After the Kefauver Harris Amendment was passed in 1962, the . FDA began the DESI review process to ensure the safety and efficacy of drugs approved under the more lenient pre-1962 standards, including Dianabol.  In 1965, the FDA pressured CIBA to further document its legitimate medical uses, and re-approved the drug for treating post-menopausal osteoporosis and pituitary-deficient dwarfism .  After CIBA's patent exclusivity period lapsed, other manufacturers began to market generic metandienone in the .
Some bodybuilders and athletes use trenbolone esters for their muscle-building and otherwise performance-enhancing effects.  Such use is illegal in the United States and many other countries. The DEA classifies trenbolone and its esters as Schedule III controlled substances under the Controlled Substances Act .  Trenbolone is classified as a Schedule 4 drug in Canada  and a class C drug with no penalty for personal use or possession in the United Kingdom .  Use or possession of steroids without a prescription is a crime in Australia .