The Drug Enforcement Administration (DEA) has issued new guidance warning that medical marijuana businesses that want to receive federal registration and protections under the Trump administration’s rescheduling reform have until late November to begin sourcing cannabis only from and to other companies that have also been granted or applied for registration in a timely fashion.
“If a Timely Applicant or DEA registrant engages in schedule III medical marijuana activities with someone other than a Timely Applicant or DEA registrant, such conduct could be potential grounds for denial of a Timely Applicant’s application or revocation of a certificate of registration, respectively,” the four-page document says.
It was published on Friday in conjunction with a Department of Justice announcement that DEA has issued federal registrations to more than 900 medical marijuana dispensaries in states across the U.S. in line with the process of federally rescheduling cannabis.
“Timely Applicants and registrants therefore should take adequate steps to confirm the status of all entities with which they will conduct schedule III medical marijuana activities,” the DEA guidance says, going on to outline due diligence steps that businesses should take to maintain compliance.
Those include:
- Obtaining from Timely Applicants (if dispensers) a copy of the “Marijuana Dispensary Information Submission” confirmation received from DEA at the time of application submission and verifying the Timely Applicant’s document control number (DCN) via the DEA Diversion Control Website;
- Obtaining from Timely Applicants (if manufacturers or distributors) a copy of the submission confirmation provided by DEA at the time of application submission and verifying the Timely Applicant’s DCN via the DEA Diversion Control Website;
- Obtaining from DEA registrants a copy of the registrant’s DEA certificate of registration; • Obtaining a copy of the entity’s relevant state license and verifying its status is active; and
- Maintaining records of all due diligence conducted.
DEA said it recognizes that some states require licensed medical cannabis businesses to send marijuana to state-licensed third-party laboratories for testing, which “can help protect public safety and prevent unlawful products from entering the market.”
Because not all medical marijuana businesses seeking federal registration have access to DEA-registered analytical laboratories, the agency said it “does not intend to penalize registrants and Timely Applicants for sending de minimis quantities of schedule III medical marijuana to a laboratory that is not DEA-registered to conduct analytical testing of schedule III medical marijuana, provided that (1) the analytical laboratory is located in the same state, and (2) the Timely Applicant/registrant retains detailed records of all such distributions.”
“This exercise of the Administrator’s discretion applies only when the use of a DEA-registered laboratory would violate state law,” the guidance says. “Specifically, it applies only to the extent that either (1) no entities anywhere in the United States are registered with DEA to conduct analytical testing of schedule III medical marijuana, or (2) state law prohibits the Timely Applicant/registrant from sending schedule III medical marijuana to an analytical laboratory in a different state, and no entities in the Timely Applicant/registrant’s state are registered with DEA to conduct analytical testing of schedule III medical marijuana.”
DEA is cautioning that the discretion “does not permit Timely Applicants and registrants to receive schedule III medical marijuana from non-DEA-registered analytical laboratories.”
The agency said it “recognizes Timely Applicants may require additional time to verify the status of their existing trading partners as Timely Applicants or registrants and to make necessary adjustments to their supply chain to comply with this information.”
As such, they are “expected to complete these activities and establish compliant supply chains ” by no later than November 29.
“Timely Dispenser Applicants and Timely Distributor Applicants may continue to possess, dispense, and distribute existing inventories of schedule III medical marijuana acquired prior to the issuance of this information, including inventory previously obtained from entities that do not qualify as Timely Applicants or DEA registrants,” the guidance says. “Such inventory may continue to be used in otherwise authorized activities.”
In April, Attorney General Todd Blanche issued an order immediately moving marijuana products regulated by a state medical cannabis license from Schedule I of the Controlled Substances Act (CSA) to Schedule III, along with marijuana products that are approved by the Food and Drug Administration (FDA).
Within days, DEA began accepting registrations from medical cannabis dispensaries with a new form, giving expedited processing to those who applied within a 60-day window. Earlier this month, the agency launched new specialized registration forms for additional types of state-licensed medical marijuana businesses such as manufacturers, distributors and analytical labs.
DEA announced on Friday that nearly 7,000 medical marijuana businesses have already applied for federal protections under rescheduling.
Meanwhile, a process considering the federal rescheduling of non-medical marijuana is underway.
