Testosterone’s Schedule III Status The Evolving U.S. Regulatory Landscape

madman

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All those so called gurus polluting social media and the half-wits pushing that more T is better mentality bull*** stinkin up those so called men's health/HRT forums!


* At the same time, the non-medical environment has evolved, with online marketplaces, informal supply chains, and social-media– driven “optimization” narratives accelerating diffusion and complicating traditional diversion-control approaches7–9






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* The evidence summarized in this review consistently differentiates supervised therapeutic use from non-medical use patterns. The most serious harms are more closely associated with high-dose, prolonged, and poorly monitored use, often alongside stacking and other co-use practices. This distinction does not eliminate risk in medical settings, but it clarifies where risk concentrates and what kinds of controls are most directly relevant. Several uncertainties remain central to scheduling judgments. Diversion pathways are not quantified with precision across settings, which complicates attribution of harm to prescription versus extra-medical sources. Practical restrictiveness also varies because federal scheduling interacts with state rules, PDMP practices, pharmacy policies, and payer controls. These layers can shape access and oversight as much as the schedule itself.




1. Introduction

Federal drug policy classifies testosterone as a Schedule III controlled substance and, specifically, as an “anabolic steroid” under the Controlled Substances Act (CSA) implementing regulations. Testosterone occupies an unusual place in United States drug policy because it is (1) an essential medicine with long-standing therapeutic use, (2) a drug with a well documented history of non-medical use in sports, and (3) a federally controlled substance listed in Schedule III. Because scheduling status dictates how medications are prescribed, dispensed, and monitored, testosterone’s classification not only acts as a legal label but also directly impacts clinical access, public health surveillance, and diversion-control strategy1

Whether testosterone should remain in Schedule III has returned as a central regulatory question. We must ask whether the current controls are still proportionate to the actual risks we see today, and whether they support the CSA’s own statutory criteria2

This debate is occurring in a medical setting that differs significantly from the one that existed when the Anabolic Steroids Control Act of 1990 was first signed into law. Congress placed anabolic steroids (including testosterone) in Schedule III through the Anabolic Steroids Control Act of 1990 and later refined the statutory framework and definitions through the Anabolic Steroid Control Act of 20043

Several recent developments have increased the salience of the scheduling question. In clinical practice, testosterone prescribing has expanded and diversified alongside changes in diagnostic norms, direct-to- consumer marketing, and evolving professional discussion about benefits and risks across patient subgroups. In parallel, demand for testosterone in gender-affirming care has increased the visibility of access barriers and continuity-of-care risks that can arise when a therapy is regulated as a controlled substance4,5

These access arguments have been articulated directly in policy communications, including a 2022 letter led by U.S. Senator Edward J. Markey urging the federal government to consider rescheduling testosterone from Schedule III to Schedule V or descheduling it entirely, framed in part around access to medically necessary gender-affirming hormone therapy6

At the same time, the non-medical environment has evolved, with online marketplaces, informal supply chains, and social-media– driven “optimization” narratives accelerating diffusion and complicating traditional diversion-control approaches7–9

The current regulatory stance often treats testosterone as if it were a high-abuse, recreationally reinforcing intoxicant. However, the data tells a much more nuanced story. When we look at non-medical use, we do not see the typical intoxication-seeking pattern associated with many controlled substances. Instead, use is largely goal-directed and driven by specific objectives associated with physical performance or aesthetic appearance in relatively small subcultures. The recent national survey of 2024 Monitoring the Future results show that lifetime steroid use among adolescents remains at or below 1.4%, continuing a steady decline from its peak twenty years ago10

Testosterone does not fit the profile of a drug driving a public health crisis of intoxication or rapid-onset reinforcement10

The policy question is also sharpened by the medical consequences





4. Regulatory Framework

4.1 The Controlled Substances Act (CSA) scheduling structure
4.2 Authorities and roles in scheduling, rescheduling, and descheduling
4.3 Why testosterone is treated as an anabolic steroid under federal law
4.4 What Schedule III means operationally for prescribing and dispensing
4.5 Pathways for change in testosterone’s federal scheduling status




5. Substance Overview Relevant to Abuse and Diversion

5.1 Therapeutic and Non-Medical Contexts
5.2 Reinforcement and Temporal Characteristics
5.3 Risk Characteristics and Management Considerations




6. Historical Record: How Testosterone Came to be Controlled

6.1 Pre-control scientific and therapeutic history
6.2 Emergence of athletic and non-medical misuse
6.3 Legislative response and Schedule III placement
6.4 Post-scheduling expansions and market adaptation
6.5 Safety and regulatory milestones shaping today’s context
6.6 Evolution of testosterone formulations and delivery systems




7. Implementation Aftermath: What Schedule III Changed in Practice

7.1 Prescribing and Dispensing Friction and Compliance Burden


7.1.1 Regulatory compliance burden in clinical practice
7.1.2 Diagnostic ambiguity under enforcement pressure
7.1.3 Pharmacy and payer amplification
7.1.4 Telehealth and access contraction
7.1.5 Limited diversion impact


7.2 Diversion-Control Tools and Their Real-World Effect

7.2.1 Assumptions underlying diversion control
7.2.2 Market adaptation and displacement
7.2.3 Sport-based enforcement as a diversion analog
7.2.4 Enforcement outcomes and public-health tradeoffs


7.3 Unintended Consequences: Illicit Sourcing Displacement and Continuity-of-Care Issues

7.3.1 Displacement toward illicit and unregulated markets
7.3.2 Risk redistribution rather than risk reduction
7.3.3 Continuity-of-care disruptions in legitimate populations
7.3.4 Feedback loop between disruption and illicit use


7.4 Where State and Payer Rules Amplify or Differ

7.4.1 State-level amplification and variability
7.4.2 Payer rules as de facto regulators
7.4.3 Interaction effects and cumulative burden




8. Current landscape: What is Being Proposed and Why

8.1 Stakeholder Map


8.2 Arguments for Maintaining Schedule III


8.2.1 Risk of Abuse and Dependence
8.2.2 Diversion and Illegal Trafficking
8.2.3 Public Health and Deterrence


8.3 Arguments for Rescheduling or Descheduling

8.3.1 Access Barriers and Healthcare Burden
8.3.2 Stigma and Appropriateness of Control
8.3.3 Recent Evidence and Risk-Benefit Reassessment


8.4 Signals to Watch

8.4.1 Formal Petitions or Legislative Proposals
8.4.2 Agency Dockets and Rulemaking
8.4.3 Enforcement and Public Safety Trends:




9. CSA 8-Factor Analysis

9.1 Actual or Relative Potential for Abuse


9.1.1 Patterns and Motivations of Non-Medical Use
9.1.2 Reinforcing Effects and Psychoactive Properties
9.1.3 Dependence and Continuation of Use
9.1.4 Population-Level Patterns and Illicit Market Dynamics


9.2 Scientific Evidence of Pharmacological Effects

9.2.1 Mechanism of Action and Primary Biological Targets
9.2.2 Central Nervous System Effects and Reinforcement
9.2.3 Dose Response Characteristics and Temporal Profile
9.2.4 Tolerance, Withdrawal, and Pharmacological Dependence
9.2.5 Regulatory Context and Emerging Consensus
9.2.6 Integration With Abuse Liability Assessment


9.3 State of Current Scientific Knowledge

9.3.1 Chemical and Biological Characterization
9.3.2 Clinical Knowledge and Therapeutic Use
9.3.3 Scientific Understanding of Misuse and Abuse
9.3.4 Neurobiological and Behavioral Evidence
9.3.5 Population-Level and Regulatory Knowledge
9.3.6 Knowledge Gaps and Ongoing Research


9.4 History and Current Pattern of Abuse

9.4.1 Historical Emergence of Non-Medical Use
9.4.2 Expansion Beyond Elite Sport
9.4.3 Modern Patterns of Abuse
9.4.4 Illicit Markets and Regulatory Influence
9.4.5 Stability and Absence of Escalating Abuse Trends


9.5 Scope, Duration, and Significance of Abuse

9.5.1 Scope of Abuse
9.5.2 Duration of Abuse Episodes
9.5.3 Significance of Abuse
9.5.4 Temporal Trends and Stability
9.5.5 Integration With Prior CSA Factors


9.6 Risk to Public Health

9.6.1 Nature of Health Risks
9.6.2 Absence of Acute Harm Signals
9.6.3 Public Health Interpretation


9.7 Psychic or Physiological Dependence Liability

9.7.1 Psychic Dependence
9.7.2 Physiological Dependence


9.8 Immediate Precursor Status

9.8.1 Chemical and Regulatory Considerations




9.9 Summary

The historical development of testosterone demonstrates that its placement under federal control occurred in response to evolving patterns of non-medical use rather than to evidence of an immediate or inherent abuse liability. As set forth in the CSA, determinations regarding scheduling are required to consider a defined set of factors related to pharmacology, patterns of use, public health impact, and dependence potential. The historical record summarized in Table 9-2 provides necessary context for evaluating these factors in a manner consistent with the statute.




10. What Happens Next: Scenarios and Decision Triggers


The future of testosterone’s scheduling cannot be predicted with certainty. Regulators, however, typically move through a limited set of legal and administrative pathways whose operational consequences are reasonably specifiable. Building on the current landscape summarized in Section 8 (stakeholders, arguments, and active policy venues), this section presents three neutral “what-if” scenarios that illustrate how different balances could be struck between access and diversion control. These are not forecasts. They are structured depictions of plausible pathways under existing legal authorities. We conclude with cross-cutting decision triggers such as procedural and evidentiary developments that would tend to precede movement toward any of the scenarios.


10.1 Scenario A: Retain Schedule III with Refined Guardrails

10.1.1 Regulatory pathway
10.1.2 Operational effects
10.1.3 Stakeholder alignment


10.2 Scenario B: Reschedule to Schedule IV or V with Risk-Mitigation Measures

10.2.1 Regulatory pathway
10.1.2 Operational effects
10.1.3 Stakeholder alignment


10.3 Scenario C: Deschedule and Rely on Prescription-Drug Controls

10.2.1 Regulatory pathway
10.1.2 Operational effects
10.1.3 Stakeholder alignment


10.4 Leading Indicators and Decision Triggers

10.4.1 Agency scientific reviews or formal recommendations
10.4.2 Rulemaking that resolves major access frictions without rescheduling
10.4.3 Congressional action beyond correspondence
10.4.4 Empirical inflection points in misuse, diversion, or health outcomes
10.4.5 Professional consensus statements that directly address scheduling-relevant premises




11. Conclusion

Testosterone’s Schedule III status reflects its dual role in federal policy. It is an established therapy with accepted medical use, and it is also treated as an anabolic steroid under a framework built to address non-medical use and diversion. Any reassessment therefore turns on proportionality under the CSA criteria and the eight-factor analysis, not on broad judgments about testosterone as a category.

The evidence summarized in this review consistently differentiates supervised therapeutic use from non-medical use patterns. The most serious harms are more closely associated with high-dose, prolonged, and poorly monitored use, often alongside stacking and other co-use practices. This distinction does not eliminate risk in medical settings, but it clarifies where risk concentrates and what kinds of controls are most directly relevant. Several uncertainties remain central to scheduling judgments. Diversion pathways are not quantified with precision across settings, which complicates attribution of harm to prescription versus extra-medical sources. Practical restrictiveness also varies because federal scheduling interacts with state rules, PDMP practices, pharmacy policies, and payer controls. These layers can shape access and oversight as much as the schedule itself.

This review does not recommend a scheduling outcome. It supports a structured approach that aligns the regulatory burden with the mechanisms most likely to reduce the harm of concern. That approach benefits from clear definitions, especially around “abuse” in this context, which is often goal-directed and not primarily driven by acute intoxication. Clarity here improves how evidence is weighed across abuse potential, dependence liability, and public health risk considerations.

Any change in testosterone’s classification would move through established pathways, including petitions and eight-factor review, HHS medical-scientific evaluation and recommendation, DEA rulemaking, or congressional amendment. Separately, implementation-level actions, including telemedicine rules for controlled substances, can materially alter access and oversight without changing the schedule. These adjacent policy moves can influence stakeholder pressure and perceived need for rescheduling.


Testosterone’s current status is best understood as a policy inheritance that can be evaluated against modern conditions. A durable path forward is a transparent application of the CSA criteria that states assumptions explicitly, distinguishes use patterns that drive risk, and ties regulatory controls to measurable public health goals.
 

Attachments

4. Regulatory Framework

4.1 The Controlled Substances Act (CSA) scheduling structure


The CSA establishes five schedules (I–V) and links each schedule to specific statutory findings regarding medical use, abuse potential, and dependence liability2. For substances placed in Schedules II–V, the CSA requires findings that include accepted medical use and a dependence profile that becomes progressively less restrictive from Schedule II to Schedule V. In particular, the CSA’s findings for Schedule III require (A) a potential for abuse less than substances in Schedules I and II, (B) a currently accepted medical use in treatment in the United States, and (C) that abuse may lead to moderate or low physical dependence or high psychological dependence.




Figure 4-1. CSA Scheduling Structure: Testosterone classified under Schedule III
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Scheduling decisions also require consideration of the CSA’s eight factors (the “8-factor analysis”), which provide a structured basis for evaluating control, transfer between schedules, or removal from control. These factors include, among other considerations, potential for abuse, scientific evidence of pharmacologic effects, current scientific knowledge, the history and pattern of abuse, scope and significance of abuse, public health risks, dependence liability, and whether the substance is an immediate precursor of another controlled substance.
 
Figure 5-1. Contrasting therapeutic testosterone replacement and non-medical use: differences in
indication, access pathway, dosing patterns, monitoring, and intended outcomes

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