No FDA Approval

1. Plain statement

2. What “not FDA-approved” means

• FDA has not reviewed the compounded medication for safety.
• FDA has not reviewed the compounded medication for effectiveness.
• FDA has not reviewed the compounded medication for quality.
• FDA has not approved a label or package insert for the compounded medication.
• FDA has not assigned the compounded medication a “therapeutic equivalence” rating versus any FDA-approved product.
• The compounded medication does not have an NDA (New Drug Application), ANDA (Abbreviated New Drug Application), or BLA (Biologics License Application).

3. What it does NOT mean

• It does not mean compounding is illegal — it is authorized by sections 503A and 503B of the FDCA.
• It does not mean every pharmacy is unaccredited — many compounding pharmacies hold LegitScript and PCAB accreditation and follow USP standards.
• It does not mean the medication is the same as the FDA-approved product. It is not the same. It is a different product prepared in a different way under a different regulatory regime.

4. Trademark and affiliation disclaimer

Ozempic® and Wegovy® are registered trademarks of Novo Nordisk A/S. Mounjaro® and Zepbound® are registered trademarks of Eli Lilly and Company. Livozo is not affiliated with, sponsored by, endorsed by, or otherwise authorized by Novo Nordisk or Eli Lilly. Any use of these names on the Platform is for comparative reference only, and never to imply equivalence, interchangeability, or endorsement.

5. Where this disclosure appears

This disclosure is also referenced from:

• The product detail and pricing pages on the marketing site.
• The checkout flow before payment.
• The post-purchase confirmation email.
• Our Refund Policy.
• Our Terms of Service.
• Our Telehealth Informed Consent and the compounded-GLP-1 supplemental consent.
• The Compounded Medication Disclosure.