What Would a Category One Designation Mean for Peptides?

Nate Hill, Co-Founder & CEO of Strive Pharmacy, walks through what a shift of peptides into FDA Category one would mean and what remains unresolved in the process. He explains that when the Pharmacy Compounding Advisory Committee (PCAC) votes to recommend a product for Category one status, the FDA has historically tended to follow that recommendation, though not in every case. Hill describes the industry's cautious optimism about peptides eventually being approved for Category one, while acknowledging what he calls "weird shenanigans" in the process that keep the company from assuming approval is guaranteed.

Hill shares that he personally attended the PCAC hearing, where physicians testified that the real issue is not whether patients will use peptides, but how they will access them. According to doctors' testimony, patients will find a source one way or another, whether through a provider recommendation or through compounding pharmacies already willing to produce peptides despite the regulatory risk. Hill is explicit that Strive has chosen not to take that risk: the company will not produce peptides until they are formally moved to Category one, citing responsibility to its employees, its licenses, and its patient base as reasons it cannot afford noncompliance.

Hill points to Strive's own manufacturing history as an example of the standards that would carry over to peptide production, including testing for potency, sterility, and beyond-use dating. He argues this level of rigor gives physicians more confidence to incorporate peptides into a patient's personalized care plan, rather than leaving patients to fend for themselves. In his view, the unresolved piece is less about whether peptides have therapeutic value, as patients and providers already believe they do, and more about ensuring the supply chain delivering them meets a verifiable standard of safety and quality.