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Biologics Compliance Guide for Clinics in New Hampshire

Learn the essential compliance steps to confidently offer biologics in New Hampshire. 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 is designed to help medical providers and practitioners in New Hampshire understand and meet compliance requirements for offering biologic therapies, such as stem cell treatments. With accessible guidelines on federal and state regulations, patient consent, and best practices, compliance can be achieved confidently and effectively.


2. FDA Compliance

Providers offering biologic therapies must comply with federal regulations set by the U.S. Food and Drug Administration (FDA). Most biologics fall under the guidelines for Human Cells, Tissues, and Cellular and Tissue-Based Products (FDA HCT/P). Clinics should verify that their therapies align with FDA regulations, which are primarily detailed under 21 CFR Part 1271. Familiarity with these requirements is crucial to ensuring lawful practices.


3. State Regulations

New Hampshire’s Department of Health and Human Services oversees health regulations, which include guidelines on advanced medical treatments. Though New Hampshire may not have specific stem cell regulations, providers should review applicable state healthcare laws and requirements. For additional information, consult the New Hampshire Department of Health and Human Services. This step is key to ensuring both federal and state compliance.


4. Provider Qualifications

In New Hampshire, only licensed healthcare professionals—such as physicians with an MD or DO are legally qualified to administer biologic therapies like stem cell injections. Credential requirements vary, and it is advisable to consult the New Hampshire Office of Professional Licensure and Certification for specific licensing requirements.


5. Patient Informed Consent

Ensuring patients are fully informed is vital to regulatory compliance. Consent forms should outline the benefits, risks, and potential outcomes of the therapy. It is also essential to include disclaimers regarding the experimental nature of many biologic treatments. The FDA's clinical trial guidelines provide insights into informed consent best practices for novel therapies.


6. Pre-Treatment and Post-Treatment Protocols
Comprehensive protocols for pre-treatment assessment and post-treatment follow-up help maintain clinical consistency and patient safety. Establishing and adhering to Standard Operating Procedures (SOPs) for these protocols can streamline processes and enhance regulatory adherence.


7. Medical Liability Insurance
It is essential for clinics to carry medical liability insurance tailored to biologic treatments. Providers should work with an insurance specialist to ensure coverage aligns with both federal and New Hampshire state requirements.


8. Marketing Compliance

Marketing materials must avoid overstatement of treatment efficacy and adhere to FDA and FTC guidelines. Ensure all claims are accurate and that any reference to biologics clearly states the experimental nature, if applicable. Refer to the FDA’s guidance on health fraud prevention for marketing integrity.

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