A policy decision rooted in a different era
This report examines the regulatory history, scheduling context, and clinical implications of testosterone policy in the United States. It provides historical background and evidence-based analysis to support informed discussion among clinicians, policymakers, and regulators.
Testosterone has been classified as a Schedule III controlled substance in the United States since 1990. That decision was driven by concerns about anabolic steroid abuse in professional sports, not by routine medical use or patient care.
Schedule III classification places testosterone alongside substances considered to have moderate abuse potential. This designation imposes limits on prescribing, refills, pharmacy dispensing, and telehealth access; even when testosterone is used under medical supervision.
At the time, this framework reflected the cultural and scientific understanding of the era. Today, many experts argue it no longer reflects how testosterone is actually used in healthcare.
Testosterone’s controlled status affects care in several concrete ways:
Some pharmacies restrict mailing or dispensing testosterone
Prescriptions are limited to short refill windows
Providers must hold DEA licenses to prescribe
Telehealth platforms face higher compliance barriers
Patients are tracked through prescription monitoring systems
These requirements can discourage routine screening, delay care, or limit provider participation; even when patients have legitimate medical needs.
Regulation influences who is evaluated, how care is delivered, and which patients face barriers to access.
In late 2025, an FDA expert panel of clinicians and public health officials publicly stated that testosterone has been underutilized due to outdated fears. Panelists compared current testosterone regulation to past overcorrections in women’s hormone therapy, where exaggerated risk narratives delayed care for decades.
FDA leadership has since signaled openness to re-examining testosterone’s classification and labeling. A public request for information was opened to gather data, clinical experience, and patient perspectives; an early step in potential policy change.
This process mirrors recent FDA action on menopausal estrogen, where public engagement and updated evidence led to the removal of long-standing boxed warnings.
Health policy does not change through research alone. Regulatory agencies rely on:
Recent hormone policy updates demonstrate that informed, organized participation can influence outcomes.
When outdated frameworks are challenged with data and lived experience, regulators take notice.
Advocacy does not mean promoting a treatment.
It means ensuring policy reflects current science and real needs.
Evidence-aligned hormone policy does not imply unrestricted access or one-size-fits-all care. It means:
Regulation proportional to actual risk
Clear clinical standards grounded in data
Research that includes women and diverse populations
Education that replaces stigma with clarity
These principles support safer, more consistent care, and reduce the harms created by misinformation and avoidance.
We do not lobby for specific products.
We do not provide medical advice.
Our work centers on education, transparency, and public engagement.
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