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TB-500 in Florida: 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 Florida, compounding is governed by the Florida Board of Pharmacy (FBP). In Florida, advanced practice registered nurses (APRNs) with prescriptive authority and physician assistants may prescribe compounded peptides within the scope of their collaborative agreement. Florida's telehealth laws permit prescribing without prior in-person visit in many contexts, which has made Florida a hub for telehealth peptide programs. Prescribers must hold a Florida license to prescribe to Florida patients.
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
Florida Pharmacy Board & Compounding Rules
Regulator
Compounding Overview
Florida has a large and active compounding pharmacy sector. The Florida Board of Pharmacy (Department of Health) regulates sterile and non-sterile compounding, requiring separate permits for each type. Florida pharmacies that compound sterile preparations must comply with USP 797 and undergo periodic inspections. Florida has specific rules for "office use" compounding — a provision that allows prescribers to order pre-mixed sterile compounds for use in their offices, which is relevant to many peptide clinics.
Notable Rules
- Florida requires separate permits for sterile and non-sterile compounding.
- Florida allows "office use" compounding with specific restrictions — relevant to many peptide clinical practices.
- USP 797 compliance is mandatory for all sterile compounding facilities.
- Florida telehealth laws are permissive by national standards, making the state a major market for telehealth peptide programs.
- Out-of-state pharmacies must be registered with the Florida Board of Pharmacy to ship into the state.
Prescribing Requirements in Florida
In Florida, advanced practice registered nurses (APRNs) with prescriptive authority and physician assistants may prescribe compounded peptides within the scope of their collaborative agreement. Florida's telehealth laws permit prescribing without prior in-person visit in many contexts, which has made Florida a hub for telehealth peptide programs. Prescribers must hold a Florida license to prescribe to Florida patients.
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 Florida
No providers currently listed in Florida 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: .