FDA Disclaimer
Purpose:
Compounded medications are prescribed based on a provider’s medical judgement for a specific patient, and require PRIOR consult with a licensed healthcare provider. While Phoenix Vitality works hard to provide optimal care too all of our clients its important to note that use of compound GLPs are not FDA approved, only regualated. The active pharmaceutical ingredients in semaglutide and tirzepatide compounds are FDA approved, however the compounded components are only FDA regulated. All compounds come from a licensed 503A and 503B compound pharmacy. During a shortage compounding is allowed, but is not meant to be an identical aide.
Knowing the difference:
FDA approved-the U.S. Food and Drug Administration has determined the benefits of a product outweigh its known and potential risks for its intended use.
FDA regulated- The FDA only manufacturing. They have not officially tested the product and given seal of approval. The manufacturer is legally required to follow strict protocols such as clean, consistent, and safe environment. The manufacturer must also have a tracking or reporting systems with any side effects caused by their products.
Medical Advice disclaimer:
The information provided in this document, or on Phoenix Vitality’s website, is for general information purposes only. It is not meant to be a substitute for professional medical advice, diagnosis, or treatment. Please seek the counsel of a physician or other qualified healthcare provider with any questions you may have regarding a medical condition or plan.
No Endorsement or Affiliation:
Phoenix Vitality is an independent entity and is not affiliated with, sponsored by, or endorsed by the U.S. Food and Drug Administration (FDA) or any specific third-party compounding pharmacy. Therefore, any reference to FDA approved active pharmaceutical ingredients, should not be interpreted as official endorsement of final compounded preparations or the services provided by Phoenix Vitality. Futhermore, these licensed compounding pharmacies operate as independent providers and do not endorse, certify, or guarantee the marketing claims or administrative services of Phoenix Vitality.