Why is Testosterone a Controlled Substance?

vials and syringe-injectionTestosterone a Controlled Substance: Why?

Did you know that as you read this your body is manufacturing a substance that the U.S. Congress has determined to be a controlled substance?  How can a hormone that the body naturally makes, not only in men, but also in women and children be considered  to be dangerous enough to classified as a controlled substance?

With the passage of the Anabolic Steroid Act of 1990 Congress bypassed the usual regulatory process (which a few years earlier under the Reagan Administration concluded that anabolic steroids should not be classified as controlled substances) that determines which drugs should be controlled, and concluded that  testosterone and other anabolic steroids be classified as controlled substances.

What few realize is that leading up to those Congressional Hearings the AMA, FDA, and DEA all opposed the classification of anabolic steroids as controlled substances – because they did not meet the criteria of the Controlled Substances Act.

Controlled Substances Act

The original purpose of the Controlled Substances Act was to provide more strict legislation related to the prescription and distribution of drugs that are principally psychoactive and which are abused exclusively by virtue and because of their psychoactive (mind-altering) effects. Though anabolic steroids are sometimes abused (as are many other drugs that are not controlled substances), they are not abused for their psychoactive effects.  Psychoactive drugs include narcotics, hallucinogens, stimulants, and depressants.

Congressional Hearings

The Congressional Hearings that led to Anabolic Steroid Act of 1990 were convened to deal with the use of anabolic steroids in sports. At the time there was a growing concern in sports related to athletes “cheating” by using anabolic steroids.  It should be pointed out that a substance does not to be controlled for a sport to ban it if it so chooses.  In fact, many drugs banned in sports are not controlled substances.  In the case of anabolic steroids the last straw was when it was discovered the Canadian sprinter Ben Johnson tested positive for anabolic steroids in the 1988 Olympics and was stripped of his gold medal. There was a huge outrage and the general feeling that something must be done to curb such “cheating” in sports (though some have made some reasonable persuasive arguments that performance enhancing drugs should be permitted in sports if athletes choose to use them – click here to see such an article).

Rick Collins is considered the foremost legal authority on anabolic steroids in the United States.  In testimony as part of a federal hearing in 2005 he made 10 points in which he provides interesting comments, observations, and distinctions between anabolic steroids and other controlled substances.  His comments will challenge those who believe anabolic steroids are as dangerous as the media and government reports.  His 10 points begin on page 8 of the following transcripts from a public hearing on April 12, 2005 in front of The United States Sentencing Commission.  Article found here: USSC April 12 2005 Collins Anabolic Steroids.

Medical Evidence: Little Presented at Congressional Hearings

Between the Senate and House of Representatives hearings that led to the Anabolic Steroid Act of 1990 there’s about 500 pages of testimony of which only 50 or so deal with the medical evidence.  In those days no randomized controlled studies existed on anabolic steroids, and back then and as is still the case today, there were no long-terms studies to guide any decision-making.  The only evidence available were “expert opinion” and case studies, which are considered the two lowest levels of evidence when judging medical information.

In his testimony to Congress, Charles Yesalis, the leading epidemiologist at the time in the area of anabolic steroids intimated that a reason a long term study has not been performed on the safety and risks of anabolic steroids was the fear that such a study would show that anabolic steroids are not as dangerous as the medical community wants society to believe possibly fueling further abuse. How revealing.

Having read the many pages of testimony at these Congressional Hearings it is my conclusion that the impetus to curb “cheating” in sports was strong enough that Congress relied on weak medical evidence to ascribe a legal remedy to what ultimately is an ethical issue – cheating in sports.

The unfortunate result is the Anabolic Steroid Act has created the perception that testosterone is dangerous even for legitimate medical purposes leading physicians and patients away from using testosterone.  Testosterone is safe when prescribed by a knowledgable physician and under close medical supervision, but synthetic anabolic steroids do carry some health risks. So there is a distinction between testosterone – the stuff your body makes – and synthetic anabolic steroids abused by athletes.

athletic performanceSince those hearing several randomized controlled studies have been performed using testosterone (not synthetic anabolic steroids) in supra-physiologic doses, the landmark study being Bhasin’s study published in the New England Journal of Medicine in 1996. This and other studies have shown that even in doses 6 to 10 times normal testosterone is relatively safe in an injectable form, though there can be transient laboratory abnormalities that resolve generally within 3 months of discontinuation of high dose testosterone use. Such laboratory abnormalities are far less frequent when physiologic or normal doses are used.

When properly prescribed and used testosterone is safer than most prescription and over the counter medications which are completely foreign to the body. This includes aspirin, ibuprofen, and acetaminophen. It is safer than birth control pills. It is safer than smoking and alchohol and recreational drugs. And, it is far safer than chemotherapy agents used in cancer treatments and the many new biologics now used to treat autoimmune diseases.

So why is testosterone a controlled substance?  In my opinion, to curb cheating in sports (yet few elite athletes have ever been prosecuted).  Unfortunately, in the process we have allowed what a few thousand professional athletes can and cannot do potentially affect the health of those in the general population who may be testosterone deficient.

For a more detailed appreciation of the history behind the Anabolic Steroid Act of 1990 we recommend you read Legal Muscle: Anabolic Steroids in America by Rick Collins.

This article was updated 7/3/15.

To learn more about the benefits of testosterone read the following the articles found on this website:

“Does Testosterone Reduce Inflammation?”

“Low Testosterone Symptoms”

“Testosterone Part II: Erectile Dysfunction”

“Treatment for a Low Testosterone Level”

“Testosterone – Not Just For Libido”

“Hormone Replacement for Men”

“Nonsexual Symptoms of Low Testosterone”


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  1. Phyllis says

    I went ot pick up my refill of HRT last night and my pharmist told I could not get a refill because the gov’t a few days a go classified my HRT as a controlles substanace now. I would have to contact my gyn to get a new prescription because now you are only allowed to have a 6 month prescript instead of a yearly prescript. Seriously because it has testosterone in it, I can have a supply of more than 6 months? This is the most assinine thing the government has ever passed.

    • Dr. Joe Jacko says


      Testosterone has been a contolled substance at the Federal level since 1990. Each state also has its own laws regarding controlled substances. I used to practice in Texas, but now practice in Ohio. There are several medications which are controlled in Ohio that are not in Texas. The pharmacy laws also vary from state to state with regards to how many monthly refills of a controlled substance can be given before the patient needs to be seen by the physician again. I suspect the pharmacy laws in your state recently changed limiting refills on a controlled substance to 6 months whereas it was probably a year previously.

    • Rob says

      In New York they have classified it as schedule 2, the same level as heroin. They now allow no prescription refills at all so I need an expensive doctors appointment every month forever. Thanks government.

      Testosterone should not be controlled by doctors at all. 99.9% of doctors know little or nothing about testosterone and their ignorance does more harm than good. A simple google search often puts the patients knowledge beyond their doctors. Doctors have no specific training on testosterone that makes us any safer in their hands. Making it a prescription drug just adds considerable cost and inconvenience for people who need trt and benefits nobody except greedy American doctors. My doctor bills $20,000 for one testosterone shot and we wonder why US healthcare is ten times more expensive than any other country.

      We should have the freedom to choose to use testosterone in our own bodies for whatever reason we feel it necessary, without being forced to waste money on useless doctors who add zero value.

      Refined sugar, alcohol and water have all killed more people than testosterone. The law is a mistake. Everyone knows it but the paralysis of government makes us powerless to change it. Nobody can defend this law with any facts or logic.

        • Rob says

          71% of men in America are overweight or obese compared to 38% worldwide. 1 in 5 of us die from obesity related health problems. That is shameful. Low T is a major cause of obesity and testosterone supplements are the very last thing that should be banned.

          This is an area where America needs to do more listening and less talking. America has the worst public health of all developed nations. We consume the vast majority of the worlds pain killers and antidepressants too.

          The only group even remotely incentivized to use dangerous amounts of testosterone is pro bodybuilders. I could sort of maybe understand banning those competitions, given that we have become a revolting police state, but they are still legal while the rest of us are punished.

          I can’t imagine many people think that bodybuilders deserve to be in prison though. We already have more people behind bars than China. Enough is enough etc.

  2. Margie says

    This is outrageous. Certainly not the way to cut health care costs, demanding that I see my doc every few months to get a new prescription. And why is a naturally occurring substance that my body needs a little help with now a controlled substance. Like calling being female a pre-existing condition and denying to cover certain medical conditions! There is little common sense in much medical legislation.

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