FDA to Review Potential Reclassification of Peptides for Compounding
The FDA will hold a meeting on July 23-24 to consider reclassifying certain peptides, which could allow pharmacies to compound them, prompting telehealth firms and compounding pharmacies to prepare for possible market changes.
The Food and Drug Administration is set to discuss whether to reclassify a group of peptides so that pharmacies can legally compound custom mixes during a meeting on July 23 and 24. The proposal would reverse a 2023 decision that barred the compounding of specific peptides.
Industry insiders say many companies are positioning themselves for a potential approval. Myra Ahmad, chief executive of telehealth platform Mochi Health, said the firm is preparing safety testing and pricing plans. Hims & Hers Health, which bought a peptide manufacturing facility in February, is developing clinical protocols and plans to testify at the hearing, according to its chief medical officer Anant Vinjamoori.
Compounding pharmacy Olympia Pharmaceuticals has invested in formula development in anticipation of regulatory changes, and its president Joshua Fritzler noted the industry’s expectation of a significant shift. Other firms, such as RxConnexion and Sapho Bio, are testing peptide formulations like BPC-157 and MOTS-c, with costs reaching six figures before products reach the market.
If the committee approves the reclassification, the FDA will still undergo a rulemaking process that includes a public comment period, a step described as lengthy by Gerard Olson, former director of research at LegitScript. Hims & Hers intends to monitor the outcome before moving forward, emphasizing a strategy of market readiness rather than being first to launch.
Some providers have already begun prescribing peptides on a limited basis. Ann Czarnik, founder of Amanecia Health, said her practice is offering compounds such as BPC-157 to a small group of patients, acknowledging the lack of FDA approval and extensive safety data. The Alliance for Pharmacy Compounding has cautioned pharmacies to adhere to existing regulations and avoid premature distribution.
Peptides currently discussed at the FDA meeting are also available from online sellers who label them as “research-grade only” and not for human consumption. Olympia Pharmaceuticals’ Fritzler emphasized that the company does not participate in that market. The proliferation of research-grade peptide producers has increased competition, according to Thomas Millman of OnTop Labs, which markets products like Melanotan II, a peptide slated for future FDA review.