Important: GLP-1 treatments offered through New Blue Health currently use compounded semaglutide and tirzepatide, prepared by U.S.-licensed compounding pharmacies. These compounded medications are not FDA-approved drugs, and their safety and effectiveness have not been reviewed by the FDA. Availability varies by patient and state, and they are only prescribed when a clinician determines they are clinically appropriate for you.
What Is Compounding?
Compounding is the practice of a licensed pharmacist preparing a customized medication for a specific patient based on a clinician's prescription. Compounded medications are produced by state-licensed 503A compounding pharmacies in response to individual patient needs. They are not mass-produced or commercially manufactured, and they are not subject to FDA pre-market approval requirements.
FDA Status
Compounded drugs are not FDA-approved. The FDA has not reviewed compounded medications for safety, efficacy, or potency. This is different from commercially manufactured drugs like Ozempic or Wegovy, which have undergone rigorous FDA review. Patients considering compounded therapies should discuss this distinction with their clinician before proceeding.
Quality Assurance & Testing
Our partner pharmacies maintain quality standards aligned with USP Chapter 797 (sterile preparations) guidelines, including sterility testing, potency verification, and endotoxin testing. However, because compounded medications are not subject to FDA oversight, quality standards may vary. We work exclusively with pharmacies that voluntarily maintain documented quality programs.
Therapeutic Substitutions
Due to ingredient supply variations, equivalent pharmaceutical substitutions (e.g., alternative salt forms or delivery vehicles) may be made with clinician approval. You will be notified of any material substitution that may affect your therapy.
Off-Label Prescribing
Licensed clinicians may prescribe medications for indications not explicitly listed in the FDA-approved label ("off-label"). Off-label prescribing is legal and common in clinical practice. Your clinician will discuss the available evidence, potential risks, and alternatives before prescribing any off-label therapy.
Your Decision
The decision to use compounded or off-label medications is yours to make in partnership with your clinician. You are encouraged to ask questions, review available evidence, and consider all available options before consenting to treatment. Contact us at admin@newbluehealth.com with any questions. See also: Telehealth Consent | Refund Policy