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Biologics Compliance Guide for Clinics in Tennessee

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

1. Summary

Offering biologics and stem cell therapies in Tennessee requires compliance with both federal and state regulations. This guide provides an overview of the necessary steps to ensure your clinic meets these requirements confidently and effectively.


2. FDA Compliance

The U.S. Food and Drug Administration (FDA) oversees the regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Clinics must adhere to the FDA’s HCT/P regulations to ensure products are used in compliance with Section 361 of the Public Health Service Act and 21 CFR Part 1271.


3. Tennessee State Regulations

Tennessee enforces its own set of guidelines regarding biologics. For specific details, visit the Tennessee Department of Health to understand state-level requirements and ensure your practices align with local laws. While Tennessee may have unique regulatory flexibility, clinics must remain updated on local legislation to maintain compliance.


4. Provider Qualifications

In Tennessee, stem cell therapy must be administered by licensed physicians MDs or DOs. For comprehensive licensing requirements, refer to the Tennessee Health Professional Boards. It’s crucial for clinics to verify that all practitioners meet the criteria to legally offer these services.


5. Patient Informed Consent

Obtaining informed consent from patients is an essential step. Clinics should present information detailing the experimental nature of some therapies, potential risks, expected benefits, and any disclaimers necessary. Proper documentation ensures that patients understand their treatment choices and that the clinic maintains a transparent, ethical practice.


6. Pre-Treatment and Post-Treatment Protocols
Standard Operating Procedures (SOPs) should be established for both pre-treatment evaluations and post-treatment care. These protocols help to minimize complications and ensure consistent, high-quality patient experiences.


7. Medical Liability Insurance
Clinics must secure appropriate medical liability insurance to safeguard against potential legal claims. This step is a critical aspect of risk management and compliance.


8. Marketing Compliance

Ensure all marketing materials comply with federal and state advertising regulations. Avoid misleading claims about the effectiveness of treatments and provide clear, evidence-based information. The FTC's advertising guidelines should be followed alongside any specific state rules.

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