Testosterone by telehealth: what federal prescribing rules mean for online TRT

DEA sorts controlled drugs into five schedules by accepted medical use and potential for abuse or dependence. It describes Schedule III drugs as having “a moderate to low potential for physical and psychological dependence,” and its drug scheduling page lists anabolic steroids and testosterone as examples.

Congress set that status. DEA’s Diversion Control Division says that through the Anabolic Steroid Control Acts of 1990 and 2004, “Congress placed a total of 64 anabolic steroids in schedule III of the Controlled Substances Act.” A 2005 Federal Register notice records that anabolic steroids came under the Act effective February 27, 1991, and DEA’s controlled substance list dated August 27, 2026 shows testosterone in Schedule III. DEA notes that approved uses of these steroids include treating testosterone deficiency.

The status shows up in paperwork. FDA-approved testosterone labels say the product contains “a Schedule III controlled substance,” and DEA says a Schedule III or IV prescription may be refilled up to five times within six months of issue, if the prescriber authorizes it.

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 sets the federal baseline for prescribing controlled substances online. In DEA’s summary, it “generally requires an in-person medical evaluation prior to the issuance of a prescription of controlled substances.”

Put simply, a prescriber may remotely prescribe a controlled substance such as testosterone only after at least one in-person medical evaluation of that patient, unless an exception applies. One exception the law lists is a practitioner holding a DEA special registration for telemedicine; DEA proposed rules for it in January 2025 but had not finalized them as of September 16, 2026. Meanwhile, temporary measures dating from the COVID-19 emergency have set the in-person requirement aside.

Sources: the Federal Register and official DEA and HHS pages.

As of September 16, 2026, the fourth temporary extension is in force: “This rule is effective January 1, 2026 through December 31, 2026.” HHS’s telehealth policy page (updated January 5, 2026) likewise says the flexibilities run through December 31, 2026.

Under the extension, a DEA-registered practitioner may prescribe Schedule II–V controlled substances by telemedicine without a prior in-person evaluation if the rule’s conditions are met, including:

• a legitimate medical purpose, in the usual course of professional practice;
• a communication with the patient over an interactive telecommunications system;
• a DEA registration authorizing that class of controlled substance, or an exemption from registration; and
• compliance with DEA’s other prescription rules (21 CFR part 1306).

HHS added that prescriptions must still be issued “in compliance with federal and state law.”

After December 31, 2026

DEA and HHS said the extension gives them time to finalize permanent rules, including the proposed special registration. The 2026 Unified Agenda, published in the Federal Register on August 14, 2026, lists “Special Registrations for Telemedicine and Limited State Telemedicine Registrations” at the “Final Rule Stage.” As of September 16, 2026, no final rule appears among DEA’s Federal Register documents, and we found no DEA or HHS announcement of what applies from January 1, 2027.

The January 2025 proposal would create three registrations: for clinicians prescribing Schedule III–V drugs, for certain specialists prescribing Schedule II–V drugs, and for covered online telemedicine platforms. Prescriptions would be sent electronically after identity verification and a nationwide prescription drug monitoring program check. The final text is not public.

Third-party report, not confirmed on a government page: Telehealth.org reported on September 9, 2026 that the White House Office of Information and Regulatory Affairs received DEA’s final special registration rule on August 25, 2026, and that the federal agenda anticipates final action in November 2026. “The text undergoing that review is not publicly available,” it added.

An in-person visit can still be part of the plan

The flexibilities authorize prescribing without an in-person evaluation; they do not require it, and clinics set their own policies. Male Excel’s TRT page, for example, says: “Based on DEA and state laws, your testosterone treatment plan may require an in-person medical exam.” Ask any clinic whether a visit could be required, and when, where and at whose cost.

State rules add a second layer

HHS says clinicians must “be licensed or legally permitted to practice in the state where the patient is located.” DEA regulations normally require a separate DEA registration in each state where a practitioner dispenses controlled substances; a March 25, 2020 DEA letter created a pandemic-era exception for practitioners authorized under both states’ laws, and HHS says the current extension covers the full set of emergency-era flexibilities. Ask how the clinic’s prescribers are registered for your state, and confirm it offers testosterone where you will be during visits.

Lab work and monitoring described in FDA labeling

The AndroGel 1.62% prescribing information (revised July 2025) tells prescribers to confirm hypogonadism before starting, with serum testosterone “measured in the morning on at least two separate days” and below the normal range. It also describes checking hematocrit, evaluating for prostate cancer before and during treatment, and monitoring blood pressure periodically.

In February 2025, FDA said blood pressure studies “confirmed an increase in blood pressure with use of all testosterone products, class-wide,” and required a blood pressure warning for products lacking one; the XYOSTED label carries a boxed warning on blood pressure increases. Citing the TRAVERSE trial, FDA also recommended removing boxed-warning language about adverse cardiovascular outcomes.

In June 2026, HHS announced that FDA is requesting further updates: removing the limitation of use for age-related hypogonadism, making therapy contraindicated “only in men with metastatic prostate cancer,” and revising benign prostatic hyperplasia warnings. HHS said the proposed labeling “continues to recommend that healthcare providers assess risk, screen patients before treatment and monitor patients during therapy.” Check a label’s revision date before relying on it.

This is a summary of rules and labels, not medical or legal advice; testing and treatment decisions belong with a licensed clinician who knows your history.

FDA said in February 2025 that testosterone “is approved solely for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.” Approved forms include oral, topical gel, transdermal patch, buccal and injection products, and FDA’s Orange Book lists drug products “approved on the basis of safety and effectiveness.”

Compounded testosterone is different. FDA states: “Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.” FDA adds that people buying compounded drugs through telehealth platforms “may not know the identity of the compounder that produced the drug.” Either way, testosterone is Schedule III.

State boards of pharmacy generally oversee state-licensed 503A pharmacies day to day, and drugs they compound are not subject to current good manufacturing practice (CGMP) requirements. 503B outsourcing facilities register with FDA, are inspected on a risk-based schedule and must meet CGMP. A clinic that names its pharmacy and its 503A or 503B status gives you something to check; see our telehealth terms glossary.

1. What is your plan after December 31, 2026? Ask whether the clinic relies on the temporary DEA flexibilities and what existing patients would need to do if the rules change.
2. Could I need an in-person visit? Ask when, where and who pays.
3. Who is my prescriber? Ask for the name, state licenses and how the prescriber is DEA-registered for your state.
4. Is the testosterone FDA-approved or compounded? Ask for the product and pharmacy names, and whether a compounding pharmacy is 503A or 503B.
5. What testing is required before and during treatment? Ask which lab runs it, whether that lab is CLIA-certified, whether testing is included in the price, and how blood pressure is tracked.
6. How do refills work? Schedule III refill limits apply.
7. How do I report a side effect? Patients can report to FDA’s MedWatch program online or at 1-888-INFO-FDA (1-888-463-6332).
8. What are the cancellation and refund terms? Save a copy before you pay.

These questions mirror how we assess clinical oversight, access and refund terms. See how we review, our men’s clinic reviews and our TRT and ED clinic checklist.