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 .
In November 1942, the Italian cyclist Fausto Coppi took "seven packets of amphetamine" to beat the world hour record on the track.  In 1960, the Danish rider Knud Enemark Jensen collapsed during the 100 km team time trial at the Olympic Games in Rome and died later in hospital. The autopsy showed he had taken amphetamine and another drug, Ronicol , which dilates the blood vessels. The chairman of the Dutch cycling federation, Piet van Dijk, said of Rome that "dope – whole cartloads – [were] used in such royal quantities."