A brief summary of the laws governing TRT in the United States
Controlled SubstancesAct (CSA): The CSA is a federal law that regulates the manufacture, distribution, and dispensing of controlled substances, including testosterone. Testosterone is classified as a Schedule III controlled substance under the CSA, which means that it has a moderate to low potential for abuse and dependence.
Food, Drug, and Cosmetic Act (FDCA): The FDCA is a federal law that regulates the safety and effectiveness of drugs and medical devices. Testosterone replacement therapy products are subject to regulation by the FDA under the FDCA.
Drug Enforcement Administration (DEA) Regulations: The DEA is responsible for enforcing the CSA and has established regulations governing the registration, prescribing, and dispensing of controlled substances, including testosterone.
State Medical Boards: State medical boards regulate the practice of medicine within their respective states, including the prescribing and administration of testosterone replacement therapy. State medical boards can discipline or revoke the licenses of healthcare providers who violate state laws or regulations related to testosterone replacement therapy.
