A Step Forward for Peptide Medicine

At The Natural Path, we have had great results providing peptides to our patients that do not fall into category 2 and can be made by some compounding pharmacies. The list is limited, as many peptides are not allowed to be made by compounding pharmacies until they receive FDA approval. I would agree that there are still some big gaps with the science and more studies are needed.

Peptide therapy is an area our doctors have been studying intently for the past few years. We are hopeful that in time, we will be able to offer some of the peptides that were in review this week with the FDA. We hope to see peptide medicine evolving.

This week, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) completed its review of 7 peptides being considered for clearance for compounding pharmacies to produce. As part of this process, the committee evaluated the scientific evidence and medical need for each peptide before making recommendations to the FDA.

During the meeting, the committee voted to include BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax. While these recommendations are not final, they represent an important step in the FDA’s review process and provide insight into the scientific evaluation of these peptides. DSIP was rejected.

The committee advises the FDA on which ingredients can be appropriate for patient-specific compounding, also known as 503A. The vote does not say these peptides are safe, effective, and ready to be produced. The FDA still has to complete the regulatory process.

What This Means for You and Using Peptides

While the FDA has not issued final determinations regarding these specific peptides. This time provides an important opportunity to prepare for what (hopefully) is to come.

We believe that if the FDA clears these peptides, it is very important for providers to have practical education on peptides, including how they work, contraindications, dosing, formulations, and clinical relevance.

Preparing for the Future of Peptide Medicine

Behind the scenes, the high-end compounding pharmacies we work with have a product development team that will continue to prepare for this change in many ways. The pharmacies we work with have rigorous quality standards, including validated sourcing and comprehensive testing.

• Qualification of API suppliers from validated sources
• 3rd party purity testing
• Research of formulations
• Stability studies
• Proper labeling
• Planning for production
• Medical oversight

This is better than people going to the “gray market” to purchase potentially unknown ingredients. This is not something we feel is safe.

We will keep you updated as these peptides continue to be considered for testing, research, and hopefully production in the future. For now, we will continue to use peptides that are within our legal scope of practice.

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