Maridose has announced the deployment of its commercial supply chain strategy. In response to the rescheduling of cannabis to Schedule III under the Controlled Substances Act, Maridose is initiating partnerships with Section 503B Outsourcing Facilities to ensure nationwide access to pharmaceutical-grade cannabinoid medicines.
As the United States moves to recognize the medical utility of cannabis, a critical gap remains between federal drug laws and patient access. "Unlike state-licensed operators who remain restricted by federal interstate commerce bans, Maridose operates under federal jurisdiction," says Richard Shain, founder of Maridose. This authorization allows the company to legally transport Active Pharmaceutical Ingredients (API) including high-purity THC and CBD isolates across state lines to DEA-registered partners.
The company's strategy focuses on the "503B Outsourcing Facility" pathway, a provision of the Drug Quality and Security Act (DQSA) that allows specialized facilities to compound drugs in bulk for hospital and clinical use. This pathway is essential for mitigating drug shortages and providing tailored therapies that FDA-approved products cannot address.
"Rescheduling is the catalyst that transforms cannabis from a localized commodity into a federal pharmaceutical ingredient," says Richard. "While the industry awaits the years-long process of new drug approvals, the 503B channel allows us to serve patients today. We are effectively unlocking the national hospital supply chain for cannabinoids. By partnering with 503B facilities, Maridose can supply the raw materials needed to compound critical medications, such as Dronabinol, particularly during periods of manufacturing shortages that threaten patient care."
Maridose's Brunswick, Maine facility is fully operational and compliant with federal security and manufacturing standards. In addition to its domestic manufacturing capabilities, Maridose has obtained import registrations to diversify its controlled substance portfolio, further cementing its status as a robust pharmaceutical supplier. The company also operates an internal Contract Research Organization (CRO) to validate the stability and safety of its API, providing 503B partners with the comprehensive data required for cGMP compliance.
"We are not a cannabis company trying to play pharma; we are a pharmaceutical company that manufactures cannabinoids," added Shain. "Our 503B strategy is the most direct, compliant, and scalable route to bringing botanical medicines into the federal fold. We invite outsourcing facilities and pharmaceutical partners to join us in defining this new standard of care."
For more information:
Maridose
www.maridose.com
