The Drug Enforcement Administration (DEA) issued a proposed rule to transfer marijuana from Schedule I of the Controlled Substances Act (CSA) to Schedule III, consistent with the view of HHS that marijuana has a currently accepted medical use as well as its views about marijuana’s abuse potential and level of physical or psychological dependence. The DEA is soliciting comments on this proposed rule, which are due on July 22. What does it all mean? If the transfer to Schedule III is finalized, the regulatory controls applicable to Schedule III-controlled substances would apply, as appropriate, along with existing marijuana-specific requirements and any additional controls that might be implemented, including those that might be implemented to meet U.S. treaty obligations. If marijuana is transferred into Schedule III, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA. Any drugs containing a substance within the CSA’s definition of ‘‘marijuana’’ would also remain subject to the applicable prohibitions in the Federal Food, Drug, and Cosmetic Act.
NCPA will continue to monitor the rescheduling of marijuana. With respect to medical marijuana, a key difference between placement in Schedule I and Schedule III is that substances in Schedule III have an accepted medical use and may lawfully be dispensed by prescription, while substances in Schedule I cannot. However, prescription drugs must be approved by the Food and Drug Administration (FDA). Although FDA has approved some drugs derived from or related to cannabis, marijuana itself is not an FDA-approved drug. Since the effective date of the DEA’s proposed rule would be 60 days after a final rule is published (the date of which is still unknown), it will likely be some time before pharmacies will be affected by this rule.
