What is a Schedule 111 Controlled Substance?

October 9, 2025 •

4 min read

The Controlled Substances Act (CSA) classifies drugs into five distinct schedules based on their potential for abuse, accepted medical use, and dependency risk. This system helps regulate manufacturing, distribution, and handling, with a Schedule 111 controlled substance representing an intermediate category with moderate potential for dependence.

Quick Summary

The Drug Enforcement Administration classifies a Schedule III controlled substance as having an accepted medical use but presenting a moderate to low potential for physical dependence and a high potential for psychological dependence. Examples include certain opioid-containing compounds, ketamine, and anabolic steroids, which are subject to specific federal and state regulations regarding their prescribing and dispensing.

Key Points

Definition: A Schedule III controlled substance has an accepted medical use but a moderate to low potential for physical dependence and a high potential for psychological dependence.
Regulation: The Drug Enforcement Administration (DEA) and state laws regulate the manufacturing, prescribing, and dispensing of Schedule III substances.
Examples: Common examples include ketamine, anabolic steroids, testosterone, and specific combination products containing limited amounts of codeine.
Prescription Rules: Prescriptions for Schedule III drugs are valid for six months and are limited to five refills within that period.
Penalties: Unauthorized possession, distribution, or trafficking of Schedule III substances carries significant federal and state legal penalties, though typically less severe than Schedule I or II offenses.
Purpose: The scheduling system ensures that medications with abuse potential are used safely while preventing their diversion and illicit use.

Defining Controlled Substances and the Scheduling System

To understand what is a Schedule 111 controlled substance, it's essential to first grasp the overarching framework of the Controlled Substances Act (CSA). The CSA, enacted in 1970, established a comprehensive system for classifying drugs and other substances based on their medical utility and potential for abuse and dependence. This classification system divides substances into five schedules, from Schedule I (the most restrictive) to Schedule V (the least restrictive). The classification directly impacts the legal controls on a substance's manufacturing, distribution, and prescribing, with enforcement primarily led by the Drug Enforcement Administration (DEA).

The Characteristics of a Schedule III Controlled Substance

Under federal law, a Schedule III controlled substance is defined by three main criteria:

Potential for Abuse: It has a potential for abuse that is less than substances in Schedules I and II. This means while abuse is a concern, it is considered less severe than with drugs like heroin or fentanyl.
Accepted Medical Use: Unlike Schedule I drugs, a Schedule III substance has a currently accepted medical use in treatment in the United States.
Dependence Potential: Abuse of the substance may lead to moderate or low physical dependence, but it can result in high psychological dependence. This psychological component is a key differentiating factor from Schedule IV substances, which have a lower potential for both types of dependence.

Examples of Schedule III Drugs

Many medications that are commonly prescribed have been classified under Schedule III due to their risk profile. Some prominent examples include:

Ketamine: A dissociative anesthetic used in both human and veterinary medicine, it has gained notoriety for its potential for misuse.
Anabolic Steroids and Testosterone: Prescribed to treat conditions like delayed puberty and muscle wasting diseases, these substances are often misused to enhance athletic performance and body image, leading to a high psychological dependence.
Buprenorphine: Used to treat opioid addiction, this opioid-based medication is an example of a controlled substance used to manage dependency on more potent substances.
Codeine-Containing Products: Specific preparations containing a limited amount of codeine, such as acetaminophen with codeine (e.g., Tylenol with codeine #3), fall under this category. Higher concentration codeine products are classified in a higher schedule.
Products Containing Dihydrocodeinone: Combination products with limited quantities of dihydrocodeinone are also classified here.

Prescription and Dispensing Regulations

Regulation for Schedule III substances is stricter than for non-controlled or lower-schedule medications but more lenient than for Schedule II drugs. Prescriptions for Schedule III substances are subject to specific rules enforced by the DEA and state-level laws.

Here is a list of key prescription regulations:

Validity: A prescription for a Schedule III substance is valid for up to six months from the date of issue.
Refills: It may be refilled up to five times within that six-month period.
Communication: Prescriptions can be issued in writing, electronically, by fax, or orally (over the phone), and must be promptly recorded by the pharmacist. This differs from Schedule II drugs, which generally cannot be refilled or issued via oral communication.
Labeling: Pharmacists must affix a label with specific information, including the pharmacy name and address, prescription number, patient's name, prescriber's name, and instructions for use.

Comparison of Controlled Substance Schedules

The table below outlines the primary differences between Schedule III and other controlled substance schedules, highlighting the criteria used for classification under the CSA.


Feature	Schedule I	Schedule II	Schedule III	Schedule IV	Schedule V
Abuse Potential	High	High	Moderate to Low	Low	Lower than IV
Medical Use	None accepted	Accepted, but with severe restrictions	Accepted	Accepted	Accepted
Dependence Risk	Severe physical and psychological	Severe physical and psychological	Low to Moderate physical, High psychological	Limited physical or psychological	Limited physical or psychological
Prescription Rules	Not available via prescription (research only)	No refills, must be written or e-prescribed	Valid for 6 months, 5 refill maximum	Valid for 6 months, 5 refill maximum	Varies (e.g., often sold over-the-counter with restrictions)
Examples	Heroin, LSD, MDMA	Oxycodone, Methamphetamine, Fentanyl	Ketamine, Anabolic Steroids, Buprenorphine	Xanax, Valium, Ambien	Cough syrup with low codeine content

Legal Consequences of Misuse

Federal law imposes significant penalties for the unauthorized manufacture, distribution, or possession of Schedule III controlled substances, though typically less severe than for Schedule I or II drugs. For example, trafficking in Schedule III substances can result in imprisonment and substantial fines, with penalties increasing for subsequent offenses. State laws can vary and may impose different sentencing guidelines and penalties.

It is crucial for individuals to be aware that even a valid prescription does not exempt them from legal consequences if they misuse or improperly distribute the medication. The DEA and other regulatory bodies require strict adherence to prescribing and dispensing protocols to prevent diversion and abuse.

Conclusion

A Schedule III controlled substance occupies a middle ground within the federal drug scheduling system, balancing a recognized medical purpose with a moderate to low risk of physical dependency and a high risk of psychological dependence. Medications like ketamine, anabolic steroids, and certain opioid combinations fall into this category, requiring specific prescription regulations to ensure their safe and controlled use. Understanding this classification is vital for healthcare professionals, pharmacists, and the public to ensure compliance with federal law and mitigate the risks of substance abuse. The legal framework of the CSA aims to ensure that while valuable medications are accessible for treatment, they are not improperly diverted or misused.

For more detailed information on specific substances, consult the official listings provided by the Drug Enforcement Administration: DEA Drug Schedules.

Frequently Asked Questions

The main difference is the potential for abuse and dependence. Schedule II drugs have a high potential for abuse and severe physical or psychological dependence. Schedule III drugs have a lower abuse potential than Schedule II, with a moderate to low potential for physical dependence but a high potential for psychological dependence.

Yes, a prescription for a Schedule III controlled substance may be refilled up to five times within six months of the date it was issued.

Yes, anabolic steroids and testosterone are classified as Schedule III controlled substances. They have accepted medical uses but also carry a risk of high psychological dependence when abused.

Yes, ketamine, an anesthetic with a known potential for abuse, is a Schedule III controlled substance.

Schedule III prescriptions can be communicated to a pharmacy orally by a practitioner, or submitted in writing, via fax, or as an electronic prescription.

Federal penalties for illegal possession can include fines and prison time, with the severity depending on the specific offense and prior history. State laws also impose varying penalties.

No. Only products containing a specific, limited quantity of codeine (e.g., not more than 90 milligrams per dosage unit) are classified as Schedule III. Higher concentration codeine products are often classified in Schedule II.