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Wisconsin

Biologics Compliance Guide for Clinics in Wisconsin

Learn the essential compliance steps to confidently offer biologics in Wisconsin. This guide covers state and FDA regulations, patient consent, and best practices to help you establish compliant stem cell therapy services.

1. Summary

This guide provides a comprehensive overview of the essential steps clinics and practitioners in Wisconsin need to take to ensure compliance when offering biologic treatments, including stem cell therapies. Covering both federal FDA guidelines and state-specific regulations, this guide aims to make the compliance process accessible, helping providers operate confidently and responsibly.

2. FDA Compliance

The U.S. Food and Drug Administration (FDA) regulates human cells, tissues, and cellular- and tissue-based products (HCT/Ps) to ensure patient safety. For clinics offering biologics in Wisconsin, understanding these regulations is critical. Key federal compliance points include:

• Adhering to FDA’s guidelines on HCT/Ps to determine if your product is regulated solely under Section 361 of the Public Health Service Act.
• Ensuring proper classification and registration if your product requires premarket approval or investigational new drug application (IND).
• Following Good Tissue Practice (GTP) standards to maintain product quality, minimizing contamination risks.

3. Wisconsin State Regulations

In addition to federal FDA guidelines, providers in Wisconsin must adhere to state-specific regulations. Wisconsin’s Department of Health Services outlines health standards that apply to biologics, which may include laboratory certifications and restrictions on certain cellular therapies. Visit the Wisconsin Department of Health Services website for current guidelines on healthcare practices in the state.

4. Provider Qualifications

In Wisconsin, only licensed physicians(MD/DO) or advanced practitioners under a supervising physician can administer treatments. Providers should ensure they hold valid credentials under Wisconsin's licensing regulations and complete any necessary training in handling biologic products. For more details, check the Wisconsin Department of Safety and Professional Services for licensing requirements specific to your field.

5. Patient Informed Consent

Patient informed consent is crucial when administering biologics, as these treatments can involve risks and may have experimental aspects. Consent forms in Wisconsin should clearly outline:

• Potential risks and benefits of the treatment
• A statement indicating that certain therapies may be experimental
• Alternative treatments available, if any
• Any disclaimers regarding outcomes and lack of FDA approval for certain applications

Having a thorough consent process helps ensure patient understanding and compliance with Wisconsin's patient rights statutes.

6. Additional Compliance Considerations

Develop protocols for pre-treatment screenings and post-treatment follow-ups to monitor patient outcomes. Adhering to these protocols supports patient safety and aligns with both FDA and Wisconsin’s best practices for medical procedures.

Implement SOPs for all aspects of biologic handling, storage, and administration. These procedures ensure consistent quality and compliance with Good Manufacturing Practice (GMP) requirements.

Ensure your clinic carries adequate medical liability insurance that covers biologic treatments. This coverage is essential for managing potential risks and liabilities associated with these therapies.

All advertising and promotional materials must accurately represent the capabilities and limitations of biologic treatments. Avoid misleading language about unproven or experimental therapies, as non-compliant marketing can attract scrutiny from both FDA and Wisconsin regulatory authorities.

This guide is provided as an informational resource to help clinics and practitioners understand general compliance requirements for biologics in Wisconsin. 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.