Is Testosterone a Controlled Substance? Laws Explained

Is testosterone a controlled substance? Yes. Testosterone is a Schedule III controlled substance under U.S. federal law, classified that way by the Anabolic Steroid Control Act of 1990 (and broadened in 2004). In practical terms, that means you cannot legally buy testosterone over the counter or import it for personal use without authorization; it requires a valid prescription from a licensed provider, typically after a confirmed diagnosis of low testosterone and with ongoing monitoring. Below, we explain exactly how the law works, why testosterone is scheduled, what the prescription rules are, and what the risks of non-prescribed sources look like.

Why is testosterone classified as a controlled substance?

Testosterone is regulated as an anabolic steroid. The Anabolic Steroids Control Act of 1990 was enacted as Title XIX of the Crime Control Act of 1990 (Pub. L. 101-647, signed November 29, 1990); it amended the Controlled Substances Act to define an anabolic steroid as a drug or hormonal substance chemically and pharmacologically related to testosterone (other than estrogens, progestins, and corticosteroids) that promotes muscle growth, and added that class to Schedule III. The standalone bill originally introduced in the House on April 26, 1990 (H.R.4658 on Congress.gov) was not itself enacted; the scheduling became law through the Crime Control Act. The current codified definition of “anabolic steroid” appears at 21 U.S.C. 802(41).

According to the U.S. Drug Enforcement Administration’s Anabolic Steroids factsheet (October 2025), Congress, by enacting the Anabolic Steroid Control Acts of 1990 and 2004, placed a total of 64 anabolic steroids in Schedule III. Testosterone and several of its esters are named among the main anabolic steroids prescribed in the United States. The expressly listed steroids now sit at 21 CFR 1308.13(f) following a DEA final rule that took effect in 2023.

What does DEA Schedule III actually mean?

The DEA’s official Controlled Substance Schedules page defines Schedule III substances as having a potential for abuse less than substances in Schedules I or II, with abuse that may lead to moderate or low physical dependence or high psychological dependence. The DEA lists Depo-Testosterone (anabolic steroids) as a Schedule III example.

It can help to see where testosterone falls relative to other schedules:

Schedule	Abuse potential (DEA)	Examples
Schedule I	High; no accepted medical use	Heroin, LSD
Schedule II	High; severe dependence risk	Oxycodone, fentanyl
Schedule III	Less than I/II; moderate-low physical or high psychological dependence	Anabolic steroids, including testosterone (Depo-Testosterone)
Schedule IV	Lower than III	Diazepam, tramadol

Classification reflects regulatory control, not a verdict on any individual’s medical need. Many people receive testosterone legally and appropriately when a provider confirms a clinical diagnosis.

Do you need a prescription for testosterone?

Yes. Because testosterone is Schedule III, it can only be dispensed with a valid prescription from a licensed provider. There is no legal over-the-counter testosterone. If you are exploring treatment, see our overview of where to get TRT and how the process works with a telehealth provider.

A controlled-substance prescription also comes with built-in limits. Under 21 CFR 1306.22, no prescription for a Schedule III or IV controlled substance may be filled or refilled more than six months after the date it was issued, and it may not be refilled more than five times. This regulation is the reason you may hear that “testosterone prescriptions are good for about six months” before a new evaluation is needed.

What diagnosis and monitoring does legal testosterone therapy require?

A legitimate prescription typically starts with a diagnosis of hypogonadism. According to the FDA-approved prescribing information for one testosterone product, XYOSTED (via DailyMed), the diagnosis of hypogonadism must be confirmed by measuring serum testosterone in the morning on at least two separate days, with concentrations below the normal range. For more on the clinical picture, see our guide to signs you may need hormone replacement therapy.

Monitoring continues throughout treatment. The same XYOSTED label instructs evaluating hematocrit approximately every 3 months and monitoring blood pressure periodically. Prostate-specific antigen (PSA) testing is also a standard part of guideline-based monitoring in men. If you want to understand the treatment arc itself, our article on how long TRT takes to work walks through typical timelines, which vary by individual.

Step	What it involves	Source
Diagnosis	Symptoms plus low serum testosterone confirmed on two separate morning tests	XYOSTED FDA label
Hematocrit	Evaluated roughly every 3 months	XYOSTED FDA label
Blood pressure	Monitored periodically, especially with hypertension	XYOSTED FDA label
PSA	Standard guideline/label monitoring in men	Endocrine Society guideline

What did the FDA change about testosterone labeling in 2025?

On February 28, 2025, the FDA issued class-wide labeling changes for testosterone products. The action did two things: it removed the Boxed Warning language about increased risk of adverse cardiovascular outcomes, and it required updated or added warnings about increased blood pressure. The FDA based this on its review of the TRAVERSE trial and required post-market ambulatory blood pressure monitoring (ABPM) studies.

On the cardiovascular question, the TRAVERSE trial (NEJM, 2023) enrolled 5,246 hypogonadal men aged 45-80 with preexisting or high cardiovascular risk. Testosterone-replacement therapy was noninferior to placebo for major adverse cardiac events: the primary endpoint occurred in 182 of 2,601 men (7.0%) on testosterone versus 190 of 2,603 (7.3%) on placebo (hazard ratio 0.96, 95% CI 0.78-1.17), over a mean follow-up of 33.0 months. The trial also reported a higher incidence of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group. These findings apply specifically to high-cardiovascular-risk hypogonadal men and should not be generalized to all men.

On blood pressure, label class language notes that testosterone products can raise it. For XYOSTED specifically, ABPM showed an average increase of 3.9/1.5 mm Hg (systolic/diastolic) from baseline after 12 weeks, per its FDA label. That number is specific to that one product and should not be applied across all testosterone formulations.

What are the risks of getting testosterone without a prescription?

Buying testosterone outside the legal supply chain carries both legal and health risks. Anabolic steroids are Schedule III controlled substances, and only a small number of them are FDA-approved for medical use; per the DEA factsheet, illegally sold steroids are mostly smuggled into the United States from abroad, and the internet is the most widely used means of buying and selling them.

On the health side, the FDA warns that body-building and steroid products sold without a prescription are unapproved drugs that have not been reviewed for safety and effectiveness. The agency recommends consumers stop using them, citing risks including serious liver injury, kidney injury, increased risk of heart attack and stroke, and testicular shrinkage and male infertility. Counterfeit or contaminated supply is also a known problem with illicit and online sources.

Some men exploring alternatives consider non-testosterone options. For context on a SERM approach, see enclomiphene vs TRT. Note that enclomiphene is compounded and not FDA-approved, and any prescription decision belongs with a licensed provider.

Frequently asked questions

Is testosterone a controlled substance in the United States?

Yes. Testosterone is a Schedule III controlled substance under the Controlled Substances Act, placed there by the Anabolic Steroid Control Act of 1990. The DEA lists anabolic steroids, including Depo-Testosterone, as Schedule III. It requires a valid prescription and cannot be legally obtained without one.

Why is testosterone a Schedule III drug instead of a higher or lower schedule?

The DEA defines Schedule III as having a potential for abuse less than Schedule I or II substances, with possible moderate or low physical dependence or high psychological dependence. Congress assigned anabolic steroids, including testosterone, to Schedule III through the 1990 and 2004 Anabolic Steroid Control Acts.

How long is a testosterone prescription valid?

Under 21 CFR 1306.22, a Schedule III prescription may not be filled or refilled more than six months after it is issued, and it may not be refilled more than five times. This federal refill rule is why testosterone scripts effectively last about six months before a new evaluation. Specific clinic policies may be stricter.

Can I buy testosterone legally without a prescription?

No. There is no legal over-the-counter testosterone in the U.S. Possessing it without a valid prescription is illegal under federal law, and the FDA warns that non-prescribed steroid products are unapproved drugs that have not been reviewed for safety and effectiveness, with risks including liver and kidney injury, heart attack, stroke, and infertility. Illicit and online sources may also be counterfeit or contaminated.

What testing is required before starting testosterone therapy?

Per the FDA-approved XYOSTED label, the diagnosis of hypogonadism should be confirmed by measuring serum testosterone in the morning on at least two separate days, with results below the normal range. Providers also monitor labs such as hematocrit (about every three months), PSA, and blood pressure during treatment. This is educational information, not a diagnosis.

Did the FDA change testosterone warnings recently?

Yes. On February 28, 2025, the FDA issued class-wide labeling changes that removed the Boxed Warning on cardiovascular risk and added or strengthened blood-pressure warnings for testosterone products. The change followed the TRAVERSE trial and required post-market blood-pressure monitoring studies.