Steroid industry regulation covers how anabolic-androgenic steroids (AAS) are manufactured, prescribed, sold, imported, and tested for in sport. In the United States, it involves several overlapping systems: controlled substance law enforced by the Drug Enforcement Administration (DEA), drug approval and safety oversight by the Food and Drug Administration (FDA), state laws, and anti-doping rules in competitive sport.
This article explains how those systems work, how related substances such as SARMs are treated, how regulation differs between countries, and what research shows about products sold outside the regulated pharmaceutical supply.
How are anabolic steroids regulated in the United States?
Schedule III controlled substances
In the United States, anabolic steroids are Schedule III controlled substances under the Controlled Substances Act. Schedule III covers drugs that have accepted medical uses but carry a potential for misuse and dependence.
This status was established by Congress through a series of laws. The Anabolic Steroid Control Act of 1990 placed anabolic steroids in Schedule III. The Anabolic Steroid Control Act of 2004 expanded the legal definition to include additional substances, including several steroid precursors that had been sold as supplements. The Designer Anabolic Steroid Control Act of 2014 added further compounds and created a framework for addressing newly developed “designer” steroids (DEA, 2025).
In August 2023, the DEA published a final rule updating its regulations to incorporate the substances added by the 2014 Act. Importantly, substances that meet the legal definition of an anabolic steroid are controlled under Schedule III even if they are not specifically named on the list (DEA, 2025).
What Schedule III status means in practice
Because anabolic steroids are Schedule III substances, they can be legally obtained only with a valid prescription from a licensed practitioner. Manufacturers, distributors, and pharmacies that handle them must be registered with the DEA and follow requirements for record-keeping and security. These requirements are one way regulation reaches the steroid production process itself, not only the end user.
Possessing anabolic steroids without a valid prescription is a federal offense, and manufacturing, distributing, or possessing them with intent to distribute carries more serious penalties. States also have their own laws, which can add further restrictions or penalties.
The role of the FDA
The FDA regulates which drugs can be marketed for human use and monitors their safety after approval. Its decisions affect which anabolic steroids remain legally available as medicines.
Two recent actions illustrate this role. In June 2023, the FDA withdrew approval of all oxandrolone tablets and later determined that the drug had been withdrawn from sale for reasons of safety or effectiveness (FDA, 2023). In February 2025, it required class-wide labeling changes for testosterone products, removing a boxed warning about cardiovascular outcomes and adding a warning about increased blood pressure (FDA, 2025).
The FDA also acts against products marketed as dietary supplements that contain anabolic steroids or similar substances, which cannot legally be sold as supplements.
Veterinary steroids
Some anabolic steroids, such as trenbolone and boldenone, were developed for veterinary use and are approved only for animals. Using veterinary drugs in humans is not legal, and these products are not manufactured to the standards required for human medicines. Our guide to the types of steroids explains the medical, veterinary, and unapproved status of commonly discussed compounds.
How are SARMs regulated?
Selective androgen receptor modulators (SARMs) act on androgen receptors but are not steroids. No SARM has been approved by the FDA for any medical use, and they are not specifically scheduled as controlled substances under federal law.
That does not make them legal to sell for human consumption. The FDA considers SARMs unapproved drugs, and products containing them cannot legally be marketed as dietary supplements. The agency has issued public warnings about SARMs in bodybuilding products, citing reports of liver injury and increased risk of heart attack and stroke. Legislation to place SARMs under the Controlled Substances Act has been introduced in Congress in past sessions but has not been enacted.
In competitive sport, SARMs are prohibited at all times under the World Anti-Doping Agency (WADA) Prohibited List.
How do other countries regulate steroids?
Steroid laws vary considerably between countries, and they can change over time.
In the United Kingdom, anabolic steroids are Class C controlled drugs. Possession for personal use is generally not an offense, but supplying them, or possessing them with intent to supply, is. In Canada, anabolic steroids are controlled under Schedule IV of the Controlled Drugs and Substances Act, which focuses on trafficking rather than simple possession. Other countries, including Australia, apply stricter controls on possession.
Because of these differences, information about the legal status of steroids in one country does not apply elsewhere. Anyone with questions about the law in their location should consult official government sources or a legal professional.
How does anti-doping regulation work?
Competitive sport has its own regulatory system, separate from criminal law. Under the World Anti-Doping Code, anabolic agents, including anabolic steroids and SARMs, are prohibited at all times, both in and out of competition (WADA, 2026).
National anti-doping organizations, such as the US Anti-Doping Agency (USADA), carry out testing and manage results for athletes under their jurisdiction. Athletes who test positive can face sanctions, including competition bans. Many professional leagues and organizations that are not bound by the World Anti-Doping Code also have their own drug policies.
What happens outside the regulated market?
Regulation exists partly to ensure that medicines contain what their labels state. Products sold outside the regulated pharmaceutical supply are not subject to those controls, and research shows the consequences.
A 2022 systematic review and meta-analysis analyzed 19 studies covering more than 5,400 steroid samples from the black market. It estimated that about 36% of the products were counterfeit, and that an additional 37% were of substandard quality, for example containing a different amount of the active ingredient than stated (Magnolini et al., 2022). Most samples in these studies were seized by authorities, so the findings may not represent every source, but the pattern was consistent across regions.
Counterfeit and substandard products add uncertainty beyond the known effects of AAS themselves, including incorrect amounts, different substances, and possible contamination. Our article on steroid market transparency discusses why product information matters.
Why does steroid regulation matter?
Regulation of anabolic steroids aims to balance two goals: keeping these drugs available for legitimate medical needs, such as testosterone replacement for hypogonadism, while limiting non-medical use because of its health risks. These risks include hormonal suppression, cardiovascular effects, liver effects, and dependence, as outlined in our guide to the key facts about steroids.
There is ongoing debate about how well the current approach works. Supporters argue that strict controls reduce access and discourage use, particularly among young people. Some public health researchers argue that criminalization pushes users toward unregulated products and can discourage them from telling doctors about their use, and they favor greater emphasis on health services and education. Both perspectives agree that people who use AAS face real health risks and benefit from medical care.
The bottom line
Steroid industry regulation in the United States rests on Schedule III controlled substance status, which makes anabolic steroids legal only with a valid prescription, combined with FDA oversight of which products can be marketed for human use. Recent developments include the DEA’s 2023 rule incorporating designer steroids, the FDA’s 2023 withdrawal of oxandrolone, and its 2025 testosterone labeling changes.
SARMs are not approved for medical use and cannot legally be sold as supplements, and anabolic agents are prohibited at all times in sport. Laws differ substantially between countries. Research on black-market products shows that a large share are counterfeit or substandard, which is one of the main reasons regulation focuses on the supply of these drugs.
References
Drug Enforcement Administration. Anabolic steroids: drug fact sheet. DEA Diversion Control Division. Accessed October 2026.
Food and Drug Administration. Determination that Oxandrin (oxandrolone) tablets, 2.5 milligrams and 10 milligrams, were withdrawn from sale for reasons of safety or effectiveness. Federal Register. 2023;88 FR 62799.
Food and Drug Administration. FDA issues class-wide labeling changes for testosterone products. February 28, 2025.
Magnolini R, Falcato L, Cremonesi A, et al. Fake anabolic androgenic steroids on the black market – a systematic review and meta-analysis on qualitative and quantitative analytical results found within the literature. BMC Public Health. 2022;22(1):1371. World Anti-Doping Agency. The 2026 Prohibited List. World Anti-Doping Code International Standard.
