What are class 5 drugs? Understanding Schedule V Controlled Substances

October 10, 2025 •

4 min read

According to the Drug Enforcement Administration (DEA), Schedule V substances have the lowest potential for abuse and dependence among all federally controlled substances. This guide explains what are class 5 drugs, their medical uses, and why they are still subject to federal regulation under the Controlled Substances Act.

Quick Summary

Class 5 drugs, or Schedule V substances, have a low potential for abuse and are used for medical purposes, primarily for antidiarrheal, antitussive, and analgesic effects. Despite their low risk, they are federally regulated and may lead to limited dependence, requiring careful handling and prescription protocols.

Key Points

Lowest Abuse Potential: Class 5 drugs (Schedule V) have the lowest potential for abuse and risk of dependence among federally controlled substances.
Accepted Medical Uses: These drugs are used to treat medical conditions like coughs, diarrhea, and nerve pain.
Contain Small Amounts of Narcotics: They primarily consist of preparations with limited quantities of narcotics, such as codeine, or other controlled ingredients like pregabalin.
Fewer Restrictions: Prescription rules for Schedule V drugs are less stringent than for higher schedules, allowing for refills if authorized by a healthcare provider.
Risk of Dependence Exists: Despite the low risk, limited physical and psychological dependence can still occur with misuse or abrupt discontinuation.
Examples: Common examples include cough suppressants with codeine (e.g., Robitussin AC), certain antidiarrheals (e.g., Lomotil), and nerve pain medications (e.g., Lyrica).

Understanding the Controlled Substances Act

In the United States, the Drug Enforcement Administration (DEA) regulates the manufacturing, distribution, and handling of certain drugs through a five-tiered system known as the drug schedules. This framework, established by the Controlled Substances Act (CSA) of 1970, classifies substances based on their accepted medical use, potential for abuse, and risk of dependence. The schedules are ranked from I to V, with Schedule I representing the highest potential for abuse and no accepted medical use, and Schedule V representing the lowest. Understanding this system is crucial for healthcare professionals and patients alike to ensure compliance with federal law and safe medication practices.

Key characteristics of class 5 drugs

Class 5 drugs, also known as Schedule V controlled substances, possess a distinct set of characteristics that differentiate them from other controlled substances. These substances are typically preparations containing limited quantities of certain narcotic and non-narcotic ingredients. The DEA's criteria for classifying a drug as Schedule V include:

Low Potential for Abuse: The potential for abuse is low relative to Schedule IV drugs, meaning they are less likely to be misused.
Accepted Medical Use: These substances have a currently accepted medical use in the United States, often for analgesic, antitussive, or antidiarrheal purposes.
Limited Dependence Risk: Abuse of these drugs may lead to limited physical dependence or psychological dependence relative to Schedule IV substances.

Common examples of Schedule V drugs

Several familiar medications fall under the Schedule V classification due to their composition. These substances are generally available by prescription, although some state laws may have differing regulations.

Commonly encountered Schedule V medications include:

Cough suppressants: Cough preparations containing small, limited quantities of codeine, such as Robitussin AC, are classified as Schedule V. The amount of codeine must not exceed 200 milligrams per 100 milliliters or 100 grams.
Antidiarrheal medications: Preparations containing diphenoxylate and atropine, such as Lomotil, are examples of Schedule V drugs used to treat diarrhea. The atropine is included to discourage abuse by causing unpleasant side effects at high doses.
Anticonvulsants and analgesics: Certain medications used to treat nerve pain and seizures, like pregabalin (brand name Lyrica), are also classified as Schedule V controlled substances. Other examples include lacosamide and ezogabine.
Antitussive preparations: Motofen, another antidiarrheal medication, also falls under this schedule.

Navigating the regulatory landscape

For patients and healthcare providers, the Schedule V classification dictates specific rules for prescriptions, dispensing, and refills. Compared to substances in higher schedules, Schedule V drugs have fewer restrictions, making them easier for patients to access while still ensuring a level of control to prevent abuse.

Key differences in regulation include:

Prescribing: Prescriptions can be communicated to a pharmacy orally, in writing, electronically, or by fax.
Refills: Refills are permitted if authorized by the prescriber, though state laws may impose additional restrictions. This stands in stark contrast to Schedule II drugs, which have no refills allowed.
Dispensing: While many Schedule V drugs require a prescription, some states allow certain preparations to be dispensed without one, as long as specific regulations are met (e.g., identity verification).

The spectrum of controlled substances: a comparison

To fully appreciate the low-risk profile of Schedule V drugs, it is helpful to compare them to other controlled substance schedules. The DEA's classification system provides a clear hierarchy based on abuse potential and medical utility. For example, Schedule I substances have no accepted medical use and the highest potential for abuse, while Schedule V represents the opposite end of the spectrum.


Feature	Schedule I	Schedule II	Schedule IV	Schedule V
Accepted Medical Use	No	Yes	Yes	Yes
Potential for Abuse	High	High	Low	Low relative to Schedule IV
Risk of Dependence	Severe physical and psychological	Severe physical and psychological	Limited physical and psychological	Limited physical and psychological relative to Schedule IV
Prescription Rules	Not available by prescription	Strict rules; no refills	May have up to 5 refills within 6 months	Can be refilled as authorized; some available OTC in certain states
Examples	Heroin, LSD	Oxycodone, Fentanyl	Xanax, Valium	Robitussin AC, Lyrica

What happens if Schedule V drugs are misused?

Despite their low abuse potential, misuse of Schedule V drugs is still possible and carries risks. While the risk of addiction is lower than with higher-scheduled substances, it is not non-existent. Overuse or abuse of codeine-containing cough syrup, for example, can still lead to dependence and addiction. Patients and healthcare providers must remain vigilant and use these medications as prescribed to minimize risk. Withdrawal symptoms can also occur if the medication is stopped abruptly.

In conclusion, understanding what are class 5 drugs is essential for safe and informed medication use. Though considered low-risk, they are still controlled substances that require careful management. Their low potential for abuse and dependence, combined with accepted medical uses, makes them a crucial part of the pharmaceutical landscape for managing various health conditions. For more detailed information on specific substances and regulations, consult the official DEA website.

Controlled Substance Schedules - DEA.gov

Frequently Asked Questions

The primary difference lies in the potential for abuse and dependence. Schedule V drugs have a lower potential for abuse and dependence relative to Schedule IV drugs, though both are considered low-risk compared to higher schedules.

While most Schedule V drugs require a prescription, some preparations containing limited amounts of controlled substances may be available over-the-counter in certain states, subject to specific regulations and pharmacist approval.

Yes, unlike Schedule II drugs, prescriptions for Schedule V medications can be refilled if authorized by the prescribing practitioner. Refill limits and expiration periods may be governed by state-specific laws.

Yes, while the potential for abuse and dependence is lower than with other controlled substances, it is still possible to develop an addiction. Misuse or overuse can lead to psychological or physical dependence.

Penalties for illegal possession of a Schedule V drug are generally less severe than for higher-scheduled substances but can still result in imprisonment and fines, depending on federal and state laws. Simple possession typically carries a lower penalty than trafficking.

Cough syrups are on the list because codeine is a narcotic with potential for abuse and dependence. Its inclusion in Schedule V is due to the limited quantity used in these preparations, which keeps the abuse potential low.

Pharmacists must still keep records for dispensing Schedule V drugs, but the requirements are less stringent than for Schedule II substances. Prescriptions can be received via phone, fax, or electronically, unlike Schedule II drugs, which often have stricter rules.