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TB-500 in Pennsylvania: 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 Pennsylvania, compounding is governed by the Pennsylvania State Board of Pharmacy (PSBP). Pennsylvania certified registered nurse practitioners (CRNPs) may prescribe compounded medications including peptides within a collaborative agreement. Physician assistants also require supervision agreements. Pennsylvania has moderately permissive telehealth rules, allowing prescribing after an appropriate telehealth evaluation. Pennsylvania prescribers must hold an active Pennsylvania license to prescribe to Pennsylvania residents.
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
Pennsylvania Pharmacy Board & Compounding Rules
Compounding Overview
Pennsylvania's State Board of Pharmacy regulates compounding pharmacies with detailed sterile and non-sterile compounding standards. Pennsylvania has historically been home to several large-scale compounding operations. The state enforces USP 797 standards for sterile products and requires annual inspections for high-risk compounding. Pennsylvania is part of the northeastern corridor with significant demand from New York, New Jersey, and Delaware markets.
Notable Rules
- Pennsylvania requires pharmacies engaged in sterile compounding to have a separate license category.
- Annual inspections are required for pharmacies performing high-risk sterile compounding.
- Pennsylvania shares regulatory burden with the FDA for pharmacies also registered as 503B outsourcing facilities.
- Non-resident pharmacies shipping compounds into Pennsylvania must be registered with the PSBP.
- Pennsylvania and New York maintain some reciprocal licensing arrangements for pharmacy professionals.
Prescribing Requirements in Pennsylvania
Pennsylvania certified registered nurse practitioners (CRNPs) may prescribe compounded medications including peptides within a collaborative agreement. Physician assistants also require supervision agreements. Pennsylvania has moderately permissive telehealth rules, allowing prescribing after an appropriate telehealth evaluation. Pennsylvania prescribers must hold an active Pennsylvania license to prescribe to Pennsylvania residents.
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 Pennsylvania
No providers currently listed in Pennsylvania 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: .