Colorado is at the forefront of natural psychedelic substance regulation, paving the way for a burgeoning market of psilocybin product manufacturers. With new state laws enabling the regulated production of psilocybin-infused products, entrepreneurs have a significant opportunity to enter this emerging market by applying for a psilocybin product manufacturing license in Colorado.
In this comprehensive guide, we’ll break down the key aspects of obtaining a Colorado psilocybin product manufacturing license, including approved activities, license availability, regulatory requirements, and the application process. At Quantum 9, we specialize in helping clients secure their licenses, maintain compliance, and thrive in this evolving industry.
Psilocybin Product Manufacturing License in Colorado
Approved Activities for Psilocybin Manufacturing License
A Natural Medicine Product Manufacturing License in Colorado allows licensees to produce regulated psilocybin products intended for oral ingestion, as well as sublingual administration if they hold an extraction endorsement. Key approved activities include:
- Manufacturing capsules and tea bags (standard license).
- Producing chocolates, gummies, and pressed tablets with an extraction endorsement.
- Creating tinctures for sublingual administration (extraction endorsement required).
- Packaging and labeling products in compliance with state regulations.
- Transferring products to other licensed businesses, including Healing Centers and Facilitators.
Important Limitations:
- Products must not resemble commercially manufactured food items or appeal to children (e.g., no shapes like animals or fruits).
- Only licensed psilocybin cultivation facilities in Colorado may supply raw materials.
- Extraction processes must use approved solvents such as water, food-grade ethanol, or natural food oils.
Number of Psilocybin Product Manufacturing Licenses Available in Colorado
Colorado has not imposed a strict cap on the number of Natural Medicine Product Manufacturing Licenses. However, the state licensing authority will review program capacity based on early data from applicants. Early entry into the market provides a strategic advantage for securing a license and establishing a foothold in the industry.
Relevant Regulations
Colorado’s psilocybin industry is regulated under several key laws and guidelines:
- Natural Medicine Health Act of 2022: Read the full act to understand the foundation of psilocybin regulation in Colorado.
- SB23-290 – Natural Medicine Regulation and Legalization: Read the full text for details on the licensing framework and regulatory structure.
- SB24-198 – Regulated Natural Medicine Implementation: Read the full text here for insights into the roles of state agencies and rules for business operations.
- Final DOR Rules: The Department of Revenue’s comprehensive rules for psilocybin businesses are essential reading.
For product manufacturers, focus specifically on “Part 6 – Regulated Natural Medicine Product Manufacturing License Requirements” of the Final DOR Rules.
Application Requirements for a Psilocybin Manufacturing License in Colorado
Eligibility
Applicants must:
- Demonstrate a thorough understanding of state regulations.
- Pass background checks for key personnel.
- Secure a compliant facility with adequate sanitation and security measures.
- Prepare Standard Operating Procedures (SOPs) detailing production, safety, and compliance processes.
Application Process
- Submit Detailed Plans: Include floor diagrams, SOPs, and documentation of security measures.
- Provide Product Information: For each product type, include manufacturing procedures, safety data, and labeling details.
- Initial Inspections: Facilities must pass inspections by the state to ensure compliance with health, safety, and regulatory standards.
Required Documents
- Identification and business formation documents.
- Proof of property ownership or lease agreement.
- Certificates of analysis for raw materials.
- Product registration forms with complete manufacturing details.
Fees
The cost structure for a Colorado psilocybin product manufacturing license includes application and compliance fees:
| License Type | Application Fee | Compliance Fee |
|---|---|---|
| Standard Product Manufacturer License | $1,000.00 | $3,000.00 |
| Product Manufacturer with Extraction | $1,000.00 | $2,500.00 |
Fees are subject to change, so staying updated with the licensing authority is essential.
- Consult Experts: Work with Quantum 9’s psilocybin consultants in Colorado to assess your business’s readiness and ensure compliance.
- Prepare Your Facility: Secure equipment, implement security measures, and develop robust SOPs.
- Submit Your Application: Include all required documentation and fees.
- Undergo Inspections: Be prepared for facility audits and follow-up requests.
- Obtain Your License: Once approved, begin manufacturing while adhering to inventory tracking and compliance reporting.
Closing Remarks
Securing a Colorado psilocybin product manufacturing license offers a unique opportunity to participate in the state’s evolving psychedelic industry. By adhering to stringent regulations and maintaining high operational standards, businesses can position themselves as leaders in this emerging market. At Quantum 9, our team of psilocybin business consultants are here to guide you through the licensing process and help you build a compliant, successful manufacturing operation.
Contact us today to learn how we can support your journey into Colorado’s psilocybin product manufacturing industry.
