- MediPharm Labs states it is positioned for potential U.S. cannabis rescheduling, having completed FDA site registration and filed a Drug Master File for CBD API
- Rescheduling cannabis to Schedule III would enable expanded medical research and access programs in the U.S., similar to those in Canada, Australia, and Germany
- The company will release its Q2 2025 financial results before markets open on Thursday, August 14, 2025, continuing its commitment to transparency and growth
- MediPharm Labs stock (TSX:LABS) last traded at $0.07
MediPharm Labs (TSX:LABS) shared its insights into its U.S. FDA site registration and strategic readiness in light of the potential federal rescheduling of cannabis in the United States.
This content has been prepared as part of a partnership with MediPharm Labs Corp. and is intended for informational purposes only.
Recent communications from the U.S. federal government and widespread media coverage suggest that the administration is actively reviewing the reclassification of cannabis from a Schedule I to a Schedule III controlled substance. This shift would mark a significant milestone in federal cannabis policy, recognizing its medical benefits and unlocking new pathways for research and patient access.
Implications of rescheduling cannabis
If cannabis is reclassified as a Schedule III drug:
- It would formally acknowledge its medical utility at the federal level
- Researchers in the U.S. would gain broader access to cannabis products for clinical trials, overcoming the restrictive barriers currently imposed by Schedule I classification
- The move could pave the way for expanded medical cannabis programs similar to those in Canada, Australia, and Germany
- Cannabis businesses would benefit from tax relief under Section 280E, which currently penalizes Schedule I and II substance handlers
MediPharm’s unique positioning
MediPharm Labs stands out as one of the few companies globally—and the only publicly listed cannabis-focused firm in North America—with a comprehensive suite of regulatory approvals and infrastructure to capitalize on this potential shift:
- The company has successfully completed the process of foreign drug manufacturing site registration with the U.S. FDA, including a week-long inspection that granted it the authority to produce, label, test, and release pharmaceutical-grade cannabis products
- MediPharm has filed a Drug Master File with the FDA for its CBD active pharmaceutical ingredient (API), an important step for enabling late-stage clinical trials and finished dose product development
- It has already shipped cannabis API and products to the U.S. for research purposes, including a National Institutes of Health-funded clinical trial—an achievement made possible through FDA registration and DEA-issued import permits
With these credentials, MediPharm sees itself in a stable position to support the anticipated surge in U.S.-based cannabis research and potential new medical access programs. The company’s purpose-built, FDA-audited facility in Canada is one of only a handful worldwide capable of meeting the stringent standards required for pharmaceutical cannabis production.
Looking ahead
MediPharm Labs continues to uphold its pharmaceutical licenses and remains committed to serving researchers and patients with its brew of cannabinoid products. The company continues to watch developments in U.S. cannabis policy, ready to expand its footprint in the American market.
The company plans to release its Q2 financial results for the three and six months ended June 30, 2025, before markets open on Thursday, August 14, 2025.
MediPharm develops and manufactures pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients and advanced derivative products.
MediPharm Labs stock (TSX:LABS) last traded at $0.07. Though up 25.00 per cent since the year began, the stock has also climbed 7.14 per cent since this time last year.
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