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TB-500 in New York: Legal Status & Provider Guide (2026)
Quick Answer
TB-500 is a prescription substance in the United States. TB-500 / Thymosin Beta-4 is explicitly identified in FDA guidance as not suitable for 503A/503B compounding. Federal compliance risk for providers offering it is high. Patients should understand the legal status before use. In New York, compounding is governed by the New York State Board of Pharmacy (NYSBP). New York requires a collaborative practice agreement for nurse practitioners prescribing controlled substances, but NPs with full prescriptive authority may prescribe most compounded peptides independently. Physician assistants require physician supervision for prescribing. New York's telehealth prescribing rules require prescribers to hold a New York license; interstate telemedicine prescribing is tightly regulated.
Federal Legal Status
FDA Approval Status
TB-500 is a synthetic peptide derived from thymosin beta-4. It is not FDA-approved and not on the FDA bulk substances lists for compounding. FDA has explicitly listed thymosin beta-4 in guidance indicating it cannot be compounded by 503A/503B facilities.
Compounding Pharmacy Rules (Federal)
TB-500 (thymosin beta-4) is specifically mentioned in FDA guidance as a substance that does not meet the criteria for 503A bulk compounding. It cannot be lawfully compounded by facilities subject to FDA oversight. Some providers offer it under research or investigational frameworks, but this carries significant federal compliance risk.
Also Known As
Thymosin Beta-4 · Tβ4
Primary Research Areas
- Tissue repair
- Wound healing
- Inflammation reduction
- Angiogenesis
New York Pharmacy Board & Compounding Rules
Compounding Overview
New York has among the most stringent pharmacy and prescribing regulations in the country. The New York State Board of Pharmacy enforces USP 797 and 795 standards and requires all compounding pharmacies to meet detailed quality and documentation requirements. New York has been particularly active in enforcing against unapproved compounded medications. In-state telehealth peptide providers are subject to strict New York Medical Board oversight.
Notable Rules
- New York requires compounding pharmacies to register separately for sterile compounding.
- The New York Department of Health has enforcement authority over unlicensed pharmaceutical activity.
- New York has stricter-than-federal requirements for documentation of medical necessity for compounded preparations.
- Interstate prescribing into New York requires a New York state license.
- New York and Pennsylvania maintain reciprocal pharmacy licensure recognition for some categories.
Prescribing Requirements in New York
New York requires a collaborative practice agreement for nurse practitioners prescribing controlled substances, but NPs with full prescriptive authority may prescribe most compounded peptides independently. Physician assistants require physician supervision for prescribing. New York's telehealth prescribing rules require prescribers to hold a New York license; interstate telemedicine prescribing is tightly regulated.
About TB-500
TB-500 is the synthetic version of the naturally occurring thymosin beta-4, a protein ubiquitous in human and animal cells. Research has focused on its role in wound healing, angiogenesis, and tissue repair. Human clinical trial data is limited.
For more research information, mechanism of action, and provider availability, see the TB-500 research profile on PeptideBase.
Frequently Asked Questions
- Is TB-500 the same as thymosin beta-4?
- TB-500 is a synthetic peptide fragment derived from thymosin beta-4, specifically the actin-binding domain. The two are often used interchangeably in informal contexts, though they are not identical. FDA guidance on thymosin beta-4 applies to TB-500 in practice.
TB-500 Providers in New York
No providers currently listed in New York for TB-500. Browse the full directory to find providers offering TB-500.
Browse all TB-500 providers →TB-500 Legal Status in Other States
Pharmacy board rules and compounding regulations vary by state. Compare TB-500 legal status across other major markets:
Content review: This educational overview is prepared by the PeptideBase editorial team and reviewed for factual accuracy. Reviewer byline coming soon (gated on 4.4). Last updated: .