Is O-304 Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• O-304 is not FDA-approved and is available for research purposes only.
• It is not listed on the FDA's compounding bulk drug substance list, restricting its compounding.
• There have been no DOJ prosecutions or FDA warning letters specifically related to O-304.
• O-304 cannot be prescribed or sold over-the-counter; it is strictly for research use.
• Patients should verify clinic legality and be cautious of red flags when seeking peptide therapies.

Current FDA Status

As of February 2026, O-304 is classified as a research compound and is not FDA-approved for any medical indication. It primarily targets epigenetic regulation, extracellular matrix remodeling, and cellular longevity by influencing DNA damage response, SIRT1 signaling, and collagen synthesis. According to the FDA, O-304 is available strictly for research purposes and is not listed on the FDA's compounding bulk drug substance list, which includes Category 1, 2, or 3 designations (FDA.gov).

Compounding Status

O-304 cannot be compounded by either 503A or 503B pharmacies due to its absence from the FDA's approved compounding list. This restriction is primarily due to its classification as a research-only substance, which raises safety and efficacy concerns that the FDA has yet to address through clinical trials or regulatory review. The FDA's stance is consistent with the agency's approach to substances lacking sufficient safety data (Federal Register Notice).

Enforcement Actions

To date, there have been no specific enforcement actions, such as DOJ prosecutions or FDA warning letters, directly linked to O-304. However, this does not imply that the compound is without regulatory scrutiny. The FDA continues to monitor the use of research compounds to ensure compliance with federal regulations. Clinics or entities found distributing O-304 outside the scope of research could face potential legal consequences.

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

O-304 is not available by prescription or over-the-counter. It is strictly categorized for research use only, meaning it can be legally obtained and used solely within a research context. The term "research use only" legally indicates that the compound is not intended for human or veterinary use and should not be administered to patients outside of a controlled research environment (FDA.gov).

State-Level Variations

Currently, there are no state-level variations in the regulation of O-304 that deviate from federal guidelines. However, state health departments may impose additional restrictions or monitoring requirements on research compounds, so it is essential for researchers and clinics to stay informed about local regulations.

What "Off-Label" Actually Means

The concept of "off-label" use applies exclusively to FDA-approved drugs. Since O-304 has never received FDA approval, prescribing it does not constitute off-label use. Instead, it would be considered prescribing an unapproved drug, which is not permissible under current FDA regulations.

What This Means for Patients

For patients interested in peptide therapies, understanding the legal status of compounds like O-304 is crucial. Clinics offering O-304 for therapeutic use may be operating outside legal boundaries. Patients should verify a clinic's compliance with federal and state regulations and watch for red flags such as lack of transparency or claims of unproven benefits.

Legal Alternatives

Given that O-304 is prohibited for therapeutic use, patients seeking similar benefits might consider legal alternatives that address epigenetic regulation and cellular longevity. Options include peptides like BPC-157 or Thymosin Beta-4, which have clearer regulatory pathways and are available through licensed providers.

FAQ

Is O-304 FDA-approved?
No, O-304 is not FDA-approved and is available only for research purposes.

Can pharmacies compound O-304?
No, pharmacies cannot compound O-304 as it is not listed on the FDA's approved compounding list.

What does "research use only" mean?
"Research use only" means the compound is intended solely for research and not for human or veterinary use.

Are there legal alternatives to O-304?
Yes, legal alternatives include peptides like BPC-157 and Thymosin Beta-4, which are available through licensed providers.

Can O-304 be prescribed off-label?
No, O-304 cannot be prescribed off-label as it is not an FDA-approved drug.

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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.