Is Follistatin 315 Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• Current FDA Status: Follistatin 315 is not FDA-approved and is classified for research purposes only.
• Compounding Legality: It cannot be compounded by 503A or 503B pharmacies due to its research-only designation.
• Prescription and Research Use: Available solely for research use; cannot be legally prescribed for therapeutic purposes.
• State-Level Variations: No significant state-level differences in regulation have been documented.
• Patient Implications: Patients should verify clinic legality and be wary of clinics offering unapproved therapies.

Current FDA Status

Follistatin 315 is not approved by the U.S. Food and Drug Administration (FDA) for any medical use. It is categorized as a research-only peptide, meaning it can be used for molecular and cellular research, but not for therapeutic applications in humans. This classification is based on the FDA's current listing of bulk drug substances not eligible for compounding under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) FDA.gov. As of the latest verification in February 2026, Follistatin 315 remains on the list of substances permitted solely for research purposes.

Compounding Status

Under current regulations, Follistatin 315 cannot be compounded by either 503A or 503B pharmacies. The FDA's prohibition is due to its classification as a research-only compound, which means it lacks the necessary safety and efficacy data to support its use in compounded medications. This aligns with the FDA's stance on substances without approved medical applications, as detailed in recent Federal Register notices.

Enforcement Actions

To date, there have been no specific Department of Justice (DOJ) prosecutions or FDA warning letters targeting Follistatin 315. However, the FDA has issued general warnings about the sale and use of research peptides for unapproved uses. Clinics or vendors offering Follistatin 315 for therapeutic purposes could face regulatory scrutiny and potential legal action.

Prescription vs. Over-the-Counter vs. Research Use

Follistatin 315 is legally available only for research use, which means it can be purchased by laboratories for scientific studies but cannot be prescribed by healthcare providers for patient treatment. The term "research use only" signifies that the peptide is intended for laboratory research and not for human or veterinary use in treating conditions. This distinction is critical for understanding the legal limitations surrounding its use.

State-Level Variations

Currently, there are no significant differences in the regulation of Follistatin 315 at the state level compared to federal guidelines. Most states defer to FDA regulations regarding the use of research-only substances, maintaining consistency across jurisdictions.

What "Off-Label" Actually Means

The concept of "off-label" prescribing applies exclusively to drugs that have received FDA approval for at least one indication. Since Follistatin 315 has never been approved by the FDA, any use outside of research settings is considered prescribing an unapproved drug, not off-label use.

What This Means for Patients

Patients interested in peptide therapies should exercise caution and ensure that any clinic they consider is compliant with FDA regulations. Clinics offering Follistatin 315 for therapeutic purposes are operating outside legal boundaries. Patients should verify the clinic's credentials and be alert to red flags, such as lack of transparency about the peptide's legal status.

Legal Alternatives

For patients seeking alternatives to Follistatin 315, legal options include FDA-approved peptides or those with established safety profiles for specific conditions. For muscle growth and related research, peptides like semaglutide may offer viable alternatives, pending their legal status and indications.

FAQ

Is Follistatin 315 FDA-approved?

No, Follistatin 315 is not FDA-approved and is designated for research use only.

Can Follistatin 315 be legally prescribed?

No, it cannot be legally prescribed as it is not approved for any therapeutic use.

Are there any legal consequences for using Follistatin 315 therapeutically?

Yes, using Follistatin 315 for therapeutic purposes can result in legal action against the provider or clinic.

Can I purchase Follistatin 315 for personal use?

Follistatin 315 can only be purchased for research purposes and not for personal therapeutic use.

What should I do if a clinic offers Follistatin 315 for treatment?

Verify the clinic's compliance with FDA regulations and consider reporting non-compliant practices to regulatory authorities.

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This content is for informational purposes only and does not constitute medical advice. Consult a licensed healthcare provider before starting any treatment. Legal status can change, and this information was last verified in February 2026.