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Colorado

Biologics Compliance Guide for Clinics in Colorado

Up-to-date information on protocols, safety, and regulations to help you deliver advanced patient care.

1. Summary

This guide is designed to help medical providers and clinics in Colorado navigate compliance for biologics and stem cell therapies. It covers FDA and Colorado state requirements, provider qualifications, patient consent essentials, and more. By following these steps, you can confidently provide biologic treatments in a compliant, ethical manner.

2. FDA Compliance

The U.S. Food and Drug Administration (FDA) regulates human cells, tissues, and cellular and tissue-based products (HCT/Ps). Clinics offering stem cell and similar therapies must comply with FDA regulations under Section 361 of the Public Health Service Act and 21 CFR Part 1271. For specific details, refer to the FDA’s HCT/P guidance.

• Ensure all products used meet the FDA’s minimal manipulation and homologous use criteria.
• Review FDA guidelines for investigational new drugs (IND) if the therapy involves more than minimally manipulated cells.
• Comply with manufacturing practices as per FDA’s Current Good Manufacturing Practices (CGMP) where applicable.

3. Colorado State Regulations

Colorado’s Department of Public Health and Environment (CDPHE) oversees regulations relevant to biologic treatments. Colorado may have specific state-level guidelines that impact stem cell therapy practices. For up-to-date regulatory information, visit the Colorado Department of Public Health and Environment (CDPHE) website.

• Check for any licensing requirements for facilities offering biologics.
• Stay informed about local health department guidelines to ensure your practice remains compliant.

4. Provider Qualifications

In Colorado, only qualified healthcare providers can perform stem cell therapies. This typically includes licensed physicians and in some cases, qualified practitioners under physician supervision. For more details on licensure requirements, refer to the Colorado Department of Regulatory Agencies (DORA).

• Physicians, physician assistants, and in some cases, nurse practitioners may be eligible to administer biologic treatments.
• Physician license (MD/DO); other providers under direct supervision can administer human tissue therapies.
• Ensure all practitioners have the necessary training and credentials as defined by Colorado state law.

5. Patient Informed Consent

Colorado law requires that patients be fully informed of the risks, benefits, and experimental nature of certain biologic therapies. It’s critical to maintain comprehensive informed consent documentation to ensure patients understand:

• Potential risks and benefits of the procedure.
• The experimental status of any unapproved therapies.
• Alternatives to biologic treatments, where applicable.

6. Additional Compliance Areas

Establishing clear protocols for both pre- and post-treatment can enhance patient safety and ensure compliance. These protocols should outline screening criteria, procedure steps, and follow-up care.

Develop and regularly update SOPs to ensure consistency in biologic handling, storage, and administration. Documenting these practices helps ensure quality and regulatory compliance.

Providers offering biologic therapies should secure appropriate medical liability insurance to cover any risks associated with these treatments. Consult with insurance providers familiar with biologic and stem cell treatments.

All marketing materials for biologic treatments in Colorado must adhere to FDA and FTC guidelines. Ensure that promotional content does not make unsubstantiated claims about treatment efficacy.

This guide is provided as an informational resource to help clinics and practitioners understand general compliance requirements for biologics in Colorado. It is not intended to serve as legal advice or replace consultation with qualified legal professionals. Regulations may vary and are subject to change; clinics and practitioners should consult legal counsel or regulatory experts for advice specific to their circumstances and ensure full compliance with all applicable federal and state laws. The authors and publishers of this guide disclaim any liability arising from its use or reliance on the information provided.