ACKRELL CAPITAL CHAPTER IV_ U.S. Legal Landscape A drug generally may not be marketed for treating a condition other than a condition for which the FDA has found the drug to be a safe and effective treatment; however, most FDA-approved drugs can be prescribed by doctors to treat other conditions (so-called “off-label” prescriptions). Nonprescription or over-the-counter drugs can be marketed after receiving FDA approval through the NDA process or by conforming the drug to an existing over-the-counter “monograph” (a “recipe book” indicating acceptable ingredients, doses, formulations and labeling) established by the FDA. Cannabinoid-Based Drugs Several drugs containing synthetic cannabinoids or cannabinoid-like compounds have been approved by the FDA. Marinol, a drug comprised of dronabinol (a synthetic THC) encapsulated with sesame oil in a soft gelatin capsule, was approved by the FDA in 1985 for treatment of nausea and vomiting asso- ciated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. It was later approved, in 1992, for treatment of anorexia associated with weight loss in patients with AIDS. Syndros, a drug comprised of dronabinol in a liquid solution, was approved by the FDA in 2016 for treatment of the same symptoms for which Marinol was approved. Cesamet, a drug comprised. of encapsulated nabilone (a synthetic cannabinoid similar to THC), was approved by the FDA in 1985 for treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Each of the drugs Marinol, Syndros and Cesamet was placed on CSA Schedule II within one to two years after its initial FDA approval (Marinol and Syndros were rescheduled from Schedule I upon recommendation of the DHHS, and Cesamet’s placement on Schedule II was its initial CSA classifica- tion). Schedule II through Schedule V substances can be prescribed by a doctor,