FDA Approval
Official authorization from the U.S. Food and Drug Administration confirming that a drug or treatment has met rigorous standards for safety and effectiveness through clinical testing. An FDA-approved peptide has undergone extensive review, while many peptides used in wellness settings have not completed this process.
Related Terms
Compounding Pharmacy
A licensed pharmacy that custom-prepares medications tailored to individual patient needs, often in forms or dosages not commercially available. Compounding pharmacies are a common source of peptide preparations, though their products do not undergo the same FDA review process as mass-manufactured drugs.
Investigational New Drug
A designation granted by the FDA that allows a new treatment to be used in clinical trials on humans before it has been approved for general use. The IND application must include preclinical data, manufacturing details, and a proposed study plan to ensure participant safety.
Off-Label Use
The practice of prescribing an FDA-approved medication for a condition, age group, or dosage that was not part of its original approval. Off-label use is legal and common in medicine when a physician believes the evidence supports a benefit for the patient.