Attorney General Pam Bondi today issued an emergency rule to allow an estimated 4,000 Floridians—many of whom are children—access to life-changing medication. The emergency rule reschedules Epidiolex, a cannabinoid-based drug, from a Schedule 1 drug to a Schedule 5 under Florida State Statutes. Epidiolex is the first U.S. Food and Drug Administration approved prescription pharmaceutical that contains a highly purified substance derived from cannabidiol—a cannabinoid lacking THC and therefore non-euphoric.
“This emergency rule will allow children and adults suffering from these terrible and rare forms of epilepsy to access life-changing, FDA approved medication,” said Attorney General Bondi.
Epidiolex is used to treat people with rare, catastrophic and debilitating forms of epilepsy—specifically Dravet and Lennox-Gastaut syndromes. These syndromes are otherwise highly treatment resistant, often causing those afflicted to suffer more seizures than those with more common forms of epilepsy.
In June, Epidiolex became the first and only FDA approved medication to treat these disorders. Last month, the U.S. Drug Enforcement Administration de-scheduled the cannabinoid-based drug on the federal level. Attorney General Bondi’s rescheduling of Epidiolex now aligns Florida state law with current federal law. Attorney General Bondi’s emergency rescheduling remains in effect until the Florida Legislature convenes, at which point lawmakers will be able to permanently reschedule Epidiolex.
All non-FDA approved cannabinoid extracts, materials, compounds, mixtures or preparations other than Epidiolex remain a Schedule 1 controlled substance under the Florida Comprehensive Drug Abuse Prevention and Control Act.
While Attorney General Bondi has used emergency powers since taking office in 2011 to schedule 133 chemical compounds commonly used in deadly synthetic drugs, this is the first time Attorney General Bondi used authority to de-schedule a drug.