What is a Schedule 3 Medication? Understanding Controlled Substances

October 10, 2025 •

3 min read

First defined by the Controlled Substances Act of 1970, Schedule III drugs are characterized by their accepted medical use and a moderate to low potential for physical dependence. A thorough understanding of what is a schedule 3 medication is crucial for patients and healthcare providers to ensure safe and compliant use.

Quick Summary

Schedule 3 medications are controlled substances with an accepted medical use and moderate to low risk of physical and high psychological dependence. They have a lower abuse potential than Schedule I and II drugs, with specific prescribing and dispensing regulations under the Controlled Substances Act.

Key Points

Definition: Schedule 3 medications have an accepted medical use but a moderate to low potential for physical dependence and a high potential for psychological dependence.
Abuse Potential: The risk of abuse is lower than Schedule I and II drugs, but higher than Schedule IV substances.
Prescribing Rules: Prescriptions can be oral, written, or electronic and may be refilled up to five times within a six-month period.
Examples: Common Schedule 3 substances include Tylenol with codeine, ketamine, and anabolic steroids.
Regulation: The Drug Enforcement Administration (DEA) regulates these substances under the federal Controlled Substances Act.
Addiction Risk: The primary concern with Schedule III abuse is the potential for high psychological dependence, which can be very powerful.

The Controlled Substances Act (CSA) and Drug Schedules

In the United States, the Controlled Substances Act (CSA) is the main federal law regulating certain drugs. Established in 1970, it created five schedules for substances based on their abuse potential, medical use, and dependency risks. The DEA enforces these regulations, classifying substances from Schedule I (highest abuse risk) to Schedule V (lowest). This system helps regulate access, ensure safety, and prevent misuse.

What Defines a Schedule 3 Medication?

Schedule III drugs have an accepted medical use in the U.S., unlike Schedule I substances. Their abuse potential is lower than Schedule I and II drugs. A defining feature of Schedule III medications is their potential for moderate or low physical dependence, but high psychological dependence, if abused.

Criteria for Schedule III Classification

Accepted Medical Use: Must have recognized medical use in the U.S..
Abuse Potential: Less than Schedule I and II drugs.
Dependence Risk: May lead to moderate or low physical dependence or high psychological dependence.

This balance places Schedule III drugs between less and more dangerous controlled substances, requiring careful handling to prevent misuse.

Common Examples of Schedule 3 Drugs

Schedule III includes various medications, such as narcotics, non-narcotics, and anabolic steroids.

Narcotic-Containing Products

Combinations with less than 90mg of codeine per dosage unit, like Tylenol with codeine.
Buprenorphine products for opioid addiction treatment.

Non-Narcotic Substances

Ketamine: An anesthetic for human and animal use.
Benzphetamine: An appetite suppressant.
Phendimetrazine: Also used for appetite suppression.

Anabolic Steroids

Includes anabolic steroids and testosterone, prescribed for conditions like low testosterone.

Regulations for Prescribing and Dispensing Schedule 3 Substances

DEA-licensed healthcare practitioners must follow specific rules for Schedule III medications to prevent diversion and ensure proper care.

Prescription Requirements

Prescription Types: Can be written, electronic, faxed, or verbal.
Refills: Up to five refills allowed within six months of issue date.
Quantity Limits: Some states may limit the dispensed quantity.
Record Keeping: Pharmacists must record all refills and dispensing information.

Comparison of Controlled Substance Schedules

Understanding how Schedule III compares to other schedules clarifies the regulatory framework. Here's a comparison with Schedule II and IV:


Characteristic	Schedule II	Schedule III	Schedule IV
Abuse Potential	High	Moderate to low	Low
Dependence Risk	Severe physical or psychological dependence	Moderate to low physical dependence or high psychological dependence	Limited physical or psychological dependence
Accepted Medical Use	Yes, with severe restrictions	Yes	Yes
Prescription Rules	No refills; written or electronic (oral for emergencies)	Up to 5 refills in 6 months; written, electronic, or oral	Up to 5 refills in 6 months; written, electronic, or oral
Examples	Oxycodone, fentanyl, methamphetamine, cocaine	Ketamine, Tylenol with codeine, anabolic steroids	Xanax, Valium, Ambien, Tramadol

Potential for Misuse and Addiction

Schedule III medications, despite lower abuse potential than Schedule II, still pose risks. High psychological dependence means users can develop a strong mental need for the drug. For example, anabolic steroid abuse can lead to addiction related to physical effects, with withdrawal causing depression. Responsible prescribing, patient education, and monitoring are vital to reduce these risks.

Conclusion

In conclusion, what is a schedule 3 medication is defined by its accepted medical use and moderate to low physical but high psychological dependence potential. These drugs, including codeine combinations, ketamine, and anabolic steroids, have specific prescribing rules, such as refill limits. The CSA's strict categorization balances medical benefits with abuse risks. Patients and professionals must collaborate for safe and intended use.

For a detailed list of controlled substances and scheduling information, consult the DEA's Diversion Control Division.

Frequently Asked Questions

A prescription for a Schedule 3 medication can be refilled up to five times. These refills must occur within six months from the date the prescription was first issued.

The main difference lies in the potential for abuse and dependence. Schedule 2 drugs have a high potential for abuse and severe dependence, while Schedule 3 drugs have a lower potential for abuse and a moderate to low potential for physical dependence.

Yes, a healthcare practitioner can make an oral prescription for a Schedule 3 medication. The pharmacist must promptly reduce the oral prescription to writing.

Schedule 3 medications are used for various medical purposes, including pain management (e.g., Tylenol with codeine), anesthesia (e.g., ketamine), and treating conditions like low testosterone or muscle wasting (e.g., anabolic steroids).

While the potential for physical dependence is considered moderate to low, Schedule 3 substances carry a high risk of psychological dependence. This can create a strong mental craving for the drug in individuals who abuse it.

Yes, anabolic steroids are classified as Schedule 3 controlled substances. They have an accepted medical use but also a potential for abuse, particularly psychological dependence in some individuals.

Penalties for illegal possession of Schedule 3 drugs vary by jurisdiction and offense number. First offenders may face up to one year in prison and a fine, with stiffer penalties for subsequent offenses.

The Drug Enforcement Administration (DEA) is the federal agency responsible for regulating controlled substances and determining their schedule classification under the Controlled Substances Act.