FDA has removed certain bulk drug substances that were placed on the category two list and has announced it will consult the Pharmacy Compounding Advisory Committee (PCAC) for potential future inclusion of some of these peptides.

The FDA stirred enormous controversy when, without much notice, they placed some of the most popular peptides on their category 2 list, which disallows the compounding with these bulk substances also known as (APIs) Active Pharmaceutical Ingredients.

Many of the peptides included in FDAs update to category 2 were extremely popular amongst patients and practitioners in the functional medicine, regenerative medicine and anti-aging space. Peptides like ibutamoren mesylate, BPC-157, Ipamorelin acetate, CJC1295, AOD-9604, Thymosin Alpha 1 and Thymosin Beta-4 (TB500) were added to category 2, just to name a few. This caused a public outcry as well as a lot of push back from the sterile compounding pharmacies (503A) and outsourcing facilities (503B) that were making them.

The FDA announced on September 27, 2024, that some of these bulk drug substances (peptides) would be removed from category 2. Some of these bulk substances have been removed due to the nomination for inclusion in category 1 was withdrawn or the nominator was going to nominate a different bulk drug substance. The FDA has decided to move forward to consult the Pharmacy Compounding Advisory Committee (PCAC) for potential future inclusion of some of these peptides. Ipamorelin acetate will be evaluated for inclusion on October 29, 2024 and CJC 1295, AOD-9604 and Thymosin Alpha 1 will be evaluated for inclusion on December 4, 2024.

While the outcome is unknown it is promising that the FDA is willing to have a dialogue with the stakeholders in this new and rising drug class, and are willing to look more closely as the safety and efficacy of many of these peptides. Many of these peptides at the very least have both anecdotal and empirical evidence from both patients and clinicians who’ve been using them to treat a multitude of conditions for years.

Let’s hope for a collaborative resolution between the FDA, the compounders and the patients who use these medications to arrive at a category 1 and a category two that properly serves the public by allowing access to peptides that are safe and effective and properly classifying those that are not.

Anderson Triggs

For more information please click the link below

https://www.fda.gov/media/94155/download