Understanding FDA Approval, Compounded Medications, and Peptides
There has been a lot of discussion recently about compounded medications and peptides, especially on the news and social media. Unfortunately, many of the comments being made suggest that people do not fully understand what FDA approval actually means or how it applies to compounded medications and peptides. Because of that, I wanted to take a few minutes to explain the difference in a simple, straightforward way.
The first thing to understand is that there is an important difference between an FDA-approved brand-name medication and a compounded medication.
FDA-approved brand-name medications, such as Ozempic®, Wegovy®, Mounjaro®, and Zepbound®, have gone through years of research, extensive clinical trials, and a rigorous FDA review process that typically costs pharmaceutical companies hundreds of millions of dollars. When the FDA approves one of these medications, it is approving that specific product, manufactured by that specific company, at specific doses and for specific medical conditions.
Compounded medications are different. A licensed compounding pharmacy prepares a medication for an individual patient based on a physician’s prescription. Compounded medications themselves are not FDA-approved products, and that has been true for decades. In fact, I have been prescribing compounded medications in my practice for more than 12 years.
The same distinction applies to semaglutide and tirzepatide. The FDA-approved brand-name products are Ozempic® and Wegovy® (semaglutide) and Mounjaro® and Zepbound® (tirzepatide). Those specific products received FDA approval after extensive testing by their manufacturers. However, the compounded semaglutide and compounded tirzepatide that we, along with thousands of other medical practices across the country, prescribe are not FDA-approved products. They are compounded medications prepared by licensed compounding pharmacies pursuant to a physician’s prescription. Retatrutide is similar in that it is currently available as a compounded medication rather than an FDA-approved brand-name product.
Many people are surprised to learn that numerous treatments used every day in medical practices across the United States are compounded and are therefore not FDA-approved products. For example, the testosterone with anastrozole that I prescribe for many of my male patients is compounded and not FDA approved. I have also prescribed bioidentical hormone pellets for both men and women for more than 10 years. These pellets are used by tens of thousands of physicians across the country, yet they are not FDA-approved products.
The same is true for many peptides. Over the past several years, peptides have become extremely popular and are now used by thousands of clinics nationwide. Most peptides prescribed in medical practices today are compounded and are not FDA-approved products.
Another point that many people don’t realize is that many products they purchase every day are not individually FDA approved. Common examples include many vitamins, minerals, and dietary supplements such as vitamin C, vitamin D, zinc, magnesium, fish oil, probiotics, and many other over-the-counter supplements. While these products are widely used, they generally do not go through the same FDA approval process required for new brand-name prescription drugs.
I think the biggest misunderstanding is that many people believe “not FDA approved” automatically means something is illegal, unsafe, or experimental. That simply is not true. In many cases, it simply means that the medication has not gone through the very specific FDA approval process required for a pharmaceutical company to market it as a brand-name drug. Compounded medications have been an accepted part of medical practice for many decades and continue to play an important role in patient care.
As a physician, my responsibility is to be completely transparent with my patients. I have personally spoken with representatives of the Louisiana State Board of Medical Examiners on multiple occasions regarding compounded medications and peptides. I have been assured that physicians may prescribe these medications when medically appropriate, provided patients are fully informed about the treatment they are receiving. That has always been my approach. I believe patients deserve complete honesty so they can make informed decisions about their healthcare.
One of my greatest concerns today is that many people are purchasing peptides and other medications over the internet from unknown and untested sources without knowing where they were manufactured, whether they were tested for purity and quality, or whether they were produced under appropriate pharmacy standards. That creates unnecessary risk.
For that reason, we obtain our medications only from compounding pharmacies that are licensed by the Louisiana Board of Pharmacy and operate under all applicable state and federal pharmacy regulations. Knowing where a medication comes from and who prepared it is incredibly important, and we take that responsibility very seriously.
For more than 12 years, my goal has been to provide patients with safe, effective treatment while being completely honest and transparent about every medication we prescribe. If a medication is compounded, we tell our patients that. If it is an FDA-approved brand-name medication, we tell our patients that as well. I believe patients deserve accurate information so they can make informed decisions based on facts rather than misconceptions.
The purpose of this blog is not to persuade anyone to choose one treatment over another. It is simply to explain what FDA approval actually means and why there is so much confusion surrounding compounded medications and peptides. My philosophy has always been simple: educate patients honestly, be transparent about every treatment we offer, and allow each patient to make an informed decision that is right for them.
Written by Mace Scott, MD
Founder and Medical Director at Chronos Body Health & Wellness
Focus: medical weight loss, hormone optimization, wellness medicine, aesthetics
Updated: July 2026
