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Why is testosterone a controlled substance?

Gender-affirming hormone therapy (GAHT) includes medications such as testosterone, estrogen, and E+ medications like T blockers. However, some of these medications are more challenging to access. For trans, nonbinary, transmasculine, and other folks who want to use testosterone for their gender transition, it can be frustrating to feel like T is out of reach. You may wonder why testosterone is a controlled substance or why this form of GAHT is treated differently from estrogen or not able to be prescribed by Plume in certain states. This blog explains why testosterone can be difficult to access as a transgender person and how Plume lowers the barriers to T. Interested in T? You can learn more and get started here.

Testosterone is a naturally occurring hormone produced by all human bodies. People can increase their natural testosterone levels with a synthetic form of T as a cream, gel, or injection. Taking testosterone will change the way your body looks, help you prepare for some surgeries, make your voice lower, and more. All hormonal treatments affect every system of the body, from the reproductive system to your skin and hair. Testosterone is no exception. Regardless of why you choose to take T, you will notice changes throughout your body within the first year on the medication.

Some people use testosterone as gender-affirming hormone therapy (GAHT), while others use it as hormone replacement therapy (HRT) or testosterone replacement therapy (TRT, sometimes called androgen replacement therapy). Plume offers testosterone as gender-affirming hormone therapy (GAHT) to trans men, transmasculine people, nonbinary people, and other folks whose transition goals include T. Anyone who takes testosterone to increase T levels—for any reason—will face comparable barriers to access. This medication is a synthetic androgen and anabolic steroid, so it is classed as a Schedule III controlled substance.

Why is testosterone a controlled substance?

Testosterone is a life-saving medication for transgender folks. So it can be surprising to hear that this important medication is considered a controlled substance. A controlled substance is a substance (in this case, a medicine) that is regulated under federal law by the DEA (Drug Enforcement Agency). Every controlled substance is placed into a category (Schedule I-V), “based upon the substance’s medical use, potential for abuse, and safety or dependence liability.” According to the DEA, Schedule III substances “have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.”

Testosterone is a steroid, so it is classed as a Schedule III controlled substance. Other Schedule III drugs include non-narcotic medications such as ketamine and buprenorphine, as well as opioids like Tylenol with codeine. Because of this classification, Plume’s ability to offer testosterone is limited in some states. Telehealth regulations vary from state to state, making it challenging to offer everyone T.

Schedule III substances require a prescription, as well as clinical guidance on how the medication is used. Estrogen is not on any controlled substance list, nor does it fall into the category of a steroid. Due to laws that regulate drug distribution and prescriptions, Schedule III substances require more oversight from prescribers and pharmacies. Medications that aren’t regulated by the DEA are not subject to the same rules. For example, both testosterone and estrogen require a prescription—but estrogen is not a steroid, and is not regulated in the same way. (Estrogen/E+ medications should still be taken with a clinician’s guidance.)

Prejudice, doping scandals, and testosterone

Drug classifications don’t always reflect how safe a drug is. A classification can indicate how addictive the government thinks a substance might be, or it can regulate how the drug is dispensed.

In 1990, fears about cheating athletes and the health risks of steroids caused the DEA to classify T as a Schedule III controlled substance. This classification dates back to 1990, when people were concerned about athletes abusing steroids to cheat in competitions. The original Controlled Substances Act was passed in 1970 and did not include steroids. However, in 1988 a Canadian Olympic sprinter was found to be using anabolic steroids as a performance-enhancing drug and was stripped of his medal.

The public outcry caused the DEA to categorize all steroids as Schedule III. 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. Steroids do not have psychoactive or hallucinogenic effects, and little was known about them in 1990 apart from their use as performance-enhancing drugs.

The DEA’s classification of steroids, as well as some other medications, reflects a moment in history. Some medications are classified as controlled substances because of their cultural affiliation, psychological effect, or physical dependency risks. For example, marijuana is classified as a Schedule I drug, along with LSD and heroin. Do these drugs belong in the same class? Probably not. Steroids can be abused—like many other substances, addictive or not. There are some risks associated with steroids, such as higher red blood cell count or higher cholesterol. However, when used under the supervision of a medical provider, these risks are minimal.

Is gender-affirming hormone therapy safe with testosterone?

Using T as a gender-affirming medication is very safe when you work with a healthcare provider who understands your transition goals. Clinical guidelines say it’s safe to use this medication for gender-affirming hormone therapy.

We suggest working with a healthcare provider to plan your gender-affirming hormone therapy so that you get the best care possible—and the results you want. Most people notice dramatic changes within their first year on T. These changes tend to plateau within the first three years of T as your body adjusts to the medication’s masculinizing effects.

While you are taking T, your care team will regularly monitor your testosterone levels and red blood cell concentration (hematocrit) to ensure your levels are within a safe range. (Whenever possible, it’s ideal to also have a primary care provider, as they can help you with other preventative health care to keep you healthy as you proceed along your journey). Your T dose may need to be adjusted, or you may stay on the same dose.

What this means for your T prescription from Plume

Regardless of why someone takes T, it is still considered a controlled substance. That means that even in states with less strict guidelines, you may still face some barriers to receiving your medication. (If you’re not sure what you need to do to access T, reach out to your healthcare team in our app to learn more.)

Licensing, prescribing, and sending prescriptions for testosterone can be challenging. Because testosterone is a Schedule III drug, your care team will need to take extra steps to get you your prescription. Our team of healthcare providers does everything possible to make sure you have the hormones you need. For example:

  • We work with state-specific DEA offices to ensure you can access T.
  • We look up your information in a state-by-state prescription drug monitoring database (PDMP) before sending your prescription.
  • We stay familiar with state laws that might affect how we transfer your prescription to a new pharmacy.
  • We prescribe to you through a secure and certified electronic system using electronic prescribing of controlled substances (EPCS).
  • We make sure our providers have appropriate state-specific licenses to prescribe controlled substances.

Each state’s laws are different, so talk to your healthcare team if you have questions. You can also check out our map before signing up to make sure we offer T in your state. Depending on where you live, Plume may not be able to offer testosterone. In other states, you may only receive 30 to 90 days of your medication at a time.

Testosterone is safe and effective—and life-saving! It is a commonly used gender-affirming medication with few health risks. Testosterone can be prescribed by Plume’s healthcare team as part of your gender journey. Our healthcare team is familiar with prescribing guidelines in your state and we can work with you to ensure you access the gender-affirming care you need. Whether you are restarting your prescription or at the beginning of your gender journey, Plume is here to help. You can get started here!

In order to provide healthcare services to you and give you medically appropriate care, we are required to get a recent blood pressure reading. You can get your blood pressure read for free at many pharmacies, go to your primary care doctor, or you may purchase a blood pressure cuff online.

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