On October 28, the FDA said licensed compounding pharmacies can prepare six peptides without facing FDA enforcement, as long as they certify the identity and purity of what they make. You probably have questions. Here's the plain version.
The announcement
The six peptides are BPC-157, TB-500, KPV, MOTS-c, Epitalon and Semax. The FDA said it won't take action against licensed compounding pharmacies that make them, provided each pharmacy certifies that the peptide is what it says it is and is free of impurities.
This isn't FDA approval, and none of the six is an FDA-approved drug. It's a policy, not a final rule, so it can change. And it applies to these six only. Blends and stacks are a separate matter.
Research on all six is still early. That's one more reason they should come through a provider who knows your history and a pharmacy you can verify.
| Peptide | Being studied for |
|---|---|
| BPC-157 | Tissue and gut health |
| TB-500 | Tissue repair and recovery |
| KPV | Inflammation, including in the gut and skin |
| Peptide | Being studied for |
|---|---|
| MOTS-c | Metabolic health |
| Epitalon | Healthy aging and sleep |
| Semax | Focus and memory |
Our approach
Our providers prescribe, and our peptides come from state-licensed 503A pharmacies.
A 503A pharmacy prepares each prescription for one patient and answers to its state pharmacy board.
Every lot we use comes with a certificate of analysis, the lab report that confirms identity and purity.
That is the same thing the FDA is now asking pharmacies to certify.
Talk to Our TeamProducts sold online as "research use only" can't answer yes to any of them.
Before you take any peptide
Was it made by a licensed compounding pharmacy, for you, with a prescription?
Can they show you a certificate of analysis for that lot?
Is a provider keeping an eye on how it's going?
What is a peptide?
A peptide is a short chain of amino acids, the same building blocks that make up proteins. Your body makes thousands of them and uses them as signals, telling cells when to repair, release a hormone or calm inflammation.
You already know some
Insulin is a peptide hormone, and your body uses many others as everyday signals. The six in the recent news are different: they're compounded medications a provider prescribes.
How they're given
Most are small injections under the skin, because digestion breaks many peptides down. Some come as nasal sprays, creams or capsules. Your provider decides the form, the amount and how long you take it, and many protocols run in cycles with breaks in between.
Why quality matters
Peptides are made in a lab, so the product is only as good as the process. An unverified product might not be the peptide on the label, might carry contaminants or might hold the wrong amount. That's why ours come from state-licensed 503A pharmacies, with a certificate of analysis for every lot.
Safety basics
Like any medication, peptides can have side effects. Tell your provider about anything unusual, store them the way the pharmacy label says, and never take more than prescribed.
Clinic locations in Tampa, Orlando, Melbourne, and Lake Mary.
No. It said it won't take action against licensed pharmacies that make them and certify their identity and purity. None of the six is FDA-approved.
The way you get care with us stays the same: a provider, a prescription and a licensed 503A pharmacy.
The announcement covers six individual peptides. Blends and stacks are a separate matter, and a provider can answer questions about anything you're taking.
Start with a free consult with our team.
Yes. It's a policy, and the FDA can revise it. We'll update this page if it does.
Prefer to talk? Call us. (813) 771-2517
Start with a free consult. We'll walk through the announcement and answer your questions.
Peptides are prescribed only after a provider evaluation. They are compounded medications and are not FDA-approved drugs. Individual results vary.
Some peptides are prescribed off-label, under physician supervision, after a review of the evidence, risks, benefits and alternatives with you.
