Compliance & Legal Reference
State Regulations & Federal Framework
State-by-state regulatory guidance for 361 HCT/P biologic therapy administration. This is a clinical reference tool — always verify with qualified legal counsel and your state medical board for current requirements.
Federal Framework
21 CFR Part 1271 — 361 HCT/P Classification
What is a 361 HCT/P?
A Human Cell, Tissue, and Cellular/Tissue-Based Product regulated solely under Section 361 of the Public Health Service Act requires NO premarket FDA approval if it meets all four criteria:
- Minimally manipulated — processing does not alter original relevant characteristics
- Homologous use — performs the same basic function in the recipient as in the donor
- Not combined with another article (except water, crystalloids, or storage agent)
- No systemic effect dependent on metabolic activity of living cells as primary function
What 361 HCT/Ps Still Require
Even without premarket approval, all 361 HCT/P manufacturers and providers must comply with:
- FDA establishment registration and product listing
- Donor eligibility determination (21 CFR Part 1271, Subpart C)
- Current Good Tissue Practices (cGTPs)
- Adverse event reporting and labeling requirements
- FDA inspection authority compliance
Important: Perinatal allograft products (Perinatal-Derived MSC Matrix, birth tissue ECM) regulated as 361 HCT/Ps do not require FDA approval but remain FDA-regulated. Exosome products (Chondrocyte-Derived Exosomes, Neural-Derived Exosomes, Specialized Exosome Complex) are in a separate regulatory category and may be subject to additional enforcement. Always consult your manufacturer's regulatory documentation and legal counsel.
50-State Reference
State-by-State Regulatory Status
Information reflects state medical board positions, specific legislation, and consent requirements as of 2024–2025. States with specific enabling legislation are noted. All states are subject to federal FDA requirements regardless of state law. Last updated: 2025. Verify independently before clinical use.
Enabling legislation enacted
Specific consent / disclosure required
Federal framework applies — no specific state law
Restrictive — board guidance or enforcement activity
| State | Status | Key Requirements & Notes |
|---|---|---|
| Alabama | Enabling Law | Permits investigational adult stem cell therapy for severe chronic or terminal disease with IRB oversight. Click for details → |
| Alaska | Federal Only | No specific stem cell or HCT/P state legislation. Federal framework governs entirely. Click for details → |
| Arizona | Federal Only | No specific enabling legislation. 361 HCT/Ps administered under federal framework. Click for details → |
| Arkansas | Federal Only | No specific stem cell legislation. Federal Part 1271 framework applies. Click for details → |
| California | Restrictive | Providers must disclose non-FDA-approved status before treatment AND in advertising. Click for details → |
| Colorado | Federal Only | No specific legislation. Federal framework applies. Click for details → |
| Connecticut | Federal Only | No specific HCT/P legislation. Standard informed consent applies. Click for details → |
| Delaware | Federal Only | No specific legislation. Federal Part 1271 framework applies. Click for details → |
| Florida | Enabling Law | Licensed MDs/DOs may administer perinatal/HCT/P products for ortho, pain, wound care. Click for details → |
| Georgia | Federal Only | No enacted legislation despite study committee proposals. Federal framework governs. Click for details → |
| Hawaii | Federal Only | No specific legislation. Federal standards apply. Click for details → |
| Idaho | Federal Only | No specific legislation. Standard off-label consent required. Click for details → |
| Illinois | Federal Only | No specific enabling legislation. Federal framework governs. Click for details → |
| Indiana | Federal Only | No specific legislation. Federal standards apply. Click for details → |
| Iowa | Federal Only | No specific legislation. Federal framework applies. Click for details → |
| Kansas | Federal Only | No specific legislation. Standard documentation and consent apply. Click for details → |
| Kentucky | Federal Only | No specific legislation. Federal Part 1271 framework applies. Click for details → |
| Louisiana | LA Board requires providers to demonstrate one of four justifications for off-label administration. Click for details → | |
| Maine | Federal Only | No specific legislation. Federal standards apply. Click for details → |
| Maryland | Federal Only | No specific legislation. Federal Part 1271 governs. Click for details → |
| Massachusetts | Federal Only | No specific legislation. Federal framework and standard consent apply. Click for details → |
| Michigan | Federal Only | No specific legislation. Standard informed consent and Part 1271 apply. Click for details → |
| Minnesota | Federal Only | No specific legislation. Federal framework applies. Click for details → |
| Mississippi | Enabling Law | Adult autologous MSCs added to Right-to-Try provisions for traumatic injury and terminal illness. Click for details → |
| Missouri | Federal Only | No specific legislation. Federal framework applies. Click for details → |
| Montana | Federal Only | No specific legislation. Federal standards apply. Click for details → |
| Nebraska | Federal Only | No specific legislation. Federal framework applies. Click for details → |
| Nevada | Federal Only | No specific legislation. Standard consent and federal framework apply. Click for details → |
| New Hampshire | Federal Only | No specific legislation. Federal Part 1271 applies. Click for details → |
| New Jersey | Federal Only | No specific legislation. Federal framework applies. Click for details → |
| New Mexico | Federal Only | No specific legislation. Federal standards apply. Click for details → |
| New York | Federal Only | No specific legislation. NY DOH maintains active oversight of biologics use. Click for details → |
| North Carolina | Enabling Law | Right-to-try expanded to include adult stem cell therapy with IRB oversight. Click for details → |
| North Dakota | Federal Only | No specific legislation. Federal framework applies. Click for details → |
| Ohio | Federal Only | No specific legislation. Federal Part 1271 applies. Click for details → |
| Oklahoma | Federal Only | No specific legislation. Standard consent and federal framework apply. Click for details → |
| Oregon | Federal Only | No specific legislation. Federal standards apply. Click for details → |
| Pennsylvania | Federal Only | No specific legislation. Federal Part 1271 governs. Click for details → |
| Rhode Island | Federal Only | No specific legislation. Federal framework applies. Click for details → |
| South Carolina | Federal Only | No specific legislation. Standard documentation and consent apply. Click for details → |
| South Dakota | Federal Only | No specific legislation. Federal framework applies. Click for details → |
| Tennessee | Federal Only | No specific legislation. Part 1271 standards apply. Click for details → |
| Texas | Enabling Law | Investigational adult stem cell therapy permitted with IRB. State registry established. Click for details → |
| Utah | Enabling Law | Permits non-FDA-approved perinatal therapy by broad range of licensed providers. Click for details → |
| Vermont | Providers must issue standardized notice and consent including in advertising. Click for details → | |
| Virginia | Providers must obtain consent with explicit non-FDA-approval disclosure. Click for details → | |
| Washington | Informed consent and standardized written notice required before treatment. Click for details → | |
| West Virginia | Federal Only | No specific legislation. Federal Part 1271 applies. Click for details → |
| Wisconsin | Federal Only | No specific legislation. Federal framework applies. Click for details → |
| Wyoming | Federal Only | No specific legislation. Standard consent and Part 1271 apply. Click for details → |
Universal Consent Standards
Minimum Informed Consent Elements
- Explicit statement that the therapy is not FDA-approved
- Product name, lot number, manufacturer
- Description of procedure and route of administration
- Known risks, side effects, and adverse event reporting
- Alternative treatment options available
- Right to withdraw consent at any time
- Patient signature and date
Required Documentation On File
- Signed informed consent (patient copy retained)
- Product lot numbers and expiration dates
- Manufacturer FDA registration number
- Clinical indication and treatment rationale
- Adverse event documentation if applicable
- Follow-up schedule and outcome tracking records