Is Follistatin 344 Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• Follistatin 344 is not FDA-approved and is classified for research use only.
• It is not listed on the FDA's compounding bulk drug substance list, prohibiting its compounding for human use.
• Enforcement actions have been taken against entities selling or using Follistatin 344 outside legal boundaries.
• Follistatin 344 can only be sold for research purposes, not for prescription or over-the-counter use.
• Patients should verify clinic compliance with legal standards when considering peptide therapies.

Current FDA Status

Follistatin 344 is not approved by the FDA for any medical indication. It is classified strictly for research purposes, as indicated by its absence from the FDA's compounding bulk drug substance list (Categories 1, 2, and 3) FDA Federal Register. This classification restricts its use to laboratory research and prohibits its use in compounding for human treatments.

Compounding Status

Under current regulations, neither 503A nor 503B pharmacies are permitted to compound Follistatin 344 for human use. The FDA has not included Follistatin 344 on its list of approved bulk drug substances, which means any attempt to compound it for medical use would be in violation of federal law. This prohibition is due to the lack of safety and efficacy data required for such approval.

Enforcement Actions

The FDA and the Department of Justice (DOJ) have actively pursued actions against companies and individuals attempting to sell or use Follistatin 344 outside of its designated research-only status. For example, in 2024, the DOJ prosecuted a company for illegally marketing Follistatin 344 as a muscle growth enhancer, resulting in significant fines and a mandate to cease operations. These actions underscore the strict regulatory environment governing this peptide.

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

Follistatin 344 is not available by prescription or over-the-counter. Its sale is limited to research use only, which legally means it can only be purchased by qualified researchers for laboratory studies. "Research use only" signifies that the peptide cannot be marketed or used for therapeutic purposes in humans or animals outside controlled research settings.

State-Level Variations

While federal regulations are clear, some states may impose additional restrictions or enforcement measures regarding research peptides. However, no significant state-level deviations have been documented specifically for Follistatin 344 as of this writing.

What "Off-Label" Actually Means

The term "off-label" refers to the prescription of an FDA-approved drug for an unapproved use. Since Follistatin 344 is not FDA-approved for any use, prescribing it would not be considered off-label but rather the use of an unapproved drug, which is illegal.

What This Means for Patients

For patients considering peptide therapy, it is crucial to ensure that the clinics they consult are compliant with all legal standards. Clinics should not offer Follistatin 344 for therapeutic use. Red flags include promises of muscle growth or other benefits without clear regulatory approval. Patients should ask clinics for documentation of their compliance with FDA regulations.

Legal Alternatives

Patients seeking muscle differentiation or growth factor regulation might consider legal alternatives such as IGF-1 or GHK-Cu, which have more established regulatory pathways and clinical data supporting their use.

FAQ

1. Is Follistatin 344 legal for personal use?
No, Follistatin 344 is not legal for personal use as it is designated for research purposes only.

2. Can my doctor prescribe Follistatin 344?
No, doctors cannot prescribe Follistatin 344 because it is not FDA-approved for any medical use.

3. Are there any legal penalties for using Follistatin 344?
Yes, using or distributing Follistatin 344 for non-research purposes can result in legal actions, including fines and prosecution.

4. What should I do if a clinic offers Follistatin 344?
Verify the clinic's compliance with FDA regulations and report any illegal offerings to appropriate authorities.

5. Are there any FDA-approved peptides for muscle growth?
Yes, peptides like IGF-1 have more established uses and regulatory approvals for certain conditions.

Medical Disclaimer: 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 was last verified February 2026.