Back to
Georgia
Biologics Compliance Guide for Clinics in Georgia
Up-to-date information on protocols, safety, and regulations to help you deliver advanced patient care.
1. Summary
This guide provides Georgia-based medical providers with the critical steps to comply with federal and state regulations for offering biologic therapies, such as stem cell treatments. It covers FDA guidelines, Georgia-specific requirements, informed consent, and additional best practices to help you provide safe and legally compliant care.
2. FDA Compliance
Providers offering biologics must adhere to federal guidelines for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The FDA’s HCT/P regulation guidelines detail requirements for registration, labeling, and use of biologic products, along with manufacturing standards to ensure patient safety.
Refer to the FDA’s 21 CFR Part 1271 for detailed federal regulations regarding the handling and administration of biologics.
3. State Regulations
Georgia’s Department of Public Health governs the use of biologics, including stem cell therapy. Compliance with Georgia’s health regulations is essential for operating within state guidelines. Visit the Georgia Department of Public Health for state-specific compliance requirements. Understanding these guidelines is an accessible way to ensure your clinic’s procedures align with state laws.
4. Provider Qualifications
In Georgia, only licensed physicians(MD/DO) are authorized by the state can administer stem cell therapies. To verify credential requirements, refer to the Georgia Composite Medical Board. Meeting these licensing criteria is achievable, and interested providers should explore Georgia’s qualification guidelines to become compliant practitioners.
5. Patient Informed Consent
Informed consent is essential for all biologic treatments, including stem cell therapies. In Georgia, this includes:
- Providing a clear explanation of the therapy’s experimental nature and potential risks and benefits.
- Obtaining signed acknowledgment from patients confirming their understanding of the treatment, its risks, and any alternative therapies.
- Documenting the consent process as part of the patient’s medical records.
6. Pre-Treatment and Post-Treatment Protocols
Develop standardized protocols for pre-treatment and post-treatment care to ensure patient safety. This can include patient evaluations, follow-up visits, and detailed instructions for care before and after treatment to minimize risk and support compliance.
7. Standard Operating Procedures (SOPs)
Implement clear SOPs for biologic procedures, including handling, storage, and administration. Adherence to SOPs improves operational safety and compliance with both FDA and state regulations.
8. Medical Liability Insurance
Medical liability insurance is recommended for all providers of biologic therapies to mitigate potential risks. Consult with an insurance provider to obtain coverage specific to stem cell and regenerative medicine services.
9. Marketing Compliance
When marketing biologic treatments, including stem cell therapies, ensure all materials are compliant with both FDA and Georgia advertising regulations. Avoid claims that suggest guaranteed outcomes, and clearly disclose the experimental status of certain therapies. Review FDA guidance on marketing for biologic products here.
This guide is provided as an informational resource to help clinics and practitioners understand general compliance requirements for biologics in Georgia. 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.