Ritalin)
- Benzodiazepines (Xanax, Valium)
- Sleep medications (Ambien)
These classifications determine how strictly the medications are controlled, and physicians must follow special prescribing requirements for these medications, including DEA registration, and patients may need to show identification when picking up prescriptions 1. The regulations exist because these substances affect brain chemistry in ways that can lead to dependence, tolerance, and addiction when misused. For example, modafinil, a medication used to treat narcolepsy, is a Schedule IV federally controlled substance due to its potential for abuse or dependency 1. Similarly, dextroamphetamine, another medication used to treat narcolepsy, is a Schedule II federally controlled substance with a high potential for abuse and prolonged administration may lead to dependence 1.
The scheduling of a medication is crucial in determining its potential for abuse and the necessary precautions to be taken when prescribing and dispensing it. Physicians and patients must be aware of the potential risks and benefits associated with scheduled controlled substances to ensure their safe and effective use.
From the FDA Drug Label
Oxycodone hydrochloride tablets contain oxycodone, a Schedule II controlled substance. Oxycodone hydrochloride tablets can be abused and is subject to misuse, addiction, and criminal diversion
Being a scheduled controlled substance means that a medication, such as oxycodone, has a high potential for abuse and addiction. In the case of oxycodone, it is classified as a Schedule II controlled substance, which indicates that it has a high potential for abuse, but also has accepted medical use in treatment in the United States [ 2 ]. This classification is associated with strict regulations and monitoring to prevent misuse, addiction, and diversion. Key points to consider include:
- Abuse and addiction risks: Oxycodone can be abused and is subject to misuse, addiction, and criminal diversion.
- Schedule II classification: Oxycodone is classified as a Schedule II controlled substance, indicating high potential for abuse, but also accepted medical use.
- Regulations and monitoring: Strict regulations and monitoring are in place to prevent misuse, addiction, and diversion of oxycodone [ 2 ].
From the Research
Definition of Scheduled Controlled Substance
A scheduled controlled substance refers to a medication or drug that has been classified and regulated by a government agency due to its potential for abuse, dependence, or harm.
Classification of Controlled Substances
- The classification of controlled substances is typically based on their potential for abuse, medical use, and potential for dependence 3, 4.
- Controlled substances are often categorized into different schedules, with Schedule I being the most restrictive and Schedule V being the least restrictive.
- Examples of scheduled controlled substances include opioids such as oxycodone, fentanyl, and morphine, which are commonly used to treat pain but also have a high potential for abuse and dependence 3, 4, 5.
Regulation of Controlled Substances
- The regulation of controlled substances is intended to prevent abuse, diversion, and harm while still allowing for legitimate medical use.
- Healthcare providers must follow strict guidelines and regulations when prescribing, dispensing, and monitoring controlled substances 6, 7.
- Patients who are prescribed controlled substances must also be aware of the potential risks and follow their healthcare provider's instructions carefully to minimize the risk of abuse, dependence, or harm.
Examples of Scheduled Controlled Substances
- Opioids such as oxycodone, fentanyl, and morphine are examples of scheduled controlled substances that are commonly used to treat pain but also have a high potential for abuse and dependence 3, 4, 5.
- Other examples of scheduled controlled substances include stimulants such as methamphetamine and cocaine, which are highly addictive and have a high potential for abuse 5.