Schedule III drugs occupy the middle of the federal controlled substance system, they have recognized medical uses, and their abuse risk sits below Schedules I and II but above Schedules IV and V. That positioning shapes how doctors prescribe them, how pharmacists dispense them, how regulators watch them, and, after a late 2025 policy move in Washington, how the rules could soon change for marijuana.
What Schedule III means
Schedule III status is defined in federal law. To qualify, a drug must have accepted medical use in the United States, abuse potential lower than Schedules I and II, and abuse may lead to moderate or low physical dependence, or high psychological dependence.
“Abuse may lead to moderate or low physical dependence, or high psychological dependence.”
In practice, Schedule III includes medications such as ketamine, buprenorphine, many anabolic steroids including testosterone, FDA approved sodium oxybate for narcolepsy, and combination analgesics that contain codeine in limited amounts. The category is large, so regulators divide it into narcotics and non narcotics, and they spell out quantity limits for codeine or morphine when those appear in combination products.
How prescribing and dispensing work
Rules for Schedule III are lighter than Schedule II, and stricter than most routine prescriptions.
- Prescriptions may be written, faxed, sent electronically, or called in by phone, then promptly reduced to writing by the pharmacist
- Refills are allowed, up to five, within six months of the prescription date, after that a new prescription is required
- A patient may request a transfer of a Schedule III prescription between pharmacies for refill purposes, typically one time, unless the pharmacies share a real time electronic system
- Electronic prescriptions for controlled substances can be transferred once for initial filling, where state law allows, and any authorized refills move with that prescription
Quick comparison of control features
Feature | Schedule II | Schedule III | Schedule IV |
|---|---|---|---|
Refills | Not allowed | Up to 5 within 6 months | Up to 5 within 6 months |
Oral prescriptions | Generally not allowed, narrow emergencies | Allowed, pharmacist documents | Allowed |
Transfers between pharmacies | Initial electronic transfer once, no refills to transfer | One time for refills, more if shared database | One time for refills, more if shared database |
Examples | Oxycodone, fentanyl | Ketamine, buprenorphine, codeine combinations, testosterone | Alprazolam, zolpidem |
What drugs are in Schedule III, and why
Ketamine and esketamine
Ketamine is an established anesthetic, it was placed in Schedule III in 1999 after diversion and misuse increased. Esketamine, a related nasal spray for treatment resistant depression, is also Schedule III, it is dispensed only under a safety program, patients are observed after dosing, and clinics maintain special controls.
Buprenorphine
Buprenorphine, often combined with naloxone, is Schedule III and is a cornerstone of treatment for opioid use disorder. Congress removed the old waiver requirement in 2023, so any clinician with DEA registration that includes Schedule III authority may prescribe it for addiction treatment if state law permits. Policymakers continue to adjust telemedicine rules to balance access with safeguards, which has kept Schedule III front and center in the opioid response.
Codeine combinations
Combination products with codeine can be Schedule III if they stay below specific limits, for example, not more than 90 milligrams per dosage unit, or not more than 1.8 grams per 100 milliliters when combined with other active ingredients in therapeutic amounts. These limits are written into federal regulation, they separate Schedule III cough or pain formulations from stronger opioids in Schedule II.
Anabolic steroids and testosterone
Congress put anabolic steroids into Schedule III in 1990 after years of rising misuse. Legitimate prescriptions treat specific medical conditions, but non medical use remains illegal, and sports bodies treat these substances as doping agents.
Sodium oxybate
FDA approved sodium oxybate for narcolepsy is Schedule III with stringent distribution controls, while illicit GHB itself is Schedule I. This split model shows how the same core chemical can receive tighter or looser controls depending on whether an approved drug product is in play.
The 2025 twist, marijuana and Schedule III
On December 18, 2025, the White House signed an executive order directing the government to move marijuana from Schedule I to Schedule III. The Justice Department had already proposed that change in 2024, which opened a formal rulemaking with public comments and a DEA hearing. The executive order accelerated the push, supporters argued it would modernize federal policy, critics warned it could downplay harms, and both sides agreed that only the DEA’s final rule can make the change legally operative.
What would a final move to Schedule III mean in practical terms
- Research, easier federal access for clinical studies, because Schedule I restrictions would no longer apply
- Taxes, relief from Internal Revenue Code Section 280E, which currently blocks normal business deductions for Schedule I and II operators
- Industry operations, potential improvements in banking and accounting practices, although many financial constraints are driven by other federal laws and risk policies
- Criminal law, no automatic federal legalization, CSA controls and registrations would still apply
Until a final rule is published, marijuana remains controlled as before, and agencies continue to apply existing law.
How Schedule III rules show up at the counter
For patients and clinicians, the controls are visible in daily steps, the prescription can be sent electronically, refills are capped at five in six months, transfers are limited, and pharmacists document each refill in a retrievable record. Many states add their own requirements, such as use of prescription monitoring programs, shorter refill windows, or extra checks for certain drugs. State law can be stricter than federal law, which is why a pharmacist’s advice often differs by location.
Related debates, safeguards, and risks
- Patient safety, several Schedule III drugs carry real risks, ketamine can impair thinking and raise blood pressure, buprenorphine can cause respiratory depression in combination with other sedatives, sodium oxybate requires sleep related safety counseling
- Diversion, regulators watch for forged telehealth visits, pharmacy shopping, and theft from clinics, which is why identity checks, audit trails, and secure storage feature prominently in Schedule III compliance
- Access versus control, addiction specialists want fewer barriers for buprenorphine, anesthesiologists and psychiatrists want careful guardrails for ketamine and esketamine, sleep physicians support narrow distribution for sodium oxybate, each camp points to outcomes data to back its view
International note, the name “Schedule 3” does not always mean the same thing
Outside the United States, a “Schedule 3” label can refer to entirely different systems. In the United Kingdom, Schedule 3 under the Misuse of Drugs Regulations includes buprenorphine, temazepam, and, since 2019, pregabalin and gabapentin, with specific storage and record rules. In Australia, Schedule 3 usually means pharmacist only medicines that do not require a doctor’s prescription. Readers should always check the jurisdiction before assuming what “Schedule 3” covers.
A brief guide to common Schedule III drugs and uses
Drug or category | Typical medical use | Notable controls |
|---|---|---|
Buprenorphine, alone or with naloxone | Opioid use disorder, pain | Prescriber needs DEA Schedule III authority, state rules apply, telemedicine rules evolving |
Ketamine, esketamine | Anesthesia, treatment resistant depression | Clinic administration for esketamine under a safety program, monitoring required |
Codeine combinations that meet Schedule III limits | Pain, cough | Quantity thresholds define placement, refills capped, counseling on sedation |
Anabolic steroids, testosterone | Endocrine disorders, delayed puberty | Non medical use illegal, sports sanctions common |
Sodium oxybate | Narcolepsy, cataplexy, daytime sleepiness | Central pharmacy distribution, patient education, nighttime dosing plan |
The bottom line
Schedule III drugs have real benefits and real risks, they sit in a legal middle ground that permits refills and phone orders, yet keeps layers of oversight. The category includes medications central to today’s health debates, from addiction treatment to sleep medicine. With marijuana’s federal status moving through the final stages of rescheduling, Schedule III is not just a legal label, it is a live policy arena that will shape research, taxes, and patient access in the months ahead.