FDA approval explained
A drug must have an FDA-approved application in effect before it can be legally introduced into interstate commerce, unless a specific exemption applies. Approval is granted to a specific product, indication, route, strength, and dosage form.
Not legal or medical advice.
This page is for informational purposes only. Always verify the current official source or consult a qualified professional before making compliance, prescribing, purchasing, or clinical decisions. Read full disclaimer.
Who this applies to
All drug products marketed in U.S. interstate commerce
Definitions
- NDA
- New Drug Application under section 505(b) of the FD&C Act.
- ANDA
- Abbreviated New Drug Application for generic copies of approved drugs.
- Active ingredient
- The molecule responsible for a drug's effect; not the same as an approved finished drug product.
Decision flow
- Is there an FDA-approved NDA/ANDA/BLA in effect for the exact product?
- If yes, what indication, route, and strengths are approved?
- If no, is there a lawful exemption (e.g., compounding, investigational, shortage)?
- Do not infer approval from an advisory committee vote, a docket, a nomination, or a shortage.
Examples
- • Tirzepatide is an active ingredient; Mounjaro and Zepbound are FDA-approved products containing it.
- • BPC-157 is not an approved drug even though it is sold online as a 'peptide' or dietary supplement.
Common mistakes / limitations
- ✗ This page does not cover devices, cosmetics, or foods.
- ✗ It does not provide legal advice for a specific product shipment or prescription.
What can change this answer
Rules can change through new legislation, FDA final guidance, declaratory orders, court decisions, or updated bulk-drug-substance lists. Check the latest controlling sources and the update feed for this rule.
Controlling law and sources
- Mounjaro (tirzepatide) Approval Letter
U.S. Food and Drug Administration · Approval letter · NDA 215866