FDA Disclosure & Compounded Medication Consent

Compounded medications are not FDA-approved

Compounded drugs are prepared by a state-licensed 503A pharmacy or an FDA-registered 503B outsourcing facility to meet an individual patient need. Compounded preparations are not reviewed or approved by the FDA for safety, effectiveness, or manufacturing quality, and the FDA does not verify their labeling. They are legal to prescribe and dispense under section 503A/503B of the Federal Food, Drug, and Cosmetic Act.

Off-label prescribing

A licensed physician may prescribe an FDA-approved medication for a condition, dose, or population outside the approved label when it is clinically appropriate. Off-label prescribing is lawful and common, but the safety and effectiveness data for that specific use may be more limited.

Research peptides and investigational compounds

Certain peptides discussed on this site are the subject of ongoing research and are not FDA-approved for the indications described. They are dispensed only when a licensed physician determines the potential benefit outweighs the risk for you individually. Nothing on this site should be read as a claim that a product is FDA-approved for that use.

No claims of diagnosis, treatment, or cure

Statements on this website have not been evaluated by the Food and Drug Administration. Nuvara content is educational and is not intended to diagnose, treat, cure, or prevent any disease. It is not a substitute for the medical judgment of your treating clinician.

Risks you are accepting

• Potency, stability, and inactive ingredients of compounded products can vary between pharmacies.
• Long-term safety data for some compounded and peptide therapies is limited.
• Side effects, allergic reactions, and drug interactions are possible.
• Individual results vary; no specific outcome is promised or guaranteed.

Reporting adverse events

Report any adverse reaction to your care team at support@mynuvara.com immediately, and to the FDA MedWatch program at fda.gov/medwatch or 1-800-FDA-1088. Seek emergency care for severe reactions.

Your consent

By purchasing and using a compounded or off-label protocol through Nuvara, you confirm that you have read this disclosure, understand that the medication is not FDA-approved for the described use, have had the opportunity to discuss alternatives with a physician, and consent to treatment.