Compounded Medication Disclosure

1. What “compounded” means

A compounded medication is a drug prepared by a state-licensed pharmacy that combines, mixes, or alters ingredients to create a medication tailored to a specific patient. Compounding is authorized by section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) when a licensed clinician writes a prescription for an identified individual patient and the pharmacy meets the conditions of 503A. Outsourcing facilities registered under section 503B may prepare batches in advance of receiving prescriptions, subject to FDA regulation.

2. Compounded medications are not FDA-approved

Compounded medications do not undergo FDA premarket review. They are not assigned an NDA, an ANDA, or a BLA. They do not have an FDA-approved label. They are not assigned an FDA “therapeutic equivalence” rating against any brand-name drug. The bulk drug substance used must appear on FDA's 503A bulks list or be a component of an FDA-approved drug or a USP/NF monograph.

3. Not generic, not interchangeable

Compounded semaglutide is nota generic of Ozempic® or Wegovy®. Compounded tirzepatide is nota generic of Mounjaro® or Zepbound®. None of these compounded products is “interchangeable” with the brand-name product in the legal or regulatory sense. Brand names belong to their respective owners; Livozo is not affiliated with, sponsored by, or endorsed by Novo Nordisk or Eli Lilly. We do not represent that a compounded medication has the same purity, potency, stability, or sterility profile as an FDA-approved medication.

4. 503A clinical-need requirement (post-shortage 2025-2026)

Following FDA's resolution of the semaglutide (Feb 21, 2025) and tirzepatide (Oct 2, 2024) shortages and the conclusion of the agency's enforcement-discretion periods in 2025, compounding pharmacies may only prepare a copy of a commercially available product when there is a documented clinical need for an individual patient that the commercially available product cannot meet. Examples recognized in FDA guidance and 503A:

• The patient has an allergy or sensitivity to an inactive ingredient in the FDA-approved product.
• The patient requires a dose or dosage form that is not commercially available (e.g., a custom titration schedule).
• The compounded product is a combination product that is meaningfully different from any commercially available product.

Our intake captures clinical-need documentation before a compounded product can be considered. If you do not have a documented clinical need, a Livozo clinician may not be able to prescribe a compounded version of an FDA-approved drug for you.

5. 503B outsourcing facilities

503B outsourcing facilities are FDA-registered and operate under current good manufacturing practice (cGMP). They may compound from substances on FDA's 503B bulks list. As of FDA's April 30, 2026 proposal, semaglutide, tirzepatide, and liraglutide are not expected to remain on the 503B bulks list. The comment window closes June 29, 2026. We track this regulatory development and will update this disclosure accordingly.

6. Current shortage status (2025-2026)

• Semaglutide: declared off shortage by FDA on February 21, 2025.
• Tirzepatide: declared off shortage by FDA on October 2, 2024.
• Liraglutide: at the time of this writing, liraglutide remains on the FDA Drug Shortage List in certain presentations. Status changes; consult FDA's Drug Shortage database for current information.

7. Known risks

• Common: nausea, vomiting, diarrhea, constipation, abdominal pain, fatigue, injection-site reaction.
• Serious: pancreatitis, gallbladder disease, kidney problems, hypoglycemia (especially when used with insulin or sulfonylureas), severe gastrointestinal disease.
• Boxed warning for branded GLP-1 receptor agonists (Wegovy, Ozempic, Mounjaro, Zepbound): risk of thyroid C-cell tumors observed in rodents; relevance to humans is unknown. These warnings inform the clinical assessment of compounded products as well.
• Compounded-specific risks: variation in concentration, sterility, stability, and impurities. Ask the dispensing pharmacy for a Certificate of Analysis for your lot.

8. Reporting adverse events

• Contact your Livozo clinician through the Platform.
• Report serious adverse events to FDA MedWatch: fda.gov/medwatch or 1-800-FDA-1088.