(a) Any term not defined in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802), except that certain terms used in part 1316 of this chapter are defined at the beginning of each subpart of that part. This article is in the category Conditions and created by healthymen Team Testosterone is an androgen, a type of hormone that is primarily produced in the testes in men and in smaller amounts in the ovaries in women. We do not lobby for specific products.We do not provide medical advice.Our work centers on education, transparency, and public engagement. These principles support safer, more consistent care, and reduce the harms created by misinformation and avoidance. Research that includes women and diverse populations FDA leadership has since signaled openness to re-examining testosterone’s classification and labeling.
That includes verifying a patient’s medical need through lab testing, documenting treatment plans, and regularly monitoring hormone levels. Today, healthcare providers must follow strict guidelines when prescribing testosterone. This scheduling ensures testosterone can only be distributed and used under the guidance of licensed healthcare professionals, such as Gameday Men’s Health.
That means that even in states with less strict guidelines, you may still face some barriers to receiving your medication. These changes tend to plateau within the first three years of T as your body adjusts to the medication’s masculinizing effects. However, when used under the supervision of a medical provider, these risks are minimal. For example, marijuana is classified as a Schedule I drug, along with LSD and heroin. Steroids do not have psychoactive or hallucinogenic effects, and little was known about them in 1990 apart from their use as performance-enhancing drugs. This was somewhat of a misnomer, as the Controlled Substances Act was intended to restrict the prescription and distribution of psychoactive drugs, such as hallucinogens. The public outcry caused the DEA to categorize all steroids as Schedule III.
Steroids can be abused—like many other substances, addictive or not. The DEA’s classification of steroids, as well as some other medications, reflects a moment in history. Due to laws that regulate drug distribution and prescriptions, Schedule III substances require more oversight from prescribers and pharmacies.
In the United States, testosterone is classified as a Schedule III controlled substance under the Controlled Substances Act. Panelists compared current testosterone regulation to past overcorrections in women’s hormone therapy, where exaggerated risk narratives delayed care for decades. Today, many experts argue it no longer reflects how testosterone is actually used in healthcare. Schedule III classification places testosterone alongside substances considered to have moderate abuse potential. In order to provide healthcare services to you and give you medically appropriate care, we are required to get a recent blood pressure reading. Our team of healthcare providers does everything possible to make sure you have the hormones you need. Using T as a gender-affirming medication is very safe when you work with a healthcare provider who understands your transition goals.
Evidence-aligned hormone policy does not imply unrestricted access or one-size-fits-all care. In late 2025, an FDA expert panel of clinicians and public health officials publicly stated that testosterone has been underutilized due to outdated fears. Men have access to multiple FDA-approved testosterone products, but decades of fear-based messaging and restrictive policy have led to under-screening and inconsistent care. Women have no FDA-approved testosterone therapy, despite producing testosterone naturally and experiencing age-related decline. It is a commonly used gender-affirming medication with few health risks.
The term collector means a registered manufacturer, distributor, reverse distributor, narcotic treatment program, hospital/clinic with an on-site pharmacy, or retail pharmacy that is authorized under this chapter to so receive a controlled substance for the purpose of destruction. Collection means to receive a controlled substance for the purpose of destruction from an ultimate user, a person lawfully entitled to dispose of an ultimate user decedent's property, or a long-term care facility on behalf of an ultimate user who resides or has resided at that facility. Central fill pharmacy means a pharmacy which is permitted by the state in which it is located to prepare controlled substances orders for dispensing pursuant to a valid prescription transmitted to it by a registered retail pharmacy and to return the labeled and filled prescriptions to the retail pharmacy for delivery to the ultimate user.
After that point, some men experience short-term symptoms such as fatigue, low sex drive and erectile dysfunction, as well as long-term ones like osteoporosis. Typically, men’s testosterone levels decline about 1% per year starting in their 30s or 40s. Now-Health Secretary Robert F. Kennedy Jr. told Newsmax in 2023 that he was taking testosterone replacement at the time as part of an "anti-aging protocol." "I think it’s an increase in the demand for a drug that can make it easier to have physiques that we see in superhero movies." "It’s not that there is an increase in the prevalence of testosterone deficiency," said Dr. Bobby Najari, a urologist at NYU Langone Health, who was not part of Wednesday’s discussion.