DEA Criteria for Schedule II

"Although the petition for review was denied, it led to a revised formulation by the DEA for determining whether a drug has a 'currently accepted medical use.' The 5-part test for fulfilling the accepted medical use criteria of Schedule II is now comprised of the following:
"• the drug’s chemistry must be known and reproducible;
"• there must be adequate safety studies;
"• there must be adequate and well-controlled studies proving efficacy;
"• the drug must be accepted by qualified experts; and
"• the scientific evidence must be widely available.
"A drug must meet all 5 criteria to be considered for rescheduling by the DEA.
"Even if marijuana were rescheduled under current law it could not be marketed or medically available for general prescription use unless it was reviewed and approved by FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA) (see below). Conceivably, a physician may be able to write a prescription for an individual patient with the cooperation of a compounding pharmacist with a schedule II license. However, the FDA treats compounded products as 'new drugs' subject to all the requirements of the FFDCA if pharmacists attempt to compound large quantities of medication."


American Medical Association, Council on Science and Public Health, "Report 3 of the Council on Science and Public Health: Use of Cannabis for Medicinal Purposes" (December 2009) p. 8.