Why are peptides like BPC-157 and TB-500 harder to get?

Trying to keep up with the rules for peptides feels like trying to read a menu in a language you don't speak. Rules change, names move around on lists, and suddenly things that were easy to find are harder to get.

Let's break down what is actually happening in the world of peptide safety and regulation as of March 2026.

Why are some peptides harder to get?

You might have noticed the FDA (the food and drug people) flagging several peptides under something called Category 2. This is their way of saying a substance has significant safety risks or we just don't have enough data on it yet. When a peptide hits this list, it becomes ineligible for routine compounding (when a pharmacy makes a custom version of a drug).

Here is who is currently on that list as of September 2023:

• BPC-157: Listed due to immunogenicity concerns (the risk of your immune system overreacting) and a lack of safety data.
• TB-500: Flagged for immunogenicity risk and because there is no data on how it affects humans.
• CJC-1295: Removed from nomination in 2024 after the FDA cited safety issues like an increased heart rate.
• GHK-Cu: Listed because of immunogenicity risks; it is not an FDA-approved injectable drug.
• Ipamorelin, AOD-9604, and Selank: These all had their nominations withdrawn or were removed in September 2024.

What about the big names like Semaglutide?

While Semaglutide has finished huge trials showing it helps with weight loss (14.9% in the STEP 1 trial) and heart health (20% reduction in major heart events in the SELECT trial), the safety data is still rolling in.

Scientists use a system called FAERS (a database of safety reports) to track signals. Here is what they are seeing:

• Stomach stuff: Nausea and vomiting are very common and usually managed by slowly increasing the dose.
• Digestion speed: Scientists have found a strong signal for Delayed Gastric Emptying (slowing down how fast your stomach clears), which is now on the label because it can affect how you absorb other pills.
• Vision concerns: There is an emerging signal for NAION (a serious eye condition). As of January 2025, the EMA (the European version of the FDA) is officially reviewing this.
• Pre-surgery risks: A signal for pulmonary aspiration (getting food in your lungs during surgery) was added to the Ozempic label in 2025 because of that slower digestion.

Wait, I saw these were approved in other countries?

This is where it gets confusing. Some things are used elsewhere but not officially FDA-approved here. For example, Thymosin Alpha-1 is approved in over 35 countries as Zadaxin, but the FDA still labels it a substance of concern. Similarly, Selank and Semax are approved in Russia, but they remain in Category 2 in the United States.

What should you do with this info?

Scientists are still working on these—turns out the human body is complicated. Who knew? If you are looking at these options, it is important to check the current status, as things move from "being looked at" to "removed" quite often.

This is a great one to bring up with your doctor. You can find peptide-experienced physicians in our Find a Doctor directory.

This content is sourced exclusively from TruthTides clinical reference data and does not constitute medical advice.