FDA Advisory Committee Recommends Six Peptides for 503A Compounding

For current status, see Can BPC-157 Be Compounded Yet? The Path to Legal Peptide Compounding.

FDA Pharmacy Compounding Advisory Committee, July 23–24, 2026

The 503A bulks list sets which bulk ingredients 503A pharmacies may use when compounding for individual patients. The advisory committee is an outside panel of experts. It gives FDA advice, but it doesn’t make decisions. This recommendation came from the committee, not from FDA, and FDA’s own reviewers had recommended against it. Before any compounder is legally cleared to make these products, FDA still has to complete its own decision process.

Why this matters

This is the furthest these peptides have moved on a lawful compounding path. If FDA adds them to the bulks list, they would fall under the same rules as other compounded drugs: ingredients from registered sources, licensed pharmacies, and state and federal oversight. Until then, product reaching patients comes from outside that framework, without those standards behind it.

The vote also stands out because FDA’s own scientific reviewers had recommended against all seven, citing limited data on characterization, human safety and effectiveness. The committee disagreed on six of them.

What this means for your practice

• These peptides still can’t be legally compounded. A committee recommendation isn’t a final decision, and the peptides aren’t on the 503A bulks list.
• FDA has to act next. It will weigh the committee’s advice against its own reviewers’ concerns. Adding a substance to the list permanently requires a proposed rule, public comment and a final rule.
• This applies only to 503A pharmacies. 503B outsourcing facilities have a separate list and a separate process, and this vote doesn’t change it.
• For now, nothing changes in what you can lawfully order. If a pharmacy offers you one of these peptides, ask which FDA document allows it. A committee recommendation isn’t one.

Steps to add a substance to the 503A bulks list permanently

Where McGuff fits

McGuff Outsourcing Solutions (MOS) is an FDA-registered 503B outsourcing facility, and we’re following this process closely. This vote applies only to 503A pharmacies, so it doesn’t change what MOS can make. For a 503B, FDA decides what can be compounded, based in part on whether there’s a clinical need for outsourcing facilities to make it. If a lawful 503B pathway opens for any of these peptides, we’ll evaluate it the same way we evaluate every product. Until then, we won’t treat a recommendation as permission to compound.

Why we’re covering this

We don’t make claims about how well these peptides work. That’s a clinical question, and it belongs to you as the treating clinician.

What we can speak to is how a drug is made. For a 503B, FDA decides what we can legally compound. You decide what’s right for your patient. Our job is everything in between: designing quality into the process from the start, sourcing raw materials from FDA-registered manufacturers, and testing every batch before it’s released, so the product is what the label says it is.

That way you don’t have to wonder whether the drug is what it says it is. With product from an unverified source, that question never fully goes away. With ours, your questions can stay where they belong: whether it’s the right drug for this patient, and how they respond to it.

Many practices are deciding whether to offer peptide therapy, and we want you to have a clear picture of where things stand when you do.

Where things stand today

This article covers the July vote. For the most current status of these peptides, for both 503A and 503B, see Can BPC-157 Be Compounded Yet? The Path to Legal Peptide Compounding. We update it as FDA acts.

Sources

McGuff Outsourcing Solutions is a DBA of McGuff Pharmaceuticals, Inc., an FDA-registered 503B outsourcing facility. Compounded drugs are not FDA approved and have not been evaluated by FDA for safety, effectiveness or quality. 503B outsourcing facilities are subject to CGMP requirements. This article is for educational purposes for healthcare professionals.