What Moments in FDA’s Review Process Should Patients and Providers be Watching Closely?

Nate Hill, Co-Founder & CEO of Strive Pharmacy, outlines the key milestones in the FDA's review process that both patients and providers should be tracking as peptides move toward potential Category one status. He identifies the Pharmacy Compounding Advisory Committee (PCAC) hearing as the pivotal early step, explaining that once a product reaches that hearing and receives a recommendation, it moves to the FDA for a final decision. History shows the FDA typically follows through on Category one recommendations once the PCAC votes in favor, which Hill says is part of why there has been notable excitement following the hearing.

He describes the next step as the FDA's formal announcement finalizing the move to Category one. According to Hill, publicly available information suggests this final decision can take anywhere from six to twelve months, though he has heard indications that the agency may move more quickly than that in this case. He mentions some anticipation that an announcement could come soon, while still cautioning that neither he nor anyone else has certainty about the exact timing.

Hill frames the process as essentially two sequential steps: the PCAC hearing and vote, which has already taken place, followed by the FDA's final approval and accompanying timeline for when compounding pharmacies would be permitted to begin producing peptides. He suggests that this FDA announcement is the moment patients, providers, and companies are all watching for since it would set the concrete start date for lawful, regulated peptide compounding.